Ventolin Nebules 2.5mg, 5mg

VentolinNebules2.5 mg and 5 mg

salbutamol sulphate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.



• If you have any further questions, ask your doctor, nurse or pharmacist.



• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same
  as yours.



• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or
  pharmacist.

In this leaflet:

• 1 What Ventolin Nebules are and what they are used for



• 2 Before you use Ventolin Nebules



• 3 How to use Ventolin Nebules



• 4 Possible side effects



• 5 How to store Ventolin Nebules



• 6 Further information

What Ventolin Nebules are and what they are used for

Ventolin Nebules contain a medicine called salbutamol. This belongs to a group of medicines called bronchodilators.

• Bronchodilators help the airways in your lungs to stay open. This makes it easier for air to get in and out.



• They help to relieve chest tightness, wheezing and cough.

Ventolin Nebules are used to treat breathing problems in people with asthma and other chest illnesses. They are usually given to people who suffer quite badly from these conditions when other forms of treatment do not help enough. Ventolin Nebules are also given to treat severe attacks of asthma.

A Nebule is a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine makes a fine mist for you to breathe in through a face mask.

Before you use Ventolin Nebules

Do not use Ventolin Nebules if:

• you are allergic (hypersensitive) to salbutamol sulphate or any of the other ingredients of Ventolin Nebules (listed in Section 6).

Take special care with Ventolin Nebules

Check with your doctor, nurse or pharmacist before taking your medicine if:

• you have high blood pressure



• you are diabetic



• you have an overactive thyroid gland



• you have a history of heart problems such as an irregular or fast heartbeat or angina



• you use another nebuliser solution e.g. ipratropium bromide, make sure the mist does not get in your eyes. This can be prevented by using a mouthpiece instead of a face mask or goggles.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

Remember to take this medicine with you if you go to hospital.

In particular tell your doctor, nurse or pharmacist if you are taking:

• medicines for an irregular or fast heartbeat



• other medicines for your asthma.

Using Ventolin Nebules with food and drink

You can use Ventolin Nebules at any time of day, with or without food.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or are breast-feeding.

Driving and using machines

Ventolin Nebules are not likely to affect you being able to drive or use any tools or machines.

You should not drive or use machinery while using the nebuliser as this makes the mist for you to inhale.

How to use Ventolin Nebules

Always use Ventolin Nebules exactly as your doctor has told you.

You should check with your doctor, nurse or pharmacist if you are not sure.

Using this medicine

• do not inject or swallow the liquid. Ventolin Nebules should only be inhaled using your nebuliser



• do not let the liquid, or the mist produced by the nebuliser get into your eyes. You can wear glasses or goggles to protect them



• your doctor, nurse or pharmacist should show you how to use your medicine



• each small plastic container (Nebule) contains some liquid



• the liquid is put into a nebuliser. This makes a fine mist for you to breathe in through a face mask or mouthpiece



• use your nebuliser in a well ventilated room as some of the mist will be released into the air and may be breathed in by others.

Adults and children over 18 months

• The usual starting dose is 2.5 mg up to four times daily.



• This may be increased to 5 mg up to four times daily.



• The usual maximum dose is 5 mg four times daily.

Using your Nebules

• 1 your Nebules are in a foil tray. Do not open the foil tray until you need to use them
  
  



• 2 open the foil tray by lifting the foil lid at the red arrow and peeling it back
  
  



• 3 hold the strip of Nebules in one hand, with your other hand hold the last Nebule in the row
  
  



• 4 twist the Nebule downwards and away from you

• 5 return the remaining Nebules to the foil tray, cover the tray with the foil lid and place the tray back in the box
  
  



• 6 hold the top of the Nebule you have just removed. Twist the body to open it

• 7 put the open end of the Nebule into the nebuliser bowl and squeeze slowly. Make sure that all the contents are emptied into the nebuliser

• 8 assemble the nebuliser and use it as directed

Diluting your Nebules

• do not dilute the contents of a Nebule unless you are told to by your doctor



• if your doctor has told you to dilute the solution, empty the contents of the Nebule into the nebuliser bowl



• add the amount of sterile normal saline your doctor has told you to use



• put the top on the nebuliser bowl and shake gently to mix the contents.

If dilution is necessary then only sterile normal saline should be used.

After use

• use a fresh Nebule for each dose. Only open a new one when you are ready to use it. If there is any liquid left over, throw it away. Do not save it to use again



• throw away any solution remaining in the nebuliser bowl



• clean your nebuliser in the recommended way.

If you use more Ventolin Nebules than you should

If you use more than you should, talk to a doctor as soon as possible.

The following effects may happen:

• your heart beating faster than usual



• you feel shaky.

These effects usually wear off in a few hours.

If you forget to use Ventolin Nebules

• If you forget a dose, take it as soon as you remember it.



• However, if it is time for the next dose, skip the missed dose.



• Do not take a double dose to make up for a forgotten dose.

If you stop using Ventolin Nebules

Do not stop using Ventolin Nebules without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

Possible side effects

If your breathing or wheezing gets worse straight after taking this medicine, stop using it immediately, and tell your doctor as soon as possible.

Like all medicines, Ventolin Nebules can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Allergic Reactions (affects less than 1 in 10,000 people)

If you have an allergic reaction, stop taking Ventolin and see a doctor straight away. Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and collapse.

Talk to your doctor as soon as possible if:

• you feel your heart is beating faster or stronger than usual (palpitations). This is usually harmless, and usually stops after you have used the medicine for a while



• you may feel your heartbeat is uneven or it gives an extra beat



• these affect less than 1 in 10 people.

If any of these happen to you, talk to your doctor as soon as possible. Do not stop using this medicine unless told to do so.

Tell your doctor if you have any of the following side effects which may also happen with this medicine:

Common (affects less than 1 in 10 people)

• feeling shaky


• headache.

Uncommon (affects less than 1 in 100 people)

• mouth and throat irritation



• muscle cramps.

Rare (affects less than 1 in 1,000 people)

• a low level of potassium in your blood



• increased blood flow to your extremities (peripheral dilatation).

Very rare (affects less than 1 in 10,000 people)

• changes in sleep patterns and changes in behaviour, such as restlessness and excitability.

The following side effects can also happen but the frequency of these are not known:

• chest pain, due to heart problems such as angina. Tell your doctor, nurse or pharmacist if this occurs. Do not stop using this medicine unless told to do so



• a condition known as lactic acidosis which may cause stomach pain, hyperventilation, shortness of breath, cold feet and hands, irregular heartbeat or thirst.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

If you think this medicine is not working well enough for you

If your medicine does not seem to be working as well as usual, talk to your doctor as soon as possible. Your chest problem may be getting worse and you may need a different medicine. Do not take extra Ventolin unless your doctor tells you to.

How to store Ventolin Nebules

• Keep out of the reach and sight of children.



• Do not store above 30°C.



• Store the Nebules in the foil tray inside the carton to protect the Nebules from light.



• When you open a foil tray:
  
  
  • note the date of opening
  
  
  
  • add 3 months to this date. This will be the ‘discard after’ date
  
  
  
  • write the ‘discard after’ date in the space provided on the foil lid
  
  
  
  • do not use any unused Ventolin Nebules remaining from that foil tray after the ‘discard after’ date, return them to your pharmacist for destruction.
  
  



• If the foil tray has not been opened, do not use Ventolin Nebules after the expiry date, which is stated on the carton, labels and foil trays after ‘EXP’. The expiry date refers to the last day of that month.



• If you are told to stop taking this medicine return any unused Ventolin Nebules to your pharmacist to be destroyed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Ventolin Nebules contains

• The active substance is salbutamol sulphate.
  
  



• Ventolin Nebules 2.5 mg:
  each 2.5 ml Nebule contains 2.5 mg of salbutamol (as salbutamol sulphate).

• Ventolin Nebules 5 mg:
  each 2.5 ml Nebule contains 5 mg of salbutamol (as salbutamol sulphate).

• The other ingredients are salt (sodium chloride), sulphuric acid and water.

What Ventolin Nebules looks like and contents of the pack

Each foil tray contains 5 Ventolin Nebules.

Each carton contains 20 Ventolin Nebules.

Marketing Authorisation Holder

Glaxo Wellcome UK Limited trading as:

Allen & Hanburys

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Manufacturer

Glaxo Wellcome GmbH & Co.

Bad Oldesloe

Germany

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Ventolin Nebules 2.5 mg, Ventolin Nebules 5 mg Reference number: 10949/0086

This is a service provided by the Royal National Institute of Blind People.

Leaflet date: January 2008

Ventolin, Nebule and Nebules are trademarks of the GlaxoSmithKline group of companies

© 2008 GlaxoSmithKline group of companies

Co-dydramol Tablets 10 / 500mg Label-Leaflet

Due to technical difficulties in printing the label-leaflet format, please find the relevant text below. Text is representative of the leaflet portion of label leaflet spec no 50416573.

Co-dydramol tablets 10/500mg

(dihydrocodeine tablets and paracetamol)

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

1. What Co-dydramol tablets are and what they are used for

2. Before you take

3. How to take

4. Possible side effects

5. How to store

6. Further information

What Co-dydramol tablets are and what they are used for

Co-dydramol tablets belong to a group of medicines called analgesics and are used for the relief of mild to moderate pain.

Before you take

Do not take Co-dydramol tablets and tell your doctor if you:

• are allergic (hypersensitive) to paracetamol, dihydrocodeine or other opioids, or any of the ingredients in the tablet (see section 6)


• have diarrhoea caused by poisoning or severe bloody diarrhoea (pseudomembranous colitis)


• have difficulty breathing, or other chronic lung disease


• are having an asthma attack.

Check with your doctor or pharmacist before taking Co-dydramol tablets if you have:

• 
  liver or kidney problems


• diseased adrenal glands (Addison’s disease) or high blood pressure caused by a tumour near a kidney (phaeochromocytoma)


• 
  inflammatory bowel disease


• 
  gall bladder disease or gall stones


• recently had surgery on your gastro-intestinal tract or urinary system


• an enlarged prostate gland and have difficulty urinating and are male


• 
  epilepsy or suffered head injury or raised pressure in the skull (may cause painful eyes, changes in vision or headache behind the eyes)


• an underactive thyroid gland


• muscle weakness (myasthenia gravis)


• 
  low blood pressure or are in shock


• suffered from alcoholism, drug abuse or dependence or mental illness.

Other important warnings:

• 
  do not take for longer than directed by your prescriber
  


• 
  taking dihydrocodeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets
  


• 
  taking a painkiller for headaches too often or for too long can make them worse.
  

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

• ciprofloxacin (antibacterial medicine)


• Monoamine Oxidase Inhibitors (MAOIs, e.g. moclobemide), or have taken these within the last 2 weeks.


• oral contraceptives (the “pill”)


• medicines to prevent blood clotting such as warfarin


• cyclizine, metoclopramide or domperidone (to prevent sickness)


• guanethidine or diuretics (“water tablets”) e.g. spironolactone, furosemide (to treat high blood pressure)


• mexiletine (to treat irregular heartbeats)


• loperamide or kaolin (to treat diarrhoea)


• selegiline (for Parkinson’s disease)


• phenytoin (to treat epilepsy)


• cimetidine (to treat stomach ulcers)


• atropine or hyoscine (anticholinergic medicines)


• cisapride (to treat gastro-oesophageal reflux disease)


• ritonavir (antiviral medicine)


• medicines which affect the nervous system such as sleeping tablets, diazepam, hydroxyzine and medicines to treat mental illness


• medicines to treat depression (e.g. tranylcypromine, amitriptyline)


• medicines which affect the liver (e.g. primidone and rifampicin)


• colestyramine (to treat high cholesterol levels)


• muscle relaxants


• barbiturates (e.g. phenobarbital)


• anaesthetics


• opioid antagonists (buprenorphine, naltrexone, naloxone)

Diet

If your diet is poor or you have a low protein intake, you may be at a higher risk of serious paracetamol poisoning when taking Co-dydramol tablets.

Driving and using machines

Co-dydramol tablets may cause dizziness, blurred vision or the inability to think clearly. Make sure you are not affected before you drive or operate machinery.

Pregnancy and breast-feeding

Do not take Co-dydramol tablets during pregnancy or whilst breast-feeding, unless advised by your doctor. Regular use during pregnancy may cause withdrawal symptoms in the newborn.

How to take

Always take Co-dydramol tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Do not drink alcohol whilst taking Co-dydramol tablets.

Swallow the tablets with water, during or after meals.

Co-dydramol tablets are normally used only for short-term relief of symptoms, take this medicine for as long as your doctor tells you to, it may be dangerous to stop without their advice.

Doses:

• Adults and children over 12 years: 1-2 tablets every 4 hours up to a maximum of 8 tablets in a day


• Children under 12 years: Not recommended


• Elderly: Dosage is usually reduced in the elderly

If you take more than you should

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick, loss of appetite, stomach pain or liver damage, coma, clammy skin, fits, confusion, drowsiness, tiredness, low blood pressure, pinpoint pupils, slow heart beat or breathing rate.

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take it as soon as you remember and then take the next dose at least 4 hours later.

If you stop taking the tablets

If you stop taking the tablets you may develop the following withdrawal symptoms tremor, difficulty sleeping, feeling or being sick, sweating and increased heart rate, breathing or blood pressure.

Possible side effects

Like all medicines, Co-dydramol tablets can cause side effects, although not everybody gets them. Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.

Contact your doctor at once if the following side effects occur:

• 
  Allergic Reactions - skin rash or itchy skin, difficulty breathing, increased sweating, redness or flushed face, mucosal lesions (such as mouth ulcers), drug fever


• 
  Abdominal pain - may be caused by spasm of the bile ducts and inflammation of the liver or pancreas

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

• 
  Gastrointestinal system - stomach irritation (mild stomach pain, heartburn and feeling sick), constipation, feeling or being sick, loss of appetite, dry mouth, difficulty in the passage of food through guts


• 
  Heart - slow heart rate, palpitations, low blood pressure especially on standing, inflammation of the heart muscle


• 
  Blood - anaemia, changes in numbers and types of blood cells. If you have an increase in number of nose bleeds or notice that you bruise more easily or have more infections talk to your doctor


• 
  Urinary system - pain and difficulty in passing urine and a less frequent need to do so, kidney problems.


• 
  Nervous system - confusion, drowsiness, dizziness, ‘spinning’ sensation, mood changes, depression, hallucinations (seeing or hearing things that are not real), restlessness, excitation, fits, increased pressure in the skull (painful eyes, changes in vision or headache behind the eyes), headache, difficulty sleeping, nightmares, reduced alertness, tolerance (medicine has less effect) or dependence (suffer from withdrawal symptoms e.g. tremor, sweating, increased heart rate, increased breathing rate, raised blood pressure and feeling or being sick if the medicine is stopped too quickly)


• 
  Eyes - blurred or double vision, extremely small pupils


• 
  Others - trembling, unusual tiredness or weakness, malaise, low body temperature, breathing difficulties, muscle stiffness, changes in sex drive

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Store below 25°C in a dry place, protected from light

Do not use Co-dydramol tablets after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Co-dydramol tablets contain

• The active substances (the ingredients that makes the tablets work) are 10mg of dihydrocodeine tartrate and 500mg paracetamol.


• The other ingredients are pregelatinised maize starch, maize starch, colloidal silicon dioxide, stearic acid and water.

What Co-dydramol tablets look like and contents of the pack

Co-dydramol are white, uncoated tablets.

Pack sizes are 100.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

UK

This leaflet was last revised in June 2010

Pharmacyclics, Inc.

Address Pharmacyclics, Inc., 995 East Arques Avenue Sunnyvale, CA 94085 Contact Details Phone: (408) 774-0330 Website: http://www.pharmacyclics.com/ Careers: http://www.pharmacyclics.com/careers.html

Care Chlorhexidine Digluconate 0.2% w / v Antiseptic Mouthwash

1. Name Of The Medicinal Product

Care Chlorhexidine Digluconate 0.2% w/v Antiseptic Mouthwash

2. Qualitative And Quantitative Composition

Chlorhexidine Digluconate 0.2% w/v (equivalent to Chlorhexidine Gluconate Solution 1.0% v/v)

For excipients see 6.1

3. Pharmaceutical Form

Mouth wash.

A clear, colourless liquid with an odour of menthol and peppermint.

4. Clinical Particulars

4.1 Therapeutic Indications

Aids prevention of dental plaque formation. Aids the treatment and prevention of gingivitis. For the maintenance of oral hygiene. Promotes gingival healing following periodontal surgery. Management of recurrent oral ulceration. For the treatment of denture stomatitis and oral thrush.

4.2 Posology And Method Of Administration

For oromucosal use.

Adults, the elderly and children: To be used as required up to twice daily. Rinse the mouth thoroughly for about 1 minute with 10ml. The mouthwash should be expelled from the mouth after rinsing.

Prior to dental surgery: Rinse the mouth thoroughly with 10ml for 1 minute. The mouthwash should be expelled from the mouth after rinsing.

Treatment of gingivitis: A course of one month is recommended.

Treatment of denture stomatitis: Soak the denture(s) in solution for 15 minutes twice daily.

Treatment of oral ulceration and oral thrush: Treatment should be continued for 48 hours after clinical resolution.

4.3 Contraindications

Known hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

For oral use only. Keep away from the eyes and ears. If the solution comes into contact with the eyes, rinse well with water. Keep out of the reach and sight of children. Do not swallow. If symptoms persist, stop using and consult your doctor or dentist.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Chlorhexidine digluconate is incompatible with anionic agents which are usually present in conventional dentrifices. These should therefore be used before the mouthwash. Rinse the mouth thoroughly with water before using the mouthwash.

4.6 Pregnancy And Lactation

No harmful effects in human pregnancy or during lactation have been reported. Nevertheless like all medicines, care should be exercised and the mouthwash should only be used on the advice of a doctor or dentist.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

Skin irritation may occur occasionally. Rarely, generalised allergic reactions to chlorhexidine have been reported.

A superficial discolouration of the dorsum of the tongue may occur which disappears after discontinuation of treatment. Discolouration of the teeth and silicate or composite restorations may also occur. The discolouration is not permanent and may be prevented by brushing daily with a conventional toothpaste prior to using the mouthwash and avoiding tannin-containing food and drinks. In some cases a professional prophylaxis (scaling and polishing) may be necessary to completely remove the stain.

Transient disturbances of taste and a burning sensation of the tongue may occur on initial use of the mouthwash but usually diminishes with continued use.

In cases where oral desquamation occurs it may be necessary to discontinue treatment.

Very occasionally, swelling of the parotid glands during use has been reported. If this happens stop using the product and the effect should go away.

In all cases spontaneous resolution has occurred on discontinuation of treatment.

4.9 Overdose

Chlorhexidine is poorly absorbed by the oral route, therefore systemic effects are unlikely even if large volumes are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

A01A B03 – Stomatological preparations, antiinfectives for local oral treatment

Chlorhexidine digluconate is a bisbiguanide antiseptic and disinfectant, which is bactericidal or bacteriostatic against a wide range of gram negative and gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. The antimicrobial activity covers most of the important species occurring in the oral microflora.

5.2 Pharmacokinetic Properties

Due to its cationic nature, chlorhexidine digluconate binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.

5.3 Preclinical Safety Data

No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Hydrogenated Polyoxyl Castor Oil

Menthol

Peppermint Oil

Ethanol (96%)

Aspartame E951

Purified Water

6.2 Incompatibilities

Care Chlorhexidine Antiseptic Mouthwash is incompatible with anionic agents which are often present in toothpastes. Therefore these should be used before the mouthwash, rinsing the mouth between applications, or at a different time of day.

6.3 Shelf Life

Unopened: 2 years

In-use: 28 days

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

300ml amber PET bottle with HDPE/PP tamper evident child resistant closure with EPE Saranex liner.

30ml CE marked polypropylene dosing cup

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite

Huddersfield

West Yorkshire

HD7 5QH

United Kingdom

8. Marketing Authorisation Number(S)

PL 00240/0118

9. Date Of First Authorisation/Renewal Of The Authorisation

09.07.2009

10. Date Of Revision Of The Text

29.03.2010

Up and Up Childrens All Day Allergy Relief

Dosage Form: liquid
Target Corp. Children's All Day Allergy Relief Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Cetirizine HCl 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose


• sneezing


• itchy, watery eyes


• itching of the nose or throat

Warnings

Do not use

if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

Ask a doctor before use if you have

liver or kidney disease. Your doctor should determine if you need a different dose.

Ask a doctor or pharmacist before use if you are

taking tranquilizers or sedatives.

When using this product

• drowsiness may occur avoid alcoholic drinks


• alcohol, sedatives, and tranquilizers may increase drowsiness


• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding:

• if breast-feeding: not recommended


• if pregnant: ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• use only with enclosed dosing cup

adults and children 6 years and over	1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over	1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children 2 to under 6 years of age	1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other information

• do not use if carton is opened, or if printed neckband is broken or missing


• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

Questions or comments?

Call 1-800-910-6874

Principal Display Panel

Children's All Day Allergy Relief

Cetirizine Hydrochloride Oral Solution 1 mg/mL

Antihistamine

Compare to active ingredient in Children's Zyrtec®

Original Prescription Strength

Indoor and Outdoor Allergies

24 Hour Relief of:

Sneezing/Runny Nose/Itchy, Watery Eyes/Itchy Throat or Nose

Dosing Cup Included

24 Hour Relief

Grape Flavor

Age 2+ Years

Children's All Day Allergy Relief Carton

Up and Up Childrens All Day Allergy Relief  cetirizine hydrochloride  liquid

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11673-974 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 5 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color YELLOW (Pale Yellow) Score      Shape Size Flavor GRAPE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11673-974-26 1 BOTTLE In 1 CARTON contains a BOTTLE 1 118 mL In 1 BOTTLE This package is contained within the CARTON (11673-974-26)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA090254	06/12/2009

Labeler - Target Corporation (006961700)

Revised: 05/2009Target Corporation

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Licide Shampoo

Pronunciation: pye-REE-thrins/pye-PEER-i-nil
Generic Name: Pyrethrins/Piperonyl
Brand Name: Examples include Licide and Tisit

Licide Shampoo is used for:

Treating head, pubic (crab), or body lice.

Licide Shampoo is a pediculicide combination. It works by interfering with the nerves of the lice, which causes death of the lice.

Do NOT use Licide Shampoo if:

• you are allergic to any ingredient in Licide Shampoo

Contact your doctor or health care provider right away if any of these apply to you.

Before using Licide Shampoo:

Some medical conditions may interact with Licide Shampoo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances, including ragweed


• if you have skin irritation

Some MEDICINES MAY INTERACT with Licide Shampoo. Because little, if any, of Licide Shampoo is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Licide Shampoo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Licide Shampoo:

Use Licide Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Licide Shampoo is for external use only. Licide Shampoo is not to be used for lice in the eyebrows or eyelashes. Contact a doctor if lice are present in these areas.


• Shake well before use.


• Use Licide Shampoo on dry hair.


• Apply to the affected area until all hair is completely wet. Allow Licide Shampoo to remain on the affected area for no more than 10 minutes. Add sufficient warm water to form a lather and shampoo as usual. Rinse completely. Close eyes tightly and protect them with a washcloth or towel when rinsing Licide Shampoo out of the hair.


• Use a fine-toothed comb to remove dead lice or eggs (nits) from hair.


• Check daily for any lice or eggs that you missed.


• Repeat this treatment in 7 to 10 days to kill any newly hatched lice.


• If infestation continues, contact a doctor for other treatments.


• If you miss a dose of Licide Shampoo, use it as soon as you remember. Continue to use it as directed by your doctor.

Ask your health care provider any questions you may have about how to use Licide Shampoo.

Important safety information:

• Do not get Licide Shampoo in your eyes, vagina, nose, or mouth. If you get Licide Shampoo in your eyes, flush them with cool tap water.


• Do not inhale Licide Shampoo. Use Licide Shampoo in a well-ventilated area.


• All hats, scarves, coats, clothes, underwear, and bed linens should be dry cleaned or washed in hot water and dried on the hot cycle of the dryer for at least 20 minutes. Hair combs and brushes should also be cleaned in hot water.


• All members of the household should be examined for the presence of lice and treated if lice are found.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Licide Shampoo during pregnancy. It is unknown if Licide Shampoo is excreted in breast milk. If you are or will be breast-feeding while you are using Licide Shampoo, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Licide Shampoo:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with the proper use of Licide Shampoo. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye irritation; infection; persistent skin or scalp irritation; skin tenderness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Licide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coughing; diarrhea; difficulty breathing; headache; nausea; unusual dizziness or drowsiness; vomiting.

Proper storage of Licide Shampoo:

Store Licide Shampoo at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not store at temperatures above 110 degrees F (43 degrees C). Keep Licide Shampoo out of the reach of children and away from pets.

General information:

• If you have any questions about Licide Shampoo, please talk with your doctor, pharmacist, or other health care provider.


• Licide Shampoo is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Licide Shampoo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Licide resources

• Licide Side Effects (in more detail)
• Licide Use in Pregnancy & Breastfeeding
• Licide Support Group
• 0 Reviews for Licide - Add your own review/rating

Compare Licide with other medications

• Head Lice
• Lice

Cream of Magnesia BP (Boots Company plc)

1. Name Of The Medicinal Product

Cream of Magnesia BP

2. Qualitative And Quantitative Composition

Active ingredient	% w/v
Light magnesium oxide	5.98
Magnesium sulphate	0.075

3. Pharmaceutical Form

A white emulsion.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of indigestion and constipation.

4.2 Posology And Method Of Administration

As an antacid

Adults and children over 12 years: 5 to 10ml (1 to 2 teaspoonfuls)

Children 6 to 12 years: 2.5 to 5 ml (0.5 to 1 teaspoonful) according to age.

These doses should be taken in a little water after meals or when required.

Elderly: Dosage may need to be reduced.

As a laxative

Adults and children over 12 years: 25 to 50ml (5 to 10 teaspoonfuls).

Children 6 to 12 years: 5 to 15ml (1 to 3 teaspoonfuls) according to age.

These doses should be taken in a little warm water at bedtime.

Children up to 6 years: As recommended by the doctor.

Elderly: Dosage may need to be reduced.

For oral administration.

4.3 Contraindications

Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Caution should be exercised in the elderly and in patients with renal impairment.

Laxatives should not be taken where there is severe abdominal pain or used regularly for prolonged periods, except on medical advice.

If symptoms persist consult your doctor.

Keep all medicines out of the reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Cream of magnesia may interfere with the absorption of cimetidine, diflunisal, digoxin, indomethacin, iron salts and tetracyclines. Absorption of buffered or enteric coated aspirin is increased by simultaneous administration of antacids. Blood concentrations of salicylates will be reduced by antacid-induced changes in urinary pH, increasing urinary excretion.

4.6 Pregnancy And Lactation

There is no adequate human data from the use of magnesium oxide and magnesium sulphate in pregnant women.

Studies in animals have not been done.

Caution should therefore be exercised when taken by pregnant women.

Although some magnesium may be secreted in breast milk, the concentration is too small to be harmful.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

May cause diarrhoea. In patients with impaired renal function there may be sufficient accumulation of magnesium to produce toxic effects.

4.9 Overdose

Symptoms of overdosage include gastrointestinal irritation and watery diarrhoea. Severe poisoning may produce hypermagnesaemia, symptoms of which include nausea, vomiting, flushing, thirst hypotension, drowsiness, confusion, loss of tendon reflexes, muscle weakness, respiratory depression, cardiac arrhythmias, coma and cardiac arrest.

Treatment consists of intravenous administration of calcium gluconate injection 10% in a dose of 10-20ml to counteract respiratory depression or heart block if renal function is normal, adequate fluids should be given to assist removal of magnesium from the body. Dialysis may be necessary in patients with renal impairment or severe hypermagnesaemia.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Magnesium hydroxide has antacid and laxative properties.

Magnesium sulphate has saline laxative properties.

5.2 Pharmacokinetic Properties

Magnesium hydroxide reacts rapidly with gastric acid to form magnesium chloride. Approximately 15-30% of the magnesium chloride formed is absorbed from the small intestine and is rapidly excreted by the kidneys in patients with normal renal function. Approximately 15-30% of an orally administered dose of magnesium sulphate is absorbed from the small intestine.

5.3 Preclinical Safety Data

Not applicable.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chloroform

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Protect from freezing.

6.5 Nature And Contents Of Container

A white or amber glass bottle having an aluminium pilfer-proof cap with flowed-in PVC liner or an expanded polyethylene liner or with an unlined polypropylene cap.

Pack size: 200, 500ml

Amber glass winchester having a thermoset plastic cap with a steran faced pulpboard liner.

Pack size: 2000 ml

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 0014/5304R

9. Date Of First Authorisation/Renewal Of The Authorisation

22 August 1990

10. Date Of Revision Of The Text

September 2002

Boots Pain Relief Heat Spray

Boots Pain Relief heat spray

(Ethyl Nicotinate 1.1% w/w, Methyl Salicylate 1.25% w/w, Racemic Camphor 0.625% w/w)

Effective relief for muscular and rheumatic pain

125 ml e

Read this can for full instructions.

Uses

A warming pain relieving spray for the relief of muscular and rheumatic pain, lumbago, fibrositis, sciatica, sprains, strains and stiffness. No massage necessary.

Before you use this medicine

Do not use:

• If you are allergic to any of the ingredients


• If you are pregnant or breastfeeding, unless your doctor agrees


• On broken or damaged skin, or on open cuts


• On children under 5 years of age

How to use

Keep the spray away from the eyes, face, lining of mouth, throat and nose, and other sensitive areas of the body. Do not inhale the spray.

Apply to the skin only.

Hold the can 6 inches (15 cm) away from the skin.

Adults and children of 5 years and over:

Spray the painful area with 2 or 3 short bursts of spray.

Only use a small amount of spray because using too much can irritate the skin.

If the symptoms do not go away, talk to your doctor.

If you accidentally use too much spray it will not usually cause any problems.

Possible side effects

Most people will not have problems.

If you get any of these stop using the spray. If you notice any side effect not listed here, please tell your pharmacist or doctor.

• Skin irritation


• Allergic reaction (such as itching or redness of the skin)

Active ingredients

This topical spray contains Ethyl Nicotinate 1.1% w/w, Methyl Salicylate 1.25% w/w, Racemic Camphor 0.625% w/w.

Also contains: denatured ethanol, butane, isobutane, propane.

Keep all medicines out of the sight and reach of children.

Use by the date on base of the can.

PL 00014/0275

Text prepared 3/06

Manufactured for the Marketing Authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

by

ColepCCL UK Limited

Atkinsons Way

Foxhills Industrial Park

Scunthorpe

North Lincolnshire

DN15 8QJ

Caution: Pressurised container. Protect from sunlight.

Do not expose to temperatures above 50°C.

Do not pierce or burn even when empty.

Do not use near, or place on painted or polished surfaces.

EXTREMELY FLAMMABLE

125 ml

175

Э

Do not spray on a naked flame or on incandescent material. Keep away from sources of ignition. No smoking.

If you need more advice ask your pharmacist.

BTC19928 vA 24/07/07

Zostrix Neuropathy

Generic Name: capsaicin topical (kap SAY sin TOP i kal)

Brand Names: Axsain, Capsicum Oleoresin, Capsin, Capzasin Back and Body, Capzasin Quick Relief, Capzasin-HP, Capzasin-P, Castiva Warming, Dolorac, Icy Hot PM, Icy Hot with Capsaicin, Menthac Arthritis Cream with Capsaicin, Qutenza, Salonpas Gel-Patch, Salonpas Pain Patch with Capsaicin, Sloan's Liniment, Trixaicin, Trixaicin HP, Zostrix, Zostrix Diabetic Foot Pain, Zostrix Foot Pain, Zostrix Neuropathy, Zostrix Sports, Zostrix-HP

What is Zostrix Neuropathy (capsaicin topical)?

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Capsaicin used on the body causes a sensation of heat that activates certain nerve cells. With regular use of capsaicin, this heating effect reduces the amount of substance P, a chemical that acts as a pain messenger in the body.

Capsaicin topical is used for temporary relief of muscle or joint pain caused by strains, sprains, arthritis, bruising, or backaches. Capsaicin topical is also used to treat nerve pain (neuralgia) in people who have had herpes zoster, or "shingles."

Capsaicin topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Zostrix Neuropathy (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies or serious medical conditions. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

Capsaicin can cause a burning sensation, which is usually mild and should lessen over time with continued use. If the burning sensation causes significant discomfort, wash the treated skin area with soap and cool water. Stop using the medication and call your doctor if you have severe burning or redness where the medicine was applied.

Avoid getting capsaicin topical in your mouth or eyes or near your nose.

Do not apply to open wounds or irritated skin, and avoid getting the medicine on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. Accidental swallowing of capsaicin can cause problems with swallowing or breathing.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days.

What should I discuss with my healthcare provider before using Zostrix Neuropathy (capsaicin topical)?

Do not use this medication if you are allergic to chili peppers, or if you have ever had an allergic reaction to capsaicin topical.

Ask a doctor or pharmacist about using capsaicin topical if you have any allergies (especially to plants), or if you have a serious medical condition.

It is not known whether capsaicin topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether capsaicin topical passes into breast milk or if it could harm a nursing baby. Do not apply capsaicin topical to your breast area if you are breast-feeding a baby. Do not use this medication on anyone younger than 18 years old without the advice of a doctor.

How should I use Zostrix Neuropathy (capsaicin topical)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

Do not apply capsaicin topical to open wounds, or to skin that is sunburned, windburned, dry, chapped, or otherwise irritated. Do not get this medication in your mouth or eyes, or near your nose where you might inhale it. If it does get into any of these areas, rinse thoroughly with water.

Also avoid getting this medication on contact lenses, dentures, and other items that come into contact with sensitive areas of your body.

To keep the medication from getting on your fingers when you apply it, you may use a rubber glove, finger cot, cotton ball, or clean tissue to apply the medicine.

Make sure your skin is clean and dry before you apply capsaicin topical.

When using capsaicin topical cream or lotion, apply a thin layer to the affected area and rub in gently until completely absorbed.

To use capsaicin topical liquid or stick, uncap the applicator and press it firmly on your skin to apply the medication. Massage gently onto the affected are until completely absorbed.

Capsaicin topical may be used up to 4 times daily or as directed on the medicine label.

To apply a capsaicin topical patch, remove the liner and apply the patch to your skin over the area of pain. Press the edges firmly into place. Remove the patch and apply a new patch 1 or 2 times daily if needed.

Wash your hands with soap and water immediately after applying capsaicin topical or handling the topical patch. If you have applied the medicine to your hands or fingers to treat pain in those areas, wait at least 30 minutes before washing your hands. Do not cover treated skin with a bandage or heating pad, which can increase the burning sensation. You may cover the skin with clothing.

Avoid taking a bath or shower within 1 hour before or after you apply capsaicin topical to your skin. Also avoid swimming or vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

If the burning sensation caused by capsaicin is painful or causes significant discomfort, wash the treated skin area with soap and cool water.

It may take up to 2 weeks of using this medicine regularly before your symptoms improve. For best results, keep using the medication as directed. Pain relief should occur gradually as the substance P in your body is decreased in the nerve cells.

Call your doctor if your pain does not improve after using this medication for 7 days, or if your symptoms get worse or get better and then come back in a few days. Store capsaicin topical at room temperature away from moisture and heat, in a place where children and pets cannot get to it.

Capsaicin topical liquid is flammable. Do not use or store near fire or open flame.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not apply capsaicin more than 4 times in one day, or use extra medicine to make up a missed dose .

A missed dose of capsaicin topical will not cause harm but may make the medication less effective reducing substance P and relieving your pain.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed it.

Accidental swallowing of capsaicin can cause severe burning in or around the mouth, watery eyes, runny nose, and trouble swallowing or breathing.

Applying too much capsaicin topical to the skin can cause severe burning or redness.

What should I avoid while using Zostrix Neuropathy (capsaicin topical)?

Avoid inhaling the odor or dried residue of capsaicin topical. Inhaling capsaicin can cause coughing, sneezing, or watery eyes, and can irritate your throat or lungs.

Avoid touching your eyes, mouth, nose, genitals, or rectum until the medication has been washed off your hands. Also avoid handling food while the medication is still on your hands.

Avoid exposing treated skin to sunlight, sunlamps, tanning beds, or a hot tub. Capsaicin can cause a burning sensation that may be made worse by heat.

Do not use other medicated skin products, including muscle pain creams or lotions, on areas where you have applied capsaicin, unless your doctor has told you to.

Zostrix Neuropathy (capsaicin topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using capsaicin topical and call your doctor at once if you have a serious side effect such as:

• 
  

  severe burning or irritation where the medicine was applied;

  
  


• 
  

  skin redness where the medicine was applied; or

  
  


• 
  

  trouble breathing or swallowing (after accidental inhalation of capsaicin odor or dried residue).

  
  

Less serious side effects may include a mild burning sensation that can last for several hours or days, especially after your first use of capsaicin topical.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Zostrix Neuropathy (capsaicin topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied capsaicin. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Zostrix Neuropathy resources

• Zostrix Neuropathy Side Effects (in more detail)
• Zostrix Neuropathy Use in Pregnancy & Breastfeeding
• Zostrix Neuropathy Drug Interactions
• 0 Reviews for Zostrix Neuropathy - Add your own review/rating

• Axsain Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Axsain Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Capzasin-P Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Qutenza Prescribing Information (FDA)


• Qutenza Consumer Overview


• Qutenza Patch MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Zostrix Neuropathy with other medications

• Burning Mouth Syndrome
• Diabetic Nerve Damage
• Osteoarthritis
• Pain
• Persisting Pain, Shingles

Where can I get more information?

• Your pharmacist can provide more information about capsaicin topical.

See also: Zostrix Neuropathy side effects (in more detail)

Cacit Effervescent Tablets 500mg

1. Name Of The Medicinal Product

Cacit Effervescent Tablets 500mg

2. Qualitative And Quantitative Composition

Each tablet contains 1.25g Calcium Carbonate Ph Eur which when dissolved in water provides 500mg of calcium as calcium citrate.

3. Pharmaceutical Form

Effervescent tablet

4. Clinical Particulars

4.1 Therapeutic Indications

1. Treatment of calcium deficiency states including osteomalacia, rickets and malabsorption syndromes affecting the upper gastrointestinal tract.

2. An adjunct to conventional therapy in the arrest or slowing down of bone demineralisation in osteoporosis.

3. In the arrest or slowing down of bone demineralisation in osteoporosis, where other effective treatment is contra-indicated.

4. As a therapeutic supplement during times when intake may be inadequate, particularly those associated with the increased demand of childhood, old age, pregnancy and lactation.

4.2 Posology And Method Of Administration

The tablets must be dissolved in a glass of water and the solution should then be drunk immediately after complete dissolution of the tablets.

Adults and the Elderly

For calcium deficiency states including malabsorption, the dosage should be tailored to the individual patient's needs. A dose of 1.0 g to 2.5g per day is recommended.

For the treatment of osteoporosis a dose of up to 1.5g per day is normally required. In patients with adequate dietary calcium intake, 500mg daily may be sufficient.

Up to 1.5g of calcium per day is the recommended dosage for therapeutic supplementation.

Children

For calcium deficiency states including malabsorption and rickets, the dosage recommendation under adult dosage should be followed.

For therapeutic supplementation, a dose of up to 1.0g per day is recommended.

4.3 Contraindications

Hypercalcaemia (eg. due to hyperparathyroidism, hypervitaminosis D, decalcifying tumours, severe renal failure, bone metastases), severe hypercalciuria, calci-lithiasis and renal calculi. Long term immobilisation accompanied by hypercalciuria and/or hypercalcaemia. Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

In mild hypercalciuria (exceeding 7.5 mmol/24 hours in adults or 0.12-0.15 mmol/kg/24 hours in children) or renal failure, or where there is evidence of stone formation in the urinary tract; adequate checks must be kept on urinary calcium excretion. If necessary the dosage should be reduced or calcium therapy discontinued. The product should be administered with caution in patients with sarcoidosis because of possible increased metabolism of vitamin D to its active form. These patients should be monitored for serum and urinary calcium.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant administration with vitamin D causes an increase in calcium absorption and plasma levels may continue to rise after stopping vitamin D therapy.

The effects of digoxin and other cardiac glycosides may be accentuated by calcium and toxicity may be produced, especially in combination with vitamin D.

Calcium salts reduce the absorption of some drugs, in particular tetracyclines. It is therefore recommended that administration of Cacit tablets be separated from these products by at least 3 hours.

Thiazide diuretics increase renal absorption of calcium, so the risk of hypercalcaemia should be considered.

Bisphosphonate, sodium fluoride: it is advisable to allow a two hour minimum period before taking Cacit (risk of reduction of the gastrointestinal absorption of bisphosphonate and sodium fluoride).

4.6 Pregnancy And Lactation

Calcium supplements have been in wide use for many years without apparent ill consequence.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Mild gastrointestinal disturbances have occurred rarely (eg. nausea, abdominal pain, diarrhoea, constipation, flatulence and eructation). Hypercalciuria and, in rare cases, hypercalcaemia in cases of long-term treatment with high doses.

Skin reactions, such as pruritis, rash, and urticaria (especially urticaria in patients with a past history of allergy) have been reported. The colouring agent E110 can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin

4.9 Overdose

The amount of calcium absorbed will depend on the individuals calcium status. Deliberate overdosage is unlikely with effervescent preparations and acute overdosage has not been reported. It might cause gastrointestinal disturbance but would not be expected to cause hypercalcaemia, except in patients treated with excessive doses of vitamin D. Symptoms of overdose may include nausea, vomiting, polydipsia, polyuria and constipation. Treatment should be aimed at lowering serum calcium levels, eg. administration of oral phosphates and rehydration.

Chronic overdoses can lead to vascular and organ calcifications as a result of hypercalcaemia.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Calcium is an essential element of tissues and plasma.

5.2 Pharmacokinetic Properties

When the tablets are added to water, insoluble calcium carbonate is converted into absorbable calcium citrate.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric acid,

Sodium saccharin

Sodium cyclamate

Sunset Yellow FCF (E110) and flavour

Cacit tablets contain no sugar and have a low sodium content.

6.2 Incompatibilities

None

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Store in a dry place.

6.5 Nature And Contents Of Container

Supplied in boxes of 76 tablets (4 polypropylene tubes with polyethylene stoppers each containing 19 tablets).

6.6 Special Precautions For Disposal And Other Handling

To be dissolved in water before administration as described in Section 4.2

Administrative Data

7. Marketing Authorisation Holder

Warner Chilcott UK Limited

Old Belfast Road,

Millbrook,

Larne,

County Antrim,

BT40 2SH

8. Marketing Authorisation Number(S)

PL 10947/0016

9. Date Of First Authorisation/Renewal Of The Authorisation

28/10/2005

10. Date Of Revision Of The Text

01/05/2010

Compound W

1. Name Of The Medicinal Product

Compound W.

2. Qualitative And Quantitative Composition

Salicylic acid Ph Eur 17.0% w/w.

3. Pharmaceutical Form

Viscous, faintly yellow liquid for topical administration.

4. Clinical Particulars

4.1 Therapeutic Indications

For the treatment of common warts and verrucae.

4.2 Posology And Method Of Administration

Adults, the elderly and children over 6 years: Gently rub the hard skin from the surface of the wart with a pumice stone or emery board. Apply to wart one drop at a time with dropper-rod until wart is covered. Allow to dry completely. Avoid surrounding skin. Repeat application daily, with regular washing, for up to twelve weeks.

4.3 Contraindications

Do not use Compound W on moles, birth marks, hairy, genital or facial warts.

4.4 Special Warnings And Precautions For Use

Do not apply to healthy skin or skin which is inflamed or broken. If the wart does not dissolve or gets worse, consult a doctor. If in doubt or have diabetes, ask a doctor.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None stated.

4.6 Pregnancy And Lactation

No contraindications known.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

None probable.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Salicylic acid facilitates desquamation by solubilising the intercellular cement that binds scales in the stratum corneum thereby loosening the keratin.

5.2 Pharmacokinetic Properties

Salicylic acid can be absorbed through the skin. It is excreted unchanged in the urine.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Acetone BP; Industrial Methylated Spirits 99% BP; Pyroxyline (Nitrocellulose DHM 10/25) BP; Castor Oil Ph Eur.

6.2 Incompatibilities

None known.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

No special precautions required.

6.5 Nature And Contents Of Container

Glass bottle with screw threaded plastic cap and plastic rod wad. Pack size: 6.5ml.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

SSL International PLC. Venus, 1 Old Park Lane, Trafford Park, Manchester, M41 7HA.

8. Marketing Authorisation Number(S)

PL 17905/0075

9. Date Of First Authorisation/Renewal Of The Authorisation

15/08/2006

10. Date Of Revision Of The Text

15/08/2006

Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection

1. Name Of The Medicinal Product

Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection

2. Qualitative And Quantitative Composition

Colistimethate Sodium 1 Million I.U. (International Units)

3. Pharmaceutical Form

Powder for Solution for Injection

White lyophilised powder in a glass vial.

4. Clinical Particulars

4.1 Therapeutic Indications

Colistimethate Sodium is indicated in the treatment of the following infections where sensitivity testing suggests that they are caused by susceptible bacteria:

• Intravenous administration for the treatment of some serious infections caused by Gram-negative bacteria, including those of the lower respiratory tract and urinary tract, when more commonly used systemic antibacterial agents may be contra-indicated or may be ineffective because of bacterial resistance.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration

Posology

The dosage is determined by the severity and type of infection, the sensitivity of the causative bacteria and the age, weight and renal function of the patient. General guidance is given below.

Should clinical or bacteriological response be slow, the dose may be increased as indicated by the patient's condition. Anomalous distribution in CF patients may require higher doses in order to maintain therapeutic serum levels.

Estimation of serum levels is particularly recommended for patients with renal impairment, neonates and patients with cystic fibrosis. Serum levels of 10 - 15 mg/l (approximately 125-200 units/ml) should be adequate for most infections.

A minimum of 5 days treatment is generally recommended.

Children and adults (including the elderly):

Over 60kg: 1-2 million units three times a day. The maximum dose is 6 million units in 24 hours.

Up to 60kg: 50,000 units/kg/day, to a maximum of 75,000 units/kg/day. The total daily dose should be divided into three doses given at approximately 8-hour intervals.

Renal Impairment: In moderate or severe renal impairment, excretion of Colistimethate is delayed. Therefore, the dose and the dose interval should be adjusted in order to prevent accumulation. The table below is a guide to dose regimen modifications in patients of 60kg bodyweight or greater. It is stressed that adjustments may still have to be made on evaluation of the individual patient based on blood levels and evidence of toxicity.

Suggested Dose Adjustment in Renal Impairment

Grade	Creatinine clearance (ml/min)	Over 60kg bodyweight
Mild	20-50	1-2 million units every 8hr
Moderate	10-20	1 million units every 12-18 hr
Severe	<10	1 million units every 18-24 hr

Method of Administration

Colistimethate Sodium can be given as a 50ml intravenous infusion over a period of 30 minutes. Patients with a totally implantable venous access device (TIVAD) in place may tolerate a bolus injection of up to 2 million units in 10ml given over a minimum of 5 minutes

For instructions on dilution of the product before administration, see section 6.6.

4.3 Contraindications

Hypersensitivity to Colistimethate sodium (also known as colistin) or to polymyxin B.

Myasthenia gravis.

4.4 Special Warnings And Precautions For Use

Use with extreme caution in patients with porphyria.

Nephrotoxicity or neurotoxicity may occur if the recommended parenteral dose is exceeded.

Use with caution in renal impairment (see Section 4.2 - Posology and method of administration). It is advisable to assess baseline renal function and to monitor during treatment. Serum colistimethate concentrations should be monitored.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Neuromuscular blocking drugs and ether should be used with extreme caution in patients receiving colistimethate sodium.

Concomitant use of colistimethate sodium with other medicinal products of neurotoxic and/or nephrotoxic potential should be avoided. These include the aminoglycoside antibiotics such as gentamicin, amikacin, netilmicin and tobramycin. There may be an increased risk of nephrotoxicity if given concomitantly with cephalosporin antibiotics.

4.6 Pregnancy And Lactation

There are no adequate data from the use of Colistimethate sodium in pregnant women. Animal studies in rats and mice do not indicate teratogenic properties. However, single dose studies in human pregnancy show that Colistimethate crosses the placental barrier and there may be a risk of foetal toxicity if repeated doses are given to pregnant patients.

Colistimethate should be used in pregnancy only if the benefit to the mother outweighs the potential risk to the foetus.

Colistimethate is secreted in breast milk, and should be administered to breastfeeding women only when clearly needed.

4.7 Effects On Ability To Drive And Use Machines

During parenteral treatment with Colistimethate sodium neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance. Patients should be warned not to drive or operate machinery if these effects occur.

4.8 Undesirable Effects

The likelihood of adverse events may be related to the age, renal function and condition of the patient.

In cystic fibrosis patients neurological events have been reported in up to 27% of patients. These are generally mild and resolve during or shortly after treatment.

Adverse effects on renal function have been reported, usually following use of higher than recommended doses in patients with normal renal function, or failure to reduce the dose in patients with renal impairment or during concomitant use of other nephrotoxic antibiotics. The effects are usually reversible on discontinuation of therapy.

In cystic fibrosis patients treated within the recommended dosage limits, nephrotoxicity appears to be rare (less than 1%). In seriously ill hospitalised non-CF patients, signs of nephrotoxicity have been reported in approximately 20% of patients.

Neurotoxicity has been reported often in association with overdose, failure to reduce dose in patients with renal insufficiency and concomitant use of either neuromuscular blocking drugs or other drugs with similar neurological effects. Reducing the dose may alleviate symptoms. Effects may include apnoea, transient sensory disturbances (such as facial paraesthesia and vertigo) and, rarely, vasomotor instability, slurred speech, visual disturbances, confusion or psychosis.

Hypersensitivity reactions including skin rash have been reported. If these occur treatment should be withdrawn.

Local irritation at the site of injection may occur.

4.9 Overdose

Overdose can result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest. Overdose can also cause acute renal failure characterised by decreased urine output and increased serum concentrations of BUN and creatinine.

There is no specific antidote. Manage by supportive treatment and measures to increase the rate of elimination of colistimethate e.g. mannitol diuresis, prolonged haemodialysis or peritoneal dialysis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antibacterials for systemic use.

ATC Code: J01X B01.

Mode of Action

Colistimethate (also known as colistin) is a cyclic polypeptide antibiotic derived from Bacillus polymyxa var. colistinus and belongs to the polymyxin group. The polymyxin antibiotics are cationic agents that work by damaging the cell membrane. The resulting physiological affects are lethal to the bacterium. Polymyxins are selective for Gram negative bacteria that have a hydrophobic outer membrane.

Resistance

Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharides due to substitution with ethanolamine or aminoarabinose. Naturally resistant Gram-negative bacteria, such as Proteus rnirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.

Cross-resistance between Colistimethate and polymyxin B would be expected. Since the mechanism of action of the polymyxins is different from that of other antibiotics, resistance to colistimethate and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes.

Breakpoints

The BSAC-recommended general MIC breakpoint to identify bacteria susceptible to Colistimethate is < 4 mg/l.

Bacteria for which the MIC of Colistimethate is > 8 mg/I should be considered resistant.

Susceptibility

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.

As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Commonly susceptible species

Acinetobacter species*

Citrobacter species

Escherichia coli

Haemophilus influenzae

Pseudomonas aeruginosa

Species for which acquired resistance may be a problem

Enterobacter species

Klebsiella species

Inherently resistant organisms

Brucella species

Burkholderia cepacia and related species.

Neisseria species

Proteus species

Providencia species

Serratia species

Anaerobes

All Gram positive organisms

*Note that the in-vitro demonstration of susceptibility may not reliably predict clinical efficacy for Acinetobacter species.

5.2 Pharmacokinetic Properties

Absorption

Absorption from the gastrointestinal tract does not occur to any appreciable extent in the normal individual.

Distribution

After administration to cystic fibrosis (CF) patients of 7.5 mg/kg/day in divided doses given as 30 minute intravenous infusions to steady state the Cmax was determined to be 23 (+6) mg/l and Cmin at 8 hr was 4.5 (+4) mg/l. In another study in CF patients given 2 million units every 8 hours for 12 days the Cmax was 12.9 mg/l (5.7 – 29.6 mg/l) and the Cmin was 2.76 mg/l (1.0 – 6.2 mg/l). In healthy volunteers given a bolus injection of 150 mg (approximately 2 million units) peak serum levels of 18mg/l were observed 10 minutes after injection.

Protein binding is low. Polymyxins persist in the liver, kidney, brain, heart and muscle. One study in CF patients estimated the steady-state volume of distribution as 0.09 l/Kg.

Biotransformation

Colistimethate sodium is converted to the base in-vivo. As 80% of the dose can be recovered unchanged in the urine, and there is no biliary excretion, it can be assumed that the remaining drug is inactivated in the tissues. The mechanism is unknown.

Elimination

The main route of elimination after parenteral administration is by renal excretion with 40% of a parenteral dose recovered in the urine within 8 hours and around 80% in 24 hours. Because Colistimethate is largely excreted in the urine, dosage reduction is required in renal impairment to prevent accumulation. Refer to the table in Section 4.2.

After intravenous administration to healthy adults the elimination half-life is around 1.5 hrs. In a study in CF patients given a single intravenous infusion over 30 minutes the elimination half-life was 3.4 + 1.4 hrs.

Colistimethate pharmacokinetics appear to be similar in children and adults, including the elderly, provided renal function is normal. Limited data are available on use in neonates that suggest that pharmacokinetics are similar to children and adults but the possibility of higher peak serum levels and prolonged half-life in these patients should be considered and serum levels monitored.

5.3 Preclinical Safety Data

Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking. Colistimethate sodium has been shown to induce chromosomal aberrations in human lymphocytes in vitro. This effect may be related to a reduction in mitotic index, which was also observed.

Reproductive toxicity studies in rats and mice do not indicate teratogenic properties. However, colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6 and 2.9% of foetuses respectively. These doses are 0.5 and 1.2 times the maximum daily human dose. In addition, increased reabsorption occurred at 9.3mg/kg.

There are no other preclinical safety data of relevance to the prescriber that are additional to safety data derived from patient exposure and already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None

6.2 Incompatibilities

In the absence of compatibility studies, reconstituted Colistimethate sodium must not be mixed with other medicinal products.

6.3 Shelf Life

2 years

From a microbiological point of view, the reconstituted product should be used immediately. If not used immediately, in-house storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours in the refrigerator (2 to 8°C) or 8 hours when stored at temperatures not exceeding 25°C.

6.4 Special Precautions For Storage

Do not store above 25°C. Store the vial in the outer carton in order to protect from light

Do not freeze. Reconstituted Colistimethate sodium solution may be kept for up to 8 hours when not stored above 25°C or for up to 24 hours stored in a refrigerator.

6.5 Nature And Contents Of Container

10 ml Type III glass vial with a rubber stopper and an aluminium cap. Each carton contains 1 or 10 vials.

6.6 Special Precautions For Disposal And Other Handling

For dilution use 0.9% sodium chloride intravenous infusion or water for injections.

The reconstituted Colistimethate sodium is a clear solution.

The outer surface of the primary container is non-sterile. For single use only. Any unused solution should be disposed of in accordance with local requirements.

Does not contain preservatives.

7. Marketing Authorisation Holder

Beacon Pharmaceuticals Ltd.

Tunbridge Wells

Kent TN1 1YG

8. Marketing Authorisation Number(S)

PL 18157/0009

9. Date Of First Authorisation/Renewal Of The Authorisation

28/09/2009

10. Date Of Revision Of The Text

22/03/2011

Beacon Pharmaceuticals Ltd.