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Galpharm Mild Diarrhoea Relief Tablets

Document: leaflet MAH BRAND_PL 16028-0008 change

ENTROCALM

(Kaolin and Calcium Carbonate)


PATIENT INFORMATION LEAFLET


Read this leaflet carefully because it

contains important information for you.

i» Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

*    You should contact a doctor if your symptoms worsen or do not improve within 24 hours.


IN THIS LEAFLET:


1.    What this medicine is for

2.    Before you take the medicine

3.    How to take the medicine

4.    Possible side effects

5.    Storing the medicine

6.    Further information

Cl WHAT THIS MEDICINE IS FOR

,Entrocalm are mottled pink/white in colour |and are flavoured with carminative oils which relieve flatulence and colic associated abdominal pain. The tablets contain light kaolin which is an absorbent to help remove toxins and bacteria from [the gut and calcium carbonate which is an antacid to calm the stomach.

[This medicine is used for the treatment of mild diarrhoea and holiday tummy.

Please note that these tablets relieve the symptoms of mild diarrhoea only and should not be used as a substitute for rehydration treatment.

Q BEFORE YOU TAKE THE MEDICINE

Do not take this medicine if:

• You are allergic to any of the ingredients listed in Section 6.

L _ _ _ _ _ _


Check with your doctor before taking this medicine if:

•    You are taking any other medicines, especially the following drugs: lincomycin, pivampicillin, tetracycline (to treat bacterial infections), digoxin (to treat heart conditions), cimetidine (to treat heartburn and peptic ulcers), chlorpromazine (to treat schizophrenia),| diflunisal (to treat pain and inflammation), or ketaconazole (to prevent or treat skini and fungal infections).

Important information about some of the ingredients of this medicine:

•    The tablets contain sucrose; if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

El HOW TO TAKE THE MEDICINE


Adults, the elderly and children over 12 years

How to take:

The tablets should be chewed before swallowing.

Dose and how often to take:

Take five tablets four times a day if necessary.

Children 6 to 12 years How to take:

The tablets should be chewed before swallowing.

Dose and how often to take:

Take two tablets four times a day if necessary.

•    Do not give to children under 6 years of age

•    If symptoms persist for more than 3 days consult your doctor.

•    DO NOT EXCEED THE STATED DOSE.

IF YOU TAKE TOO MUCH: If you take more tablets than you should, tell your doctor or pharmacist.

_ Further information overleaf.)


El POSSIBLE SIDE EFFECTS

(There are no known side effects with this medicine but as with all medicines, side jeffects may occur occasionally.

Allergic reaction:

Stop taking the medicine and contact your doctor immediately if you notice:

i» skin rashes or other signs of allergic reaction such as itching, swelling of the lips, tongue or throat, or difficulty in breathing.

Reporting of side effects

Ilf you get any side effects, talk to your doctor, pharmacist or nurse. This includes |any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: ywvw.mhra.gov.uk/yellowcard.

By reporting side effects you can help [provide more information on the safety of this medicine.


Contents of the pack:

The pack contains 24, 36, 48 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Galpharm Healthcare Ltd., Wrafton, Braunton, Devon, EX33 2DL,

United Kingdom.

Manufacturer:

Galpharm International Ltd.,

Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.

Text revised: September 2013.


STORING THE MEDICINE


Store below 25°C in a dry place.


Do not use the tablets after the expiry |date shown on the pack.

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


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Whi


FURTHER INFORMATION


l/hat is in this medicine:

The active ingredients in the tablets

lare: Light kaolin 400mg and calcium carbonate 75mg.

The other ingredients in the tablets are: Icing sugar, maize starch, talc, clove .oil, cinnamon oil, nutmeg oil, magnesium (stearate and erythrosine (E127).


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