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Asda Anti-Diarrhoea Capsules

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PATIENT INFORMATION LEAFLET


Dioraleze® 2mg Capsules

(loperamide hydrochloride)

Read this leaflet carefully because it contains important information for you.

•    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

n WHAT THIS MEDICINE IS FOR

Dioraleze 2mg Capsules are blue and grey in colour and contain Loperamide hydrochloride which is an anti-diarrhoeal medicine which helps to stop diarrhoea by making the stools more solid and less frequent.

This medicine is used for the treatment of sudden short-lived (acute) attacks of diarrhoea.

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


0 BEFORE YOU TAKE THE MEDICINE

Do not take this medicine if:

•    You suffer from colitis (inflammation of the colon) or any other inflammatory bowel disease.

•    You have a swollen stomach or tummy, and/or constipation.

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

•    You are pregnant or breastfeeding (unless instructed by your doctor).

•    You are suffering from dysentery with blood in your stools and a high temperature.

Check with your doctor before taking this medicine if:

•    You suffer from liver or kidney problems, including difficulty in urinating.

•    You have severe and persistent diarrhoea and vomiting.

If you have AIDS and your stomach becomes swollen, stop taking the capsules immediately and contact your doctor

Important information about some of the ingredients of this medicine:

•    The capsules contain lactose; 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 capsules should be swallowed whole with a drink of water.

Dose and how often to take:

After the first loose stool (bowel motion) take 2 capsules with water. After each further loose stool, take 1 capsule.


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•    Rehydration sachets are available separately.

•    Do not give to children under 12 years of age.

•    Do not take more than 6 capsules in any 24 hours.

•    Do not take the capsules for more than 24 hours unless advised by a doctor.

•    If symptoms persist for more than 24 hours consult your doctor.

•    DO NOT EXCEED THE STATED

DOSE._

IF YOU TAKE TOO MUCH: If you

take more capsules than you should, tell your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Most people take the capsules without any problems, but as with all medicines, side effects may occur occasionally.

Very rarely (affects less than 1 in

10.000    people)

Allergic reaction:

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

•    Skin rashes or other signs of allergic reaction such as itching, swelling of the lips, tongue or throat, or difficulty in breathing

•    Skin rashes which may be severe and include blistering or peeling skin.

Other side effects which may occur are:

Very rarely: (affects less than 1 in

10.000    people)

•    Stomach pains, a swollen stomach, nausea, vomiting, constipation, flatulence (wind), indigestion and heartburn

•    Tiredness and dizziness

•    Dry mouth

•    Difficulty urinating.


Reporting of side effects

If 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: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

H STORING THE MEDICINE

Do not store above 25°C. Store in the original packaging.

Do not use the capsules after the expiry date shown on the pack.

Keep out of the sight and reach of children.

H FURTHER INFORMATION

What is in this medicine:

The active ingredient in the capsules is: Loperamide Hydrochloride 2 mg.

The other ingredients in the capsules are: Lactose, Maize Starch, Talc, Magnesium Stearate, Gelatin, Quinoline Yellow (E104), Erythrosine (E127), Patent Blue (E131) and Titanium Dioxide (E171).

Contents of the pack:

The pack contains 6 capsules.

Marketing Authorisation Holder:

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

Distributed by: Sanofi, One Onslow Street, Guildford, Surrey GU1 4YS

Manufacturer: Galpharm International Ltd, Elmhirst Park, Middle Field Road, Barnsley, South Yorkshire, S75 4LS, United Kingdom.

Leaflet revised: 01/2015 MH/DRUGS/KD-49    4004953