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1. Loperamide Galpharm 2 Mg Capsules Hard
2. Loperamide Galpharm 2 Mg Capsules Hard

1.3 PRODUCT INFORMATION.

1.3.1    SPC, LABELLING AND PACKAGE LEAFLET.

PACKAGE LEAFLET : INFORMATION FOR THE USER

Loperamide Galpharm 2mg Capsules

Loperamide Hydrochloride

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

This medicine is available without prescription. However, you still need to take Loperamide Galpharm 2mg Capsules carefully to get the best results from it.

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

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

•    You must contact a doctor if your symptoms worsen or do not improve within 48 hours.

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

IN THIS LEAFLET:

1.    What Loperamide Galpharm 2mg Capsules is and what it is used for

2.    Before you take Loperamide Galpharm 2mg Capsules

3.    How to take Loperamide Galpharm 2mg Capsules

4.    Possible side effects

5.    Storing Loperamide Galpharm 2mg Capsules

6.    Further information

1.    WHAT LOPERAMIDE GALPHARM 2MG CAPSULES IS AND WHAT IT IS USED FOR

This medicine contains Loperamide 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 in adults and children over 12 years of age. This medicine must not be used for more than 2 days without medical prescription and surveillance.

Please note that this medicine only relieves the symptoms of diarrhoea and it is important to drink sufficient fluid to replace the water lost in the loose stools.

2.    BEFORE YOU TAKE LOPERAMIDE GALPHARM 2MG CAPSULES Do not take this medicine if:

•    You are allergic (hypersensitive to loperamide or to any of the ingredients in this medicine (see section 6).

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

•    You have severe diarrhoea after taking antibiotics.

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

•    You are suffering from acute dysentery the symptoms of which may include blood in your stools and a high temperature.

If any of these apply to you, get advice from a doctor or pharmacist.

•    Take special care with Loperamide Galpharm 2mg Capsules. Check with your doctor before taking this medicine:If you have AIDS and your stomach becomes swollen. Stop taking the capsules immediately and contact your doctor.

•    If you suffer from liver problems.

•    If you have severe diarrhoea.

•    If your diarrhoea lasts for more than 48 hours stop taking the capsules and consult your doctor.

•    If you develop a bowel obstruction stop taking the capsules and consult your doctor.

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, particularly: o ritonavir (used to treat HIV).

o quinidine (used to treat abnormal heart rhythms or malaria). o oral desmopressin (used to treat excessive urination). o Itraconazole or ketoconazole (used to treat fungal infections). o gemfibrozil (used to treat high levels of lipids in the blood).

Consult a doctor before taking [product name] if you use any of the above mentioned medicines.

Taking Loperamide Galpharm 2mg Capsules with food and drink

You can take Loperamide Galpharm 2mg Capsules with food and drink.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant, think you are pregnant or planning to become pregnant. Do not take this medicine if you are breastfeeding as small amounts may get into your milk. Talk to your doctor about a suitable treatment.

Driving and using machines

This medicine may make you feel dizzy, tired or sleepy. You may also lose consciousness, feel faint or less alert. If affected do not drive or operate machinery.

Important information about some of the ingredients of this medicine:

[product name] 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.

3. HOW TO TAKE LOPERAMIDE GALPHARM 2MG CAPSULES

If you take more Loperamide Galpharm 2mg Capsules than you should, contact your doctor or nearest Accident and Emergency department (Casualty) taking this leaflet with you.

If you forget to take the medicine

You should only take this medicine as required following the dosage instructions carefully. If you forget to take a dose, take a dose after the next loose stool (bowel movement). Do not take a double dose.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Loperamide Galpharm 2mg Capsules can cause side effects, although not everybody gets them.

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

If you experience any of the following stop using the medicine and seek immediate medical help:

Rarely: (between 1 in 10,000 and 1 in 1000 people are effected)

•    Allergic reactions including unexplained wheezing, shortness of breath, swelling of the face and throat

•    Loss of consciousness or reduced level of consciousness (feeling faint or less alert)

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

If you experience any of the following stop taking the medicine and talk to your doctor:

Rarely: (between 1 in 10,000 and 1 in 1000 people are effected)

•    Itchiness or hives

•    Constriction of the pupil

•    Difficulty passing water (urine)

•    A swollen stomach, a burning sensation in the mouth, lips or tongue

•    Fatigue.

Uncommonly: (between 1 in 1000 and 1 in 100 people are effected)

•    Tiredness, drowsiness

•    Stomach pains, vomiting, indigestion and heartburn, dry mouth.

Commonly: (between 1 in 100 and 1 in 10 people are effected)

•    Headache, dizziness

•    Nausea (feeling sick), constipation, flatulence (wind).

5.    STORING LOPERAMIDE GALPHARM 2MG CAPSULES This product requires no special storage precautions.

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

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

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.

6.    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).

What this medicine looks like and contents of the pack

[Product name] are grey and blue hard gelatin capsules containing a white powder. The pack contains 6, 8, 10, 12 or 20 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

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

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

This leaflet was revised in April 2016.

Loperamide Hydrochloride 2mg Capsules / Module 1.3.1 (UK) / April 2016