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LOPERAMIDE GALPHARM 2 MG CAPSULES HARD

Active substance(s): LOPERAMIDE HYDROCHLORIDE

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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.
2.
3.
4.
5.
6.
1.

What Loperamide Galpharm 2mg Capsules is and what it is used for
Before you take Loperamide Galpharm 2mg Capsules
How to take Loperamide Galpharm 2mg Capsules
Possible side effects
Storing Loperamide Galpharm 2mg Capsules
Further information
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.

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

1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.






If
If
If
If

you suffer from liver problems.
you have severe diarrhoea.
your diarrhoea lasts for more than 48 hours stop taking the capsules and consult your doctor.
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

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.
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.
• If symptoms persist for more than 48 hours, stop taking the capsules and consult your doctor.
• DO NOT EXCEED THE STATED DOSE.
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

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

1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.

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.

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

1.3

PRODUCT INFORMATION.

1.3.1

SPC, LABELLING AND PACKAGE LEAFLET.

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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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