GALPHARM DIARRHOEA RELIEF INSTANTS 2 MG ORODISPERSIBLE TABLETS, BOOTS DIARRHOEA RELIEF INSTANT-MELTS 2 MG ORODISPERSIBLE TABLETS, SUPERDRUG DIARRHOEA RELIEF INSTANT-MELTS 2 MG ORODISPERSIBLE TABLETS, SAINSBURYS HEALTHCARE ANTI-DIARRHOEA INSTANTS 2 MG - patient leaflet, side effects, dosage

3. How to take the medicine

4. Possible side effects

• 5. Storing the medicine

• 6. Further information

Q WHAT THIS MEDICINE IS FOR

Superdrug Diarrhoea Relief Instant-Melts 2mg Orodispersible Tablets 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 in adults and children of 12 years and over. It can also be used by adults of 18 years and over who have irritable bowel syndrome (IBS), which has been previously diagnosed by a doctor, to relieve short term diarrhoea associated with it.

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

BE BEFORE YOU TAKE THE MEDICINE

Do not take this medicine if:

• you are allergic to loperamide or any other ingredient in this medicine,
• you are a child under 12 years of age (or under 18 for an IBS patient),
• you have severe diarrhoea after taking antibiotics,
• you are having a flare up of an inflammatory bowel condition, such as ulcerative colitis,
• you are constipated, or your stomach appears swollen (especially in children with severe dehydration),
• you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature,
• you are pregnant or breast-feeding, unless instructed by your doctor.

Check with your doctor before taking this medicine:

• If you have AIDS and your stomach becomes swollen. Stop taking the tablets immediately and talk to your doctor.
• If you have liver problems.
• If you have diarrhoea that lasts for more than 48 hours.
• If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal.
• If you develop a bowel obstruction stop taking the tablets and consult your doctor.
• If you have IBS but have not had this condition previously diagnosed by a doctor.
• If you have IBS, which has previously been diagnosed by a doctor, but you notice any of the following new symptoms:

o you are 40 years or over and it is some time since your last IBS attack, or if the symptoms are different this time

o you have recently passed blood in the bowel

o you have severe constipation o you are feeling sick or being sick o you have lost your appetite or lost weight o you have difficulty or pain passing urine o you have a fever

o you have recently travelled abroad.

Warnings and precautions

Do not take this product for anything other than its intended use (see section 1) and never take more than the recommended amount (see section 3). Serious heart problems (symptoms of which include fast or irregular heartbeat) have been reported in patients who have taken too much loperamide, the active ingredient in this medicine.

If you take other medicines:

Talk to your pharmacist before taking this medicine if you are taking any other medicines, particularly the following:

• ritonavir (used to treat HIV),
• quinidine (used to treat abnormal heart rhythms or malaria),
• oral desmopressin (used to treat excessive urination),
• itraconazole or ketoconazole (used to treat fungal infections),
• gemfibrozil (used to treat high cholesterol).

If you are unsure about any of the medicines you are taking, talk to your pharmacist.

Further information overleaf w

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HOW TO TAKE THE MEDICINE

Rehydration sachets are available separately.

If you take more medicine than you should

If you have taken too much of this medicine, immediately contact a doctor or hospital for advice. Symptoms may include: increased heart rate, irregular heartbeat, changes to your heartbeat (these symptoms can have potentially serious, life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

Children react more strongly to large amounts of this medicine than adults. If a child takes too much or shows any of the above symptoms, call a doctor immediately.

Q POSSIBLE SIDE EFFECTS

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

Stop taking the medicine and contact your doctor immediately if you notice: Rare: (affects less than 1 in 1,000 but 1 or more in 10,000 people)

• Allergic reactions including unexplained wheezing, shortness of breath, or swelling of the face and throat.
• Skin rashes, which may be severe and include blistering or peeling skin.
• Loss of consciousness or reduced level of consciousness (passing out, feeling faint or less alert), uncoordinated movements.

If you get any of these, stop using the medicine and get medical help at once.

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 affected)

• 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 affected)

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

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

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

Contents of the pack:

This pack contains 6 or 12 Orodispersible tablets.

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: May 2017. higoofvji