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Loperamide Hydrochloride Tablets 2mg

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Patient Information Leaflet for Loperamide Hydrochloride 2mg Tablets

Read this leaflet carefully before taking this medicine. It does not contain all the information about your medicine that you may need to know, so please ask your doctor or pharmacist if you have any questions. This leaflet only applies to Loperamide Hydrochloride 2mg Tablets.

1.    WHAT THESE TABLETS DO

These tablets contain Loperamide Hydrochloride which is used to treat diarrhoea (loose bowels), by slowing down the movements of your intestine to prevent loose bowels.

Loperamide Hydrochloride 2mg Tablets can be used to relieve short term sudden attacks of diarrhoea in adults and children aged 12 years and over. If the condition does not get better within 24 hours, please speak to your doctor or pharmacist

These tablets 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.

2.    CHECK BEFORE YOU TAKE

The following information should be read before using this product Do not take these tablets if you:

•    Are allergic to Loperamide Hydrochloride, similar medicines or any of the other ingredients listed in section 6

•    If it is for a child aged under 12 (or under 18 for an IBS patient).

•    If you have severe diarrhoea after taking antibiotics.

•    If you are having a flare-up of an inflammatory bowel condition like ulcerative colitis.

•    If you are constipated, or your stomach appears swollen (especially in children with severe dehydration).

•    If you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature.

If any of these applies to you, talk to a doctor or pharmacist and do not take these tablets. Take special care and tell your doctor if you:

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

•    If you suffer from liver disease.

•    If you have diarrhoea that lasts for more than 48 hours.

•    If you have been told by your doctor that you have an intolerance to some sugars as these tablets contain lactose.

•    If you have severe diarrhoea as your body loses more fluid, sugars and salts than normal.

Extra Warnings for IBS patients

•    Only take loperamide HCl to treat acute episodes of diarrhoea associated with irritable bowel syndrome (IBS) if your doctor has previously diagnosed IBS.

•    If any of the following now apply, do not use the product without first consulting your doctor, even if you know you have IBS:

•    If you are 40 years or over and it is some time since your last attack of IBS or the symptoms are different this time

•    If you have recently passed blood from the bowel

•    If you suffer from severe constipation

•    If you are feeling sick or vomiting

•    If you have lost your appetite or lost weight

•    If you have difficulty or pain passing urine

•    If you have a fever

•    If you have recently travelled abroad

Tell your doctor or pharmacist if you are already taking any of the following medicines:

•    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, show the bottle or pack to your pharmacist.

If any of these applies to you (now or in the past), talk to a doctor or pharmacist. Pregancy and Breastfeeding

As your doctor or pharmacist for advice before taking this medicine as it is not advised to take these tablets if you are pregnant or breastfeeding.

Driving and using machinery

Diarrhoea or this medicine may cause people to feel tired, sleepy or dizzy. You should not drive or use machines, until you are sure you are not affected.

3. HOW TO TAKE THE TABLETS

Swallow each tablet with water.

Short term diarrhoea

Adults and children of 12 years and over Two tablets to start with. After that, take one tablet after each loose bowel movement.

Don’t take more than 6 tablets in any 24 hours.

Don’t take for more than 48 hours.

Diarrhoea associated with irritable bowel syndrome, which has been diagnosed by a doctor

Adults only (18 years and over) Two tablets to start with.

After that, take one tablet as needed until stools become solid.

Don’t take more than 6 tablets in any 24 hours.

Don’t take for more than 14 days.

Make sure that you drink plenty of liquid than normal to replace the lost fluids in the diarrhoea

If you take more tablets than you should:

Seek medical attention immediately, and take this leaflet with you.

If you forget to take these tablets.

Take a dose after the next loose stool. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Loperamide Hydrochloride 2mg Tablets can have side-effects, like all medicines, although these don’t affect everyone and most are usually mild.

Serious Allergic reactions

•    unexplained wheezing, shortness of breath, passing out or swelling of 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 experience any of the above symptoms after taking this medicine go to the nearest hospital IMMEDIATELY

•    Itchiness or hives.

•    Stomach pain or swollen stomach.

•    Difficulties passing water.

•    Severe constipation.

•    Burning or prickling sensation of the tongue.

•    Miosis (narrowing of the pupils of the eye).

•    Feeling sick, constipation or wind.

•    Headache.

•    Dizziness or drowsiness.

•    Vomiting, indigestion.

•    Dry mouth.

•    Tiredness.

If you experience any of these or any other side effects and they get serious, contact your doctor or pharmacist.

5. STORING YOUR MEDICINE

Keep your medicine in a safe place where children cannot see or reach it.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

6. MORE ABOUT YOUR MEDICINE

The active ingredient in these tablets is 2 mg Loperamide Hydrochloride.

The inactive ingredients are lactose monosterate, polyvinylpyrollidone and magnesium stearate

The product license holder and manufacturer is Aspar Pharmaceuticals Ltd, 29 - 30 Capitol Way, Colindale, London, NW9 0EQ. PL 08977/0044

Packs containing 18, 20, and 30 tablets are available from your pharmacy, although not all pack sizes may be marketed

Leaflet revised in 12/2012