LOPERAMIDE HYDROCHLORIDE TABLETS 2MG

Active substance: LOPERAMIDE HYDROCHLORIDE

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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

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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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