Loperamide 2 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Loperamide 2 mg Tablets
(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 use Loperamide Tablets carefully to get die 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 after 24 hours in case of acute diarrhoea and 14 days in case of diarrhoea associated with Irritable Bowel Syndrome (IBS).
If any of die side effects gets serious, or if you notice any side effects not listed in diis leaflet, please tell your doctor or pharmacist.
1. What Loperamide Tablets are and what diey are used for
2. Before you take Loperamide
3. How to take Loperamide
4. Possible side effects
5. How to store Loperamide
6. Furdier information.
The name of your medicine is Loperamide 2 mg Tablets. In die rest of diis leaflet your medicine is called Loperamide. Loperamide hydrochloride is die active ingredient of Loperamide Tablets. The tablets are available in one strength.
Loperamide is one of a group of medicines called "antidiar-rhoeals" which are used to treat diarrhoea.
Loperamide 2 mg tablets are used to treat sudden short dived (acute) attacks of diarrhoea in adults and children aged 12 years and over.
It can also be used to treat diarrhoea associated with Irritable Bowel Syndrome (IBS) in adults aged 18 years and over after your doctor has diagnosed you are suffering from this condition.
The tablets help reduce diarrhoea by slowing down an overactive bowel, which helps the body to absorb water and salts from this organ, making the stools more solid and less frequent.
if you are allergic (hypersensitive) to loperamide hydrochloride or any other ingredient of Loperamide if it is for a child under 12 years old 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
(particularly in children with severe dehydration)
if you have acute dysentery, the symptoms of which may
include blood in your stools and a high temperature.
Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Loperamide tablets.
Take special care with Loperamide
If any of the following points apply to you now or in the
past, talk to a doctor or pharmacist:
if you have AIDS and your stomach becomes swollen,
stop taking the tablets immediately and contact your doctor
if you suffer from liver problems
if your diarrhoea lasts for more than 24 hours (or 2
weeks if your diarrhoea is related to IBS)
if you have severe diarrhoea as your body loses more
fluid, sugars and salts than normal.
If you are unsure about any of the medicines you are taking, show the bottle or pack to your pharmacist.
Special warnings:
Loperamide only treats the symptoms of diarrhoea.
When you have diarrhoea, your body can lose large amounts of fluids and salts. You will need to replace the fluid by drinking more liquid than usual. Ask your pharmacist about special powders (known as oral rehydration therapy) winch replace fluids and salts lost during diarrhoea. The prevention of fluid depletion (dehydration) is of particular importance in infants, children and frail and elderly people with acute diarrhoea. You can use Loperamide for diarrhoea associated with IBS winch has been diagnosed by your doctor. If your symptoms change or you are concerned about anything you should talk to your doctor.
If your IBS related diarrhoea continues for longer than 2 weeks you should talk to your doctor.
Special warnings about use in Irritable Bowel Syndrome
If any of the following 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 tins 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
Consult your doctor if you develop new symptoms, if your symptoms worsen, or your symptoms have not improved over two weeks.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor or phannacist if you are taking any of the following:
ritonavir (used to treat HIV)
quinidine (used to treat abnormal heart rhythms or malaria) oral desmopressin (used to treat excessive urination) any other antidiarrhoeal preparations (except for oral rehydration therapy)
Pregnancy and breast-feeding
Ask your doctor for advice before taking any medicine if you are pregnant, think you might be pregnant or are planning to become pregnant.
Do not take Loperamide if you are breast-feeding as small amounts may get into your milk. Talk to your doctor about suitable treatment.
Driving and using machines
Do not drive if you feel dizzy, tired or sleepy after taking Loperamide. 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 Loperamide
Tins medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking tins medicinal product.
CM
<D JS "5 .22 "c .a
I H5
<1)
Q.
O
Size 200 x 372 (text area 179 x 312 mm)
Font size lOpt, Font used Times Roman Regular and Bold as placed Minimum document line spacing 4.23 mm
Always take Loperamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
- Take this medicine by mouth.
- Swallow the correct number of tablets whole with a drink of water.
- Do not take more than 6 tablets in any 24 hour period.
- This medicine is not recommended for children under 12 years old. Other pharmaceutical forms/strengths (e.g. syrup) are available for children aged 4 years and over.
Adults and children 12 years and over:
Swallow two tablets initially, followed by one tablet
after each loose bowel movement.
- Do not take more than 6 tablets in any 24 hour period.
- If symptoms persist for more than 24 hours, talk to your doctor.
Diarrhoea associated with Irritable Bowel Syndrome already diagnosed hv a doctor
Adults aged 18 years and over:
Swallow two tablets initially, followed if required, by one tablet after every further loose bowel movement depending on the severity of your symptoms, or as advised previously by your doctor.
- Do not take more than 6 tablets in any 24 hour period.
- If your symptoms change, or if your diarrhoea persists for more than 2 weeks, talk to your doctor.
If you take more Loperamide than you should If you or anyone else takes too many Loperamide tablets, contact your doctor or go to the nearest accident and emergency department (casualty) straight away taking this leaflet with you.
If you forget to take Loperamide
- You should only take this medicine as required following the dosage instructions above carefully.
- If you forget to take a dose, take a dose after the next loose stool (bowel movement).
- 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.
Other effects reported include:
- Tiredness.
- Dry mouth.
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.
Keep out of the reach and sight of children.
Do not use Loperamide after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month.
Store in the original package.
If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.
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.
Like all medicines, Loperamide can cause side effects, although not everybody gets them.
If you experience any of the following, stop using the medicine and seek immediate medical help:
Very rarely: (less than 1 in 10,000 people are affected)
- Allergic reactions including unexplained wheezing, shortness of breath, passing out or swelling of face and throat.
Skin rashes which may be severe and include blistering or peeling of the skin.
If you experience any of the following, stop using the medicine and talk to your doctor:
Very rarely: (less than 1 in 10,000 people are affected)
- Itchiness or hives.
- Difficulties passing water.
Stomach pain or swollen stomach.
Severe constipation.
Other effects which may occur include:
Very rarely: (less than 1 in 10,000 people are affected)
- Dizziness or drowsiness.
- Feeling sick, vomiting, indigestion, constipation or wind.
The active substance is loperamide hydrochloride. Each tablet contains 2 mg loperamide hydrochloride.
The other ingredients are maize starch, lactose monohydrate, povidone (K-30), Brilliant Blue FCF (E133), quinoine yellow (E104), magnesium stearate, talc, colloidal anhydrous silica and sodium starch glycolate and purified water.
What Loperamide looks like and contents of the pack
Loperamide 2 mg Tablets are light green coloured capsule shaped, biconvex uncoated tablets with ‘2’debossed on one side and scoreline on other side.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses Loperamide is presented in a blister pack of 6 tablets.
Marketing Authorisation Holder:
APTIL Pharma Limited,
9th floor, CP House,
97-107 Uxbridge Road, Ealing,
London W 5 5TL
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th floor, CP House,
97-107 Uxbridge Road, Ealing,
London W 5 5TL