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 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 after 24 hours in case of acute diarrhoea and 14 days in case of diarrhoea associated with Irritable Bowel Syndrome (IBS).

-    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.

In this leaflet:

1.    What Loperamide Tablets are and what they are used for

2.    Before you take Loperamide

3.    How to take Loperamide

4.    Possible side effects

5.    How to store Loperamide

6.    Further information.

1. WHAT LOPERAMIDE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Loperamide 2 mg Tablets. In the rest of this leaflet your medicine is called Loperamide. Loperamide hydrochloride is the 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-lived (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.

2. BEFORE YOU TAKE LOPERAMIDE

DO NOT TAKE Loperamide

-    if you are allergic (hypersensitive) to loperamide hydrochloride or any other ingredient of Loperamide

-    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 give this medicine to a child under 12 years old.

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) which 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 which 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 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

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 pharmacist 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

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

PACKAGING DEVELOPMENT

NOTE TO THE PRINTER :

•    Return approved artwork alongwith the proof.

•    The proof must be verified against the approved hardcopy, should be certified and signed by an authorised QA person. The unsigned proof will not be accepted.

•    Colour scheme must be as approved by packaging development co-ordinator.

•    Any deviation must be brought to the notice of packaging development co-ordinator immediately.

•    For any clarification, please contact packaging development co-ordinator immediately.

Font : Times New Roman Bodytext: 10pt Heading text: 10pt Main Heading text: 15pt

3. HOW TO TAKE LOPERAMIDE

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 should not be given to children under 12 years old. Other pharmaceutical forms/strengths (e.g. syrup) are available for children aged 4 years and over.

Short-lived (acute) diarrhoea Adults and children 12 years and over:

-    Swallow two tablets initially, followed by one tablet

after each loose bowel movement.

-    If symptoms persist for more than 24 hours, talk to your doctor.

Diarrhoea associated with Irritable Bowel Syndrome already diagnosed by 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.

-    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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine

5. HOW TO STORE LOPERAMIDE

Keep out of the sight and reach 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.

6. FURTHER INFORMATION

4. POSSIBLE SIDE EFFECTS

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.

What Loperamide contains

-    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 /Sldebossed 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:

Cipla (EU) Limited, Hillbrow House,

Hillbrow Road, Esher, Surrey, KT10 9NW,

United Kingdom.

Manufacturer:

Cipla (EU) Limited,

4th Floor, 1 Kingdom Street,

London, W2 6BY, United Kingdom

This leaflet was last revised in February 2014.

Cipla

Cipla Inventory Code

GSL