PACKAGE LEAFLET: INFORMATION FOR THE USER

Loperamide 2 mg Tablets

(Loperamide hydrochloride)

Read all of this leaflet carefully before you start taking this

medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    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 "antidiarrhoeals" 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 9 years and over and long-lasting (chronic) diarrhoea in adults.

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.

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.

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.

3. HOW TO TAKE LOPERAMIDE

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 9 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 you have acute dysentery, the symptoms of which may include blood in your stools and a high temperature. You will also need to be given other medicines to treat this.

-    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.

Always take Loperamide exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The dose of Loperamide that you will need will depend on whether your diarrhoea is a sudden, short lived attack (acute) or a long-lasting condition (chronic).

-    Take this medicine by mouth.

-    Swallow the correct number of tablets whole with a drink of water.

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

-    Take two tablets to begin with and then one tablet after each episode of diarrhoea for up to 5 days.

-    Never take more than 8 tablets in any 24 hour period. Children aged 9-12 years:

-    Take one tablet 4 times daily until diarrhoea is controlled or for up to 5 days.

-    Never take more than this dose.

Children aged under 9 years old:

This medicine should not be given to children under 9 years old.

Other pharmaceutical forms/strengths (e.g. syrup) are available for children aged 4 years and over.

If your symptoms are not getting better within 2 days of taking your first dose of Loperamide, you should see your doctor again, who may want to examine you to further check on the cause of the diarrhoea.

Long-lasting (chronic) diarrhoea Adults only:

-    Your doctor will tell you how much Loperamide tablets to take.

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-    The initial dose will probably be between two and four tablets per day taken in divided doses, but will depend on each individual's needs. When your doctor is satisfied that you are receiving the daily dose that best suits you, he or she will then probably suggest that you take your tablets twice a day.

-    Never take more than 8 tablets in any 24 hour period.

Children:

NOT recommended.

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.

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.

Stop using Loperamide tablets and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment.

Very rare (affects less than 1 in 10,000 people)

-    Sudden swelling of the face lips, or throat.

Hives (also known as nettle rash or urticaria).

Severe irritation, reddening or blistering of yourthe skin. These may be signs of a severe allergic reaction

-    Blistering of your skin, mouth, eyes or genitals

-    Stomach pain or severe swollen stomach

-    Severe constipation

-    Loss of consciousness or reduced level of consciousness (feeling faint or les alert)

Tell your doctor if you notice any of the following side effects while using Loperamide tablets:

Very rare (affects less than 1 in 10,000 people)

-    Itchy skin and rash

-    Difficulty passing water

Other side effects which may occur:

Very rare (affects less than 1 in 10,000 people)

-    Feeling sick (nausea), being sick (vomiting), indigestion (dyspepsia)

-    Feeling drowsy or dizzy

-    Wind

Other side effects that may be due to the medicine or diarrhoea:

-    Feeling tired

-    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

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 ABebossed 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 12 or 30 tablets. Not all pack sizes may be marketed.

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.

5. HOW TO STORE LOPERAMIDE

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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.

Cipla

Cipla Inventory Code

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.

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