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PAGE 1: FRONT FACE (INSIDE OF REEL)

LOPERAMIDE 2 mg CAPSULES

Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

♦    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

♦    Ifyou get any side effects, talkto your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Loperamide is and what it is used for

2.    What you need to know before you take Loperamide

3.    How to take Loperamide

4.    Possible side effects

5.    How to store Loperamide

6.    Contents of the pack and other information

OWhat Loperamide is and what it is used for

Loperamide belongs to a group of drugs called antidiarrhoeals.

Loperamide Capsules are used:

♦ to treat the symptoms of acute

(short-lived) diarrhoea for periods of up to 5 days, in adults and children over 8 years old

♦ to treat chronic (long-lasting) diarrhoea in adults, providing the cause has been established.

[2 What you need to know before you take Loperamide

Do not take Loperamide if you:

♦ are allergic (hypersensitive) to

loperamide hydrochloride or any ofthe other ingredients ofthis medicine (listed in section 6)

♦ have acute dysentery, which is

characterised by blood in your stools and a high temperature ♦ have acute ulcerative colitis

(inflammation ofthe large intestine, accompanied by ulcers)

♦ have a bacterial infection ofthe

intestines, such as salmonella poisoning ♦ have an infection ofthe large intestine following the use of antibiotics ♦ have constipation, or any form of inflammation or blockage of the bowel ♦ have abdominal distension, which produces a bloated stomach • these capsules should not be taken by children under 2 years old.

Warnings and precautions

Talk to your doctor or pharmacist before

taking this medicine if you:

♦    have liver problems

♦    have AIDS.

Other medicines and Loperamide Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine:

♦    quinidine (used to treat an uneven heart beat)

♦    ritonavir (used to treat HIV)

♦    itraconazole or ketoconazole (used to treat fungal infections)

•    gemfibrozil (used to reduce high fat levels (cholesterol and triglycerides) in the blood)

•    desmopressin (reduces the amount of urine produced bythe kidneys).

Tell your doctor or pharmacist ifyou are taking, have recently taken or might take any other medicine.

Loperamide contains lactose Patients who are intolerant to lactose should note that Loperamide capsules contain a small amount of lactose. Ifyour doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy, breast-feeding and fertility Ifyou are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines Loperamide may make you feel tired, dizzy or drowsy. Do not drive or use machinery until you are sure you are not affected.

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. If you see another doctor or go into hospital, let him or the staff know what medicines you are taking.

When you have diarrhoea, your body loses large amounts of fluid and salts, which need to be replaced. Drink plenty of fluids but preferably not plain water. You can replace the lost salts by taking oral rehydration therapy, which is a powder containing salts and sugar. Ask your doctor or pharmacist for advice about these.

The capsules should be swallowed preferably with a drink of water.

Your dosage will depend on the type of diarrhoea that you have. Acute diarrhoea comes on suddenly and lasts a short time; chronic diarrhoea persists over a longer period oftime.The usual dose is:

Acute Diarrhoea

•    Adults (including the elderly)

Two capsules should be taken to start with, followed by a further capsule after each episode of diarrhoea. Do not take more than 8 capsules a day.

•    Children 8-17 years

One capsule should be taken to start with, followed by a further capsule after each episode of diarrhoea. Do not take more than 3 capsules per 20 kg of the child's bodyweight, up to a maximum of 8 capsules a day.

•    Children 2-8 years

Loperamide capsules are not suitable for children ofthis age. Loperamide syrup is available for use instead.

•    Children under 2 years Loperamide should not be taken by children under 2 years old.

If you still have diarrhoea after 48 hours treatment, you should consult your doctor. Chronic Diarrhoea • Adults (including the elderly)

The dose required is not the same for everyone and may need to be adjusted according to your response to treatment. The starting dose is normally 2 capsules a day; this should be adjusted until 1-2 solid stools a day are obtained. The amount taken will depend on the severity ofthe diarrhoea. The usual maintenance dose is between 1 and 6 capsules per day. Do not take more than 8 capsules per day.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

• Children

Loperamide is not recommended for use

in children to treat chronic diarrhoea.

If you take more Loperamide than you should

If you (or someone else) swallow a lot of the capsules all together, or ifyou think a child has swallowed any ofthe capsules, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause constipation, problems passing water, tight muscles, drowsiness, slow breathing, and abnormal co-ordination. Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.

If you forget to take Loperamide If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose.Take the remaining doses at the correct time.

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

Possible side effects

Like all medicines, Loperamide can cause side effects, although not everybody gets them.

If the following happens, stop taking the capsules and tell your doctor immediately or go to the casualty department at your nearest hospital:

♦    an allergic reaction (swelling ofthe lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

♦    blisters/bleeding/peeling ofthe lips, eyes, nose, mouth and genitals.

These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

In addition, the following side effects have been reported at the approximate frequency shown:

Other side effects

Common (may affect up to 1 in 10 people):

♦    constipation, feeling sick (nausea), wind (flatulence)

♦    headache

♦    dizziness.

Uncommon (may affect upto 1 in 100 people):

♦    stomach pain or discomfort, dry mouth

♦    upper stomach pain, being sick (vomiting)

♦    indigestion (dyspepsia)

♦    rash.

Rare (may affect up to 1 in 1,000 people):

♦    stomach bloating (abdominal distension).

Not known (Frequency cannot be estimated from the available data):

♦    loss of consciousness, stupor, reduced consciousness

♦    reduced pupil size (miosis)

♦    bowel obstruction (ileus), enlarged intestine (megacolon), a burning or tingling sensation ofthe lips ortongue (glossodynia)

♦    stomach bloating (abdominal distension)

♦    problems passing water (urinary retention)

♦    tiredness (fatigue)

♦    drowsiness (somnolence).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

^r5 How to store Loperamide

Keep this medicine out of the sight and reach of children.

These capsules should be stored in the package or container supplied. Do not transfer them to another container.

Do not use Loperamide afterthe expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.

©Contents of the pack and other

information

What Loperamide capsules contain:

♦ The active ingredient is loperamide hydrochloride.

♦ The other ingredients are maize starch, lactose monohydrate, povidone (E1202), sodium starch glycolate (Type A) and magnesium stearate (E572).The capsule shell contains gelatin, titanium dioxide (E171), yellow iron oxide (E172) and patent blueV (E131).The printing ink contains shellac, simeticone, titanium dioxide (E171) and propylene glycol (E1520).

What Loperamide capsules look like and contents of the pack:

♦ The Loperamide Capsules are green and dark grey capsules containing a fine white powder. They are printed 'LOP2'.

♦ The product is available in pack sizes of 30, 100, 250 and 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: 10/2014 PL 00289/0247

™

TEVA UK LIMITED    160X 323