Document: leaflet MAH GENERIC_PL 00289-1979 change

• leaflet MAH BRAND_PL 00289-1979
• leaflet MAH GENERIC_PL 00289-1979
• leaflet MAH GENERIC_PL 00289-1980

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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.

This medicine is available without prescription. However, you still need to take Loperamide Capsules carefully to get the best results from them.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.

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

•    Ask your pharmacist if you need more information or advice.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    You must talk to a doctor if you do not feel better or if you feel worse after 48 hours.

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 is used:

•    to treat the symptoms of short-lived (acute) cases of diarrhoea in adults and children aged 12 years and over

•    to treat acute diarrhoea associated with Irritable Bowel Syndrome in adults following diagnosis by a doctor.

What you need to know before you take Loperamide

Do not take Loperamide if you:

•    are allergic (hypersensitive) to loperamide or any of the other ingredients of this 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 of the large intestine, accompanied by ulcers)

•    have a bacterial infection of the intestines, such as salmonella poisoning

•    have an infection of the 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 12 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 by the kidneys)

Loperamide 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist 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

If your doctor has prescribed this medicine, always take Loperamide exactly as your doctor has told you. Otherwise follow the instructions below.

If you are not sure how to take this medicine, talk to your doctor or pharmacist.

If you see a 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 pharmacist for advice about these.

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

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 12-17 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.

If you still have diarrhoea after 48 hours treatment, you should consult your doctor.

Irritable Bowel Syndrome

•    Adults (including the elderly)

Two capsules should be taken to start with. The usual dose is 2 to 4 capsules a day in divided doses. Do not take more than 8 capsules a day.

If the pattern of your symptoms changes you should return to your doctor. You should also return to your doctor if your episodes of acute symptoms continue for more than two weeks or if you require treatment for more than two weeks.

Children under 12 years

Loperamide is not recommended for use in children under 12 years.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you take more Loperamide than you should

If you (or someone else) swallow a lot of the capsules all together, or if you think a child has swallowed any of the 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 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 of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives)

•    blisters/bleeding/peeling of the lips, eyes, nose, mouth and genitals

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

Other side effects

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

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

•    headache

•    dizziness.

Uncommon (may affect up to 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 of the lips or tongue (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 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.

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 after the 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 (E1201), sodium starch glycolate (Type A) and magnesium stearate (E572). The capsule shell contains gelatin, titanium dioxide (E171), yellow iron oxide (E172) and patent blue V (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 10 and 12 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture is TEVA UK Limited, Eastbourne BN22 9AG England.

This leaflet was last revised: August 2016 PL 00289/1979

TFWTI