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Asda Diarrhoea Relief 2mg Capsules

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PATIENT INFORMATION LEAFLET

Loperamide Hydrochloride 2mg Capsules

(Loperamide Hydrochloride USP)

Please read all of this leaflet carefully before you use Loperamide Hydrochloride

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

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

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

■    Contact your doctor if your symptoms become worse or do not improve after 24 hours.

■    If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist

In this leaflet:

Q What this medicine is and what it is used for    14 Possible side effects

2 Before you take    □ How to store

3 How to take    □ Further information


0 What this medicine is and what it is used for

Loperamide Hydrochloride belongs to a group of medicines called 'antidiarrhoeals' which are used to treat diarrhoea.

Loperamide is used to treat sudden, short lived (acute) attacks of diarrhoea in adults and children over 12 years of age.

It reduces diarrhoea by slowing down an overactive bowel. It also helps the body to absorb more water and salts from the bowel.

[2| Before you take

Do not take Loperamide if:

■    you are allergic to Loperamide or any of the other ingredients (see ‘Important information about some of the ingredients', section 2 and 6)

■    you need to keep the bowel movements normal to avoid complications such as blockage of the bowel and abnormal or rapid widening of the colon

■    you have constipation, blockage of the bowel or a bloated tummy (in particular, in children with severe dehydration)

■    you have acute ulcerative colitis (a form of inflammatory bowel disease) which can cause abdominal pain, bloody diarrhoea, fever and weight loss

■    you have a bacterial infection of the small intestine and colon (caused by bacteria such as salmonella, shigella and campylobacter)

■    you have inflammation of the colon after taking antibotics (symptoms may include watery or bloody diarrhoea)

■    you have dysentery, the symptoms of which may include blood in your stools and a high temperature.

Take special care if:

■    you have or think you may have lost body fluids and salts through diarrhoea. Particularly important for children and frail or elderly patients with severe diarrhoea (see ‘Replacing fluids and salts', section 3)

■    you have liver disease. You should consult your doctor or pharmacist before taking Loperamide as it may cause side effects

■    you have inflammatory bowel disease (inflammation of the intestines), which can cause abdominal pain and bloody diarrhoea

■    you have a bloated tummy and you have AIDS. You should stop taking the capsules immediately and contact your doctor

If any of the above apply to you, please

consult your doctor or pharmacist.

Taking other medicines

Loperamide may interact with other medicines. If you are taking other medicines, including medicines obtained without a prescription and you are unsure about taking Loperamide, you should contact your doctor or pharmacist.

Loperamide should not be taken with the following:

■ Other antidiarrhoea preparations, except for oral rehydration therapy (see "Replacing fluids and salts" in section 3)

Loperamide may cause serious side effects if

taken with the following:

■    Quinidine, for abnormal and increased heart rhythm

■    Digoxin, for heart failure

■    Ritonavir & tipranavir, for HIV infection and AIDS

■    Itraconazole and Ketoconazole, for fungal infections (antibiotic)

■    Gemfibrozil, used to lower levels of cholesterol and other lipids (fats) in the blood

Loperamide increases the blood levels of the

following:

■    Oral desmopressin, for reducing urine production (antidiuretic)

Pregnancy and breast-feeding

If you are pregnant or planning to become pregnant, you are advised not to take Loperamide. It is not known if it is safe to take, especially during the first 3 months of pregnancy.

If you are breast-feeding, you should not take Loperamide, as small amounts of this medicine get into your breast milk.

Driving and using machinery

This medicine may make you feel tired, dizzy or drowsy. If affected, you are advised not to drive or operate machinery.

Important information about some ingredients of Loperamide Lactose: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

Colouring agent Sunset Yellow FCF (E110):

it may cause allergic reaction.

Continued....

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How to take

Follow the instructions below or ask your pharmacist for help if you are not sure how to take this medicine.

■    Loperamide is for oral use only

■    Swallow the capsules whole with some liquid

Adults and children over 12 years:

To treat sudden, short-lived (acute) attacks of diarrhoea

■    2 capsules (4mg) initially

■    This should be followed by 1 capsule (2mg) after each loose stool (bowel movement)

■    The usual dose is 3-4 capsules (6 - 8mg) a day

■    The maximum dose is 6 capsules (12mg) in 24 hours

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

Children under 12 years:

This medicine should not be given to children under 12 years of age.

Elderly and patients with kidney problems

Same dose as for adults

Patients with liver problems

See 'Take special care' (section 2)

Do not take Loperamide for longer than 24 hours. If your symptoms do not improve within 24 hours, please contact your doctor.

Replacing fluids and salts

When you have diarrhoea your body loses large amounts of fluid and salts. In addition to your medicine, you should take more liquids which contain sugar and salts, than normal.

■    Drink plenty of clear fluids containing salt and sugar (special oral rehydration powders are available from pharmacists), unsweetened fruits juices or clear soups

■    Avoid excessive plain water

■    Do not drink alcohol or milk

■    Do not eat fruit, green vegetables or fatty foods

■    Two or three days after symptoms have disappeared you may return to your normal diet

If you take more Loperamide than you should

Contact your doctor or go to your nearest casualty department immediately. Take the carton and this leaflet with you so that people will know what you have taken.

Symptoms of an overdose include:

Constipation, difficulty passing urine, feeling bloated, stupor, difficulty co-ordinating movements, pupils of the eyes become smaller, increased muscle tension, difficulty sleeping, breathing problems or abnormally slow breathing.

If you forget to take Loperamide:

Take it as soon as you remember. Never double up a dose to make up for the dose you have missed.

[4 Possible side effects

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

Stop taking your medicine and contact your doctor immediately or nearest hospital if you experience the following (rare side effects):

■    Bloated tummy and you have AIDS

■    Allergic reactions such as swollen face, lips or eyelids and serious reactions such as passing out, difficulty breathing and dizziness

■    Blistering of the skin, mouth, eyes and genital area (Stevens Johnson Syndrome or toxic epidermal necrolysis)

Common side effects (affect less than 1 in 10 people)

■    Headache

■    Constipation

■    Feeling sick (nausea)

■    Stomach wind (flatulence)

Uncommon side effects (affect less than 1 in 100 people)

■    Dizziness

■    Drowsiness

■    Stomach pain or discomfort

■    Dry mouth

■    Being sick (vomiting)

■    Indigestion

■    Rash

Rare side effects (affect less than 1 in 1,000 people)

■    Loss of consciousness

■    Reduced ability to respond to stimulation (stupor) or reduced consciousness

■    Abnormal increase in muscle tension

■    Difficulty co-ordinating movement

■    Pupils of the eyes become smaller

■    Blockage of the bowel

■    Enlargement of the large intestine, which may cause constipation, bloating and tenderness of the stomach or fever (megacolon or toxic megacolon)

■    Painful or burning feeling of the tongue

■    Bloated tummy

■    Itchy rash (urticaria) or itching (pruritus)

■    Difficulty in urinating (passing water)

■    Tiredness

If any of the side effects listed become serious or you notice any side effects not listed, please contact your doctor or pharmacist.

How to store

Store out of reach and sight of children.

Keep this medicine in a dry, cool place (below 25°C) away from the light.

Do not take after the expiry date, which is stated on the carton after EXP.

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.

\3 Further information

What Loperamide Capsules contain:

Active ingredient:

Loperamide Hydrochloride USP 2mg

Other ingredients:

lactose, maize starch, talc, magnesium stearate, gelatine, colouring agents sunset yellow FCF (E110), erythrosine (E127), patent blue (E131), indigotine (E132) and titanium dioxide (E171). (see 'Important information about some of the ingredients', section 2, page 2)

What Loperamide Hydrochloride Capsules look like and the contents of the pack

Loperamide capsules have a grey cap body colour and dark green cap hood colour.

The pack contains 6 capsules.

Marketing Authorisation Holder & Manufacturer

Tillomed Laboratories Ltd,

3 Howard Road, Eaton Socon, St. Neots, Cambridgeshire, PE19 8ET, UK

Legal category: General Sale List (GSL) Medicine Product Licence Number: PL 11311/0151

Date of last revision: May 2012

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