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Loperamide Hydrochloride 2mg Tablets

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PATIENT INFORMATION LEAFLET

Loperamide Hydrochloride 2mg Tablets

Read all of this leaflet carefully before you start using 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, please 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.

•    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.

What is in this leaflet:

1    What this medicine is and what it is used for    H    Possible side effects

2    What you need to know before you take Loperamide    S    How to store Loperamide

3    How to take Loperamide    Q    Contents of the pack and    other information


What this medicine is and what it is used for

The active ingredient is Loperamide which 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.

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 (see section 6 "Contents of the pack and other information”)

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

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

■    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 antibiotics (symptoms may include watery or bloody diarrhoea)

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

Warnings and precautions

Talk to your doctor before taking Loperamide if:

■    you have or think you may have lost body fluids and salts through 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 are taking Loperamide to treat diarrhoea caused by Irritable Bowel Syndrome (IBS). You should consult your doctor if:

-    there is no improvement in your symptoms within 48 hours

-    your symptoms change

-    your episodes of diarrhoea last for more than 2 weeks

■    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 this medicine immediately and contact your doctor

If any of the above apply to you, please consult your

doctor or pharmacist.

Other medicines and Loperamide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

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

■    Ritonavir or tipranavir, for HIV infection and AIDS

■    Itraconazole and ketoconazole, for fungal infections

■    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 breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor for advice before taking Loperamide.

Pregnancy

It is not known if it is safe to take, especially during the first 3 months of pregnancy. Talk to your doctor about a suitable treatment.

Breast-feeding

If you are breast-feeding, you should not take Loperamide, as small amounts of this medicine get into your breast milk. Talk to your doctor about a suitable treatment.

Driving and using machines

This medicine may make you feel tired, dizzy or drowsy. You may feel less alert, feel faint or pass out.

If affected, you are advised not to drive or operate machinery.

Loperamide contains lactose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

How to take Loperamide

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

■    Loperamide is for oral use only

■    Swallow the tablets whole with some liquid

■    The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses

Adults and children over 12 years:

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

continued....

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