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Furamide Tablets

Document: leaflet MAH GENERIC_PL 20072-0225 change

Package leaflet: Information for the patient 102445/LF/034/02


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Diloxanide 500 mg Tablets amdipharm

Diloxanide furoate

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 symptoms 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 Diloxanide 500 mg Tablets are and what they are used for

2.    What you need to know before you take Diloxanide 500 mg Tablets

3.    How to take Diloxanide 500 mg Tablets

4.    Possible side effects

5.    How to store Diloxanide 500 mg Tablets

6.    Contents of the pack and other information

1.    What Diloxanide 500 mg Tablets are and what they are used for

The name of your medicine is Diloxanide 500 mg Tablets.

The active ingredient is diloxanide furoate. Diloxanide belongs to a group of medicines called amoebicides (amoebicides are a group of medicines used to treat infections).

Diloxanide 500 mg Tablets are used in adults and children weighing over 25 kg to treat acute and chronic intestinal amoebiasis. Intestinal amoebiasis is a type of infection affecting the intestines.

2.    What you need to know before you take Diloxanide 500 mg Tablets

Do not take Diloxanide Tablets if

• you are allergic to diloxanide furoate or any of the other ingredients of this medicine, listed in section 6 (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing);

• you are pregnant, planning to become pregnant or are breast-feeding.

Children

Do not give this medicine to children weighing less than 25 kg.

Other medicines and Diloxanide 500 mg Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.

Pregnancy and breast-feeding

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. The safety of diloxanide furoate during pregnancy and when breast-feeding has not been established.

Driving and using machines

Dizziness is a side effect associated with this product and it may affect some patient's ability to drive or operate machinery.

3. How to take Diloxanide 500 mg Tablets

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

The recommended doses of Diloxanide Tablets are as follows:

Adults

One tablet three times a day, for ten days.

Use in children

This medicine is NOT suitable for children weighing less than 25 kg.

The dose depends on the weight of the child. It will be worked out on the basis of 20 mg per kg of body weight, in divided doses (three times a day), for ten days.

If you are not sure about how much medicine to take, please speak to your doctor or pharmacist.

If you take more Diloxanide 500 mg Tablets than you should

If you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine with you.

If you forget to take Diloxanide 500 mg Tablets

If you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.

4.    Possible side effects

Like all medicines, Diloxanide Tablets can cause side effects, although not everybody gets them. You are unlikely to get any of the following, but if you do, tell your doctor immediately:

•    skin reddening, itching, difficulty in breathing or swelling. These could be signs of an allergic reaction and might not happen immediately-they may be experienced at the beginning of treatment or they may be delayed;

•    flatulence (wind);

•    feeling or being sick;

•    diarrhoea;

•    stomach pain;

•    loss of appetite;

•    headache;

•    dizziness;

•    itching;

•    skin rash.

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,

website: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Diloxanide Tablets

Do not use after the expiry date that is stated on the carton and labels.

KEEP THIS MEDICINE OUT OF SIGHT AND REACH OF CHILDREN

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AMDIPHARM

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 protect the environment.

6. Contents of the pack and other information What Diloxanide 500 mg Tablet contains:

Diloxanide Tablets contain 500 mg of the active substance, diloxanide furoate.

The other ingredients are: maize starch, pregelatinised maize starch, dried maize starch and magnesium stearate.

What Diloxanide 500 mg Tablets look like and the contents of the pack:

Diloxanide Tablets are flat, white tablets scored with a characteristic engraving E/F on one face. Diloxanide 500 mg Tablets are available in: aluminium tubes containing 15 tablets; polythene bottles containing 30 tablets; glass bottles containing 250 tablets; polythene bottles containing 250 tablets;

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Amdipharm UK Limited,

Capital House, 85 King William Street,

London EC4N 7BL,

UK

Remember: This medicine is for you and has been prescribed for you by a doctor. Never give it to anybody else, even if their symptoms are the same as yours.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet applies only to Diloxanide Tablets.

This leaflet was last revised in January 2015.