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Patient Information Leaflet GB 726-8873-APIL


SOVEREIGN

MEDICAL

Diloxanide 500 mg Tablets


Diloxanide furoate

Read all of this leaflet carefully before you start taking this medicine.

-    Please 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects become severe, or

if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:
1.    What Diloxanide 500 mg Tablets are and what they are used for
2.    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.    Further 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 to treat acute and chronic intestinal amoebiasis. Intestinal amoebiasis is a type of infection affecting the intestines.

2.    BEFORE YOU TAKE DILOXANIDE 500 MG TABLETS

Do not take this medicine if:

• you have ever had an allergic reaction to any of the ingredients of Diloxanide 500 mg Tablets (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.

Taking other medicines

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

Tell your doctor if you become pregnant, or if you are breast-feeding.

Driving and using machines

There have been no reported effects on the ability to drive or operate machinery while taking this medicine.

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 usual doses of Diloxanide 500 mg Tablets are as follows:

Adults

One tablet three times a day, for ten days. 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.


Do not stop taking your medicine suddenly as it is important that you finish the full course of tablets prescribed for you. Do not stop just because you feel better. If you stop taking the tablets too soon, your condition may get worse.

If you take more 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 your medicine

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 500 mg 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);

•    sickness;

•    itching;

•    skin rash.

If you notice any side effects mentioned above, please tell your doctor or pharmacist.

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


5.    HOW TO STORE DILOXANIDE 500 MG TABLETS

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

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN

Return any unused medicine to your pharmacist.

6.    FURTHER INFORMATION

What Diloxanide 500 mg Tablets contains:

Diloxanide 500 mg 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 looks like and the contents of the pack:

Diloxanide 500 mg Tablets are flat, white tablets scored with a characteristic engraving E/F on one face. Each pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer

Sovereign Medical,

Sovereign House, Miles Gray Road,

Basildon, Essex, SS14 3FR.

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 500 mg Tablets.


^SOVEREIGN

■Mb medical


Date of preparation of leaflet: October 2011