Patient Product Information

UK/IRELAND
Roche

Fansidar ® tablets

Sulfadoxine + Pyrimethamine
500/25mg

Please read this leaflet carefully before you start to take your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What is Fansidar?

Fansidar is an anti-malarial. It contains two active ingredients sulfadoxine and pyrimethamine. Each tablet contains 500mg sulfadoxine and 25mg pyrimethamine. The tablets also contain maize starch, lactose monohydrate, gelatin, talc and magnesium stearate. The tablets are white with Roche and a hexagon on one face and the other side is cross-scored.

The tablets are available in amber glass bottles or foil strips in packs of 3, 10 and 150.

What is Fansidar used for?

This medicine is used for the treatment of malaria and is occasionally used to help prevent you from catching malaria. Malaria is a life threatening disease and a major health risk for travellers visiting tropical countries. It occurs when small parasites are passed from one person to another by the bites of certain mosquitoes. The tablets are especially useful if you are travelling to countries where there is a type of malaria which is particularly difficult to treat. No single medicine is effective against all malaria parasites. The choice of a particular medicine depends on the sensitivity of the malaria parasites found in the area to be visited. Your doctor will advise you whether Fansidar is suitable for the area you wish to go to.

To help minimise your chance of catching the disease it is important that you read this leaflet carefully. Ask your doctor to explain anything you do not understand.

When must Fansidar not be used?

• If you are allergic to Fansidar, any of the ingredients it contains or similar medicines containing sulphonamides or pyrimethamine.
• If you have reactions such as rash, redness, itching, sore throat or genitals, jaundice (yellow skin/eyes), fever or general malaise, infections, cough or breathlessness, stop taking Fansidar and see a doctor straight away, as you may be allergic to this medicine.
• If you have severe kidney, liver or blood problems, you should not take Fansidar for prevention of malaria.
• If you are pregnant or breast feeding, unless your doctor tells you to.
• Fansidar should not be taken by premature babies and infants under 2 months.

When should you be extra careful when using Fansidar?

Make sure your doctor knows if you are taking any other medicines e.g. trimethoprim, co-trimoxazole, methotrexate, anticonvulsants or chloroquine. Taking Fansidar with other medicines can make the unwanted effects worse or may weaken your protection against malaria.

Avoid exposure to the sun (or ultraviolet light).

How should Fansidar be used?

Always take the tablets as your doctor tells you to. This will depend on whether you are taking the tablets for prevention or treatment. Take the tablets with plenty of water. Swallow the tablets whole, do not suck or chew them. If you take too many tablets by mistake, or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

Malaria treatment
Please read the following section if you are taking the tablets to treat malaria.

Your doctor will tell you how much medicine you need to take. This will depend on your weight and whether you have been living in a malarious area. The usual dose for adults is 2 – 3 tablets taken as a single dose. Adults weighing over 60kg may be given a higher dose. For children over 5kg (11lbs) the dose is shown in the table below. In certain cases your doctor may prescribe other medicines such as quinine as additional treatment.

Weight	Age (approx.)	Dose
5 - 10kg	under 2 years	Half tablet
11 - 20kg	2 - 5 years	1 tablet
21 - 30kg	5 -10 years	One and a half tablets
31 - 45kg	10 - 14 years	2 tablets

Malaria prevention
Please read the following section if you are taking the tablets to help prevent you from catching malaria.

Important

• The tablets should be taken once weekly, always on the same day of the week.
• You should start taking the tablets 1 week before departure and should continue throughout your stay and for 4 - 6 weeks after your return. If you forget to take a dose, take one as soon as you remember, then go on as before.
• For effective prevention you must take the full course of tablets.
• No anti-malarial tablets are completely effective. Malaria can occur during or after preventative medication. If you develop a fever or flu-like symptoms during your travels or within 2 to 3 months after you leave the malarious area, check with a doctor immediately.

Below is an example which gives the recommended dose for a 3-week stay in an area where malaria is present:

Adult dose

	Before travel	During travel			On return
Week	1	2	3	4	5	6	7	8	9	10
Dose	1 tablet	1	1	1	1	1	1	1	1	1

10 tablets are enough to help prevent you from catching malaria if you are staying for up to 5 weeks in an area where malaria is present. If your stay is longer than 5 weeks, consult your doctor as regular blood counts are recommended for use over 12 weeks (1 week before travelling, 5 weeks during stay, 4 - 6 weeks after return). Fansidar should not be taken for more than 2 years.

Children's dose
The tablets are not recommended for children under 2 months of age, i.e., those who weigh less than 5kg (11lbs). For children over this weight, the dose is shown in the table below. The tablets can be divided by breaking along the score lines. As in adults, the dose should be taken once weekly on the same day, started 1 week before travelling and continued for 4 - 6 weeks after return. Seek your doctor's advice for stays longer than 5 weeks.

What are the possible unwanted effects of Fansidar?

In addition to the beneficial effects of Fansidar it is possible that unwanted effects will occur during treatment, even when it is used as directed.

How should Fansidar be stored?

• Keep this medicine out of the reach and sight of children.
• This medicine must not be used after the date (EXP) which is printed on the blister, and carton. Return any left over medicine to your pharmacist. Only keep it if your doctor tells you to.
• REMEMBER this medicine is for you. Only a doctor can prescribe it for you. Never give it to others. It may harm them even if their symptoms are the same as yours.

Further information:

You can get more information on Fansidar from your doctor or pharmacist.

It is essential that you follow the recommendations given for taking the tablets. Although no preventative medication is 100% effective, the following important activities together with preventative medication will substantially reduce the risk of catching malaria:

• Make sure you sleep in a room that is screened against mosquitoes or that you use a mosquito net (preferably one that has been treated with an insect repellent) over the bed.
• Use insect repellents; ointments, lotions and sprays, to deter mosquitoes.
• In the evening, cover arms and legs with light-coloured, long-sleeved clothes and trousers, and use an insect repellent. Anklets are also available which have been treated with repellent.
• Vaporising electric "mats", mosquito coils or tablets can be used at night-time around exposed areas of the body (ankles and feet).