patient information leaflet daraprim

Patient Information Leaflet

Daraprim® 25 mg tablets

pyrimethamine

Please read this leaflet carefully before taking this medicine, or giving it to someone you are looking after. It contains important information about the treatment. If you have any doubts or questions, or are not sure about anything, ask your doctor or pharmacist. Keep it safe as you may want to read it again.

What is in your Daraprim tablets?

Daraprim tablets are white and round with the marking “GS A3A”. Each tablet contains 25 mg of the active ingredient pyrimethamine.

There are also some other ingredients: lactose monohydrate, maize starch, hydrolysed starch, docusate sodium and magnesium stearate.

Daraprim is supplied in cartons containing 30 tablets.

What type of medicine is Daraprim?

Daraprim belongs to a group of medicines called antiprotozoals, which are used against infections of the blood caused by the parasites called Plasmodium (which causes malaria) and Toxoplasma (which causes a disease called toxoplasmosis).

What are Daraprim tablets for?

Daraprim is used:

To protect against malaria for people living in areas where the malaria parasite is sensitive to pyrimethamine.
When taken with a sulphonamide antibiotic and a folate supplement, to treat toxoplasmosis infections of the:-
- brain (encephalitis) and other organs, if you have a deficient immune system/AIDS
- eye, that could affect the eyesight
- unborn baby, transferred from the infected mother during pregnancy.

Before taking Daraprim tablets

DO NOT take Daraprim tablets, if you:

Have ever had an allergy or bad reaction to pyrimethamine or any of the tablet ingredients in Daraprim listed above
Are three months (12 weeks) pregnant, or less

If you answer ‘YES’ to any of the following questions, tell your doctor before taking this medicine.

Are you more than three months (12 weeks) pregnant, trying to become pregnant or breast-feeding?
Do you have kidney, liver or blood disease (anaemia)?
Have you ever had seizures (fits)?
Are you taking or likely to be taking any of the following medicines whilst you are taking Daraprim: (Please check with your doctor if you are not sure)
- antibiotics (e.g. trimethoprim or co-trimoxazole)
- antimalarials (e.g. proguanil or quinine)
- antivirals (e.g. zidovudine)
- anticancer medicines (e.g. methotrexate, daunorubicin, cytosine arabinoside)
- sleeping tablets (e.g. lorazepam)
- blood thinning tablets (e.g. warfarin)
- antacid indigestion remedies
- antidiarrhoeal remedies containing kaolin

Daraprim tablets are NOT SUITABLE for children under 5 years of age.

How do I take Daraprim tablets?

It is important to take your medicine as directed. The label on the pack will tell you how many tablets to take and how often to take them. If the label does not say or if you are not sure, ask your doctor or pharmacist.

Swallow the tablet with some water.
Do not exceed the stated dose.

Malaria

To help protect against malaria infection the usual dose is as follows:
- Adults and children over 10 years: One tablet regularly once weekly
- Children 5 to 10 years: Half a tablet regularly once weekly
- Children under 5 years: There is no recommended dose
You should take your first tablet during the week before going to a malarious area, and you must continue your weekly tablet throughout your visit and for a further 4 weeks after your return to a malaria-free area.
Extra precautions to protect yourself against malaria should be taken (see below).

Toxoplasmosis

To treat toxoplasmosis Daraprim should be taken together with an appropriate sulphonamide medicine and a folate supplement, as prescribed by your doctor.

Your treatment course will usually last for 3 to 6 weeks. If you need a further course, a gap of two weeks should elapse between treatments.

The usual dosages are as follows:-

To treat toxoplasmosis infections of the brain (encephalitis) and other organs, in adults and children over 5 years with a deficient immune system/AIDS: A starting dose of four to eight tablets daily for the first 2 – 3 days, followed by a dose of between one and four tablets each day. To treat toxoplasmosis infections of the eye, in adults and children over 5 years: A starting dose of four tablets daily for the first 1 – 2 days, followed by a dose of one to two tablets each day.
To treat toxoplasmosis infections of the unborn baby, during mid and late pregnancy: Daraprim may cause harm to the baby in early pregnancy and an alternative treatment should therefore be used until the 13th week of pregnancy. From the 13th week onwards, Daraprim treatment may prevent the toxoplasmosis infection of the mother damaging the unborn baby. The usual dose is one to two tablets each day.

What if I miss a dose?

If you forget to take a dose, take another one as soon as you remember and then go on as before. Do not double your next dose.

What if I take too many tablets?

If you take too many tablets or someone else takes your medicine by mistake, tell your doctor at once.

Do Daraprim tablets have side effects?

Daraprim tablets can cause side effects in some people.

Please tell your doctor IMMEDIATELY if you get any of the following while you are taking Daraprim:

Sore throat, an unexpected illness or skin reaction e.g. a rash or irritation, or abnormal bruising, tiredness, weakness, giddiness or breathlessness. These symptoms may mean that you are suffering from a type of anaemia, or might be at risk of infection or bleeding. Your doctor will be able to confirm this by carrying out a blood test, and if necessary, will give you appropriate treatment.

If you have been prescribed Daraprim to protect against malaria, tell your doctor or pharmacist:

If you become unwell during or after your return to the United Kingdom or Ireland (particularly if you have been taking the medicine for a long time) and you are unable to think of another reason for your feeling unwell.

Daraprim tablets may possibly bring on seizures (fits) in patients who are prone to epilepsy.

If you have been prescribed Daraprim for toxoplasmosis please also check the precautions for the sulphonamide medicine you have been prescribed.

Looking after your Daraprim tablets

Store these tablets below 30°C and inside the original packaging to protect them from light.

Keep out of the reach and sight of children.

Do not use after the expiry date on the pack.

If your doctor tells you to stop taking the tablets, please return any which are left over to your pharmacist. Only keep them if your doctor tells you to.

REMEMBER

This medicine is for you. Never give it to anyone else. It may harm them.
If you are taking Daraprim to prevent malaria, no antimalarial agent gives complete protection. Further precautionary measures such as covering exposed areas of the body, application of insect repellents and the use of mosquito nets is advised.
If you are taking Daraprim to prevent malaria, it is essential to take medical advice on which antimalarial prophylactic medicine to take. For some countries it may NOT be suitable to take Daraprim.

Medicine: daraprim