Sulfadoxine and tablets Before you start to take it Your doctor must know about all the following before you start to take Sulfadoxine and Pyrimethamine. This information is a summary only. It does not contain all information about

this medicine. If you would like more information about the medicine you are

taking, check with your doctor or other health care provider. No rights can be Tell your doctor if:

derived from the information provided in this medicine leaflet. 1. you are pregnant or plan to become pregnant Sulfadoxine and Pyrimethamine is not generally recommended for use in pregnant women unless the benefits of treatment outweigh the risk to the What Sulfadoxine and Pyrimethamine is used for unborn baby. Sulfadoxine and Pyrimethamine tablets contains the active ingredients sulfadoxine and pyrimethamine. 2. you have any other health problems, especially the following: Sulfadoxine and Pyrimethamine tablets belongs to a group of medicines called  kidney problems anti-malarial agents.  liver problems Sulfadoxine and Pyrimethamine is used for prevention and treatment of .  any type of blood disease Sulfadoxine and Pyrimethamine tablets belongs to a group of medicines called sulfonamides. If you have not told your doctor about any of the above, tell them before you Pyrimethamine belongs to a group of medicines called diaminopyrimidines. Both start taking substances work together in the prevention and treatment of malaria. Sulfadoxine and Pyrimethamine.

Where and how you can contract malaria Taking other medicines Malaria is an infectious disease that is widespread in tropical and subtropical Tell your doctor if you are taking any other medicines, including any that you have areas of Africa, Latin America, Asia and countries around the Pacific. There are bought from a pharmacy, supermarket or health food shop. different forms of malaria, each of them caused by a specific parasite transmitted Some medicines may interfere with Sulfadoxine and Pyrimethamine. These to humans by the bite of the Anopheles mosquito. medicines include:  , a medicine used to treat or prevent malaria Symptoms of malaria  , a medicine used to treat cramps The symptoms of malaria may often be mild. However, malaria should be  some cancer medicines suspected if, after one week in a malarial area, you suffer unexplained fever with  some local anaesthetics or without other symptoms such as headache, aching limbs, weakness, shaking,  sulfonylureas, medicines used to treat diabetes chills, and sometimes diarrhoea, vomiting and cough. These symptoms can easily  methotrexate, a medicine used to treat psoriasis and some cancers. be confused with influenza. If these symptoms are due to the most dangerous form of malaria caused by the These medicines may be affected by Sulfadoxine and Pyrimethamine, or may falciparum parasite, and they are not treated in time, severe organ damage, loss affect how well it works. You may need to take different amounts of your of consciousness and death can occur within a short period. The less dangerous medicine, or you may need to take different medicines. Your doctor will advise forms of malaria, which are not life threatening, can break out months or even you. years after the end of a stay in a malarial area. Your doctor or pharmacist has more information on medicines to be careful with Diagnosis and treatment of malaria or avoid while taking Sulfadoxine and Pyrimethamine. Early diagnosis is critical for successful treatment. Anyone suspected of malaria should seek medical attention promptly and request that a blood sample be Ask your doctor or pharmacist if you are not sure about this list of medicines. taken and examined microscopically for malaria parasites. Most tourists and business travelers will normally be able to receive medical How to take Sulfadoxine and Pyrimethamine attention. However, if this is not readily available, anti-malarial drug treatment Follow all directions given to you by your doctor or pharmacist carefully. can be self-administered ('stand-by treatment'). They may differ from the information contained in this leaflet. Consult your doctor about the need to carry 'stand-by treatment' on your trip. Medical advice should still be sought after self-administered drug treatment. How much to take There are many different types of medicines used to treat malaria. Take Sulfadoxine and Pyrimethamine exactly as your doctor has prescribed. Your doctor, however, may have prescribed Sulfadoxine and Pyrimethamine for Your doctor will tell you how many Sulfadoxine and Pyrimethamine tablets to another purpose. take each day.

Ask your doctor if you have any questions about why Sulfadoxine and Treatment of malaria Pyrimethamine has been prescribed for you. The recommended dose for adults and children over 14 years of age is a single Sulfadoxine and Pyrimethamine is not addictive. This medicine is available only dose of 2 to 3 tablets. with a doctor's prescription. For children under 14 years of age, the dose of Sulfadoxine and Pyrimethamine depends on the age of your child. Your doctor will tell you how much your child Do not take Sulfadoxine and Pyrimethamine if: should be given.  you have had an allergic reaction to Sulfadoxine and Pyrimethamine, to another medicine in the or diaminopyrimidine group Prevention of malaria  you develop a skin reaction while taking this drug, if you develop a skin The recommended dose for prevention is dependent on your immune status and reaction you must stop taking Sulfadoxine and Pyrimethamine immediately. age. Your doctor will tell you how many tablets to take.  you have kidney disease The first dose should be taken 1 – 2 weeks before departure to an endemic area.  you have liver disease Administration should be continued during the stay and for the first 4 weeks after  you have a blood disorder known as blood dyscrasia returning.  you have a blood disorder known as megaloblastic anaemia  you are breast-feeding or intend to breast-feed How to take it Sulfadoxine and Pyrimethamine passes into breast milk and may affect your Swallow tablets whole with a glass of water. baby. During treatment make sure that you drink plenty of fluids.  the package is torn or shows signs of tampering  the expiry date (EXP) printed on the pack has passed When to take it  If you take this medicine after the expiry date has passed, it may not work It does not matter whether you take Sulfadoxine and Pyrimethamine food or not. as well.  Do not give Sulfadoxine and Pyrimethamine tablets to infants under 2 How long to take it months of age. Continue taking Sulfadoxine and Pyrimethamine until your doctor tells you to  If you are not sure if you should be taking Sulfadoxine and Pyrimethamine , stop. talk to your doctor. The length of therapy will depend on whether Sulfadoxine and Pyrimethamine is used for treatment or prevention of malaria.

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If you forget to take it Side effects If it is almost time for your next dose, skip the dose you missed and take your Tell your doctor or pharmacist as soon as possible if you do not feel well while next dose when you are meant to. you are taking Otherwise, take it as soon as you remember and then go back to taking it as you Sulfadoxine and Pyrimethamine. would normally. If you are not sure what to do, ask your doctor or pharmacist. Sulfadoxine and Pyrimethamine helps most people with malaria but it may have If you have trouble remembering your dose, ask your pharmacist for some hints. unwanted side effects in a few people. All medicines can have side effects. In case of an overdose Sometimes they are serious, most of the time they are not. You may need Immediately telephone your doctor, or go to Accident and Emergency at your medical treatment if you get some of the side effects. nearest hospital, if you think you or anyone else may have taken too much Sulfadoxine and Pyrimethamine. Do this even if there are no signs of discomfort When Sulfadoxine and Pyrimethamine is used for treatment of malaria, side or poisoning. effects may occur more often than when it is used for prevention of malaria. You may need urgent medical attention. If you are taking Sulfadoxine and Pyrimethamine for the treatment of malaria, you may not be able to distinguish between the side effects of the drug and the Things you must do disease itself. Avoid excessive exposure to the sun while taking Sulfadoxine and Pyrimethamine. Taking Sulfadoxine and Pyrimethamine increases the sensitivity of your skin to the Tell your doctor if you notice any of the following and they worry you: sun.  dizziness  stomach upset including nausea (feeling sick), vomiting Tell all doctors, dentists and pharmacists who are treating you that you are  loss of appetite taking Sulfadoxine and Pyrimethamine.  diarrhoea  tiredness Tell your doctor if you become pregnant while taking Sulfadoxine and  headache Pyrimethamine.  sore mouth or mouth ulcers and cold sores Women of child-bearing potential should use effective contraception throughout  symptoms of sunburn (such as redness, itching, swelling, blistering) which therapy with SULFADOXINE AND PYRIMETHAMINE and for at least 3 months may occur more quickly than normal after taking the last dose.  slight hair loss (reversible on withdrawal of the drug)

Tell your doctor that you are taking Sulfadoxine and Pyrimethamine if you are These are the more common side effects of Sulfadoxine and Pyrimethamine. going to have any laboratory tests. Mostly these are mild. Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Tell your doctor immediately or go to Accident and Emergency at your nearest Otherwise, your doctor may think that it was not effective and change your hospital if you notice any of the following: treatment unnecessarily.  skin reactions such as sudden or severe itching, skin rash, hives If you are taking Sulfadoxine and Pyrimethamine for the treatment of malaria, tell  bleeding or bruising more often than normal your doctor if you feel the tablets are not helping your condition.  tiredness, headache, shortness of breath when exercising, looking pale and If you are taking Sulfadoxine and Pyrimethamine for the treatment of malaria, be yellowing of the skin and/or eyes sure to keep all of your appointments with your doctor so that your progress can  frequent infections such as fever, severe chills, sore throat or mouth ulcers be checked.  coughing, shortness of breath Things you must not do Do not stop taking Sulfadoxine and Pyrimethamine or change the dose without These may be serious side effects. first checking with your doctor. You may need urgent medical attention. Serious side effects are rare. Do not let yourself run out of medicine over the weekend or on holidays. This is not a complete list of all possible side effects. Others may occur in some Do not give Sulfadoxine and Pyrimethamine to anyone else even if they have the people and there may be some side effects not yet known. same condition as you. Do not use Sulfadoxine and Pyrimethamine to treat other complaints unless your Tell your doctor if you notice anything else that is making you feel unwell, even doctor says to. if it is not on this list. Do not take any other medicines whether they require a prescription or not Do not be alarmed by this list of possible side effects. You may not experience any without first telling your doctor or consulting a pharmacist. of them.

Things to be careful of Storage Be careful driving or operating machinery until you know how Sulfadoxine and Keep your tablets in the blister pack until it is time to take them. Pyrimethamine affects you. If you take the tablets out of the blister pack they may not keep well. As with many other medicines used to treat malaria, may cause dizziness, Keep Sulfadoxine and Pyrimethamine in a cool dry place where the temperature drowsiness or stays below 30 degrees C. light-headedness in some people. Make sure you know how you react to before Do not store it, or any other medicine, in a bathroom or near a sink. you drive a car, operate machinery or do anything else that could be dangerous if Do not leave it in the car or on window sills. you are dizzy, drowsy or light-headed. If you drink alcohol, dizziness, drowsiness or light-headedness may be worse. Disposal If your doctor tells you to stop taking Sulfadoxine and Pyrimethamine, or the Further Information tablets have passed their expiry date, ask your pharmacist what to do with any The best protection against malaria is to avoid mosquito bites. The mosquito that tablets that are left over. causes malaria mainly bites between dusk and dawn. Therefore the following precautionary measures are recommended:  during this period, wear clothes that cover as much of your skin as possible  apply mosquito repellent to your uncovered skin and to your clothes  when sleeping in rooms that are not protected against mosquitoes, use an effective mosquito net  well tucked under the mattress  additional protection is provided by smoke spirals, insect sprays and candles.

Lagaay International BV Van Helmontstraat 99 3029 AA Rotterdam, The Netherlands Tel: +31 - 10 4123871