Malarone 250mg/100mg Tablets

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 Malarone belongs to a group of medicines called antimalarials. It contains two active ingredients, atovaquone and proguanil hydrochloride.

What Malarone is for

Malarone has two uses:

• to prevent malaria

• to treat malaria

Dosage instructions for each use are in Section 4, How to take Malarone.

How to take Malarone.

Malaria is spread by the bite of an infected mosquito, which passes the malaria parasite (Plasmodium falciparum) into the bloodstream. Malarone prevents malaria by killing this parasite. For people who are already infected with malaria, Malarone also kills these parasites.

(Plasmodium falciparum) into the bloodstream. Malarone prevents malaria by killing this parasite. For people who are already infected with malaria, Malarone also kills these parasites.

Protect yourself from catching malaria

People of any age can get malaria. It is a serious disease, but is preventable. As well as taking Malarone, it is very important that you also take steps to avoid being bitten by mosquitoes.

• Use insect repellent on exposed areas of the skin

• Wear light coloured clothing that covers most of the body, especially after sunset as this is the time when mosquitoes are most active

especially after sunset as this is the time when mosquitoes are most active

• Sleep in a screened room or under a mosquito net impregnated with insecticide

or under a mosquito net impregnated with insecticide

• Close windows and doors at sunset, if they are not screened

• Consider using an insecticide (mats, spray, plug-ins) to clear a room of insects or to deter mosquitoes from entering the room.

(mats, spray, plug-ins) to clear a room of insects or to deter mosquitoes from entering the room.

 If you need further advice, talk to your doctor or pharmacist.

If you need further advice, talk to your doctor or pharmacist.

It is still possible to get malaria after taking the necessary precautions.

Some types of malaria infection take a long time to cause symptoms, so the illness may not start until several days, weeks or even months after returning from abroad.

 See a doctor immediately if you get symptoms such as high temperature, headache, shivering and tiredness after returning home.

See a doctor immediately if you get symptoms such as high temperature, headache, shivering and tiredness after returning home.

Do not take Malarone:

Do not take Malarone:

• if you are allergic (hypersensitive) to atovaquone, proguanil hydrochloride or any ingredient

(hypersensitive) to atovaquone, proguanil hydrochloride or any ingredient

• for preventing malaria, if you have severe kidney disease.

 Tell your doctor if either of these apply to you.

Tell your doctor if either of these apply to you.

Pregnancy and breast feeding

If you are pregnant, do not take Malarone unless your doctor recommends it.

unless your doctor recommends it.

 Ask your doctor or pharmacist for advice before taking Malarone.

Ask your doctor or pharmacist for advice before taking Malarone.

Do not breast feed while taking Malarone, as the ingredients of Malarone may pass into breast milk and may harm your baby.

, as the ingredients of Malarone may pass into breast milk and may harm your baby.

Other medicines and Malarone

Tell your doctor or pharmacist if you’re taking any other medicines, or have recently taken any, including medicines you’ve bought without a prescription.

Some medicines can affect the way Malarone works, or Malarone itself can strengthen or weaken the effectiveness of other medicines taken at the same time. These include:

• metoclopramide, used to treat nausea and vomiting

, used to treat nausea and vomiting• the antibiotics, tetracycline, rifampicin and rifabutin

• indinavir, used to treat HIV

, used to treat HIV

• warfarin and other medicines that stop blood clotting.

and other medicines that stop blood clotting.

 Tell your doctor if you are taking any of these. Your doctor may decide that Malarone isn’t suitable for you, or that you need extra check ups while you’re taking it.

Tell your doctor if you are taking any of these. Your doctor may decide that Malarone isn’t suitable for you, or that you need extra check ups while you’re taking it.

 Remember to tell your doctor if you start taking any other medicines while you’re taking Malarone.

Remember to tell your doctor if you start taking any other medicines while you’re taking Malarone.

Taking Malarone with food and drink

Taking Malarone with food and drink

Take Malarone with food or a milky drink, where possible. This will increase the amount of Malarone your body can absorb, and make your treatment more effective.

, where possible. This will increase the amount of Malarone your body can absorb, and make your treatment more effective.

Driving and using machines

If you feel dizzy, do not drive. Malarone makes some people feel dizzy. If this happens to you, do not drive, use machines or take part in activities where you may put yourself or others at risk.

Malarone makes some people feel dizzy. If this happens to you, do not drive, use machines or take part in activities where you may put yourself or others at risk.If you are sick (vomit):

For preventing malaria:

• if you are sick (vomit) within 1 hour of taking your Malarone tablet, take another dose straight away

(vomit) within 1 hour of taking your Malarone tablet, take another dose straight away

• it is important to take the full course of Malarone. If you have to take extra tablets due to sickness, you may need another prescription.

. If you have to take extra tablets due to sickness, you may need another prescription.

• if you have been vomiting, it is especially important to use extra protection, such as repellents and bednets. Malarone may not be as effective, as the amount absorbed will be reduced.

, it is especially important to use extra protection, such as repellents and bednets. Malarone may not be as effective, as the amount absorbed will be reduced.

For treating malaria:

• if you have vomiting and diarrhoea tell your doctor, you will need regular blood tests. Malarone will not be as effective, as the amount absorbed will be reduced. The tests will check whether the malaria parasite is being cleared from your blood.

Always take Malarone exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take Malarone with food or a milky drink, where possible. It is best to take Malarone at the same time each day.

To prevent malaria

 The usual dose for adults is 1 tablet once a day, taken as below.

 The usual dose for adults is 1 tablet once a day, taken as below. Not for children, talk to your doctor.

Not recommended for preventing malaria in children

Not recommended for preventing malaria in children, or in adults who weigh less than 40 kgs.

There may be a different type of Malarone tablet available for children in your country.

To prevent malaria in adults:

• start taking Malarone 1 to 2 days before travelling to an area which has malaria

• continue taking it every day during your stay

• continue taking it for another 7 days after your return to a malaria-free area.

To treat malaria

The usual dose for adults is 4 tablets once a day for 3 days.

is 4 tablets once a day for 3 days.For children the dose depends on their bodyweight:

• 11-20 kg – 1 tablet once a day for 3 days

• 21-30 kg – 2 tablets once a day for 3 days

• 31-40 kg – 3 tablets once a day for 3 days

• over 40 kg – dose as for adults.

Not recommended for treating malaria in children who weigh less than 11 kgs.

For children who weigh less than 11 kgs talk to your doctor. There may be a different type of Malarone tablet available in your country.

If you take too much Malarone

Contact a doctor or pharmacist for advice. If possible show them the Malarone pack.

If you forget to take Malarone

It is very important that you take the full course of Malarone.

If you forget to take a dose, don’t worry. Just take your next dose as soon as you remember. Then continue your treatment as before.

Don’t take a double dose to make up for a missed dose.

Don’t stop Malarone without advice

Keep taking Malarone for 7 days after you return to a malaria-free area. Take the full course of Malarone for maximum protection. Stopping early puts you at risk of getting malaria, as it takes 7 days to ensure that any parasites that may be in your blood following a bite from an infected mosquito are killed. Do not take Malarone for longer than 37 days. If you are expecting to stay in an area with malaria for more than 28 days check with your doctor before travelling. Malarone may not be suitable for you.

 

Keep taking Malarone for 7 days after you return to a malaria-free area. Take the full course of Malarone for maximum protection. Stopping early puts you at risk of getting malaria, as it takes 7 days to ensure that any parasites that may be in your blood following a bite from an infected mosquito are killed. Do not take Malarone for longer than 37 days. If you are expecting to stay in an area with malaria for more than 28 days check with your doctor before travelling. Malarone may not be suitable for you.

Keep taking Malarone for 7 days after you return to a malaria-free area. Take the full course of Malarone for maximum protection. Stopping early puts you at risk of getting malaria, as it takes 7 days to ensure that any parasites that may be in your blood following a bite from an infected mosquito are killed. Do not take Malarone for longer than 37 days. If you are expecting to stay in an area with malaria for more than 28 days check with your doctor before travelling. Malarone may not be suitable for you.

Take the full course of Malarone for maximum protection. Stopping early puts you at risk of getting malaria, as it takes 7 days to ensure that any parasites that may be in your blood following a bite from an infected mosquito are killed. Do not take Malarone for longer than 37 days. If you are expecting to stay in an area with malaria for more than 28 days check with your doctor before travelling. Malarone may not be suitable for you.Like all medicines, Malarone can cause side effects, although not everybody gets them. Look out for the following severe reactions. They have occurred in a small number of people, but their exact frequency is unknown.

Severe allergic reactions -

Severe allergic reactions - signs include:

•

• rash and itching

•

• sudden wheezing, tightness of the chest or throat, or difficulty breathing

•

• swollen eyelids, face, lips, tongue or other part of the body.



 Contact a doctor immediately if you get any of t

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