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MALARONE 250MG/100MG TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Malarone® 250mg/100mg Tablets
(atovaquone/proguanil hydrochloride)
Your medicine is known as the above but it will be referred to as
Malarone throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
 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 only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
 If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Malarone is and what it is used for
2. What you need to know before you take Malarone
3. How to take Malarone
4. Possible side effects
5. How to store Malarone
6. Contents of the pack and other information
1.

What Malarone is and what it is used for

Malarone belongs to a group of medicines called antimalarials. It
contains two active ingredients, atovaquone and proguanil
hydrochloride.
What Malarone is used for
Malarone has two uses:
■ to prevent malaria
■ to treat malaria
Dosage instructions for each use are in Section 3, 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.
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
Sleep in a screened room 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.

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.
2.

What you need to know before you take Malarone

Do not take Malarone:
if you are allergic to atovaquone, proguanil hydrochloride or
any of the ingredients of this medicine listed in section 6.
■ for preventing malaria, if you have severe kidney disease.


Tell your doctor if either of these apply to you.
Take special care with Malarone
Talk to your doctor or pharmacist before taking Malarone if:
■ you have severe kidney disease
■ your child is being treated for Malaria and weighs less than 11
kg. There is another tablet strength to treat children who weigh
less than 11 kg (see section 3).
Tell your doctor or pharmacist if any of these applies to you.
Other medicines and Malarone
Tell your doctor or pharmacist if you are taking, have recently
taken, or might take any other medicines, 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
■ the antibiotics, tetracycline, rifampicin and rifabutin
■ efavirenz or certain highly active protease-inhibitors used to
treat HIV
■ warfarin and other medicines that stop blood clotting
■ etoposide used to treat cancer.

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.
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.
Pregnancy and breast-feeding
If you are pregnant, do not take Malarone unless your doctor
recommends it.
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.
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.
3.

How to take Malarone

Always take this medicine exactly as your doctor or pharmacist
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.
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
■ 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 been vomiting, it is especially important to use
extra protection, such as repellents and bed nets. 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.



To prevent malaria
The recommended usual dose for adults is 1 tablet once a day,
taken as below.
Not recommended for preventing malaria in children, or in
adults who weigh less than 40 kgs.
Malarone paediatric tablets are recommended for preventing
malaria in adults and children who weigh less than 40 kgs.
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 recommended dose for adults 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 more Malarone than you should
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 extra tablets to make up for a missed dose.
Just take your next dose at the usual time.
Don’t stop taking Malarone without advice
Keep taking Malarone for 7 days after you return to a malariafree 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.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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