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MALARONE 250MG/100MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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Malarone® 250mg/100mg Film-coated Tablets
(atovaquone/proguanil hydrochloride)
Patient Information Leaflet
Your medicine is known by the above name but will be referred to as
Malarone throughout 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 weigh less than 11kg. There is
another tablet strength to treat children who weighs less than 11kg (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 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.
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 40kgs.
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.

Rare side effects
These may affect up to 1 in 1,000 people:
 seeing or hearing things that are not there (hallucinations)

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.

Other side effects
 Other side effects have occurred in a small number of people but their exact
frequency is unknown.
 Inflammation of the liver (hepatitis)
 blockage of the bile ducts (cholestatis)
 increase in heart rate (tachycardia)
 inflammation of the blood vessels (vasculitis) which may be visible as red or
purple raised spots on the skin but can affect other parts of the body
 fits (seizures)
 panic attacks, crying
 nightmares
 severe mental health problem in which the person loses contact with reality
and is unable to think and judge clearly
 mouth ulcers
 blisters
 peeling skin
 increased sensitivity of the skin to sunlight.

Don’t stop taking 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.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.

4) Possible side effects
Like all medicines, this medicine 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 - 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 these symptoms. Stop
taking Malarone.
Severe skin reactions
 skin rash, which may blister and looks like small targets (central dark spots,
surrounded by paler area with a dark ring around the edge) (erythema
multiforme)
 severe widespread rash with blisters and peeling skin, particularly occurring
around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
If you notice any of these symptoms contact a doctor urgently.
Most of the other side effects reported have been mild and have not lasted
very long.

Other side effects that may show up in your blood tests:
 A decrease in all types of blood cells (pancytopenia).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety
of this medicine.

5) How to store Malarone
 Keep out of the sight and reach of children.
 Malarone does not require any special storage conditions.
 Do not use this medicine after the expiry date which is stated on the carton
and the blister pack. The expiry date refers to the last day of that month.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to do.
 Medicines should not be thrown in your bin or put down the drain. If they are
out of date, or no longer suitable for you, return them to your pharmacist for
safe disposal. These measures will help to protect the environment.

6) Contents of the pack and other information
Very common side effects
These may affect more than 1 in 10 people:
 headache
 feeling sick and being sick (nausea and vomiting)
 stomach pain
 diarrhoea.
Common side effects
These may affect up to 1 in 10 people:
 dizziness
 sleeping problems (insomnia)
 strange dreams
 depression
 loss of appetite
 fever
 rash which may be itchy
 cough.
Common side effects, which may show up in your blood tests are:
 reduced numbers of red blood cells (anaemia) which can cause tiredness,
headaches and shortness of breath
 reduced numbers of white blood cells (neutropenia) which may make you
more likely to catch infections
 low levels of sodium in the blood (hyponatraemia)
 an increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in 100 people:
 anxiety
 an unusual awareness of abnormal beating of the heart (palpitations)
 swelling and redness of the mouth
 hair loss.
Uncommon side effects that may show up in your blood tests:
 an increase in amylase (an enzyme produced in the pancreas).

What Malarone contains
The active ingredients are atovaquone and proguanil hydrochloride.
Each tablet contains 250mg of atovaquone and 100mg of proguanil
hydrochloride.
The other ingredients are:
tablet core: poloxamer 188, microcrystalline cellulose, hydroxypropyl
cellulose, povidone K30, sodium starch glycolate (Type A), magnesium
stearate
tablet coating: hypromellose, titanium dioxide (E171), iron oxide red (E172),
macrogol 400 and macrogol 8000
Tell your doctor without taking Malarone if you might be allergic to any of
these ingredients.
What Malarone looks like and contents of the pack
Malarone tablets are round, biconvex, film-coated pink tablets engraved ‘GX
CM3’ on one side and plain on the reverse.
Malarone tablets are available in blister packs of 12 tablets.
PL 10383/2121

Malarone 250mg/100mg Film-coated Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Glaxo Wellcome S.A., Avenida de
Extremadura, 3 09400 Aranda de Duero, Burgos, Spain. Procured from within
the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 01.10.2014

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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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