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MALARONE TABLETS 250 MG/100 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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Package leaflet: information for
the patient

Malarone®
250 mg/100 mg film-coated
tablets
atovaquone/proguanil
hydrochloride
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:
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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.
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areas of the skin
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FRYHUV PRVW RI WKH ERG\, especially
after sunset as this is the time when
mosquitoes are most active
Ě 6OHHS LQ D VFUHHQHG URRP or under
a mosquito net impregnated with
insecticide
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sunset, if they are not screened

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(mats, spray, plug-ins) to clear
a room of insects or to deter
mosquitoes from entering the room.
➔ ,I \RX QHHG IXUWKHU DGYLFH, 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.
➔ 6HH D GRFWRU LPPHGLDWHO\ LI
you get symptoms such as high
temperature, headache, shivering
and tiredness after returning home.

What you need to

2 know before you
take Malarone

Do not take Malarone:
Ě LI \RX DUH DOOHUJLF to atovaquone,
proguanil hydrochloride or any of the
ingredients of this medicine listed in
section 6.
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KDYH VHYHUH NLGQH\ GLVHDVH
➔ 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:
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Ě \RXU FKLOG LV EHLQJ WUHDWHG IRU 0DODULD
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
DUH WDNLQJ 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:
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nausea and vomiting
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rifampicin and rifabutin
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protease-inhibitors used to treat HIV
Ě ZDUIDULQ and other medicines that
stop blood clotting
Ě HWRSRVLGH 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
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take Malarone unless your doctor
recommends it.
➔ Ask your doctor or pharmacist for
advice before taking Malarone

Do not breast-feed while taking
0DODURQH as the ingredients of
Malarone may pass into breast milk and
may harm your baby.

Driving and using
machines
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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.

How to take

3 Malarone

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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)
)RU SUHYHQWLQJ PDODULD
Ě LI \RX DUH VLFN (vomit) within
1 hour of taking your Malarone
WDEOHW take another dose straight
away
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course of Malarone. If you have to
take extra tablets due to sickness,
you may need another prescription.
Ě LI \RX KDYH EHHQ YRPLWLQJ 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:
Ě LI \RX KDYH YRPLWLQJ DQG
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.
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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:
Ě VWDUW WDNLQJ 0DODURQH 1 to 2 days
before travelling to an area which
has malaria
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your stay
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after your return to a malaria-free
area.

10000000115379

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:
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3 days
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3 days
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3 days
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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
,W LV YHU\ LPSRUWDQW WKDW \RX WDNH WKH
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.
'RQďW WDNH H[WUD WDEOHWV WR PDNH XS
for a missed dose. Just take your
QH[W GRVH DW WKH XVXDO WLPH

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.

Possible

4 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.
6HYHUH DOOHUJLF UHDFWLRQV  signs
include:
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chest or throat, or difficulty breathing
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other part of the body.
➔ Contact a doctor immediately if
you get any of these symptoms. 6WRS
taking Malarone.
6HYHUH VNLQ UHDFWLRQV
Ě VNLQ UDVK ZKLFK PD\ EOLVWHU DQG
looks like small targets (central dark
spots, surrounded by paler area
with a dark ring around the edge)
(erythema multiforme)
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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.

Very common side effects
These may affect more than 1 in
10 people:
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and vomiting)
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Common side effects
These may affect up to 1 in 10 people:
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Common side effects, which may show
up in your blood tests are:
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(anaemia) which can cause tiredness,
headaches and shortness of breath
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(neutropenia) which may make you
more likely to catch infections
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(hyponatraemia)
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8QFRPPRQ VLGH HIIHFWV
These may affect up to 1 in 100 people:
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beating of the heart (palpitations)
(
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Uncommon side effects that may show
up in your blood tests:
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produced in the pancreas).

Rare side effects
These may affect up to 1 in
 SHRSOH
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there (hallucinations)
Other side effects
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a small number of people but their
exact frequency is unknown.
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(cholestatis)
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(vasculitis) which may be visible as
red or purple raised spots on the skin
but can affect other parts of the body
Ě ILWV seizures

)
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which the person loses contact with
reality and is unable to think and
judge clearly
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sunlight.
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your blood tests:
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(
(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 this medicine out of the sight
and reach of children.
Do not use this medicine after the
H[SLU\ GDWH shown on the carton.
Malarone does not require any
special storage conditions.
Do not throw away any medicines via
waste water or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. This will
help protect the environment.

6

Contents of the
pack and other
information

What Malarone contains
7KH DFWLYH LQJUHGLHQWV DUH 250 mg
of atovaquone and 100 mg of proguanil
hydrochloride in each tablet.
The other ingredients are:
tablet core: poloxamer 188,
microcrystalline cellulose, hydroxypropyl
cellulose, povidone K30, sodium starch
glycollate (Type A), magnesium stearate
tablet coating: hypromellose, titanium
dioxide (E171), iron oxide red (E172),
macrogol 400 and polyethylene glycol
8000 (see section 2).
➔ 7HOO \RXU GRFWRU ZLWKRXW WDNLQJ
Malarone if you might be allergic to
any of these ingredients.

The marketing authorisation holder
is Glaxo Wellcome UK Ltd, Stockley Park
West, Uxbridge, UK
The manufacturer is
Glaxo Wellcome S.A., Aranda de Duero,
Burgos, Spain
2WKHU IRUPDWV
To listen to or request a copy of this
leaflet in Braille, large print or audio,
please call, free of charge:

   8. 2QO\
Please be ready to give the following
information:
Product name
Malarone
250 mg/100 mg
film-coated tablets
Reference number 10949/0258
This is a service provided by the Royal
National Institute of Blind People.
7KLV OHDIOHW ZDV ODVW UHYLVHG LQ
July 2013
Malarone is a registered trademark of
the GlaxoSmithKline group of companies.
©2013 GlaxoSmithKline group of
companies. All rights reserved.

What Malarone looks like
and contents of the pack
Malarone tablets are round, pink
film-coated tablets engraved ‘GX CM3’
on one side. They are supplied in blister
packs containing 12 tablets.
10000000115379

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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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