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MALARONE TABLETS 250 MG/100 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE / ATOVAQUONE / PROGUANIL HYDROCHLORIDE / ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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3
62000000013873
GSK-ESP-Aranda-ESARA

Package leaflet: Information for
the patient

Malarone

Malarone
250 mg/100 mg film-coated
tablets
atovaquone/proguanil
hydrochloride

N/A
02-01-XX-273-02

N/A
N/A
1
K

0

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:
0

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

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

• C
 onsider 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.

How to take

3 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
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.

62000000013873

PHARMA CODE N° 6335

United Kingdom-GBR

What Malarone is
and what it is
used for

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62000000013873
GSK-ESP-Aranda-ESARA

To treat malaria

United Kingdom-GBR
Malarone
N/A
02-01-XX-273-02

N/A
N/A
1

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

K

0

0

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 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.
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.

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
• itchy, bumpy rash (hives).
Uncommon side effects that may show
up in your blood tests:
• an increase in amylase (an enzyme
produced in the pancreas).

Rare side effects
These may affect up to 1 in
1,000 people:
• seeing or hearing things that are not
there (hallucinations)
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
• indigestion
• mouth ulcers
• blisters
• peeling skin
• increased sensitivity of the skin to
sunlight.
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 or pharmacist. 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
expiry date which is stated on the
carton after EXP. The expiry date refers to
the last day of that month.
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
The active ingredients are: 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).
➔ Tell your doctor, without taking
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., Avenida de
Extremadura, 3, 09400 Aranda de Duero,
Burgos, Spain
Other formats:
To listen to or request a copy of this
leaflet in Braille, large print or audio,
please call, free of charge:

0800 198 5000 (UK Only)
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.
This leaflet was last revised in
June 2017.
Trade marks are owned by or licensed to
the GSK group of companies.
© 2017 GSK group of companies or its
licensor.

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.

62000000013873

PHARMA CODE N° 6335

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 8.0pt
Leading: 9.0pt
Horizontal Scale: 100%
Smallest text size: 8.0pt
Microtext:No

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Expand Transcript

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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