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MALARONE PAEDIATRIC 62.5MG/25 MG FILM-COATED TABLETS

Active substance(s): ATOVAQUONE / PROGUANIL HYDROCHLORIDE

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Malarone
1 What
Paediatric is and
Package leaflet: Information for
the user

®

Malarone
Paediatric

62.5 mg/25 mg film-coated
tablets
atovaquone/proguanil
hydrochloride
Read all of this leaflet carefully
before you start taking this medicine
or give it to your child 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 or your child 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 or your child 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 Paediatric is and
what it is used for
2 What you need to know before
you give Malarone Paediatric
3 How to give Malarone Paediatric
4 Possible side effects
5 How to store Malarone Paediatric
6 Contents of the pack and other
information

what it is used for
Malarone Paediatric belongs to a group
of medicines called antimalarials. Each
tablet contains two active ingredients,
atovaquone and proguanil hydrochloride.

Ě Sleep in a screened room or under
a mosquito net impregnated with
insecticide
Ě Close windows and doors at
sunset, if they are not screened
Ě Consider using an insecticide
(mats, spray, plug-ins) to clear a room
of insects or to deter mosquitoes from
entering the room.

What Malarone Paediatric
is used for

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

Malarone Paediatric has two uses:
Ě to prevent malaria (for children
weighing between 11 kg and 40 kg)
Ě to treat malaria (for children
weighing between 5 kg and <11 kg).
Dosage instructions for each use are in
Section 3, How to give Malarone Paediatric.
Although this medicine is usually used
for children and teenagers, it can also be
prescribed for adults weighing less than
40 kg.

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.

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

Protect your child from
catching malaria.
People of any age can get malaria. It is a
serious disease, but is preventable.
As well as taking Malarone Paediatric, it
is very important that you also take steps
to avoid being bitten by mosquitoes.
Ě Use insect repellent on exposed
areas of the skin
Ě Wear light coloured clothing that
covers most of the body, especially
after sunset as this is the time when
mosquitoes are most active

➔ See a doctor immediately if your
child gets symptoms after
returning from abroad - such as high
temperature, headache, shivering
and tiredness.

What you need to
2 know
before you
give Malarone
Paediatric
Do not give Malarone
Paediatric:
Ě if your child is allergic to
atovaquone, proguanil hydrochloride
or any of the ingredients of this
medicine (listed in section 6).
Ě for preventing malaria, if your
child has severe kidney disease.
➔ Tell your doctor if either of these
apply to your child.

Take special care with Malarone
Paediatric
Talk to your doctor or pharmacist
before you give Malarone Paediatric
to your child if:
Ě your child has severe kidney disease
Ě your child is being treated for Malaria
and weighs less than 5 kg or is given
Malarone Paediatric to prevent
Malaria and weighs less than 11 kg.

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

➔ Tell your doctor or pharmacist if
any of these applies to your child.

If you or your child is pregnant, do
not take Malarone Paediatric unless
your doctor recommends it.

Other medicines and
Malarone Paediatric
Tell your doctor or pharmacist if your
child is taking, have recently taken or
might take any other medicines,
including medicines bought without a
prescription.
Some medicines can affect the way
Malarone Paediatric works, or Malarone
Paediatric itself can strengthen or weaken
the effectiveness of other medicines taken
at the same time. These include:
Ě metoclopramide, used to treat
nausea and vomiting
Ě the antibiotics, tetracycline,
rifampicin and rifabutin
Ě efavirenz or certain highly active
protease-inhibitors used to treat HIV
Ě warfarin and other medicines that
stop blood clotting
Ě etoposide used to treat cancer.

Malarone Paediatric with
food and drink

Pregnancy and breast-feeding

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

Driving and using machines
If you feel dizzy, do not drive.
Malarone Paediatric 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.

to give
3 How
Malarone Paediatric
Always give this medicine exactly as
your doctor or pharmacist has told
you. Check with your doctor or
pharmacist if you are not sure.

➔ Tell your doctor if your child is
taking any of these. Your doctor may
decide that Malarone Paediatric isn’t
suitable for them, or that they need
extra check ups while taking it.

Give Malarone Paediatric with food or a
milky drink, where possible. The tablets
should be swallowed whole. However,
for children who find them difficult to
swallow, they may be crushed just before
being taken and mixed with food or a
milky drink.

➔ Remember to tell your doctor if
your child starts taking any other
medicines while they’re taking
Malarone Paediatric.

It is best to give Malarone Paediatric at
the same time each day.

If your child is sick (vomits)
For preventing malaria:
Ě if your child is sick (vomits) within
1 hour of taking Malarone Paediatric,
give another dose straight away
Ě it is important to take the full
course of Malarone Paediatric. If
your child has to take extra tablets
due to sickness, they may need
another prescription.
Ě if your child has been vomiting, it
is especially important to use extra
protection, such as repellents and
bednets. Malarone Paediatric may not
be as effective, as the amount
absorbed will be reduced.
For treating malaria:
Ě if your child has vomiting and
diarrhoea tell your doctor. Your child
will need regular blood tests.
Malarone Paediatric will not be as
effective, as the amount absorbed will
be reduced. The tests will check
whether the malaria parasite is being
cleared from their blood.

To prevent malaria
The recommended dose to prevent
malaria depends on your child’s weight.
11-20 kg - 1 tablet once a day
21-30 kg - 2 tablets once a day
(as a single dose)
31-40 kg - 3 tablets once a day
(as a single dose)
Ě Start giving Malarone Paediatric 1 to
2 days before travelling to an area
which has malaria
Ě Continue giving it every day during
the stay
Ě Continue giving it for another 7 days
after your return to a malaria-free
area.
For maximum protection your child
must take the full course of treatment.
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To treat malaria
The recommended dose to treat
malaria depends on your child’s weight.
5-8 kg - 2 tablets once a day for 3 days
9–10 kg - 3 tablets once a day for 3 days

If your child takes more
Malarone Paediatric than
they should have
Contact a doctor or pharmacist for
advice. If possible show them the
Malarone Paediatric pack.

If you forget to give
Malarone Paediatric
It is very important that your child
takes the full course of Malarone
Paediatric tablets.
If you forget to give your child a dose,
don’t worry. Just give the next dose as
soon as you remember. Then continue
the 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 giving Malarone
Paediatric without advice
Keep giving Malarone Paediatric for
7 days after you return to a
malaria-free area. Give the full course
of tablets for maximum protection.
Stopping early puts your child 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:
Ě rash and itching
Ě sudden wheezing, tightness of the
chest or throat, or difficulty breathing
Ě swollen eyelids, face, lips, tongue or
other part of the body.
➔ Contact a doctor immediately if
your child gets any of these symptoms.
Stop giving Malarone Paediatric.
Severe skin reactions
Ě 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)
Ě 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:
Ě headache
Ě feeling sick and being sick (nausea
and vomiting)
Ě stomach pain
Ě diarrhoea.

Common side effects
These may affect up to 1 in 10 people:
Ě dizziness
Ě sleeping problems (insomnia)
Ě strange dreams
Ě depression
Ě loss of appetite
Ě fever
Ě rash which may be itchy
Ě cough.
Common side effects which may show up
in blood tests are:
Ě reduced numbers of red blood cells
(anaemia) which can cause tiredness,
headaches and shortness of breath
Ě reduced numbers of white blood cells
(neutropenia) which may make you
more likely to catch infections
Ě low levels of sodium in the blood
(hyponatraemia)
Ě an increase in liver enzymes.
Uncommon side effects
These may affect up to 1 in
100 people:
Ě anxiety
Ě an unusual awareness of abnormal
beating of the heart (palpitations)
Ě swelling and redness of the mouth
Ě hair loss.
Uncommon side effects that might show
up in blood tests:
Ě an increase in amylase (an enzyme
produced in the pancreas)
Rare side effects
These may affect up to 1 in
1,000 people:
Ě 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.
Ě Inflammation of the liver (hepatitis)
Ě blockage of bile ducts (cholestatis)
Ě increased heart rate (tachycardia)
Ě 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
Ě fits (seizures)
Ě panic attacks, crying
Ě nightmares
Ě severe mental health problem in
which the person loses contact with
reality and is unable to think and
judge clearly
Ě mouth ulcers
Ě blisters
Ě peeling skin
Ě increased sensitivity of the skin to
sunlight.
Other side effects, which may show up in
blood tests are:
Ě A decrease in all types of blood cells
(Pancytopenia).
Reporting of side effects
If your child gets 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.

How to store
5 Malarone
Paediatric

What Malarone Paediatric
looks like and contents of
the pack

Keep this medicine out of the sight
and reach of children.

Malarone Paediatric tablets are round,
pink film-coated tablets. They are
supplied in blister packs containing
12 tablets.

Do not use this medicine after the
expiry date shown on the carton.
Malarone Paediatric does not require
any special storage conditions.

The marketing authorisation holder
is Glaxo Wellcome UK Ltd, Stockley Park
West, Uxbridge, UK

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.

The manufacturer is
Glaxo Wellcome S.A., Aranda de Duero,
Burgos, Spain

6 Contents of the pack

To listen to or request a copy of this
leaflet in Braille, large print or audio,
please call, free of charge:

What Malarone Paediatric
contains

0800 198 5000 (UK Only)

The active ingredients are: 62.5 mg of
atovaquone and 25 mg of proguanil
hydrochloride in each tablet.

Please be ready to give the following
information:

and other information

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, before giving
Malarone Paediatric tablets to
your child, if you think your child
might be allergic to any of these
ingredients.

Other formats:

Product name

Malarone Paediatric
62.5 mg/25 mg
film-coated tablets
Reference number 10949/0363
This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in July
2013.
Malarone is a registered trademark of
the GlaxoSmithKline group of companies.
©2013 GlaxoSmithKline group of
companies. All rights reserved.

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10000000115380

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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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