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MALARONE PAEDIATRIC TABLETS

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Read right through this leaflet carefully before you take this medicine or give it to your child.
This medicine has been prescribed for you or your child. Don’t pass it on to other people – it may harm them even if their
symptoms seem to be the same as yours.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist (chemist).

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In this leaflet:
1. What Malarone Paediatric is and what it’s for
2. Before you give Malarone Paediatric
3. While giving Malarone Paediatric
4. How to give Malarone Paediatric
5. Possible side effects
6. How to store Malarone Paediatric
7. Further information
1. What Malarone Paediatric is and what it's for
Malarone Paediatric belongs to a group of medicines called antimalarials. Each tablet contains two active ingredients, atovaquone
and proguanil hydrochloride.
What Malarone Paediatric is for
Malarone Paediatric has two uses:
• to prevent malaria (for children weighing between 11kg and 40kg)
• to treat malaria (for children weighing between 5kg and 11kg).
Dosage instructions for each use are in Section 4, How to give Malarone Paediatric.

PROOF HISTORY:
v.1 - waymade - 05/10/12

Although this medicine is usually used for children and teenagers, it can also be prescribed for adults weighing less than 40kg.
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.
Protecting 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.



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.

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See a doctor immediately if your child gets symptoms after returning from abroad – such as high temperature, headache,
shivering and tiredness.
2. Before you give Malarone Paediatric
Do not give Malarone Paediatric:
• If your child is allergic (hypersensitive) to atovaquone, proguanil hydrochloride or any ingredient
• For preventing malaria, if your child has severe kidney disease.
Tell your doctor if either of these apply to your child.

Q.A.
APPROVED:

DATE:
05/10/12

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







DATE OF PROOF:

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.

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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.

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ARTWORKER:
Malarone Paediatric tabs
PRODUCT:

CUSTOMER: Waymade

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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:

PRE-PRESS NO.:

Other medicines and Malarone Paediatric
Tell your doctor or pharmacist if your child is taking any other medicines, or has recently taken any, including medicines
bought without a prescription.

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

Remember to tell your doctor if your child starts taking any other medicines while taking Malarone Paediatric.
3. While giving Malarone Paediatric
Giving Malarone Paediatric with food and drink
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.
Driving and using machines
Malarone Paediatric is not expected to affect your ability to drive or use machinery.
If your child is sick (vomits)
For preventing malaria:
• if your child is sick (vomits) within 1 hour of taking Malarone Paediatric, give another dose straight away
• 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.
• 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:
• 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.
4. How to give Malarone Paediatric
Always give Malarone Paediatric exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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.
It is best to give Malarone Paediatric at the same time each day.
To prevent malaria
The usual dose to prevent malaria depends on your child’s weight:
11-20kg
21-30kg
31-40kg

1 tablet once a day
2 tablets once a day (as a single dose)
3 tablets once a day (as a single dose)

• Start giving Malarone Paediatric 1 to 2 days before travelling to an area which has malaria.
• Continue giving it every day during the stay.
• 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.
To treat malaria
The usual dose to treat malaria depends on your child’s weight.
5-8kg
2 tablets once a day for 3 days.
9-10kg
3 tablets once a day for 3 days.

WARNING!

CUSTOMER
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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, and 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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Leaflet Flat Size = 180 x 429

If you or your child has serious side effects, or if you notice any side effects not listed in this leaflet, tell your doctor or
pharmacist.

WARNING!

This medicine is called by the above name, but will usually be referred to as Malarone Paediatric in this leaflet.
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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

MALARONE® PAEDIATRIC TABLETS
(atovaquone/proguanil hydrochloride)
Patient Information Leaflet

000-0000F

Don’t take a double dose to make up for a missed dose.
Don’t stop 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 product, ask your doctor or pharmacist.
5. Possible side effects
Like all medicines, Malarone Paediatric can cause side effects, although not everybody gets them.

Contact a doctor immediately if your child gets any of these symptoms. Stop giving Malarone Paediatric.
Severe skin reactions
• skin rash which may blister and look like small targets (central dark spots, surrounded by paler areas with a dark ring
around the edge) (erytheme 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.

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.

WARNING!

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.
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Most of the other side effects reported have been mild and have not lasted very long.

Common side effects which may show up in 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.

UK PIL DATED OCTOBER 2011

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06/07/12

DATE:

Uncommon side effects that might show up in blood tests:
• an increase in amylase (an enzyme produced in the pancreas).

DATE OF PROOF:

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Malarone Paediatric tabs
PRODUCT:

CUSTOMER: Waymade

ARTWORKER:

Q.A.
APPROVED:

Uncommon side effect
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.

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 bile ducts (cholestatis)
• increased 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
• seeing or hearing things that are not there (hallucinations)
• nightmares
• mouth ulcers
• blisters
• peeling skin
• increased sensitivity of the skin to sunlight.
Other side effects, which may show up in blood tests are:
• decrease in all types of blood cells (Pancytopenia).
If your child gets any side effects
If any of the side effects gets serious or troublesome or if you notice any side effects not listed in this leaflet:
Tell a doctor or pharmacist.






6. How to store Malarone Paediatric
Keep Malarone Paediatric Tablets out of the sight and reach of children.
Do not use Malarone Paediatric Tablets after the expiry date printed on the carton.
Do not store above 30˚C.
If you have any unwanted Malarone Paediatric Tablets, don’t dispose of them in your waste water or household rubbish.
Take them back to your pharmacist who will dispose of them in a way that won’t harm the environment.
If your tablets become discoloured or show any other signs of deterioration you should seek the advice of your
pharmacist.

7. Further information
What Malarone Paediatric Tablets contain
Each film-coated tablet of Malarone Paediatric Tablets contains 62.5mg of atovaquone and 25mg of proguanil hydrochloride as
the active ingredients.
There are also some inactive ingredients in Malarone Paediatric Tablets. These are: poloxamer 188, microcrystalline cellulose,
low-substituted hydroxypropylcellulose, povidone K30, sodium starch glycollate (type A), magnesium stearate, hypromellose,
titanium dioxide (E171), iron oxide red (E172), macrogol 400 and macrogol 8000.
Tell your doctor, before giving Malarone Paediatric Tablets to your child, if you think your child might be allergic to any of these
ingredients.
What Malarone Paediatric Tablets look like and contents of the pack
Malarone Paediatric Tablets are pink, round, film-coated tablets marked 'GX' and 'CG7' on one side and plain on the reverse.
Malarone Paediatric Tablets are available as packs of 12 tablets.
Manufacturer and Marketing Authorisation Holder
POM

PL No: 6464/2604

This product is manufactured by Glaxo Wellcome GmbH & Co. Bad Oldesloe, Germany and procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision and issue date (Ref.) 1.10.2012
Malarone is a registered trademark of GlaxoSmithKline group of companies

WARNING!

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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.

PROOF HISTORY:
v.1 - waymade - 05/10/12

Leaflet Flat Size = 180 x 429

Look out for the following severe reactions. They have occurred in a small number of people, but their exact frequency is unknown.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

If you forget to give Malarone Paediatric
It is very important that your child takes the full course of Malarone Paediatric.
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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

If your child takes too much Malarone Paediatric
Contact a doctor or pharmacist for advice. If possible show them the Malarone Paediatric pack.

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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