PACKAGE LEAFLET: INFORMATION FOR THE USER Malarone® Paediatric 62.5 mg/25 mg film-coated tablets 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). 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. _________________________________________________________________________ In this leaflet What Malarone Paediatric is and what it’s for Before you give Malarone Paediatric While giving Malarone Paediatric How to give Malarone Paediatric Possible side effects 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 tabletcontains two active ingredients, atovaquone and proguanil hydrochloride. What Malarone Paediatric is for Malarone Paediatric has two uses:
to prevent malaria (for children weighing between 11 kg and 40 kg)
to treat malaria(for children weighing between 5 kg and 11 kg).
Dosage instructions for each use are in Section 4, 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. 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 MalaronePaediatric, 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
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 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 your child gets symptoms after returning from abroad - such as
high temperature, headache, shivering and tiredness. 2 Before you give MalaronePaediatric 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. Pregnancy and breast feeding
If you or your child is pregnant, do not take Malarone Paediatric unless your doctor recommends it. Do not breast feed while taking Malarone Paediatric tablets, as the ingredients may pass into breast milk and may harm your baby. 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.
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: 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 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. →
Remember to tell your doctor if your child starts taking any other medicines while they’re
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
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.
11-20 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)
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 treatmalaria The usual 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 too much Malarone Paediatric
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 a double dose to make up for a missed dose. Don’t stop Malarone Paediatricwithout 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.
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:
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 your child gets any of these symptoms. Stop giving Malarone Paediatric. 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:
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)
Uncommon side effects
These may affect up to 1 in 100 people:
an unusual awareness of abnormal beating of the heart (palpitations)
Uncommon side effects that might show up in blood tests:
an increase in amylase (an enzyme produced in the pancreas) 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
seeing or hearing things that are not there (hallucinations)
increased sensitivity of the skin to sunlight.
Other side effects, which may show up in blood tests are:
A 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 out of the reach and sight of children. Do not use Malarone Paediatric after the expiry date printed on the carton. Malarone Paediatric does not require any special storage conditions.
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. 7 Further information What Malarone Paediatriccontains
The active ingredients are: 62.5 mg of atovaquone and 25 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. 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 Paediatriclooks like and contents of the pack Malarone Paediatric tablets are round, pink film-coated tablets. They are supplied in blister packs containing 12 tablets.
The marketing authorisation holder is GlaxoSmithKline UK, Stockley Park West, Uxbridge, UK
The manufacturer is Glaxo Wellcome GmbH & Co., Bad Oldesloe, Germany or Glaxo Wellcome S.A., 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 Paediatric 62.5 mg/25 mg film-coated tablets
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in October 2011.
Malarone is a registered trademark of the GlaxoSmithKline group of companies. 2011 GlaxoSmithKline group of companies. All rights reserved.
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