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MALARONE TABLETS

Active substance: PROGUANIL HYDROCHLORIDE

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MALARONE TABLETS
Patient Information Leaflet
Please read this information leaflet carefully before you start to take your medicine. It
contains all the information you should need to know. If you have any questions or
are not sure about anything, ask your doctor or pharmacist. Keep this leaflet whilst
you are taking this medicine, you may wish to refer to it again.
ABOUT YOUR MEDICINE:
Your medicine is called Malarone Tablets.
Malarone Tablets are round, pink, biconvex, film- coated tablets marked "GX CM3"
on one side and plain on the reverse. Each tablet contains the active ingredients
atovaquone 250mg and proguanil hydrochloride 100mg.
There are also some inactive ingredients in Malarone Tablets. These are: poloxamer
188, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, povidone
K30, sodium starch glycollate, magnesium, stearate, methylhydroxypropyl cellulose,
titanium dioxide (E171), iron oxide red (E172), macrogol 400 and polyethylene glycol
8000.
Malarone Tablets are available as blister packs of 12 tablets.
|POM|

PL No: 10383/1123

Your medicine is manufactured by Glaxo Wellcome Operations, Temple Hill,
Dartford, Kent, DA1 5AH and is procured from within the EU and repackaged by the
Product Licence Holder: Primecrown Ltd, 28 Sarum Complex, Uxbridge, Middlesex,
UB8 2R2.
WHY YOU NEED TO TAKE THIS MEDICINE:
Malarone Tablets belong to a group of medicines called antimalarials. They are used
as a form of protection (prophylaxis) against malaria and to treat malaria caused by
an infection of the blood with the parasite Plasmodium falciparum.
Malarone Tablets contain two active ingredients which work by killing the malarial
parasites in your body to treat or prevent the malaria infection.
BEFORE YOU TAKE YOUR MEDICINE:
This medicine suits most people but there are a few people who should not take it.
Ask yourself these questions to check whether Malarone Tablets are right for you:










Have you ever had an allergic reaction to atovaquone, proguanil hydrochloride
or to any of the other ingredients in Malarone Tablets listed above?
Have you been told that your malaria infection is severe and is affecting your
lungs, kidneys and/or brain?
Have you had malaria before?
Are you pregnant, trying to become pregnant, or breast-feeding?
Are you currently suffering from diarrhoea and/or vomiting?
Do you have kidney disease?
Is the medicine to be taken for the treatment of malaria by a child who weighs
less than 11kg?
Is the medicine to be taken for the prevention of malaria and you or the patient
weigh less than 40kg?
Are you expecting to stay in an area where there is malaria for more than 28
days?

If the answer is "YES" to any of these questions, tell your doctor.
Driving and using machines:
Dizziness has been reported. If you feel affected you should not drive, operate
machinery or take part in activities where you may put yourself or others at risk.
Can you take Malarone Tablets with other medicines?
Always tell your doctor about any other medicines you are taking, including those
you can buy yourself.
Some medicines can stop Malarone Tablets working properly, these are:




Metoclopramide - used to treat sickness (vomiting) and feelings of sickness
(nausea).
Tetracycline, rifampicin or rifabutin - antibiotics
Indinavir

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2005

HOW TO TAKE YOUR MEDICINE:
It is important to take your medicine at the right times, and in the way your
doctor has told you to. The label on your pack will tell you how many tablets to
take and how often. If the label doesn't say, or if you are not sure, ask your
doctor or pharmacist.
Malarone Tablets can be taken for two reasons:

To prevent malaria infection (prophylaxis)

To treat malaria infection
The following important information applies whether you are taking your Malarone
Tablets for prevention or treatment of malaria







If possible take Malarone Tablets with food or a milky drink, so that the
medicine is absorbed better and works properly.
It is also important to take your tablets at the same time each day and complete
the full course.
If you are sick (vomit) within one hour of taking your tablets, take another dose
and then go on as before. If you do this you should contact your doctor for more
Malarone Tablets to replace those you brought up. If you have diarrhoea,
continue taking these tablets as normal.
If you feel ill again, particularly if you develop a fever at any time up to a month
after finishing your tablets see your doctor immediately.
There are no special doses for elderly patients.

To prevent malaria infection:
If you are expecting to stay in an area with malaria for more than 28 days check
before travelling, with a pharmacist or doctor, whether Malarone Tablets are
appropriate for you.
«

The usual dose in adults is one tablet daily.



Start the course of tablets 1 to 2 days before arriving in an area which has
malaria.
Continue taking these tablets every day during your stay.
Continue taking these tablets for a further 7 days after your return to a malaria
free area.


«

This may be different to how other medicines are used to prevent malaria, however,
it is important to follow these instructions unless your doctor has told you otherwise.
If you weigh less than 40 kilograms (Kg), it is recommended that you do NOT take
Malarone Tablets to prevent malaria infection.
There is other very important information on how, in addition to taking Malarone
Tablets, you can protect yourself against malaria infection at the end of this leaflet.
To treat malaria infection:
The usual dose in adults is four tablets once a day for 3 days.
The dose for children depends upon their bodyweight, as follows:
11 -20kg:
21-30kg:
31-40kg:
Over 40kg:

ONE tablet daily for 3 days.
TWO tablets daily for 3 days.
THREE tablets daily for 3 days.
Dose as for adults.

If you are taking Malarone Tablets to treat an attack of malaria and you have
diarrhoea or are sick (vomit), tell your doctor. Your doctor may want to check how
well these tablets are working and if necessary may decide to change your
treatment. A few days after finishing your treatment course you should visit your
doctor to check that your malaria has been fully treated.
WHAT TO DO IF AN OVERDOSE IS TAKEN:
It is important to stick to the dose on the label of your medicine. If you take too many
Malarone Tablets, or if someone else takes your medicine by mistake, tell your
doctor at once.
WHAT TO DO IF YOU MISS A DOSE:
If you forget to take a dose, don't worry. Just take one as soon as you remember
and then take the next dose at the right time.
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;

AFTER TAKING YOUR MEDICINE:
Does Malarone Tablets have any side effects?
Although most people find taking Malarone Tablets causes no problems, like all
medicines Malarone Tablets can have side effects, however some of these can be
symptoms of malaria. The following side effects have been reported in persons
taking Malarone Tablets, most of these have been mild and have not lasted very
long;














Tiredness, weakness, giddiness or breathlessness, these symptoms may mean
that you are suffering from a reduction in red blood cell count (anaemia).
A reduction in white blood cells (neutropenia).
Disturbance of the salt balance of the body (hyponatraemia).
Feeling sick (nausea) and/or being sick (vomiting), stomach pain, diarrhoea.
Loss of appetite.
Inflammation of the mouth (stomatitis) and mouth ulcers.
Headache.
Difficulty in sleeping (insomnia).
Cough.
Fever.
Allergic reactions, including rash, itching and swelling.
Hair loss.
Dizziness.

STOP taking Malarone Tablets and seek medical attention immediately if you
experience any of the following severe allergy symptoms after taking Malarone
Tablets. Although they are rare these symptoms could be serious:




Sudden wheezing, tightness of the chest or throat, or difficulty in breathing.
Swollen eyelids, face, lips, tongue or other part of the body.
Wide spread rash.

Temporary increases of some enzymes produced by your liver and pancreas have
been reported in some patients. You may not notice any symptoms if this happens.
These substances can be measured in your blood and therefore, if you have any
blood tests, remind your doctor that you are taking Malarone Tablets.
Tell your pharmacist or doctor if you get these or any other side effects from your
medicine, which are not mentioned here.
STORING YOUR MEDICINE:
Do not use after the expiry date printed on the carton, label or blister strip.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the
pharmacist (chemist) for safe disposal. Only keep the tablets if your doctor tells you
to.
If the tablets become discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist who will tell you what to do.
IMPORTANT:
This medicine is for YOUR use only. It can only be prescribed by a doctor. Never
give it to anyone else. It may harm them even if their symptoms are the same as
yours.
This leaflet does not contain complete information about your medicine. If you have
any questions, or are not sure about anything, ask your doctor or pharmacist who
has access to additional information.
More about Malaria:
What is Malaria?
Malaria is a serious but preventable disease spread by the bite of an infected
mosquito. Anyone, of any age, can get malaria.
To protect yourself against malaria, it is important to know the risks, avoid being
bitten, take preventative treatment where appropriate and seek early diagnosis and
treatment if necessary.
Know the risks
It is important for all people to seek advice before travelling to an area where malaria
is prevalent.

JS/Regislralion/Malarone Tablels/PLPM 0383/1123/PIL Mup/02.06.2005/Page 3 of 4

Avoid being bitten





Wear light coloured clothing that covers most of the body especially after
sunset. In particular do not forget to cover your arms and legs.
Use insect repellant on exposed areas of the skin.
Sleep in a screened room or under a mosquito net impregnated with
insecticide. If windows and doors are not screened - close them at sunset.
Consider the use of an insecticide (mats, spray, plug-ins) to clear a room of
insects before going to bed or to deter mosquitoes from entering the room.

Your pharmacist will be able to offer advice on the appropriate products to use.
Prevention (why take a prophylactic medication?)
Antimalarial prophylactic medication can protect you against contracting malaria.
It is essential to seek medical advice on which antimalarial prevention (prophylactic)
medicine to take, as Malarone Tablets may not provide adequate protection in some
countries. It is important to take your tablets correctly (see 'How do I take Malarone
Tablets?').
Prompt treatment
A few people may still get malaria despite taking the necessary precautions.
The initial signs may be mild and often appear flu-like (fever with or without
weakness, shivering, pain in the joints, headaches, diarrhoea, vomiting).
Should you develop any illness within 1 year and particularly within 3 months
of returning from an area where malaria is prevalent, you must contact your
doctor immediately.
Finding out more

You may be able to find out more from public libraries.

If you have any other questions about malaria or are not sure about anything,
ask your doctor or pharmacist, who will be able to advise you.
Leaflet date: 02.06.2005

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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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