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6. How to store Malarone

Do not use after the expiry date printed on the carton label or blister strip.

There are no special storage requirements for Malarone tablets.

Keep out of the sight and reach of children.

If your doctor tells you to stop taking the tablets, please take them back to the pharmacist 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.

If you have any unwanted Malarone, don't dispose of it in your waste water or household rubbish. Take it back to your pharmacist who will dispose of it in a way that won't harm the environment.

7. Further information

Your medicine is called Malarone tablets.

Each tablet contains 250mg of the active ingredient, atovaquone and 100mg of the active ingredient proguanil hydrochloride in a pink round film-coated tablet, which is marked ‘GX CM3' on one side and plain on the other side.

Malarone tablets also contain the following:

microcrystalline cellulose, poloxamer 188, povidone K30, magnesium stearate, low substituted hypromellose, macrogol 400, macrogol 8000, sodium starch glycollate and opadry oy-s-24972.

Malarone tablets are available as blister packs of 12 tablets.

POM    PL No: 6464/1488

This product is manufactured by Glaxo Wellcome Operations, Temple Hill, Dartford, England and is procured from within the EU and repackaged by the Product Licence holder who is:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date (Ref.) 1.10.2012

Malarone is a registered trademark of the Glaxo Wellcome Group.

MALARONE® TABLETS

(atovaquone/proguanil hydrochloride)

Patient Information Leaflet

This medicine is called by the above name, but will usually be referred to as Malarone in this leaflet.

•    Read right through this leaflet carefully before you start taking this medicine.

•    This medicine has been prescribed for you personally. 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 have serious side effects, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

In this leaflet

1.    What Malarone is and what it's for

2.    Before you take Malarone

3.    While you're taking Malarone

4.    How to take Malarone

5.    Possible side effects

6.    How to store Malarone

7.    Further information

1. What Malarone is and what it’s for

Malarone belongs to a group of medicines called antimalarials. It contains two active ingredients, atovaquone and proguanil hydrochloride.

What Malarone is for Malarone has two uses:

•    to prevent malaria

•    to treat malaria

Dosage instructions for each use are in Section 4, 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

•    Consider 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. Before you take Malarone

Do not take Malarone:

•    if you are allergic (hypersensitive) to atovaquone, proguanil hydrochloride or any ingredient

•    for preventing malaria, if you have severe kidney disease.

Tell your doctor if either of these apply to you.

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.

Other medicines and Malarone

Tell your doctor or pharmacist if you’re taking any other medicines, or have recently taken any, 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.

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WARNING! 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 BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING! 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.

UK PIL DATED OCTOBER 2011

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TeN 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.

3. While you’re taking Malarone

Taking 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.

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.

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.

4. How to take Malarone

Always take Malarone exactly as your doctor 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.

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 too much Malarone

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 a double dose to make up for a missed dose.

Don’t stop 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.

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Like all medicines, Malarone can

Look out for the following severe 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.

Uncommon side effects that may show up in your 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 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

•    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 that may show up in your blood tests:

• A decrease in all types of blood cells (pancytopenia).

If you get 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.

WARNING! 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 BETAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING! 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.