Malarone Tablets
Malarone Tablets
(atovaquone/proguanil hydrochloride)
Patient Information Leaflet
Your medicine is known by the above name but will be referred to as Malarone throughout 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
has 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.
-V Tell 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 the 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 your child is 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.
To prevent malaria
The usual dose for adults is 1 tablet once a day, taken as below.
Not for children, talk to your doctor.
Not recommended for preventing malaria in children, or in adults who weigh less than 40 kgs.
There may be a different type of Malarone tablet available for children in your country.
To prevent malaria in adults:
• start taking Malarone 1 to 2 days before travelling to an area which has malaria
• continue taking it every day during your stay
• continue taking it for another 7 days after your return to a malaria-free area. To treat malaria
The usual dose for adults is 4 tablets once a day for 3 days.
For children the dose depends on their bodyweight:
• 11 -20 kg - 1 tablet once a day for 3 days
• 21 -30 kg - 2 tablets once a day for 3 days
• 31 -40 kg - 3 tablets once a day for 3 days
• over 40 kg - dose as for adults.
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 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.
Do not take Malarone for longer than 37 days. If you are expecting to stay in an area with malaria for more than 28 days check with your doctor before travelling. Malarone may not be suitable for you.
5) Possible side effects
Like all medicines, Malarone 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:
• 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 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 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, which 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.
6) How to store Malarone
• Do not use after the expiry date printed on the carton, label or blister strip.
• Keep all medicines out of the sight and reach of children.
• 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 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 contains
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.
What Malarone looks like and contents of the pack
Malarone Tablets are round, pink, biconvex, film- coated tablets marked “GX CM3” on one side and plain on the reverse.
Malarone Tablets are available as blister packs of 12 tablets.
PL 10383/1123 Malarone Tablets [POM]
Who makes and repackages your medicine?
Your medicine is manufactured by Glaxo Wellcome GmbH & Co., Industriestrasse 32-36, 23843 Bad Oldesloe, Germany. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.