250 mg / 100 mg film-coated tablets
atovaquone / proguanil hydrochloride
What Malarone is and what it is used for
Malarone belongs to a group of medicines called malaria drugs. Each tablet contains two active substances, atovaquone, and proguanil hydrochloride.
What Malarone is used for
Malarone has two uses:
- prophylaxis (prevention) against malaria
- treatment of malaria .
Dosage instructions for each area of use can be found in section 3, How to take Malarone.
Malaria is spread through the bite of infected mosquitoes, which carry the malaria parasite ( Plasmodium falciparum ) further into the bloodstream. Malarone kills the parasite and can thus prevent malaria from developing ( prophylaxis ). Malarone also kills Plasmodium falciparum parasites in individuals who have already developed malaria.
Advice on how to protect yourself against malaria
People of all ages can get malaria. It is a serious disease, but it can be prevented.
In addition to taking Malarone, it is very important that you also make sure to avoid mosquito bites, e.g. by:
- use insect repellent on exposed skin surfaces
- wear light clothing that covers most of the body , especially after sunset because that is when the mosquitoes are most active
- sleep in a room with mosquito nets or under a mosquito net impregnated with insect repellent
- close windows and doors at sunset if mosquito nets are missing
- Consider using insect repellent (substrate, spray, electric mosquito coil) to get rid of mosquitoes before nightfall or to prevent mosquitoes from entering.
- If you need further advice , talk to your doctor or pharmacist.
However, you can get malaria even though all precautions have been taken. In some types of malaria infection, it takes a long time for symptoms to appear, and the disease only breaks out after several days, weeks, or even months after you have returned home from your stay abroad.
- Seek medical attention immediately if you experience symptoms such as fever, headache, chills and fatigue after returning home.
What you need to know before you take Malarone
Do not take Malarone:
- if you are allergic to atovaquone, proguanil hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- as prophylaxis (prevention) against malaria if you have a serious kidney disease.
- Tell your doctor if any of these apply to you.
Take special care with Malarone
Talk to your doctor or pharmacist before taking Malarone if:
- you have a serious kidney disease
- your child is being treated for malaria and weighs less than 11 kg. There is another tablet strength (Malarone Junior) for the treatment of children weighing less than 11 kg (see section 3).
- Tell your doctor or pharmacist if any of these apply to you.
Other medicines and Malarone
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may affect the effect of Malarone and Malarone may also increase or decrease the effect of other medicines taken at the same time, for example:
- metoclopramide (antiemetic and antiemetic)
- tetracycline s , rifampin and rifabutin ( antibiotics )
- efavirenz or some very active protease inhibitors (used to treat HIV )
- warfarin and other blood thinners
- etoposide (used to treat cancer).
- Tell your doctor if you are taking any of these medicines. Your doctor may decide that Malarone is not suitable for you or that closer monitoring is needed while you are taking Malarone.
- Remember to tell your doctor if you start taking any other medicine while you are taking Malarone.
Intake of Malarone with food and drink
Whenever possible, take Malarone with food or milk. Food increases the body’s uptake of Malarone and makes the treatment more effective.
Pregnancy and breastfeeding
Do not use Malarone if you are pregnant unless your doctor tells you to.
- Ask your doctor or pharmacist for advice before taking Malarone.
Do not breastfeed while taking Malarone as the ingredients may pass into breast milk and thus harm your baby.
Driving and using machines
If you get dizzy, do not drive.
Some people get dizzy when taking Malarone. If you feel affected, do not drive, operate machinery or engage in risky activities.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Malarone contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to take Malarone
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Whenever possible, take Malarone with food or milk.
It is best if Malarone is taken at the same time each day.
In case of illness ( vomiting )
Prophylaxis (prevention) against malaria
- If you vomit within an hour after taking the tablet , take a new dose immediately .
- It is important that you complete the prescription one of Malarone . If you have to take additional tablets due to vomiting, you may need to get more Malarone prescribed.
- If you have vomited , it is especially important to use other protective measures such as. insecticides and mosquito nets. The effect of Malarone can be reduced because the amount of drugs taken up in the body then becomes smaller.
Treatment of malaria
- If you experience vomiting and diarrhea , consult your doctor as regular blood tests should be taken. The effect of Malarone decreases because the amount of drugs taken up in the body then becomes smaller. Blood samples are taken to show if the malaria parasite has disappeared from the blood.
Prophylaxis (prevention)
The recommended dose, for prophylaxis, for adults: 1 tablet daily as below.
Malarone 250 mg / 100 mg tablets are not recommended as prophylaxis against malaria infection in children or adults weighing less than 40 kg. Malarone Junior is recommended as a prophylaxis against malaria infection in children or adults weighing less than 40 kg.
For prophylaxis in adults, one should
- start treatment with Malarone 1 to 2 days before arrival in a malaria-infected area
- continue to take Malarone every day throughout the stay
- continue to take Malarone for another 7 days after returning to the malaria-free area.
Treatment
The recommended dose, treatment for adults: 4 tablets once daily for 3 days.
Dosage in the treatment of children is based on body weight:
- 11-20 kg – 1 tablet daily for 3 days
- 21-30 kg – 2 tablets once daily for 3 days
- 31-40 kg – 3 tablets once daily for 3 days
- more than 40 kg – adult dosage.
Malarone is not recommended as a treatment for malaria infection in children weighing less than 11 kg.
Talk to your doctor if your child weighs less than 11 kg, as there is another tablet, Malarone Junior, which is intended for children.
If you take more Malarone than you should
Contact a doctor, hospital, or the Poison Information Center (tel. 112). Bring the packaging if you can.
If you forget to take Malarone
You must complete the prescription one of Malarone.
Do not worry if you forget to take a dose. Take the next dose as soon as possible. Then continue treatment according to the prescribed dosing schedule.
Do not take additional tablets to make up for a forgotten dose, but take your next dose at the usual time.
Do not stop your Malarone treatment without advice
Continue taking Malarone for 7 days after returning to the malaria-free area. For maximum protection, a prescription must be completed. If treatment is stopped earlier, you risk getting malaria because it must be 7 days since the mosquito bite to be sure that all the parasites in the blood have died.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Be aware of the following serious reactions. They have occurred in a few individuals, but the exact occurrence is unknown.
Severe allergic reactions – symptoms include:
- skin rash and itching
- wheezing, swelling of the airways or throat and difficulty breathing that occurs suddenly
- swelling of the eyelids, face, lips, tongue or other parts of the body.
- Contact a doctor immediately if you experience any of these symptoms. Stop taking Malarone .
Severe skin reactions
- rash, possibly with blisters that look like small bumps (annular, dark spots, surrounded by a lighter area with a dark ring around the edge) ( erythema multiforme )
- severe, widespread rash with blisters and scaling, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ).
- If you notice any of these symptoms contact your doctor immediately.
Most other side effects reported have been mild and transient.
Very common side effects are
May affect more than 1 in 10 people :
- headache
- nausea and vomiting
- abdominal pain
- diarrhea.
Common side effects are
May affect up to 1 in 10 people :
- dizziness
- insomnia
- strange dreams
- Depression
- loss of appetite
- fever
- skin rash, possibly itchy
- cough.
Common side effects that can be detected with blood tests:
- decreased number of red blood cells ( anemia ), which can cause fatigue, headaches and shortness of breath
- decreased number of white blood cells ( neutropenia ) which may make you more likely to catch the infection you
- low levels of sodium in the blood ( hyponatremia )
- elevated liver enzyme values.
Uncommon side effects are
May affect up to 1 in 100 people :
- anxiety
- palpitations experienced unpleasant ( palpitation s )
- swelling and redness in the oral cavity
- hair loss
- itchy, uneven rash (hives)
Uncommon side effects that can be detected by blood tests:
- elevated amylase values ( an enzyme produced in the pancreas ).
Rare side effects are
May affect up to 1 in 1,000 people :
- to see and hear things that do not exist ( hallucinations )
Other side effects ar
Other side effects have occurred in a few individuals, but the exact occurrence is unknown.
- inflammation of the liver ( hepatitis )
- clogging of the bile ducts (bile stasis )
- increased heart rate ( tachycardia )
- inflammation of the blood vessels ( vasculitis ). This can appear as red or dark violet raised spots on the skin, but can also affect other parts of the body.
- cramps
- panic attacks, crying
- nightmares
- severe mental problems where the person loses contact with reality and is unable to think and act clearly
- indigestion
- sores in the oral cavity
- blisters
- scaly skin
- increased sun sensitivity of the skin.
Other side effects that can be detected with blood tests:
- decreased number of all blood cells ( pancytopenia ).
How to store Malarone
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
Active substances : 250 mg atovaquone and 100 mg proguanil hydrochloride in each tablet.
Other ingredients:
tablet core: poloxamer 188, microcrystalline cellulose, hydroxypropyl cellulose, povidone K30, sodium starch glycolate (type A), magnesium stearate
film coatings: hypromellose, titanium dioxide (dye E171), red iron oxide (dye E172), macrogol 400, polyethylene glycol 8000 (see section 2).
- Contact your doctor before taking Malarone if you are allergic to any of the ingredients.
What the medicine looks like and contents of the pack
Malarone tablets are round, pink, and film-coated with “GX CM3” engraved on one side. They are supplied in blister packs containing 12 tablets.
Marketing Authorisation Holder:
GlaxoSmithKline AB, Box 516, 169 29 Solna.
Tel: 08 – 638 93 00
Email: info.produkt@gsk.com
Manufacturer:
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
or
Glaxo Wellcome SA, Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.