Malarone

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Malarone
250 mg + 100 mg, film-coated tablets
Atovaquone + Proguanil hydrochloride
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Malarone is and what it is used for
2. Important information before taking Malarone
3. How to take Malarone
4. Possible side effects
5. How to store Malarone
6. Contents of the pack and other information

1. What Malarone is and what it is used for

Malarone belongs to a group of medicines called antimalarials. It contains two active substances:
atovaquone and proguanil hydrochloride.
Indications for Malarone
Malarone has two uses:

• for the prevention of malaria;
• for the treatment of malaria.

Dosage recommendations for each indication are provided in section 3, How to take Malarone.
Malaria is transmitted through bites from infected mosquitoes, which introduce the parasite
(Plasmodium falciparum) into the bloodstream. Malarone prevents malaria by destroying the cells of this
parasite. In individuals already infected with malaria, Malarone also destroys the cells of these
parasites.
You should protect yourself against malaria infection.
Malaria can affect people of any age. It is a serious illness, but it can be prevented.
It is very important to take measures to prevent mosquito bites in addition to taking Malarone.

• Apply insect repellent to exposed areas of skin.
• Wear light-coloured clothing covering most of the body, especially after sunset, as mosquitoes are particularly active at this time.
• Sleep in a protected room or under an insecticide-impregnated mosquito net.
• Close windows and doors at sunset, if they are not protected by screens.
• Consider using an insecticide (mats, aerosols, plug-in devices) to eliminate insects from the room or prevent mosquitoes from entering. → If you have further questions, consult your doctor or pharmacist.

Malaria infection may occur despite taking all necessary precautions.
In some forms of malaria, the time between infection and the appearance of symptoms may be long, so the disease may manifest itself several days, weeks, or even months after returning from abroad.
→ If, after returning from abroad, you experience symptoms such as high fever, chills, headache, and fatigue, you must contact a doctor immediately.

2. Important information before using Malarone

When not to use Malarone

• If the patient is allergic to atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
• For malaria prevention in patients with severe kidney disease.

→ If any of these situations apply to the patient, the doctor should be informed.
When to exercise special caution when using Malarone
Before starting to take Malarone, tell the doctor or pharmacist
if:

• the patient has severe kidney disease;
• a child weighing less than 11 kg is being treated for malaria. Children weighing 11 kg or less should be treated with tablets containing a different dose of active substances (see section 3).

→ If any of the above situations apply to the patient, the doctor or
pharmacist should be informed.
Malarone and other medicines
Tell the doctor or pharmacist about all medicines currently taken or recently taken,
as well as any medicines the patient plans to take, including those available without a prescription.
Some medicines may affect the action of Malarone, or Malarone may enhance or weaken the effect of other medicines taken at the same time. These include:

• metoclopramide, used to treat nausea and vomiting;
• antibiotics, tetracycline, rifampicin, and rifabutin;
• efavirenz or certain boosted protease inhibitors used in the treatment of HIV;
• warfarin and other anticoagulant medicines;
• etoposide, used in the treatment of cancer.

→ If the patient is taking any of these medicines, the doctor should be informed. The doctor
may decide that Malarone should not be taken or may recommend additional monitoring during treatment.
→ If the patient starts taking other medicines while using Malarone, remember to inform the doctor.
Taking Malarone with food and drink
Malarone should be taken with food or a milky drink whenever possible.
This will improve the absorption of Malarone and increase treatment effectiveness.
Pregnancy and breastfeeding
If the patient is pregnant, she should not take Malarone unless otherwise advised by a doctor.
→ Before using Malarone, consult a doctor or pharmacist.
Breastfeeding should not be undertaken during treatment with Malarone, as the active ingredients of Malarone pass into breast milk and may harm the infant.
Driving and operating machinery
Do not drive if dizziness occurs.
Malarone may cause dizziness in some people. If this symptom occurs, the patient should not drive, operate machinery, or perform any activities that could pose a risk to themselves or others.
Malarone contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to use Malarone

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Malarone should be taken with food or a milk drink, if possible.
It is best to take Malarone at the same time each day.

If the patient vomits:
When preventing malaria

• If the patient vomits within 1 hour after taking Malarone, an additional dose should be taken immediately.
• It is important to complete the full course of treatment with Malarone. If additional doses have been taken due to vomiting, an extra prescription may be needed.
• If the patient vomits, it is especially important to use additional protective measures, such as insect repellents and mosquito nets. Malarone may not be effective, as the amount of medicine absorbed may be reduced.

When treating malaria

• If the patient vomits and has diarrhoea, inform the doctor, who will recommend regular blood tests. Malarone may not be effective, as the amount of medicine absorbed may be reduced. Blood tests will help determine whether the malaria parasite has been eliminated from the patient's blood.

Preventing malaria:
The recommended dose of Malarone for adults is one tablet once daily, as follows.
Malarone is not recommended for malaria prevention in children or in adults weighing
less than 40 kg. For adults and children weighing 40 kg or less, the use of Malarone paediatric tablets is recommended.
To prevent malaria in adults, you should:

• start taking Malarone 1 to 2 days before travelling to a malaria-risk area;
• continue taking the medicine daily during your stay;
• continue taking the medicine for a further 7 days after returning to a malaria-free area.

Treating malaria:
The recommended dose of Malarone for adults is 4 tablets once daily for 3 days.
Dosage for children depends on body weight:

• 11–20 kg – 1 tablet once daily for three days;
• 21–30 kg – 2 tablets as a single daily dose for three days;
• 31–40 kg – 3 tablets as a single daily dose for three days;
• over 40 kg – same dosage as for adults.

Malarone is not recommended for the treatment of malaria in children weighing less than 11 kg.
If a child weighs less than 11 kg, inform your doctor. In some countries, Malarone tablets with different strengths may be available.

Taking more Malarone than recommended
Seek advice from your doctor or pharmacist immediately. If possible, bring the Malarone packaging with you.

If you miss a dose of Malarone
It is important to complete the full course of treatment with Malarone.
If you miss a dose of Malarone, take it as soon as possible and continue treatment as directed.
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.
Do not stop taking Malarone without your doctor’s advice.
Continue taking the medicine for a further 7 days after returning to a malaria-free area. To achieve maximum protection, complete the full course of treatment with Malarone. Stopping the medicine earlier may put the patient at risk of malaria, as it takes 7 days to ensure that all parasites which may have entered the bloodstream following a bite from an infected mosquito are destroyed.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Particular attention should be paid to the following serious adverse reactions. These occurred in a small number of people, but the exact frequency of occurrence is unknown.

Severe allergic reactions – symptoms include:

• rash and itching;
• sudden wheezing, tightness in the chest or throat, or difficulty breathing;
• swelling of the eyelids, face, lips, tongue or other parts of the body.
• If any of the above symptoms of an allergic reaction occur in a patient, contact a doctor immediately. Do not take any further tablets.

Severe skin reactions:

• rash, which may be blistering and resemble target lesions (dark spots in the centre, surrounded by a paler area with a dark ring around it) (erythema multiforme);
• severe widespread rash with blisters and peeling skin, particularly affecting the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome).
• If any of these symptoms occur, contact a doctor urgently.

Other adverse reactions were mostly mild and transient.

Very common adverse reactions
May occur in more than 1 in 10 patients:

• headache;
• nausea and vomiting;
• abdominal pain;
• diarrhoea.

Common adverse reactions
May occur in less than 1 in 10 patients:

• dizziness;
• sleep disturbances (insomnia);
• unusual dreams;
• depression;
• loss of appetite;
• fever;
• rash, which may be itchy;
• cough.

Common adverse reactions that may be detected in blood tests:

• decreased number of red blood cells (anaemia), which may cause fatigue, headaches and shortness of breath;
• decreased number of white blood cells (neutropenia), which may increase susceptibility to infections;
• decreased concentration of sodium in the blood (hyponatraemia);
• increased liver enzyme activity.

Uncommon adverse reactions
May occur in less than 1 in 100 patients:

• anxiety;
• sensation of irregular heartbeat (palpitations);
• mouth inflammation and redness;
• hair loss;
• itchy blistering rash (urticaria).

Uncommon adverse reactions that may be detected in blood tests:

• increased amylase activity (an enzyme produced by the pancreas).

Rare adverse reactions
May occur in less than 1 in 1000 patients:

• seeing or hearing things that are not real (hallucinations).

Other adverse reactions
Other adverse reactions that occurred in a small number of people, but their exact frequency is unknown:

• hepatitis;
• blockage of bile ducts (cholestasis);
• increased heart rate (tachycardia);
• inflammation of blood vessels, which may appear as red or purple lumps on the skin, but may also affect other parts of the body;
• seizures;
• panic attacks, crying;
• nightmares;
• serious mental health disorders, during which the patient loses touch with reality and is unable to think or assess situations clearly;
• indigestion;
• mouth ulcers;
• blisters;
• skin peeling;
• increased skin sensitivity to sunlight.

Other adverse reactions that may be detected in blood tests:

• decreased number of all types of blood cells (pancytopenia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Malarone

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Malarone contains
The active substances in this medicine are: atovaquone 250 mg and proguanil hydrochloride 100 mg in each tablet.
Other ingredients are:
poloxamer 188, microcrystalline cellulose, low-substituted hydroxypropylcellulose, povidone K 30, sodium carboxymethyl starch (type A), magnesium stearate;
tablet coating: hypromellose, titanium dioxide (E 171), iron oxide red (E 172), macrogol 400, macrogol 8000.

• If the patient is allergic to any of these ingredients, before starting treatment with Malarone, inform your doctor.

What Malarone looks like and contents of the pack
Malarone coated tablets are pink and round, with the imprint “GX CM3” on one side.
They are packed in PVC/Aluminium/paper blisters containing 12 coated tablets per cardboard box.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, the country of export:
GlaxoSmithKline BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands
Manufacturer:
Glaxo Wellcome S.A.
Avenida de Extremadura, 3
09400 Aranda de Duero
Burgos
Spain
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in the Netherlands, the country of export: RVG 25386
Parallel import authorisation number: 608/15
This medicine is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Czech Republic, Finland, Germany, Greece, Spain, Netherlands, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Norway, Poland, Portugal, Slovakia, Slovenia, Sweden, Hungary, Italy, United Kingdom (Northern Ireland): Malarone