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 this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 parasite's cells. In individuals already infected with malaria, Malarone also destroys these parasitic cells.

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 products to exposed 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 a mesh screen.
• Consider using an insecticide (mats, aerosols, plug-in devices) to eliminate insects from the room or prevent mosquitoes from entering. → If you have any further doubts, consult your doctor or pharmacist.

Malaria may still occur despite taking all necessary precautions.
In some forms of malaria, the time between infection and the appearance of symptoms may be long; therefore, the disease may manifest 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, seek medical advice immediately.

2. Information before using Malarone

When not to take 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, tell the doctor.
When to take special care with 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 less than 11 kg should be treated with tablets containing different amounts of active substances (see section 3).

→ If any of the above situations apply to the patient, tell the doctor or
pharmacist.
Malarone and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including medicines available without a prescription.
Some medicines may affect the action of Malarone, or Malarone may enhance or reduce the effects 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, tell the doctor. 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 being treated with Malarone, remember to inform the doctor.
Taking Malarone with food and drink
Malarone should be taken with food or a milky drink, if possible. This will increase the absorption of Malarone and improve treatment effectiveness.
Pregnancy and breastfeeding
If the patient is pregnant, she should not take Malarone unless advised otherwise by a doctor.
→ Consult a doctor or pharmacist before taking Malarone.
Breastfeeding should be avoided during treatment with Malarone, because 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, i.e. it 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, if possible, with food or a milk drink.
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 a Malarone tablet, an additional dose should be taken immediately.
• It is important to complete the full course of treatment with Malarone. If the patient has taken extra doses due to vomiting, an additional 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 or 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 confirm whether the malaria parasite has been cleared 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.
In adults and children weighing 40 kg or less, Malarone paediatric tablets are 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 another 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.
Dosing in 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,
• • above 40 kg: same dose as in 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 of different strengths may be available.
Taking more Malarone than recommended
Contact your doctor or pharmacist immediately. If possible, bring the Malarone packaging with you.
If a dose of Malarone is missed
It is important to complete the full course of treatment with Malarone.
If a dose is missed, 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 another 7 days after returning to a malaria-free area. To achieve maximum protection, complete the full course of Malarone treatment. Stopping the medicine early may put the patient at risk of malaria, as it takes 7 days to ensure that all parasites that may have entered the bloodstream following a mosquito bite have been eliminated.
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 not everyone will experience them.
Please pay attention to the occurrence of the following serious adverse reactions. These have 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 the patient experiences any of the above symptoms of an allergic reaction, seek medical advice immediately. Do not take any further tablets.

Severe skin reactions

• rash, which may be blistering and look like target-shaped spots (dark spots in the center, surrounded by a paler area with a dark ring around it) (erythema multiforme),
• severe widespread rash with blisters and peeling skin, particularly affecting areas around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). → If the patient develops any of these symptoms, seek medical advice urgently.

Other adverse reactions were mostly mild and temporary.
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 sodium concentration in the blood (hyponatraemia),
• increased liver enzyme activity.

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

• anxiety,
• awareness of irregular heartbeat (palpitations),
• swelling and redness of the mouth,
• 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 contact with reality and is unable to think or assess situations clearly,
• indigestion,
• mouth ulcers,
• blisters,
• peeling of the skin,
• increased sensitivity of the skin 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, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 4921301, fax: +48 22 4921309,
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 precautions.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Malarone contains
The active substances are: atovaquone 250 mg and proguanil hydrochloride 100 mg in each tablet.
The other ingredients are:
tablet core: poloxamer 188, microcrystalline cellulose (E 460), low-substituted hydroxypropylcellulose (E 463), povidone K 30 (E 1201), sodium carboxymethylstarch (type A), magnesium stearate (E 470B);
tablet coating: polyethylene glycol 400, Opadry Pink OY-S-24972: hypromellose (E 464), titanium dioxide (E 171), iron oxide red (E 172), polyethylene glycol 8000 (see section 2).
→ If the patient is allergic to any of these ingredients, they must inform their doctor before starting treatment with Malarone.

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 responsible party or the parallel importer.

Responsible party in the Netherlands, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Dutch (country of export) registration number: RVG 25386
Parallel import registration number: 358/14

This medicinal product is authorised 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