Malarone

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Malarone

250 mg + 100 mg, film-coated tablets

Atovaquone + Proguanil hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Malarone and what is it 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 is Malarone and what is it used for

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

Indications for use of Malarone

Malarone has two uses:

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

Dosing recommendations for each indication can be found in section 3. How to take Malarone.
Malaria is spread through the bites of infected mosquitoes, which transmit the parasite (Plasmodium falciparum) into the blood. Malarone prevents malaria by killing the cells of this parasite. In people who are already infected with malaria, Malarone also kills the cells of these parasites.

Protection against malaria infection is necessary.

Malaria can be contracted at any age. It is a serious disease that can be prevented.
It is very important to take measures to prevent mosquito bites in addition to taking Malarone.

Insect repellents should be used on exposed skin surfaces.

• Wear light-colored, protective clothing, especially after sunset, as mosquitoes are most active at this time.
• Sleep in a protected areaor under a mosquito net treated with insecticide.
• Close windows and doors at sunsetif they are not screened.
• Consider using an insecticide(mats, aerosols, plugs) to clear the room of insects or prevent mosquitoes from entering the room. → In case of further doubts, consult a doctor or pharmacist.

Malaria can occur despite taking the necessary precautions.

In some types of malaria, the time from infection to the appearance of symptoms can be long,
so the disease may only become apparent after several days, weeks, or even months after returning from abroad.
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If symptoms such as high temperature, chills, headache, and fatigue occur after returning from abroad, consult a doctor immediately.

2. Important information before taking Malarone

When not to take Malarone

• If the patient is allergicto atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6).

In the prevention of malaria in patients with severe kidney disease.

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If the patient has any of these conditions, they should tell their doctor.

When to exercise special caution when taking Malarone

Before starting to take Malarone, the patient should tell their doctor or pharmacist if:

• the patient has severe kidney disease
• the patient is a child being treated for malaria who weighs less than 11 kg. For the treatment of children weighing less than 11 kg, tablets with a different active substance content are available (see section
• 3).

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If the patient has any of the above conditions, they should tell their doctor or pharmacist.

Malarone and other medicines

The patient should tell their doctor or pharmacist about all medicinesthey are taking or have recently taken, including those obtained without a prescription.
Some medicines may affect the action of Malarone or Malarone may increase or decrease the effect of other medicines taken at the same time. These include:

• metoclopramide, used to treat nausea and vomiting,
• antibiotics, tetracycline, rifampicin, rifabutin,
• efavirenzor certain protease inhibitorsused to treat HIV,
• warfarinand other medicines that prevent blood clotting,
• etoposide, used to treat cancer.

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If the patient is taking any of these medicines, they should tell their doctor. The doctor may decide not to prescribe Malarone or recommend additional tests during its use.
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If the patient starts taking other medicines while taking Malarone, they should remember to tell their doctor.

Taking Malarone with food and drink

Malarone should be taken with food or a milk drink, if possible. This will increase the absorption of Malarone and the effectiveness of the treatment.

Pregnancy and breastfeeding

If the patient is pregnant, they should not take Malarone, unless their doctor recommends it.
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Before taking Malarone, the patient should consult their doctor or pharmacist.
The patient should not breastfeed while taking Malarone, as the active substances of Malarone pass into breast milk and may harm the baby.

Driving and operating machinery

The patient should not drive if they experience dizziness.

Malarone may cause dizziness in some people. If the patient experiences this symptom, they should not drive, operate machinery, or perform tasks that may pose a risk to themselves or others.

Malarone contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Malarone

This medicine should always be taken according to the doctor's or pharmacist's instructions.If in doubt, the patient should consult their doctor or pharmacist.
If possible, Malarone should be taken with food or a milk drink.
It is best to take Malarone at the same time every day.

If the patient vomits

During prevention of malaria

• If the patient vomits within 1 hour of taking a Malarone tablet, they should take another dose immediately.
• It is essential to complete the full treatment cycle with Malarone.If the patient has taken extra doses due to vomiting, they may need an additional prescription.
• 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 absorbed medicine will decrease.

During treatment of malaria

• If the patient vomits and has diarrhea, they should tell their doctor, who will recommend regular blood tests. Malarone may not be effective, as the amount of absorbed medicine will decrease. Blood tests will help check if the malaria parasite has been removed from the patient's blood.

Prevention of malaria

The recommended dose of Malarone for adultsis one tablet once a day, taken as follows.
Malarone is not recommended for the prevention of malaria in childrenor adults with a body weight below 40 kg.
For adults and children with a body weight below 40 kg, Malarone pediatric tablets are recommended.
To prevent malaria in adults, the patient should:

• - start taking Malarone 1 to 2 days before traveling to a malaria area;
• - continue taking Malarone every day during their stay;
• - continue taking Malarone for 7 days after returning to a malaria-free area.

Treatment of malaria

The recommended dose of Malarone for adultsis 4 tablets once a day for 3 days.
Dosing for childrendepends on body weight:

• - 11-20 kg - 1 tablet once a day for three days,
• - 21-30 kg - 2 tablets in one daily dose for three days,
• - 31-40 kg - 3 tablets in one daily dose for three days,
• - above 40 kg - dosing as for adults.

This medicine is not recommended for the treatment of malaria in childrenwith a body weight below 11 kg.
If the child's body weight is below 11 kg, the patient should tell their doctor. In some countries, Malarone tablets with a different strength may be available.

Taking more Malarone than recommended

The patient should consult their doctor or pharmacist. If possible, they should show them the packaging of Malarone.

Missing a dose of Malarone

It is essential to complete the full treatment cycle with Malarone.

If a dose of Malarone is missed, the patient should take it as soon as possible and continue treatment as recommended.
The patient should not take a double dose to make up for a missed dose. They should take the next dose at the usual time.

The patient should not stop taking Malarone without their doctor's advice.

The patient should continue taking Malarone for 7 days after returning to a malaria-free area.

Malaria.To achieve maximum protection, the patient should complete the full treatment cycle with Malarone. Stopping the treatment early may put the patient at risk of malaria, as it takes 7 days to ensure that all parasites that may have appeared in the blood after a mosquito bite have been killed.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Malarone can cause side effects, although not everybody gets them.
The patient should be aware of the following serious side effects. They have occurred in a small number of people, but the exact frequency is unknown.
Severe allergic reactions- symptoms include:

• rash and itching,
• sudden wheezing, chest tightness or throat constriction, 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, they should contact their doctor immediately. They should not take any more tablets.

Severe skin reactions

• a rash that may be blistering and looks like small targets (dark spots in the center, surrounded by a lighter area with a dark ring around it) (erythema multiforme),
• a severe, widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).→

If the patient experiences any of these symptoms, they should contact their doctor urgently.

Other side effects were mostly mild and temporary.

Very common side effects

May affect more than 1 in 10 people:

• - headache,
• - nausea and vomiting,
• - abdominal pain,
• - diarrhea.

Common side effects

May affect less than 1 in 10 people:

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

Common side effects that may appear in blood tests:

• decrease in red blood cell count (anemia), which may cause fatigue, headaches, and shortness of breath,
• decrease in white blood cell count (neutropenia), which may increase the risk of infections,
• decrease in sodium levels in the blood (hyponatremia),
• increase in liver enzyme activity.

Uncommon side effects

May affect less than 1 in 100 people:

• anxiety,
• abnormal heart rhythm (palpitations),
• swelling and redness of the mouth,
• hair loss,
• itchy rash with blisters (hives).

Uncommon side effects that may appear in blood tests:

• increase in amylase activity (an enzyme produced in the pancreas).

Rare side effects

May affect less than 1 in 1000 people:

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

Other side effects

Other side effects that have occurred in a small number of people, but the exact frequency is unknown.

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

Other side effects that may appear in blood tests:

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

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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 side effects will help gather more information on the safety of this medicine.

5. How to store Malarone

The medicine should be stored out of sight and reach of children.

The medicine should not be used after the expiry date stated on the packaging.The expiry date refers to the last day of the month stated.

There are no special precautions for storage.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Malarone contains

The active substances of Malarone are:atovaquone 250 mg and proguanil hydrochloride 100 mg, in each tablet.

Other ingredients of Malarone are:

tablet core: poloxamer 188, microcrystalline cellulose (E 460), low-substituted hydroxypropylcellulose (E 463), povidone K 30 (E 1201), sodium carboxymethylcellulose (type A), magnesium stearate (E 470B);
tablet coating: macrogol 400, hypromellose (E 464), titanium dioxide (E 171), red iron oxide (E 172), macrogol 8000 (see section 2).
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If the patient is allergic to any of these ingredients, they should inform their doctor before taking Malarone.

What Malarone looks like and contents of the pack

Malarone film-coated tablets are pink and round, with the imprint "GX CM3" on one side.
They are packaged in a blister pack of PVC-aluminum/foil, child-resistant, containing 12 tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Ireland, the country of export:

GlaxoSmithKline (Ireland) Ltd., 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Ireland export license number: PA1077/111/001

Parallel import license number: 115/24

This medicine is authorized in the Member States of the European Economic Area and in 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
Date of leaflet approval:14.03.2024
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