Malarone

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Malarone

250 mg +100 mg, film-coated tablets

Atovaquone + Proguanil hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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.Dosage recommendations for each indication can be found in section 3. How to take Malarone.

Malaria is spread through bites from 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.

You should protect yourself from malaria infection.

Malaria can be contracted at any age. It is a serious disease, but it 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.

• You should wear light-colored clothing that covers most of your body,especially after sunset, when mosquitoes are most active.
• You should sleep in a protected roomor under a mosquito net treated with an insecticide.
• You should close windows and doors at sunsetif they are not screened.
• You should consider using an insecticide(mats, aerosols, plugs) to clear the room of insects or prevent mosquitoes from entering the room. → If you have further doubtsyou should consult a doctor or pharmacist.

Malaria infection can occur despite taking the necessary precautions.

Be careful. In some types of malaria, the time between infection and the onset of symptoms can be long, so the disease may only become apparent after several days, weeks, or even months after returning from abroad. → If you experience symptoms such ashigh temperature, chills, headache, and fatigue after returning from abroad, you should contact 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. → If these circumstances apply to you, you should tell your doctor.

When to exercise special caution when taking Malarone

Before starting to take Malarone, you should tell your doctor or pharmacist if:

• you have severe kidney disease;
• the patient is a child being treated for malaria who weighs less than 11 kg. For the treatment of children whose body weight does not exceed 11 kg, tablets with a different active substance content are intended (see section 3).

→If you are affected by the above circumstances, you should tell your doctor or pharmacist.

Malarone and other medicines

You should tell your doctor or pharmacist about all medicinesyou are taking, or have recently taken, and about medicines you plan to take, including those that are available 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 some boosted protease inhibitorsused to treat HIV;
• warfarinand other medicines that prevent blood clotting;
• etoposide, used to treat cancer. → If you are taking any of these medicines, you should tell your doctor.Your doctor may decide that you should not take Malarone or may recommend additional tests during its use. → If you start taking other medicines while taking Malarone, you should remember to tell your 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 you are pregnant, you should not take Malarone, unless your doctor recommends otherwise. → Before taking Malarone, you should consult a doctor or pharmacist. You should not breastfeed while taking Malarone, as the ingredients of Malarone pass into breast milk and may harm your baby.

Driving and using machines

You should not drive if you experience dizziness.

Malarone may cause dizziness in some people. If you experience this symptom, you should not drive, operate any machinery, or perform any tasks that may pose a risk to you 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 recommendations.If you have any doubts, you should consult a 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 you vomit

During malaria prevention

• If you vomit within 1 hour of taking a Malarone tablet, you should take an additional dose immediately.
• It is essential to complete the full treatment cycle with Malarone. If you have taken additional doses due to vomiting, you may need an additional prescription.
• If you vomit, 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 malaria treatment

• If you vomit and have diarrhea, you should tell your doctor, who will recommend regular blood tests. Malarone may not be effective, as the amount of absorbed medicine will decrease. Blood tests will allow your doctor to check if the malaria parasite has been removed from your blood.

Malaria prevention

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 whose body weight does not exceed 40 kg, it is recommended to use Malarone in the form of pediatric tablets. To prevent malaria in adults, you should:

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

Malaria treatment

The recommended dose of Malarone for adultsis 4 tablets once a day for 3 days. Dosage 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;
• over 40 kg - the same dosage as for adults.

This medicine is not recommended for the treatment of malaria in childrenwith a body weight less than 11 kg. If the child's body weight is less than 11 kg, you should tell your doctor. In some countries, Malarone tablets with a different active substance content may be available.

Taking more Malarone than recommended

You should consult a doctor or pharmacist. If possible, you should show them the packaging of Malarone.

Missing a dose of Malarone

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

If you miss a dose of Malarone, you should take it as soon as possible and continue treatment according to the recommendations. You should not take a double dose to make up for a missed dose. You should take the next dose of Malarone at the usual time.

You should not stop taking Malarone without your doctor's recommendation.

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

malaria.To achieve maximum protection, you should complete the full treatment cycle with Malarone. Stopping the treatment early may put you 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 destroyed. If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

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

• rash and itching;
• sudden wheezing, chest tightness or throat tightness, or difficulty breathing;
• swelling of the eyelids, face, lips, tongue, or other parts of the body.
• If you experience any of the above symptoms of an allergic reaction, you should contact a doctor immediately. Do 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 you experience any of these symptoms, you should contact a doctor immediately.

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 cause increased susceptibility to 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 heartbeat (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 their exact frequency is unknown:

• hepatitis;
• blockage of the bile ducts (bile duct obstruction);
• rapid heartbeat (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 contact 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide 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.

Do not use this medicine 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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, low-substituted hydroxypropyl cellulose, povidone K 30, sodium carboxymethyl cellulose (type A), magnesium stearate; tablet coating:hypromellose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 400, macrogol 8000 (see section 2).

• If you are allergic to any of these ingredients, you should inform your doctor before taking Malarone.

What Malarone looks like and what the pack contains

Malarone film-coated tablets are pink and round, with the inscription "GX CM3" on one side. They are packaged in a blister pack containing 12 tablets, in a cardboard box. For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, the country of export:

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

Manufacturer:

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
Glaxo Wellcome S.A.
Avenida de Extremadura 3
09400 Aranda de Duero, Burgos
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Ireland, the country of export:PA1077/111/001

Parallel import authorization number: 132/24

This medicine is authorized for sale 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: 26.03.2024

[Information about the trademark]