Malarone

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is 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.
• In case of 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 malariaDosage recommendations for each indication can be found in the 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.

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.

On exposed skin surfaces, use insect repellents.

• Wear light-colored clothing that covers most of the body, especially after sunset, as mosquitoes are most active at this time.
• Sleep in a protected roomor under a mosquito net impregnated with an 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.
• If in doubt, consult a doctor or pharmacist.

Malaria infection can occur despite taking precautions.

Be cautious.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.

• If the following symptoms occur after returning from abroad, such as: high temperature, chills, headache, and fatigue, 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 the patient, they should tell their doctor.

When to exercise special caution when taking Malarone

Before starting to take Malarone, you should tell your 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 whose body weight does not exceed 11 kg, tablets with a different active substance content are intended (see section 3).
• If the above circumstances apply to the patient, they should tell their doctor or pharmacist.

Malarone and other medicines

You should tell your doctor or pharmacist about all medicinesthat the patient is taking, or has recently taken, and about medicines that the patient plans to take, including those that are available without a prescription. Some medicines may affect the action of Malarone or Malarone may enhance or weaken the action of other medicines taken at the same time. These medicines include:

• metoclopramide, used to treat nausea and vomiting
• antibiotics, tetracycline, rifampicin, rifabutin
• efavirenzor certain protease inhibitorsused to treat HIV
• warfarinand other medicines that inhibit blood clotting
• etoposide, used to treat cancer.
• If the patient is taking any of these medicines, they should tell their doctor.The doctor may decide that Malarone should not be taken or may recommend additional tests during its use.
• 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 a meal 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, she should not take Malarone, unless the doctor recommends otherwise.

• Before taking Malarone, the patient should consult a doctor or pharmacist.

The patient should not breastfeed while taking Malarone, as the ingredients of Malarone pass into breast milk and may harm the baby.

Driving and using machines

The patient should not drive vehicles if they experience dizziness.

Malarone may cause dizziness in some people. If the patient experiences this symptom, they should not drive vehicles, operate any machines, or perform any activities 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 that the medicine is considered "sodium-free".

3. How to take Malarone

This medicine should always be taken according to the doctor's or pharmacist's recommendations.In case of doubts, the patient should consult a doctor or pharmacist. If possible, Malarone should be taken with a meal or a milk drink. It is best to take Malarone at the same time every day.

If the patient vomits

During malaria prevention

• If the patient vomits within 1 hour of taking a Malarone tablet, they should take an additional dose immediately.
• It is essential to complete the full treatment cycle with Malarone.If the patient has taken additional doses due to vomiting, they may need an additional prescription.
• If the patient vomits, it is especially important to take additional precautions, such as using insect repellents and mosquito nets. Malarone may not be effective, as the amount of absorbed medicine will decrease.

During malaria treatment

• 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 allow the doctor to check if the malaria parasite has been removed from the patient's blood.

Malaria prevention

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

• start taking Malarone 1 to 2 days before traveling to a malaria-endemic area;
• continue taking Malarone every day during their 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.

Malarone 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, the patient should tell their doctor. In some countries, Malarone tablets with a different active substance content may be available.

Taking more Malarone than recommended

The patient should contact a doctor or pharmacist. If possible, they should show the packaging of Malarone.

Missing a dose of Malarone

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

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

The patient should not stop taking Malarone without the doctor's recommendation.

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 destroyed. If the patient has any further doubts about taking this medicine, they should consult a 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 tightness, 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 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 the patient experiences any of these symptoms, they should contact a doctor immediately.Other side effects were mostly mild and temporary.

Very common side effects

May affect more than 1 in 10 patients:

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

Common side effects

May affect less than 1 in 10 patients:

• dizziness
• sleep disturbances (insomnia)
• unusual dreams
• depression
• loss of appetite
• fever
• rash that 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 patients:

• anxiety
• feeling of 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 patients:

• 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 duct obstruction)
• rapid heartbeat (tachycardia)
• inflammation of the 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
• serious 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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. By reporting side effects, it is possible to gather more information on the safety of the 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. The patient should ask their 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, 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.

• If the patient is allergic to any of these ingredients, they should inform their 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 blisters containing 12 film-coated tablets in a cardboard box. For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

GlaxoSmithKline, S.A.
PTM – C/Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain

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:

Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź
Marketing authorization number in Spain, the country of export: 653915.6
Parallel import authorization number: 443/19
This medicinal product is authorized in all Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the name:
Malarone.

Date of leaflet approval: 09.10.2024

[Information about the trademark]