Malarone

Package leaflet: information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Malarone
250 mg + 100 mg, film-coated tablets
Atovaquone + Proguanil hydrochloride
Please read this leaflet carefully before taking this medicine because 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 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, tell your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Malarone is and what it is used for
2. What you need to know 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 parasite cells.
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 skin.
• Wear light-coloured clothing covering most of the body, especially after sunset, when mosquitoes are particularly active.
• Sleep in a protected room or under an insecticide-impregnated mosquito net.
• Close windows and doors at sunset, if they are not protected by mesh screens.
• Consider using an insecticide (mats, aerosols, plug-in devices) to eliminate insects from the room or to 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 certain types of malaria, the time between infection and onset of symptoms may be long, so the disease
may manifest itself several days, weeks or even months after returning from abroad.
→ If you develop symptoms after returning from abroad, such as: high fever, chills, headache and fatigue, you should contact a doctor immediately.

2. 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, tell the doctor.
When to be cautious when taking Malarone
Before starting Malarone, tell the doctor or pharmacist if:

• the patient has severe kidney disease,
• treating malaria in a child weighing less than 11 kg. For treatment of children weighing 11 kg or less, tablets with different active ingredient content are available (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 obtained without a prescription.
Some medicines may affect the action of Malarone, or Malarone may enhance or reduce 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 blood-thinning 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 using Malarone, remember to tell 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 otherwise advised by a doctor.
→ Before taking Malarone, consult a doctor or pharmacist.
Breastfeeding should not be undertaken during treatment with Malarone, because the components 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. the medicine is considered "sodium-free".

3. How to take Malarone

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Malarone should, if possible, be taken 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 additional doses 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 absorbed medicine 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 absorbed medicine may be reduced. Blood tests will allow confirmation that 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, taken as follows.
Malarone is not recommended for malaria prevention in children or in adults weighing less than
40 kg.
For adults and children whose body weight does not exceed 40 kg, Malarone paediatric tablets are recommended.
To prevent malaria in adults, you should:

• • start taking Malarone 1 to 2 days before travel to a malaria-risk area;
• • continue taking the medicine daily during the 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.
Dosage 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 dosage as in adults.

This medicine is not recommended for the treatment of malaria in children weighing less than 11 kg.
If a child weighs less than 11 kg, inform the doctor. In some countries, Malarone tablets with different strengths may be available.
Taking more Malarone than recommended
Contact a doctor or pharmacist immediately. If possible, bring the Malarone packaging.
Missed dose of Malarone
It is important to complete the full course of treatment with Malarone.
If a dose of Malarone 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 consulting a doctor.
Continue taking the medicine for another 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 that may have entered the bloodstream following a bite from an infected mosquito are destroyed.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, 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 onset of 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 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 area around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome). → If the patient experiences any of these symptoms, seek urgent medical advice.

Other adverse reactions were mostly mild and transient.

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

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

Common adverse reactions
May occur in less than 1 out of 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 blood (hyponatraemia),
• increased liver enzyme activity.

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

• anxiety,
• awareness of 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 out of 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),
• vasculitis, 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,
• skin peeling,
• 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, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for 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 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 required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 components are:
tablet core: poloxamer 188, microcrystalline cellulose (E 460), low-substituted hydroxypropylcellulose (E 463), povidone K 30 (E 1201), sodium starch glycolate (type A), magnesium stearate (E 470B);
tablet coating: macrogol 400, hypromellose (E 464), titanium dioxide (E 171), iron oxide red (E 172), macrogol 8000 (see section 2).
→ If the patient is allergic to any of these components, before starting treatment with
Malarone, inform your doctor.

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 packed in a PVC-aluminium/paper blister pack with child-resistant packaging, containing 12 tablets in a cardboard box.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Ireland, country of export:
GlaxoSmithKline (Ireland) Ltd., 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Manufacturers:
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

Irish Marketing Authorisation Number (country of export): PA1077/111/001
Parallel Import Licence Number: 115/24

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