Malarone

Patient Information Leaflet

Warning! Keep this leaflet! Information on the outer 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, 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 ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet 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 described in section 3, How to take Malarone.

Malaria is transmitted through bites from infected mosquitoes, which carry the parasite
(Plasmodium falciparum) into the bloodstream. Malarone prevents malaria by destroying the cells of this
parasite. In people already infected with malaria, Malarone also destroys the cells of these
parasites.

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 that, in addition to taking Malarone, you take measures to avoid mosquito bites.

• Apply insect-repellent products 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 with screens.
• Consider using an insecticide (mats, aerosols, plug-in devices) to clear the room of insects or prevent mosquitoes from entering.
• If you have further questions, 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, so the disease may manifest several days, weeks, or even months after returning from abroad.

• If, after returning from abroad, you develop symptoms such as: high fever, chills, headache, and fatigue, you should contact a doctor 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. Tablets with a different active ingredient content are intended for children weighing up to 11 kg (see section 3).
• If any of the above situations apply to the patient, tell the doctor or pharmacist.

Malarone with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines planned for future use, including those available without a prescription.
Some medicines may affect the action of Malarone, or Malarone may enhance or reduce the effects of other medicines taken simultaneously. 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 using 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 increases the absorption of Malarone and improves 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 using Malarone.

Breastfeeding should be avoided while taking 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
The medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine 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 preferably 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 of taking a Malarone tablet, an additional dose should be taken immediately.
• It is important to complete the full course of Malarone treatment. 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 may 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 eliminated 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.
For 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 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 for 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
Seek advice from your doctor or pharmacist immediately. If possible, show them the Malarone packaging.

If you forget to take a dose of Malarone
It is important to complete the full course of Malarone treatment.
If you miss a dose of Malarone, 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 your doctor.
Continue taking the medicine for 7 days after returning to a malaria-free area.
To achieve maximum protection, it is essential to 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 which 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 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 their occurrence is unknown.

Severe allergic reactions – symptoms include:

• rash and itching –
• sudden onset of wheezing, chest tightness or throat tightness, or breathing difficulties –
• swelling of the eyelids, face, lips, tongue or other body parts. –
• If the patient experiences any of the above symptoms of an allergic reaction, contact a doctor immediately. Do not take any further tablets.

Severe skin reactions

• rash, which may be blistering and resemble target lesions (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 the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome). –
• If the patient experiences any of these symptoms, contact a doctor urgently.

Other adverse reactions were mostly mild and transient.
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 disorders (insomnia) –
• unusual dreams –
• depression –
• loss of appetite –
• fever –
• rash, which may be itchy –
• cough. –

Common adverse reactions that may be detected in blood tests:

• decrease in red blood cells (anaemia), which may cause fatigue, headaches and shortness of breath –
• decrease in 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 in 100 patients:

• anxiety –
• sensation 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 in 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 judge 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:

• decrease in 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 a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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.
Adverse reactions can also be reported to the marketing authorisation holder or parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Malarone

Keep this medicine out of the 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 instructions apply.
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, hydroxypropylcellulose, povidone K 30,
sodium carboxymethyl starch (type A), magnesium stearate; tablet coating: hypromellose, titanium
dioxide (E 171), iron oxide red (E 172), macrogol 400, 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 blisters containing 12 tablets per cardboard carton.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Spain, 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing authorisation number in Spain, country of export: 653915.6
Parallel import authorisation number: 120/25
This medicinal product is authorised for sale in 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