Malarone

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Malarone
250 mg + 100 mg, film-coated tablets
Atovaquone + Proguanil hydrochloride
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 provided in section "3. How to take Malarone".
Malaria is transmitted through bites from infected mosquitoes, which introduce a parasite
(Plasmodium falciparum) into the bloodstream. Malarone prevents malaria by destroying the
parasite's cells. In individuals already infected with malaria, Malarone also destroys the cells of
these parasites.
Protection against malaria infection is essential.
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 avoid 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, as mosquitoes are particularly active at this time.
• Sleep in a protected room or under an insecticide-impregnated mosquito net.
• Close windows and doors at sunset, if they are not protected by a mesh screen.
• Consider using an insecticide (mats, aerosols, plug-in devices) to eliminate insects from the room or prevent mosquitoes from entering.
• If you have further questions, consult your doctor or pharmacist.

Malaria infection may 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 you experience symptoms such as high fever, chills, headache, or fatigue after returning from abroad, seek medical advice immediately.

2. Important 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 prophylaxis 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 Malarone, tell your doctor or pharmacist if:

• the patient has severe kidney disease
• treating a child with malaria who weighs less than 11 kg. Children weighing less than 11 kg should be treated with tablets containing a different dose of active substances (see section 3).
• If any of the above situations apply to the patient, tell the doctor or pharmacist.

Malarone with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
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 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 used 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 will improve the absorption of Malarone and increase treatment effectiveness.
Pregnancy and breastfeeding
If the patient is pregnant, she should not take Malarone unless otherwise advised by a doctor.

• Consult a doctor or pharmacist before using Malarone.

Breastfeeding should be avoided during treatment with Malarone, because the active ingredients of Malarone pass into breast milk and may harm the infant.
Driving and using machines
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, meaning 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 tablets should be taken with food or a milk drink, if possible.
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 Malarone treatment. If additional doses have been taken 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 be ineffective, as the amount of medicine absorbed may be reduced.

When treating malaria

• If the patient vomits or has diarrhoea, inform the doctor, who will recommend regular blood tests. Malarone may be ineffective due to reduced absorption of the medicine. Blood tests will help confirm whether the malaria parasite has been cleared from the patient's blood.

Preventing malaria
The recommended dose of Malarone for adults is one tablet once daily, as described below.
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:

• 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 an additional 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 – adult dosing applies.

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 than the recommended dose of Malarone
Seek advice from a doctor or pharmacist. If possible, bring the Malarone packaging.
Missing a dose of Malarone
It is important to complete the full course of Malarone treatment.
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 medical advice.
Continue taking the medicine for 7 days after returning to a malaria-free area. To ensure maximum protection, 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 bite from an infected mosquito are eliminated.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following serious adverse reactions should be noted. They occurred in a small number of people, but the exact frequency is unknown.

Serious allergic reactions – symptoms include:

• rash and itching
• sudden 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, contact a doctor immediately. Do not take any further tablets.

Serious skin reactions

• rash, which may be blistering and resemble target-like 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 develops 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 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:

• 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 levels in the 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 1,000 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 (liver inflammation)
• blockage of bile ducts (cholestasis)
• increased heart rate (tachycardia)
• inflammation of blood vessels, which may appear as red or purple skin nodules, 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 or assess situations 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 or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will 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.
Other components of the medicine 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.

• 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 coated tablets are pink and round, with the imprint “GX CM3” on one side.
They are packed in blisters containing 12 coated tablets per cardboard box.
For more detailed information, please contact the marketing authorisation holder or the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3, 91-342 Łódź
Marketing authorisation number in Spain, country of export: 653915.6
Parallel import authorisation number: 443/19
This medicinal product is authorised for marketing in all European Economic Area countries and in the United Kingdom (Northern Ireland) under the name: Malarone.