MALARONE 250 mg/100 mg FILM-COATED TABLETS

Introduction

Package Leaflet:information for the patient

Malarone 250 mg/100 mg film-coated tablets

atovaquone/hydrochloride proguanil

Read all of this leaflet carefully before you start taking this medicine,because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• 1. If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Malarone and what is it used for
2. What you need to know before you take Malarone
3. How to take Malarone
4. Possible side effects
5. Storing 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 hydrochloride proguanil.

What Malarone is used for

Malarone has two uses:

• Prevention of malaria
• Treatment of malaria

The dosage instructions for each use are included in section 3, How to take Malarone.

Malaria is transmitted by the bite of an infected mosquito, which introduces the malaria parasite (Plasmodium falciparum) into the blood. Malarone prevents malaria by eliminating this parasite. In people who have already been infected with malaria, Malarone also eliminates these parasites.

Protect yourself from getting malaria

Anyone, of any age, can get malaria. It is a serious disease, but it is preventable.

Even when taking Malarone, it is very important that you take precautions to avoid being bitten by mosquitoes.

• Use mosquito repellent on all exposed areas of the body.
• Wear light-colored clothing that covers as much of the body as possible, especially in the evening when mosquitoes are most active.
• Sleep in a room protectedagainst mosquitoes or under a mosquito net impregnated with insecticide.
• Close windows and doors at sunset,if they are not protected.
• Consider using an insecticide(tablet, spray, electric) to clear the room of insects or prevent them from entering the room.

If you need clarification, talk to your doctor or pharmacist.

Even when taking all necessary precautions, it is possible to get malaria.Some types of malaria infection take a long time to cause symptoms; therefore, the disease may not start until several days, weeks, or even months after returning from travel.

Consult your doctor immediately if you have symptoms such as:fever, headache, chills, or fatigue, after returning from abroad.

2. What you need to know before you take Malarone

Do not take Malarone:

• to atovaquone, hydrochloride proguanil, or any of the other ingredients of this medicine (listed in section 6).
• to prevent malaria if you have severe kidney disease.

Consult your doctor if any of these cases apply to you.

Warnings and precautions

Consult your doctor or pharmacist before taking Malarone if:

• you have severe kidney disease
• your child is being treated for malaria and weighs less than 11 kg. There is another formulation of this medicine to treat children who weigh less than 11 kg (see section 3).

Consult your doctor or pharmacist if any of these cases apply to you.

Other medicines and Malarone

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any othermedicine, including those obtained without a prescription.

Some medicines may affect how Malarone works, or Malarone may increase or decrease the effect of other medicines used at the same time as Malarone. These medicines include:

• metoclopramide, used to treat nausea and vomiting;
• antibiotics: tetracycline, rifampicin, and rifabutin;
• efavirenzor some highly active protease inhibitorsused to treat HIV;
• warfarinand other anticoagulant medicines;
• etoposideused to treat cancer.

Consult your doctorif you are taking any of these medicines. Your doctor may decide that Malarone is not suitable for you or that you need additional checks while taking it.

Remember to consult your doctorif you start taking any other medicine while taking Malarone.

Taking Malarone with food and drinks

Take Malarone with food or a dairy drink, if possible. This will increase the amount of Malarone that your body can absorb, and make your treatment more effective.

Pregnancy and breastfeeding

Do not take Malarone if you are pregnant, unless your doctor recommends it.

Consult your doctor or pharmacist before taking any medicine.

Do not breastfeed while taking Malarone, as the components of Malarone may pass into breast milk and harm your baby.

Driving and using machines

If you feel dizzy, do not drive.

Malarone can make some people feel dizzy. If this happens to you, do not drive, use machines, or take part in activities that may put you or others at risk.

Malarone contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

3. How to take Malarone

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Take Malarone with food or a dairy drink, if possible.

It is best to take Malarone every day at the same time.

If you vomit

Malaria prevention:

• , take another dose as soon as possible;
• it is essential to take the full course of Malarone.If you need to take an additional dose due to vomiting, you may need another prescription;
• it is especially important to use additional protection, such as repellents and mosquito nets. Malarone may not be as effective, as the amount absorbed may be reduced.

Malaria treatment:

• , consult your doctor. You will need regular blood tests. Malarone may not be as effective, as the amount absorbed may be reduced.

Blood tests allow checking if the malaria parasite has been eliminated from the blood.

Malaria prevention

The recommended dose in adultsis 1 tablet per day, taken as indicated below.

Malarone is not recommended for preventing malaria in children, or in adults who weigh less than 40 kg. Malarone pediatric tablets are recommended for preventing malaria in adults or children who weigh less than 40 kg.

For preventing malaria in adults:

• start taking Malarone 1 or 2 days before traveling to a malaria area;
• continue taking it daily while you are in the area
• continue taking it for 7 days after returning to a malaria-free area.

Malaria treatment:

The recommended dose in adultsis 4 tablets once a day for 3 days.

For childrenthe dose depends on their body weight:

• 11-20 kg – 1 tablet per day for 3 days
• 21-30 kg – 2 tablets per day for 3 days
• 31-40 kg – 3 tablets per day for 3 days
• over 40 kg – the same dose as for adults.

Malarone is not recommended for treating malaria in childrenwho weigh less than 11 kg.

For children who weigh less than 11 kg, consult your doctor. In your country, a different type of Malarone tablet may be available for children.

If you take more Malarone than you should

Contact your doctor or pharmacist for advice on what to do. If possible, show them the Malarone pack.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91.562.04.20, indicating the medicine and the amount ingested.

It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Malarone

It is very important that you complete the full course of Malarone.

If you forget a dose, do not worry. Take the next dose as soon as you remember. Then continue with the treatment as you were doing before.

Do not take more tablets to make up for a forgotten dose. Simply take the next dose when it is due.

Do not stop taking Malarone without consulting your doctor.

Continue taking Malarone for 7 days after returning to a malaria-free area.Take the full course of Malarone to get maximum protection. If you stop it earlier, you are at risk of getting malaria, as 7 days are needed to ensure the death of any parasites that may be in your body due to the bite of an infected mosquito.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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. The signs include:

• rash and itching
• sudden wheezing, chest pain or tightness, or difficulty breathing
• swelling of the eyes, face, lips, tongue, or any other part of the body.

Contact your doctor immediatelyif you have any of these symptoms. Stop taking Malarone

Severe skin reactions

• skin rash, which may have blisters and looks like targets (dark spots in the center surrounded by a paler area with a dark ring around the edge) (erythema multiforme)
• widespread severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

If you notice any of these symptoms, contact your doctor urgently.

Most other side effects reported have been mild and have not lasted long.

Very common side effects

These may affect more than 1 in 10 people:

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

Common side effects

These may affect up to 1 in 10 people:

• dizziness
• sleep problems (insomnia)
• strange dreams
• depression
• loss of appetite
• fever
• rash that may cause itching
• cough.

Common side effects that may appear in blood tests are:

• decrease in the number of red blood cells (anemia)which may cause tiredness, headache, and shortness of breath
• decrease in the number of white blood cells (neutropenia)which may make you more prone to infections
• low sodium levels in the blood (hyponatremia)
• increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

• anxiety
• feeling of abnormal heartbeat (palpitations)
• swelling and redness of the mouth
• hair loss
• itchy lumpy rash (hives).

Uncommon side effects that may appear in blood tests are:

• increase in amylase (an enzyme produced in the pancreas).

Rare side effects

These may affect up to 1 in 1,000 people:

• seeing or hearing things that are not there (hallucinations).

Side effects with frequency not known:

Their frequency cannot be estimated from the available data

• inflammation of the liver (hepatitis)
• blockage of the bile ducts (cholestasis)
• increase in heart rate (tachycardia)
• inflammation of blood vessels (vasculitis)which may appear as raised patches on the skin, red or purple in color, although it can also affect other parts of the body
• seizures (convulsions)
• panic attacks, crying
• nightmares
• serious mental problem where the person loses contact with reality and is unable to think and judge clearly
• indigestion
• mouth ulcers
• blisters
• skin peeling
• increased sensitivity of the skin to sunlight.

Other side effects that may appear in blood tests:

• decrease in all types of blood cells (pancytopenia).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Malarone

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry datestated on the pack after EXP. The expiry date is the last day of the month shown.

Malarone does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Malarone

The active substances are:250 mg of atovaquone and 100 mg of hydrochloride proguanil per tablet.

The other ingredients are:

tablet core:poloxamer 188, microcrystalline cellulose, hydroxypropylcellulose, povidone K30, sodium starch glycolate (type A) (from potato), magnesium stearate.

tablet coating:hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 400, polyethylene glycol 8000 (see section 2).

Consult your doctor before taking Malaroneif you may be allergic to any of these ingredients.

Appearance and packaging

Malarone tablets are film-coated, pink, round, and marked with “GX CM3” on one side. They come in blisters of 12 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

or

Glaxo Wellcome S.A.

Avenida de Extremadura, 3

09400 Aranda de Duero (Burgos)

This medicine is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Germany, Austria, Belgium, Slovenia, Slovakia, Spain, Finland, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic, and Sweden: Malarone

Date of last revision of this leaflet:January 2022.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/