Label:patient information

Malarone 250 mg/100 mg film-coated tablets

atovaquone/hydrochloride of proguanil

Read this label carefully before starting to take this medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to others even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this label. See section 4.

Malarone belongs to a group of medications known asantimalarialsorantipaludics. It contains two active ingredients: atovaquone and hydrochloride of proguanil.

What is Malarone used for

Malarone has two uses:

• Prevention of malaria
• Treatment of malaria

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

Malaria or paludism 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 the case of people who have already been infected with malaria, Malarone also eliminates these parasites.

Protect yourself from contracting malaria

Anyone, regardless of age, can contract malaria or paludism. It is a serious disease, but it is preventable.

Even taking Malarone, it is very important to take precautions to avoid mosquito bites.

• 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 more active.
• Sleep in a mosquito-protected roomor under a mosquito net treated with insecticide.
• Close windows and doors in the evening,if they are not protected.
• Consider using an insecticide(pill, spray, electric) to clear the room of insects or prevent them from entering the room.

?If you need clarification, speak with your doctor or pharmacist.

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

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

Do not take Malarone:

• if you are allergicto atovaquone, hydrochloride of proguanil, or any of the other componentsofthis medication (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 starting to take Malarone if:

• you have severe kidney disease
• your child is being treated for malaria and weighs less than11 kg. There is another presentation of this medication for treating children who weigh less than11 kg(see section 3).

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

Other medications and Malarone

Inform your doctor or pharmacist if you are taking, have recently takenor may need to takeany othermedication, including those purchased without a prescription.

Some medications may affect the way Malarone works, or Malarone may enhance or reduce the effect of other medications used at the same time as Malarone. Among these medications are:

• metoclopramide, used to treat nausea and vomiting;
• antibiotics:tetracycline,rifampicinandrifabutin;
• efavirenzor some very active protease inhibitorsused for HIV treatment;
• warfarinand other anticoagulant medications;
• etoposideused for cancer treatment.

?Consult your doctorif you are taking any of these medications. 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 medication while taking Malarone.

TakingMalaronewith food and drinks

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

Pregnancy and breastfeeding

If you are pregnant, do not take Malaroneunless your doctor recommends it.

?Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

If you feel dizzy, do not drive.

Malarone makes some people feel dizzy. If this happens to you, do not drive, operate machinery, or participate in activities that may put you or others at risk.

Malarone contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication is indicated by your doctor or pharmacist.Consult your doctor or pharmacist again in case of doubt.In case of doubt, consult your doctor or pharmacist again.

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

It is better to take Malarone every day at the same hour.

If you vomit

Malaria prevention:

• If you vomit during the first hour after taking Malarone tablets, take another dose as soon as possible;take another dose as soon as possible.
• It is essential to take the entire Malarone treatment.If you need to take an additional dose due to vomiting, you may need another prescription;
• If you have been vomiting,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:

• If you have been vomiting and have diarrhea,consult your doctor. You will need regular blood tests. Malarone may not be as effective, as the amount absorbed may be reduced.

Tests allow you to check if the malaria parasite has been eliminated from the blood.

Malaria prevention

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

It is not recommended for preventing malaria in children,or in adults weighing less than40 kg. Malarone pediatric tablets are recommended for preventing malaria in adults or children weighing less than40 kg.

To prevent malaria in adults:

• Start taking Malarone 1 or 2 days before traveling to a malaria area;
• Continue taking it daily while you are there;
• Continue taking it for another 7 days after returning to a malaria-free area.

Malaria treatment:

The recommended dose for 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.

It is not recommended for malaria treatment in childrenwho weigh less than11 kg.

For children weighing less than11 kgconsult 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 packaging.

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

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Malarone

It is very important to take the complete Malarone treatment.

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

Do not take more tablets to compensate for a missed dose. Simply take the next dose when it is due.

Do not interrupt the Malarone treatment without consulting your doctor.

Continue taking Malarone for 7 days after returning to a malaria-free area.Take the complete Malarone treatment to achieve maximum protection. If you interrupt it before, you put yourself at risk of contracting malaria, as 7 days are needed to ensure the death of any parasites that may have been in your body due to an infected mosquito bite.

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Be careful with the following severe adverse reactions. They have occurred in a small number of people, although their exact frequency is unknown.

Severe allergic reactions. The signs include:

?Immediately contact your doctorif you experience any of these symptoms.Stop taking Malarone

Severe dermatological reactions

• skin eruption, which may present with blisters and appear as small, dark spots (punctate lesions) in the center surrounded by a pale area with a dark circle around the edge)(erythema multiforme)
• severe generalized eruption 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 reported side effects have been mild and did not last long.

Very common side effects

These may affectmore than 1 in 10 people:

Common side effects

These may affectup to 1 in 10 people:

The common side effects that may appear in blood tests are:

• decrease in red blood cell count(anemia)which may cause fatigue, headache, and shortness of breath
• decrease in white blood cell count(neutropenia)which may make you more susceptible to infections
• low sodium levels in the blood(hyponatremia)
• increased liver enzymes.

Uncommon side effects

These may affectup to 1 in 100 people:

The uncommon side effects that may appear in blood tests are:

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

Rare side effects

These may affectup to 1 in 1,000 people:

• seeing or hearing things that do not exist (hallucinations).

Side effects of unknown frequency:

The frequency cannot be calculated with the available data

Other side effects that may appear in blood tests:

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration datethat appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Malaronedoes not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Malarone

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

The other components are:

tablet core:poloxamer 188, microcrystalline cellulose, hydroxypropylmethylcellulose, povidone K30, sodium carboxymethylcellulose (type A) (potato), magnesium stearate.

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

?Consult your doctor before taking Malaroneif you are allergic to any of these components.

Appearance of the product and contents of the packaging

Malarone tablets are film-coated tablets, pink in color, round, and marked on one face with “GX CM3”. They are presented in a blister pack 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 the last review of this leaflet:January 2022.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/