MALAWAY 250 MG/100 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Malaway 250 mg/100 mg film-coated tablets EFG

Atovaquone/Proguanil Hydrochloride

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. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Malaway is and what it is used for
2. What you need to know before you take Malaway
3. How to take Malaway
4. Possible side effects
5. Storing Malaway
6. Contents of the pack and other information

1. What Malaway is and what it is used for

Malaway belongs to a group of medicines called antimalarials. It contains two active substances, atovaquone and proguanil hydrochloride.

Malaway has two uses:

• Prevention of malaria in adults and children weighing over 40 kg
• Treatment of malaria in adults and children weighing over 11 kg

Malaria is spread by the bite of an infected mosquito, which injects the malaria parasite (Plasmodium falciparum) into the blood. Malaway prevents malaria by killing this parasite. For people who have already been infected with malaria, Malaway also kills 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 Malaway, 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 mosquito killer) to clear the room of insects or prevent them from entering the room.

If you need more advice,consult your doctor or pharmacist.

Even when taking all necessary precautions, it is still possible to get malaria.Some types of malaria infection can 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 a doctor immediately if you have symptomssuch as fever, headache, chills, or fatigue after returning from abroad.

2. What you need to know before you take Malaway

Do not take Malaway

• If you are allergic to atovaquone and/or proguanil or any of the other ingredients of this medicine (listed in section 6).

• For the prevention of malaria, if you have severe kidney problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

For the prevention of malaria:

• If you feel unwell (vomit) during the first hour after taking Malaway tablets, take another dose quickly.
• It is essential to take all of the Malaway medicine. 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. Malaway may not be as effective, as the amount absorbed will be lower.

For the treatment of malaria:

• If you have been vomiting and have diarrhea, consult your doctor. You will need regular blood tests. As the amount of Malaway absorbed is reduced, it may not be as effective. The tests will check if the malaria parasite is being eliminated from your blood.
• If you have severe kidney disease, your doctor may want to prescribe a different medicine.
• If you contract any infection while being treated with Malaway, your doctor may prescribe a different type of medicine instead of Malaway.
• If malaria is treated, but you still get it again, or if the malaria is caused by a certain type of parasite, your doctor may prescribe another medicine in addition to Malaway.

Other medicines and Malaway

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines may affect how Malaway works, or Malaway may enhance or reduce the effect of other medicines used at the same time. These include:

• Metoclopramide, used to treat nausea and vomiting.
• Antibiotics: tetracycline, rifampicin, rifabutin.
• Efavirenz or some protease inhibitors used to treat HIV.
• Indinavir, used to treat HIV.
• Warfarin and other anticoagulant medicines.
• Etoposide used to treat cancer.

Tell your doctor if you are taking any of these. Your doctor may decide that Malaway is not suitable for you, or that you need to have additional checks while taking it.

Rememberto consult your doctor if you start taking any other medicine while taking Malaway.

Taking Malaway with food and drinks

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

It is preferable not to split the tablets.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Malaway unless your doctor advises you to.

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

Driving and using machines

If you feel dizzy, do not drive. Malaway 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.

3. How to take Malaway

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Take Malaway with food or a dairy drink whenever possible.

It is recommended to take Malaway every day at the same time.

Prevention of malaria:

The usual dose in adults and adolescents weighing over 40 kg is one tablet once a day, taken as indicated below.

In children, consult your doctor.

Malaway is not recommended for the prevention of malaria in children or in adults or adolescents weighing less than 40 kg.

In your country, a different type of Malaway tablet may be available for children.

For the prevention of malaria in adults:

• Start taking Malaway 1 or 2 days before traveling to a malaria area.
• Continue taking it daily during the trip and continue taking it for another 7 days after returning to a malaria-free area.

Take all the Malaway tablets for maximum protection.

Stopping it early means a risk of getting malaria, as 7 days are needed to ensure the death of the parasites that may be in your body from the bite of an infected mosquito.

Treatment of malaria:

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

For children weighing 11 kg or more:

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

Malaway is not recommended for the treatment of malaria in children weighing less than 11 kg.

For children weighing less than 11 kg, consult your doctor. There may be another type of Malaway tablet available for children in your country.

If you take more Malaway than you should

Contact your doctor or pharmacist for advice and, if possible, show them the medicine 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.

If you forget to take Malaway

It is very important that you take the complete treatment of Malaway. If you forget a dose, do not worry. Take the next dose as soon as you remember. Then continue the treatment as you were doing before. Do not take a double dose to make up for forgotten doses.

Do not stop treatment with Malawaywithout consulting your doctor

Continue taking Malawayfor 7 days after returning from a malaria-free area. Take the complete treatment of Malaway to achieve maximum protection. If you stop it early, you risk getting malaria, as 7 days are needed to ensure the death of the parasites that may be in your body from the bite of an infected mosquito.

Consult your doctor or pharmacist for advice on what to do.

If you have any further questions on the use of this product, 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 reactions. They have been seen in a small number of people, although their exact frequency is unknown.

Severe allergic reactions. The signs include:

• Rash and itching.
• Sudden wheezing, chest or throat tightness, or difficulty breathing.
• Swelling of the eyelids, face, lips, tongue, or any other part of the body.

If you get any of these symptoms, contact a doctor immediately. Stop taking Malaway.

Severe skin reactions:

• A skin rash that may have blisters and looks like targets (central dark spots surrounded by lighter areas with a dark ring around the edge) (erythema multiforme).
• A severe widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

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

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

Very common side effects (may affect more than 1 in 10 people):

• Headache
• Feeling and being sick (nausea and vomiting)
• Stomach pain
• Diarrhea

Common side effects (may affect up to 1 in 10 people):

• Dizziness
• Sleeping problems (insomnia)
• Unusual dreams
• Depression
• Lack of appetite
• Fever
• Skin rash
• Cough
• Allergic reactions
• Itching (pruritus)

Common side effects that may be found in your blood tests:

• Decrease in the number of red blood cells (anemia) that can cause tiredness, headache, and difficulty breathing.
• Decrease in the number of white blood cells (neutropenia) that makes you more prone to infections.
• Low sodium levels in the blood (hyponatremia).
• Increased liver enzymes

Uncommon side effects (may affect up to 1 in 100 people)

These may affect up to 1 in 100 people:

• Anxiety
• An unusual awareness of an abnormal heartbeat (palpitations),
• Swelling and redness of the mouth
• Red, itchy lumps on the skin (urticaria)
• Hair loss

Uncommon side effects that may be found in your blood tests:

• Increased amylase (an enzyme produced in the pancreas)

Rare side effects: may affect up to 1 in 10,000 people

• Seeing or hearing things that are not there (hallucinations)

Other side effects:Other side effects have occurred in a small number of people, although their frequency is unknown

• Liver inflammation (hepatitis)
• Bile duct obstruction (cholestasis)
• Increased heart rate (tachycardia)
• Blood vessel inflammation (vasculitis) that can be seen as red or purple spots, although it can affect other parts of the body
• Seizures (convulsions)
• Panic attacks, crying
• Nightmares
• Serious mental health problems, in which the person loses contact with reality and is unable to think and judge clearly
• Mouth ulcers
• Blisters
• Peeling of the skin
• Increased sensitivity of the skin to light
• Stomach problems (gastric intolerance)

Other side effects that may be found in your blood tests:

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report side effects 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 Malaway

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Malaway

• The active ingredients are atovaquone and proguanil hydrochloride.

Each tablet contains 250 mg of atovaquone and 100 mg of proguanil hydrochloride.

• The other components are:

Tablet core: poloxamer 188, microcrystalline cellulose, low-substituted hydroxypropylcellulose, povidone K30, sodium carboxymethyl starch (type A) (potato), colloidal anhydrous silica, magnesium stearate.

Film coating: hypromellose, titanium dioxide (E171), red iron oxide (E172), Macrogol 400, Macrogol 8000.

Appearance of the Product and Container Content

Malaway are pink-brown, round, biconvex tablets, with a beveled edge, film-coated, and marked on one side with "404" and with "G" on the other.

Malaway is presented in PVC/PVDC (transparent) blisters and rigid and tempered aluminum PVC/PVDC sheets.

Container sizes: 12, 24, 36, 60 tablets.

Only some container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibíchova 143

566 17 Vysoké Mýto

Czech Republic

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medication is authorized in the member states of the European Economic Area under the following names:

Date of the Last Revision of this Prospectus:December 2023.

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