Package Leaflet: Information for the User

Malaway 250 mg/100 mg Film-Coated Tablets EFG

atovaquone/hydrochloride of proguanil

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

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

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Malaway is and what it is used for

2.What you need to know before you start taking Malaway

3.How to take Malaway

4.Possible side effects

5.Storage of Malaway

6.Contents of the pack and additional information

Malaway belongs to a group of medications known asantimalarials.It contains two active principles, atovaquone andhydrochloride of proguanil.

Malaway has two uses:

• Prevention of malaria in adults and children with a weight of 40 kg or more
• Treatment of malaria in adults and children with a weight of 11 kg or more

Malaria is transmitted by the bite of an infected mosquito, which introduces 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 contracting malaria

Anyone, regardless of age, can contract malaria. It is a serious disease, but it is preventable. Even when taking Malaway, 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 impregnated with insecticide.
• Close windows and doors in the evening,if they are not protected.
• Consider using an insecticide(pill, 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 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 have symptomssuch as fever, headache, chills, or fatigue, after returning from abroad.

Do not take Malaway

• If you are allergic to atovacuona and/or proguanil or to any of the other components of this medication (listed in section 6).

• To prevent malaria, if you have severe kidney failure.

Warnings and precautions

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

Toprevent malaria:

• If you feel unwell(vomiting)during the first hour after taking Malaway tablets, take another dose quickly.
• It is essential to take all of Malaway medication. 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 less.

To treat malaria:

• If you have been vomiting and have diarrhea, consult your doctor. You will need periodic blood tests. As the amount of Malaway absorbed has been 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 medication.
• If you contract any type of infection while taking Malaway, your doctor may prescribe other types of medication instead of Malaway.
• If you are treated for malaria, but still contract it or if malaria is caused by a certain type of parasite, your doctor may prescribe another medication in addition to Malaway.

Other medications and Malaway

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• metoclopramide, used to treat nausea and vomiting.
• antibiotics: tetracycline, rifampicin, rifabutin.
• efavirenz or some very active protease inhibitors used for HIV treatment.
• indinavir, used for HIV treatment.
• warfarin and other anticoagulant medications.
• etoposide used for cancer treatment

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

REMEMBER to consult with your doctor if you start taking any other medication while taking Malaway.

Taking Malaway with food and drinks

Take Malaway with food or a lactose 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 break the tablets.

Pregnancy and breastfeeding

If you are pregnant, or in a breastfeeding period, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication. Do not take Malaway unless your doctor recommends it.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Take Malaway with food or a milk-based beverage 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 more than 40 kg is one tablet per day, taken as indicated below.

For children, consult your doctor.

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

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

For malaria prevention 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 once you have returned to a malaria-free area.

Take all the Malaway tablets in the treatment for maximum protection.

Stopping it early implies a risk of contracting malaria, as 7 days are needed to ensure the death of the parasites that may have been in your body from the mosquito bite.

Treatment of malaria:

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

For children weighing 11 kg or more:

• 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.
• More than 40 kg – the same dose as for adults.

Malaway is not recommended for malaria treatment 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 help and, if possible, show them the medication packaging.

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

If you forget to take Malaway

It is very important to take the complete Malaway treatment. 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 compensate for the missed doses.

Do not interrupt the Malaway treatment without consulting your doctor

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

Consult your doctor or pharmacist for advice.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

Be aware of the following severe reactions. They have been observed in a reduced 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 experience any of these symptoms, contact a doctor immediately. Stop taking Malaway.

Severe skin reactions:

• Skin rash that may present with blisters and appear as small, dark spots surrounded by lighter areas with a dark ring around the edge (erythema multiforme).
• Severe widespread skin rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

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

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

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

• Headache
• Feeling and being unwell (nausea and vomiting)
• Abdominal pain
• Diarrhea

Common side effects (may affect between 1 and 10 in 100 patients):

• Dizziness
• Difficulty sleeping (insomnia)
• Strange dreams
• Depression
• Loss of appetite
• Fever
• Rashes
• Cough
• Allergic reactions
• Itching (pruritus)

Common side effects that may be discovered in blood tests:

• Decreased red blood cell count (anemia) that may cause fatigue, headache, and difficulty breathing.
• Decreased white blood cell count (neutropenia)that makes you more prone to infections.
• Low sodium concentration in the blood (hyponatremia).
• Increased liver enzymes

Rare side effects (may affect between 1 and 10 in 1,000 patients)

These may affect up to 1 in 100 people:

• Anxiety
• An unusual perception of an irregular heartbeat (palpitations),
• Swelling and redness of the mouth
• Red, swollen patches on the skin (urticaria)
• Hair loss

Rare side effects that may be discovered in blood tests:

• Increased amylase (an enzyme produced in the pancreas)

Very rare side effects: may affect between 1 and 10 in 10,000 people

• To see or hear things that do not exist (hallucinations).

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

• Liver inflammation (hepatitis)
• Blockage of the bile ducts (bile duct obstruction)
• Increased heart rate (tachycardia)
• Inflammation of the blood vessels (vasculitis)that may be visible as red or purple spots, although it may affect other parts of the body
• Seizures
• Panic attacks, crying
• Nightmares
• Severe mental health problems, in whichthe personlosescontact with realityandis unable to thinkand judgeclearly
• Mouth ulcers
• Blisters
• Skin peeling
• Increased skin sensitivity to light
• Effects on the stomach (gastrointestinal intolerance)

Other side effects that may appear in blood tests:

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

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting 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 it directly through theSpanish System for the 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.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on the box and the blister packafter CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition of Malaway

- The active principles are atovaquone and proguanil hydrochloride.

Cada comprimido contiene 250 mg de atovaquona y 100 mg de hidrocloruro de proguanil.

- The other components are:

Core of the tablet : poloxamer 188, microcrystalline cellulose, hydroxypropylmethylcellulose with low degree of substitution, povidone K30, sodium carboxymethylcellulose (type A) (from potato), anhydrous colloidal silica, magnesium stearate.

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

Appearance of the product and contents of the package

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

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

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer and responsible manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibíchova 143

566 17 Vysoké Mýto

Czech Republic

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: December 2023.

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