Malaway 250 mg/100 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Malaway 250 mg/100 mg film-coated tablets EFG

atovaquone/proguanil hydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

1. What Malaway is and what it is used for
2. What you need to know before taking Malaway
3. How to take Malaway
4. Possible adverse effects
5. How to store 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 known as antimalarials. It contains two active substances: atovaquone and proguanil hydrochloride.

Malaway has two uses:

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

Malaria is transmitted by the bite of an infected mosquito, which introduces the malaria parasite (Plasmodium falciparum) into the bloodstream. Malaway prevents malaria by killing this parasite. In people already infected with malaria, Malaway also kills these parasites.

Protect yourself from getting malaria

Anyone, of any age, can get malaria. It is a serious illness, 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 skin.
• Wear light-colored clothing that covers as much of the body as possible, especially at dusk, when mosquitoes are most active.
• Sleep in a room protected against mosquitoes or under an insecticide-impregnated mosquito net.
• Close windows and doors at dusk, if they are not protected.
• Consider using an insecticide (tablet, spray, electric mosquito repellent) to clear the room of insects or prevent them from entering.

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

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

Seek medical advice immediately if you experience symptoms such as fever, headache, chills, or fatigue after returning from abroad.

2. What you need to know before taking Malaway

Do not take Malaway

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

• For the prevention of malaria, if you have severe renal impairment.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

For the prevention of malaria:

• If you feel unwell (vomiting) within one hour after taking Malaway tablets, take another dose immediately.
• It is important to take the full dose of Malaway. If you need to take an additional dose due to vomiting, you may require another prescription.
• If you have been vomiting, it is especially important to use additional protective measures, such as repellents and mosquito nets. Malaway may be less effective, as the amount absorbed will be reduced.

For the treatment of malaria:

• If you have been vomiting and have diarrhoea, consult your doctor. You will need periodic blood tests. Since the amount of Malaway absorbed may be reduced, it might not be as effective. Blood tests will check whether the malaria parasite is being cleared from your blood.
• If you have severe kidney disease, your doctor may consider prescribing a different medicine.
• If you develop any kind of infection while being treated with Malaway, your doctor may prescribe other types of medicines instead of Malaway.
• If you are treated for malaria but become infected 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 need to take any other medicines.

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

• metoclopramide, used to treat nausea and vomiting.
• antibiotics: tetracycline, rifampicin, rifabutin.
• efavirenz or certain potent protease inhibitors used for the treatment of HIV.
• indinavir, used for the treatment of HIV.
• warfarin and other anticoagulant medicines.
• etoposide, used for the treatment of cancer.

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

REMEMBER to 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 milky drink, if possible. This will increase the amount of Malaway absorbed by your body 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 become pregnant, consult your doctor or pharmacist before using this medicine. 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 may cause dizziness in some people. If this happens to you, do not drive, operate machinery, or engage in activities that could put you or others at risk.

3. How to take Malaway

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

Take Malaway with food or a milk drink whenever possible.

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

Prevention of malaria:

The usual dose for adults and adolescents weighing more than 40 kg is one tablet once daily, taken as described below.

For 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.

A different type of Malaway tablet for children may be available in your country.

To prevent malaria in adults:

• Start taking Malaway 1 or 2 days before travelling to a malaria-risk area.
• Continue taking it daily during your trip and keep taking it for another 7 days after returning to a malaria-free area.

Take all tablets in the Malaway course to achieve maximum protection.

Stopping earlier increases the risk of contracting malaria, as 7 days are required to ensure the elimination of any parasites that may have entered your body through the bite of an infected mosquito.

Treatment of malaria:

The recommended dose for adults is 4 tablets once daily 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.
• more than 40 kg – 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. Another type of Malaway tablet for children may be available in your country.

If you take more Malaway than you should

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

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

If you forget to take Malaway

It is very important that you complete the full course of Malaway. If you miss a dose, do not worry. Take the next dose as soon as you remember. Then continue the treatment as before. Do not take a double dose to make up for a missed dose.

Do not stop treatment with Malaway without consulting your doctor

Continue taking Malaway for 7 days after returning from a malaria-free area. Complete the entire Malaway course to achieve maximum protection. If you stop earlier, you risk contracting malaria, as 7 days are required to ensure the elimination of any parasites that may have entered your body through the bite of an infected mosquito.

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Be alert for the following serious reactions. These have been observed in a small number of people, although their exact frequency is unknown.

Severe allergic reactions. Signs include:

• Rash and itching.
• Sudden wheezing, tightness in the chest or throat, 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 which may blister and appear as small targets (dark central spots surrounded by paler areas with a dark ring around the edge) (erythema multiforme).
• Severe widespread rash with blistering 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 of the other reported adverse effects have been mild and short-lived.

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

• Headache
• Feeling unwell (nausea and vomiting)
• Stomach pain
• Diarrhea

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

• Dizziness
• Sleep problems (insomnia)
• Strange dreams
• Depression
• Loss of appetite
• Fever
• Skin rashes
• Allergic reactions
• Itching (pruritus)

Common adverse effects that may be detected in blood tests:

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

Uncommon adverse effects (may affect between 1 and 10 in 1,000 patients):

These may affect up to 1 in 100 people:

• Anxiety
• Unusual awareness of an abnormal heartbeat (palpitations)
• Swelling and redness in the mouth
• Red, swollen skin patches (urticaria)
• Hair loss

Uncommon adverse effects that may be detected in blood tests:

• Increased amylase (an enzyme produced in the pancreas)

Rare adverse effects: may affect between 1 and 10 in 10,000 people

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

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

• Inflammation of the liver (hepatitis)
• Blockage of the bile ducts (cholestasis)
• Increased heart rate (tachycardia)
• Inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, although it may affect other parts of the body
• Seizures
• Panic attacks, crying
• Nightmares
• Severe mental health problems, where the person loses touch with reality and is unable to think or judge clearly
• Mouth ulcers
• Blisters
• Peeling of the skin
• Increased sensitivity of the skin to light
• Effects on the stomach (gastric intolerance)

Other adverse effects that may appear in blood tests:

• Decrease in all types of blood cells (pancytopenia)

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Malaway

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Malaway

• The active substances 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 hydroxypropyl cellulose, povidone K30, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, magnesium stearate.

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

Appearance of the product and pack contents

Malaway are pinkish-brown, round, biconvex, film-coated tablets with bevelled edges, marked with "404" on one side and "G" on the other.

Malaway is available in PVC/PVDC (transparent) blisters with rigid and tempered PVC/PVDC aluminum foil laminates.

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

Only some pack 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: December 2023.

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