Patient Medication Information: uses, side effects, how to take - Malarone

What MALARONE / MALARONE PEDIATRIC is used for:

MALARONE / MALRONE PEDIATRIC is used to prevent and to treat malaria caused by a parasite (P. falciparum) that is often resistant to some other drugs.

How MALARONE / MALARONE PEDIATRIC works:

MALARONE / MALARONE PEDIATRIC contains two active ingredients which kill the malarial parasites in your body.

The ingredients in MALARONE / MALARONE PEDIATRIC are:

Medicinal ingredients: atovaquone and proguanil hydrochloride

Non-medicinal ingredients: Hypromellose, low substituted hydroxypropyl cellulose, macrogol 400, magnesium stearate, microcrystalline cellulose, poloxamer 188, polyethylene glycol 8000, povidone K30, red iron oxide, sodium starch glycollate, and titanium dioxide.

MALARONE / MALARONE PEDIATRIC comes in the following dosage forms:

MALARONE: Tablets; 250 mg atovaquone and 100 mg proguanil hydrochloride.

MALARONE PEDIATRIC: Tablets; 62.5 mg atovaquone and 25 mg proguanil hydrochloride.

Do not use MALARONE / MALARONE PEDIATRIC if:

You are allergic to atovaquone or to proguanil hydrochloride.
You are allergic to any of the other ingredients in MALARONE / MALARONE PEDIATRIC or to any part of the container.
You have severe kidney problems. Your healthcare professional will assess this.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MALARONE / MALARONE PEDIATRIC. Talk about any health conditions or problems you may have, including if you:

Have had severe skin reactions with MALARONE / MALARONE PEDIATRIC in the past.
Have been told that your malaria infection is severe.
Have or have had epilepsy in the past.
Have or have had mental health problems in the past.
Have ever had malaria before.
Are vomiting or have diarrhea.
Are fasting or unable to eat food.
Have kidney problems.
Have liver problems.
Are taking other medicines to treat or prevent malaria.

Other warnings you should know about:

Driving and using machines:

Dizziness may occur after using this medication. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything requiring you to be alert.

Use in children:

MALARONE / MALARONE PEDIATRIC is not approved for the prevention of malaria in children who weigh less than 11 kg. MALARONE / MALARONE PEDIATRIC is not approved for the treatment of malaria in children who weigh less than 11 kg or who are under 3 years of age.

Severe skin reactions:

MALARONE / MALARONE PEDIATRIC can cause severe skin reactions, some of which can be life-threatening or fatal. These include the following severe skin reactions: Stevens-Johnson syndrome (SJS), drug eosinophilia and systemic symptoms (DRESS) and erythema multiforme (EM). Stop taking MALARONE / MALARONE PEDIATRIC and contact your healthcare professional immediately if you or your child develops the following symptoms:

Redness, blistering, pain, burning, peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, along with by fever, sore throat, chills, headache, cough, body aches, swollen glands.
Fever, fatigue, severe widespread red skin rash, swelling of the face, itching, peeling skin, abnormal blood and liver function tests.
Raised red or purple skin patches, possibly with blister or crust in the center that look like a target or bullseye, itching and burning of skin, sores in mouth, on lips, genital or eyes, fatigue, weakness, headache, joint pain, itchy, red or sore eyes.

Pregnancy:

Before you take MALARONE / MALARONE PEDIATRIC, tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. There is no information on the use of MALARONE / MALARONE PEDIATRIC in pregnant women. MALARONE / MALARONE

PEDIATRIC should only be used in a pregnant woman following a careful risk-benefit assessment by the prescribing health care professional.

Breastfeeding:

Before you take MALARONE / MALARONE PEDIATRIC, tell your healthcare professional if you are breastfeeding. Patients taking MALARONE / MALARONE PEDIATRIC should not breastfeed a baby. This is because the ingredients can pass into the breast milk and harm your baby. Talk to your healthcare professional about the best way to feed your baby when you are taking MALARONE / MALARONE PEDIATRIC.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MALARONE / MALARONE PEDIATRIC:

Tetracycline, rifampicin, rifabutin, antibiotics used to treat bacterial infections.
Metoclopramide, used to treat nausea and vomiting.
Indinavir, ritonavir, efavirenz, or highly active protease-inhibitors, used to treat HIV and other viral infections.
Warfarin and other coumarins, used to treat or prevent blood clotting.
Other medicines used to treat or prevent malaria.

How to take MALARONE / MALARONE PEDIATRIC:

Take MALARONE / MALARONE PEDIATRIC exactly as your healthcare professional has told you to.
Take MALARONE / MALARONE PEDIATRIC with food or milk.
Take it at the same time each day.
It is best to swallow tablets whole.
For children who have trouble swallowing tablets, the tablets may be crushed and mixed with condensed milk right before administration.
If you vomit within 1 hour of taking MALARONE / MALARONE PEDIATRIC, take the dose again. Talk to your healthcare professional if you keep vomiting. Your healthcare professional may consider a different treatment for your malaria and will monitor your disease.

Usual dose:

The usual dose of MALARONE / MALARONE PEDIATRIC depends on whether you are an adult or a child and whether it is being used for the prevention or the treatment of malaria.

Prevention of Malaria

Adults: 1 tablet of MALARONE once a day.

Children: 1, 2 or 3 tablets of MALARONE PEDIATRIC once a day depending on your child’s weight (see table below). For children over 40 kg, 1 tablet of MALARONE (adult strength) once a day.

Dosage for Prevention of Malaria in Pediatric Patients

Weight (kg)	Dosage Regimen
11-20	1 tablet of MALARONE PEDIATRIC daily
21-30	2 tablets of MALARONE PEDIATRIC as a single dose daily
31-40	3 tablets of MALARONE PEDIATRIC as a single dose daily
>40	1 tablet of MALARONE (adult strength) daily

In order to prevent malaria, you must take MALARONE / MALARONE PEDIATRIC every day. Start taking it 1 or 2 days before travelling to a country where malaria is transmitted. Keep taking it every day while you are there and for another 7 days after you leave.

For maximum protection you must take the full course of MALARONE / MALARONE PEDIATRIC. Stopping early puts you at risk of getting malaria. It takes seven days to ensure that parasites sensitive to MALARONE / MALARONE PEDIATRIC are killed.

MALARONE / MALARONE PEDIATRIC is not approved for prevention of malaria in children who weigh less than 11 kg.

Treatment of Malaria

Adults: 4 tablets of MALARONE once a day for 3 days.

Children: 1, 2 or 3 tablets of MALARONE (adult strength) once a day for 3 days depending on your child's weight (see table below). For children over 40 kg in weight, 4 tablets of MALARONE (adult strength) once a day for 3 days.

Dosage for Treatment of Malaria in Pediatric Patients

Weight (kg)	Dosage Regimen
11-20	1 tablet of MALARONE (adult strength) daily for 3 consecutive days
21-30	2 tablets of MALARONE (adult strength) as a single dose daily for 3 consecutive days
31-40	3 tablets of MALARONE (adult strength) as a single dose daily for 3 consecutive days
>40	4 tablets of MALARONE (adult strength) as a single dose daily for 3 consecutive days

MALARONE / MALARONE PEDIATRIC is not approved for the treatment of malaria in children who weigh less than 11 kg or who are under 3 years of age.

Overdose:

If you think you, or a person you are caring for, have taken too much MALARONE / MALARONE PEDIATRIC, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. The dose should not be doubled to make for a missed dose. If you are not sure what to do, ask your healthcare professional.

Possible side effects from using MALARONE / MALARONE PEDIATRIC:

These are not all the possible side effects you may have when taking MALARONE / MALARONE PEDIATRIC. If you or your child experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

Tiredness, weakness, giddiness or breathlessness. These symptoms may mean that you are suffering from a reduction in red blood cell count (anemia).
A reduction in white blood cells (neutropenia)
Abnormal blood test showing a low salt level in the body (hyponatremia)
Loss of appetite, feeling sick (nausea) and/or being sick (vomiting), stomach pain, diarrhea or constipation
Mouth inflammation (swelling, redness, pain) and mouth ulcers
Headache, difficulty in sleeping, raised body temperature, eyesight problems
Psychiatric symptoms such as strange dreams, depression, anxiety, feeling of panic, crying, nightmares or mental health problems
Seeing or hearing things that are not there
Hair loss
Fever
Cough
Dizziness
Abnormal heartbeats
Back pain, muscle pain
Inflammation of the liver, yellow discoloration of the skin or eyes
Inflammation of blood vessels which may be visible as red or purple raised spots on the skin, but can affect other parts of the body

MALARONE / MALARONE PEDIATRIC may cause abnormal blood test results such as:

Reduction in the number of red blood cells, white blood cells, and in people with severe kidney problems also a reduction in the number of platelets (cells necessary for blood clotting).
Increase in amylase, which is an enzyme produced by the pancreas, and an increase of enzymes produced by the liver.

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional
Only if severe	In all cases
Unknown
Drug reaction with eosinophilia and systemic symptoms (DRESS) (severe skin reaction that may affect more than one organ): fever, fatigue, severe widespread red skin rash, swelling of the face, itching, peeling skin, abnormal blood and liver function tests.		✓
Erythema multiforme (skin reaction): raised red or purple skin patches, possibly with blister or crust in the center that look like a target or bullseye, itching and burning of skin, sores in mouth, on lips, genital or eyes, fatigue, weakness, headache, joint pain, itchy, red or sore eyes.		✓
Allergic reactions: wheezing, tightness of the chest or throat, difficulty breathing, swollen eyelids, face, lips, tongue or other part of the body, hives, rash, itching, feeling sick.		✓
Stevens-Johnson syndrome (severe skin reaction): redness, blistering, pain, burning, peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, along with by fever, sore throat, chills, headache, cough, body aches, swollen glands.		✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store your tablets between 15˚C - 30˚C.

Keep out of reach and sight of children.

If you want more information about MALARONE / MALARONE PEDIATRIC:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.gsk.ca; or by calling 1-800-387-7474.

Date of Authorization: 2026-03-17

Trademarks are owned by or licensed to the GSK group of companies

Malarone: Uses, Side Effects and Dosage