Malarone

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Malarone, 250 mg + 100 mg, Film-Coated Tablets

Atovaquone + Proguanil Hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Malarone and what is it used for
• 2. Important information before taking Malarone
• 3. How to take Malarone
• 4. Possible side effects
• 5. How to store Malarone
• 6. Contents of the pack and other information

1. What is Malarone and what is it used for

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

Indications for Use of Malarone

Malarone has two uses:

• for the prevention of malaria;
• for the treatment of malaria.

Dosing recommendations for each indication can be found in section 3. How to take Malarone.
Malaria is spread through the bites of infected mosquitoes, which transmit the parasite (Plasmodium falciparum) into the blood. Malarone prevents malaria by destroying the cells of this parasite. In people who are already infected with malaria, Malarone also destroys the cells of these parasites.

Protect Yourself from Malaria Infection

Malaria can be contracted at any age. It is a serious disease, but it can be prevented.
It is very important to take measures to prevent mosquito bites in addition to taking Malarone.

Use Insect Repellents on Exposed Skin Surfaces

• Wear light-colored clothing that covers most of the body,especially after sunset, as mosquitoes are most active at this time.
• Sleep in a protected areaor under a mosquito net impregnated with an insecticide.
• Close windows and doors at sunsetif they are not screened.
• Consider using an insecticide(mats, aerosols, plugs) to clear the area of insects or prevent mosquitoes from entering the area. → If you have further doubts, consult your doctor or pharmacist.

Malaria Infection Can Occur Despite Taking Precautions

Be cautious. In some types of malaria, the time from infection to the appearance of symptoms can be long, so the disease may only become apparent after several days, weeks, or even months after returning from abroad.
→ If symptoms such ashigh fever, chills, headache, and fatigue occur after returning from abroad, seek medical attention immediately.

2. Important Information Before Taking Malarone

When Not to Take Malarone

• If the patient is allergicto atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6).

In Preventing Malaria in Patients with Severe Kidney Disease

When to Exercise Special Caution When Taking Malarone

Before Starting Malarone, Tell Your Doctor or Pharmacist If:

• the patient has severe kidney disease;
• malaria is being treated in a child who weighs less than 11 kg. Tablets with a different active substance content are intended for the treatment of children whose body weight does not exceed 11 kg (see section 3).

→If the above circumstances apply to the patient, tell your doctor or pharmacist.
Malarone and Other Medicines

Tell your doctor or pharmacist about all medicinesthe patient is taking, has recently taken, or plans to take, including those obtained without a prescription.
Some medicines may affect the action of Malarone or Malarone may enhance or weaken the action of other medicines taken at the same time. These include:

• metoclopramide, used to treat nausea and vomiting;
• antibiotics, tetracycline, rifampicin, rifabutin;
• efavirenzor certain protease inhibitorsused to treat HIV;
• warfarinand other medicines that inhibit blood clotting;
• etoposide, used to treat cancer. → If the patient is taking any of these medicines, tell your doctor.The doctor may decide that Malarone should not be taken or may recommend additional tests during its use. → If the patient starts taking other medicines while taking Malarone, remember to tell your doctor.

Taking Malarone with Food and Drink

Malarone should be taken with food or a milk drink, if possible.
This will increase the absorption of Malarone and the effectiveness of the treatment.

Pregnancy and Breastfeeding

If the patient is pregnant, she should not take Malarone, unless the doctor recommends otherwise.
→ Before taking Malarone, consult your doctor or pharmacist.
Do not breastfeed while taking Malarone, as the ingredients of Malarone pass into breast milk and may harm the baby.

Driving and Operating Machines

Do Not Drive If You Experience Dizziness

Malarone may cause dizziness in some people. If this symptom occurs, the patient should not drive vehicles, operate machinery, or perform tasks that may pose a risk to themselves or others.

Malarone Contains Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to Take Malarone

Always take this medicine exactly as your doctor or pharmacist has told you.If you are unsure, consult your doctor or pharmacist.
If possible, take Malarone with food or a milk drink.
It is best to take Malarone at the same time every day.

If the Patient Vomits

During Malaria Prevention

• If the patient vomits within 1 hour of taking Malarone, an additional dose should be taken immediately.
• It is essential to complete the full treatment cycle with Malarone. If the patient has taken additional doses due to vomiting, an additional prescription may be needed.
• If the patient vomits, it is especially important to use additional protective measures, such as insect repellents and mosquito nets. Malarone may not be effective, as the amount of absorbed medicine will decrease.

During Malaria Treatment

• If the patient vomits and has diarrhea, tell your doctor, who will recommend regular blood tests. Malarone may not be effective, as the amount of absorbed medicine will decrease. Blood tests will allow checking if the malaria parasite has been removed from the patient's blood.

Malaria Prevention

The recommended dose of Malarone for adultsis one tablet once daily, as described below.
Malarone is not recommended for malaria prevention in childrenor adults with a body weight below 40 kg.
For adults and children whose body weight does not exceed 40 kg, Malarone is recommended in the form of pediatric tablets.
To prevent malaria in adults, you should:

• start taking Malarone 1 to 2 days before traveling to a malaria-endemic area;
• continue taking Malarone daily during your stay;
• continue taking Malarone for 7 days after returning to a malaria-free area.

Malaria Treatment

The recommended dose of Malarone for adultsis 4 tablets once daily for 3 days.
Dosing in childrendepends on body weight:

• 11-20 kg - 1 tablet once daily for three days;
• 21-30 kg - 2 tablets in one daily dose for three days;
• 31-40 kg - 3 tablets in one daily dose for three days;
• over 40 kg - dosing as for adults.

This medicine is not recommended for the treatment of malaria in childrenwith a body weight less than 11 kg.
If the child's body weight is less than 11 kg, tell your doctor. In some countries, Malarone tablets with a different strength may be available.

Taking More Than the Recommended Dose of Malarone

Consult your doctor or pharmacist. If possible, show them the packaging of Malarone.

Missing a Dose of Malarone

It is Essential to Complete the Full Treatment Cycle with Malarone

If a dose of Malarone is missed, take the dose as soon as possible and continue treatment as recommended.
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

Do Not Stop Taking Malarone Without Your Doctor's Advice

Continue Taking Malarone for 7 Days After Returning to a Malaria-Free Area

Malaria. To achieve maximum protection, complete the full treatment cycle with Malarone. Stopping the treatment too early may put the patient at risk of malaria, as it takes 7 days to ensure that all parasites that may have appeared in the blood after a mosquito bite are destroyed.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, Malarone can cause side effects, although not everybody gets them.
Pay attention to the following serious side effects. They have occurred in a small number of people, but their exact frequency is unknown.
Severe Allergic Reactions- symptoms include:

• rash and itching;
• sudden wheezing, chest tightness or throat tightness, or difficulty breathing;
• swelling of the eyelids, face, lips, tongue, or other parts of the body.
• If the patient experiences any of the above symptoms of an allergic reaction, seek medical attention immediately. Do not take any more tablets.

Severe Skin Reactions:

• a rash that may be blistering and looks like small targets (dark spots in the center, surrounded by a pale area with a dark ring around) (erythema multiforme);
• a severe, widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
• If the patient experiences any of these symptoms, seek medical attention immediately.

Other side effects were mostly mild and temporary.

Very Common Side Effects

May affect more than 1 in 10 patients:

• headache;
• nausea and vomiting;
• abdominal pain;
• diarrhea.

Common Side Effects

May affect less than 1 in 10 patients:

• dizziness;
• sleep disturbances (insomnia);
• unusual dreams;
• depression;
• loss of appetite;
• fever;
• rash, which may be itchy;
• cough.

Common side effects that may appear in blood tests:

• decrease in red blood cell count (anemia), which may cause fatigue, headaches, and shortness of breath;
• decrease in white blood cell count (neutropenia), which may cause increased susceptibility to infections;
• decrease in sodium levels in the blood (hyponatremia);
• increase in liver enzyme activity.

Uncommon Side Effects

May affect less than 1 in 100 patients:

• anxiety;
• abnormal heartbeat (palpitations);
• swelling and redness of the mouth;
• hair loss,
• itchy rash with blisters (hives).

Uncommon side effects that may appear in blood tests:

• increase in amylase activity (an enzyme produced in the pancreas).

Rare Side Effects

May affect less than 1 in 1000 patients:

• seeing or hearing things that are not real (hallucinations).

Other Side Effects

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

• liver inflammation;
• bile duct obstruction (bile stasis);
• rapid heartbeat (tachycardia);
• inflammation of blood vessels, which may appear as red or purple spots on the skin but may also affect other parts of the body;
• seizures;
• panic attacks, crying;
• nightmares;
• serious mental health disorders, in which the patient loses contact with reality and is unable to think clearly and assess the situation;
• indigestion;
• mouth ulcers;
• blisters;
• peeling skin;
• increased sensitivity of the skin to sunlight.

Other side effects that may appear in blood tests:

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

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the online reporting system at [website URL].
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Malarone

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

Do Not Use This Medicine After the Expiration Date Stated on the Packaging

The Expiration Date Refers to the Last Day of the Month

No Special Precautions for Storage

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

6. Contents of the Pack and Other Information

What Malarone Contains

The active substances of Malarone are:atovaquone 250 mg and proguanil hydrochloride 100 mg, in each tablet.

Other Ingredients of Malarone Are:

tablet core:poloxamer 188, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, povidone K 30, sodium carboxymethyl cellulose (type A), magnesium stearate;
tablet coating:hypromellose, titanium dioxide (E 171), red iron oxide (E 172), macrogol 400, macrogol 8000.

• If the patient is allergic to any of these ingredients, tell your doctor before taking Malarone.

What Malarone Looks Like and What the Pack Contains

Malarone film-coated tablets are pink and round, with the inscription "GX CM3" on one side.
They are packaged in a PVC/Aluminum/paper blister pack containing 12 tablets, in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing Authorization Holder in Spain, the Country of Export:

GlaxoSmithKline, S.A.
PTM – C/Severo Ochoa, 2
28760 Tres Cantos (Madrid)
Spain

Manufacturer:

Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
Glaxo Wellcome S.A.
Avenida de Extremadura, 3
09400 Aranda de Duero (Burgos)
Spain

Parallel Importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Spanish Marketing Authorization Number:653915.6
Parallel Import Authorization Number:6/17
This medicinal product is authorized in all Member States of the European Economic Area under the name Malarone.
Date of Leaflet Approval: 05.01.2022
[Information about the trademark]