MALARONE PEDIATRIC 62.5 mg/25 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Malarone Pediatric 62.5 mg/25 mg film-coated tablets

atovaquone/hydrochloride proguanil

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

• This medication has been prescribed to you or your child only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If your child or you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Malarone Pediatric is and what it is used for
2. What you need to know before starting to administer Malarone Pediatric
3. How to administer Malarone Pediatric
4. Possible side effects
5. Storage of Malarone Pediatric
6. Package contents and additional information

1. What Malarone Pediatric is and what it is used for

Malarone Pediatric belongs to a group of medications called antimalarials. It contains two active ingredients: atovaquone and hydrochloride proguanil.

What Malarone Pediatric is used for

Malarone Pediatric has two uses:

• Prevention of malaria (in children weighing 11 to 40 kg)
• Treatment of malaria (in children weighing between 5 kg and ≤11 kg)

The dosage instructions for each use are included in section 3, How to administer Malarone Pediatric.

Although this medication is normally used in children and adolescents, it may also be prescribed for adults weighing less than 40 kg.

Malaria is transmitted by the bite of an infected mosquito, which introduces the malaria parasite (Plasmodium falciparum) into the blood. Malarone Pediatric prevents malaria by killing this parasite. In people who have already been infected with malaria, Malarone Pediatric also eliminates these parasites.

Protect your child from contracting malaria

Anyone, of any age, can contract malaria. It is a serious disease, but it is preventable.

Even when taking Malarone Pediatric, it is very important that you 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 at dusk when mosquitoes are most active.
• Sleep in a mosquito-protected roomor under a mosquito net impregnated with insecticide.
• Close windows and doors at dusk, if they are not protected.
• Consider using an insecticide(tablet, spray, electric) to clear the room of insects or prevent them from entering the room.

If you need clarification, talk to your doctor or pharmacist

Even with all necessary precautions, it is possible to contract malaria.Some types of malaria infection 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 your doctor immediately if your child presents symptoms such as:fever, headache, chills, or fatigue, after returning from abroad.

2. What you need to know before starting to administer Malarone Pediatric

Do not administer Malarone Pediatric:

• to atovaquone, hydrochloride proguanil, or any of the other components of this medication (listed in section 6).
• to prevent malaria if your child has severe kidney failure.

Consult your doctor if any of these cases apply to your child.

Warnings and precautions

Consult your doctor or pharmacist before starting to administer Malarone Pediatric to your child if:

• your child has severe kidney disease
• your child is being treated for malaria and weighs less than 5 kg or is being administered Malarone Pediatricto prevent malaria and weighs less than 11 kg.

Consult your doctor or pharmacistif any of these cases apply to your child.

Other medications and Malarone Pediatric

Tell your doctor or pharmacist if your child is using, has recently used, or may need to use any other medication, including those purchased without a prescription.

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

• metoclopramide, used to treat nausea and vomiting;
• antibiotics: tetracycline, rifampicin, and rifabutin;
• efavirenzor certain highly active protease inhibitorsused to treat HIV;
• warfarinand other anticoagulant medications;
• etoposideused to treat cancer.

Consult your doctorif your child is taking any of these medications. Your doctor may decide that Malarone Pediatric is not suitable for them or that additional checks are needed while taking it.

Remember to consult your doctorif your child starts taking any other medication while taking Malarone Pediatric.

Taking Malarone Pediatric with food and drinks

Administer Malarone Pediatric with food or a dairy drink,if possible. This will increase the amount of Malarone that your child's body can absorb, making the treatment more effective.

Pregnancy and breastfeeding

If you or your daughter is pregnant, do not take Malarone Pediatricunless your doctor recommends it.

Do not breastfeed while taking Malarone Pediatric, as its components may pass into breast milk and harm your baby.

Driving and using machines

If you feel dizzy, do not drive.

Malarone Pediatric can make some people feel dizzy. If this happens to you, you should not drive, use machines, or engage in activities that may put you or others at risk.

Malarone Pediatric contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially, "sodium-free".

3. How to administer Malarone Pediatric

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

Administer Malarone Pediatric with food or a dairy drink, if possible. The tablets should be swallowed whole. However, in the case of children with difficulty swallowing, the tablets can be broken or crushed just before taking them and mixed with food or a dairy drink.

It is best to give Malarone Pediatric at the same time every day.

If your child vomits

Malaria prevention:

• , administer another dose quickly;
• it is essential to take the entire Malarone Pediatric treatment. If your child needs to take an additional dose due to vomiting, they may need another prescription;
• , it is especially important to use additional protection, such as repellents and mosquito nets. Malarone Pediatric may not be as effective, as the amount absorbed may be reduced.

Malaria treatment:

• , consult your doctor. They will need regular blood tests. Malarone Pediatric may not be as effective, as the amount absorbed may be reduced. The tests will check if the malaria parasite has been eliminated from the blood.

Malaria prevention

The recommended dose for preventing malariadepends on the child's weight.

11 - 20 kg: 1 tablet per day

21 - 30 kg: 2 tablets per day (as a single dose)

31 - 40 kg: 3 tablets per day (as a single dose)

• Start administering Malarone Pediatric 1 or 2 days before traveling to a malaria zone
• Continue administering it daily while staying in the area
• Continue administering it for 7 days after returning to a malaria-free zone.

To achieve maximum protection,your child must take the complete treatment.

Malaria treatment

The recommended dose for treating malariadepends on the child's weight.

5 - 8 kg: 2 tablets once a day, for 3 consecutive days.

9 - 10 kg: 3 tablets once a day, for 3 consecutive days.

If your child takesmore Malarone than they should

Contact your doctor or pharmacist for advice on what to do. If possible, show them the Malarone Pediatric packaging.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medication and the amount taken.

The medication packaging and leaflet should be taken to the healthcare professional.

If you forget to administer Malarone Pediatric

It is very important that your child takes the complete Malarone Pediatric treatment.

If you forget to give your child a dose, do not worry. Give them the next dose as soon as you remember. Then continue the treatment as before.

Do not administer more tablets to make up for a missed dose. Simply administer the next dose when it is due.

Do not interrupt Malarone Pediatric treatment without consulting your doctor.

Continue administering Malarone Pediatric for 7 days after returning to a malaria-free zone.Administer the complete treatment to achieve maximum protection. If you interrupt it earlier, you put your child at risk of contracting malaria, as 7 days are needed to ensure the death of any parasites that may be in their body due to the bite of an infected mosquito.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Be cautious with the following serious adverse reactions. They have occurred in a small number of people, but their exact frequency is unknown.

Severe allergic reactions. The signs include:

• rash and itching
• sudden wheezing, chest or throat pressure, or difficulty breathing
• swelling of the eyes, face, lips, tongue, or any other part of the body.

• Contact your doctor immediatelyif your child experiences any of these symptoms. Stop giving Malarone Pediatric.

Severe skin reactions

• skin rash, which may have blisters and looks like small targets (dark spots in the center surrounded by a lighter area with a dark ring around the edge) (erythema multiforme)
• widespread severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).

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

Most other adverse effects reported have been mild and short-lived.

Very common side effects

These may affect more than 1 in 10 people:

• headache
• nausea and vomiting
• stomach pain
• diarrhea.

Common side effects

These may affect up to 1 in 10 people:

• dizziness
• sleep problems (insomnia)
• strange dreams
• depression
• loss of appetite
• fever
• rash that may cause itching
• cough.

Common side effects that may appear in blood tests are:

• decrease in the number of red blood cells (anemia) that may cause fatigue, headache, and shortness of breath
• decrease in the number of white blood cells (neutropenia) that may make you more prone to infections
• low sodium levels in the blood (hyponatremia)
• increased liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

• anxiety
• abnormal heart rhythm (palpitations)
• swelling and redness of the mouth
• hair loss
• raised, itchy rash (hives).

Uncommon side effects that may appear in blood tests are:

• increased amylase (an enzyme produced in the pancreas).

Rare side effects

These may affect up to 1 in 1,000 people:

• seeing or hearing things that do not exist (hallucinations).

Other side effects

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

• inflammation of the liver (hepatitis)
• blockage of the bile ducts (cholestasis)
• increased heart rate (tachycardia)
• inflammation of the blood vessels (vasculitis) that may appear as raised red or purple spots on the skin, but may also affect other parts of the body
• seizures (convulsions)
• panic attacks, crying
• nightmares
• serious mental problem where the person loses contact with reality and is unable to think and judge clearly
• indigestion
• mouth ulcers
• blisters
• skin peeling
• increased sensitivity of the skin to sunlight.

Other side effects that may appear in blood tests:

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

Reporting 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 them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Malarone Pediatric

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

Do not use this medication after the expiration dateshown on the packaging after EXP. The expiration date is the last day of the month indicated.

Malarone Pediatricdoes not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Content and Additional Information

Composition of Malarone Pediatric

The active ingredients are:62.5 mg of atovaquone and 25 mg of proguanil hydrochloride.

The other components are:

core of the tablet:poloxamer 188, microcrystalline cellulose, hydroxypropylcellulose, povidone K30, sodium carboxymethyl starch (type A), magnesium stearate.

tablet coating:hypromellose, titanium dioxide (E171), red iron oxide (E172), macrogol 400, polyethylene glycol 8000 (see section 2).

? Consult your doctor before administering Malarone Pediatricto your child, if you consider that they may be allergic to any of these components.

Appearance of Malarone Pediatric and packaging content:

Malarone Pediatric is presented in the form of film-coated tablets, pink, round, and is marketed in a blister pack with 12 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

GlaxoSmithKline, S.A.

P.T.M. C/ Severo Ochoa, 2

28760 Tres Cantos (Madrid)

Tel: +34 900 202 700

[email protected]

Manufacturer:

Glaxo Wellcome S.A.

Avenida de Extremadura, 3

09400 Aranda de Duero (Burgos)

or

Aspen Bad Oldesloe GmbH

Industriestrasse 32-36

23843 Bad Oldesloe

Germany

This medicinal product is authorized in the Member States of the European Economic Areaand in the United Kingdom (Northern Ireland)under the following names:

Germany, Belgium, Luxembourg, Norway, Netherlands, Sweden: Malarone Junior

Spain, Greece, United Kingdom (Northern Ireland): Malarone Pediatric

Italy: Malarone Bambini

Date of the last revision of this leaflet:January 2022.

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