Label:information for the user

Malarone Pediatric 62.5 mg/25 mg film-coated tablets

atovaquone/hydrochloride of proguanil

Read this label carefully before starting to take this medication,because it contains important information for you.

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

-This medication has been prescribedonlyto you or your child, and should not be given to other people even if they havethe same symptomsas you,as it may harm them.

• If your child or you experience adverse effects,consult your doctor or pharmacist, evenifthey are not listed in this label. See section 4.

Malarone Pediatric belongs to a group of medications calledantimalarials. 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 5 kg to ≤11 kg)

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

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

Malaria or 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, regardless of age, can contract malaria or malaria. It is a serious disease, but it is preventable.

Even taking Malarone Pediatric, 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 an insecticide-treated mosquito net.
• Close windows and doors in the evening,if they are not protected.
• Use an insecticide(pill, spray, electric) to clear the room of insects or prevent them from entering the room.

?If you need clarification, speak with your doctor or pharmacist

Even with all necessary precautions, it is possible to contract malaria.Some types of malaria infection takelong time to cause symptoms; therefore, the disease will not begin until several days, weeks or even months after returning from travel.

?Consult a doctor immediately if your child presents symptoms such as:fever, headache, chills or fatigue, after returning from abroad.

Do not administer Malarone Pediatric:

• if your child is allergicto atovaquone, hydrochloride proguanil or to any of the other componentsofthis medication (listed in section 6).
• to prevent malaria if your child has severe kidney disease.

?Consult with 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 administeredMalarone Pediatricto prevent malaria and weighs less than 11 kg.

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

Other medications and Malarone Pediatric

Inform your doctor or pharmacist if your child is using, has used recentlyor may need to useany other medication, including those purchased without a prescription.

Some medications may affect the way Malarone Pediatric acts, or Malarone Pediatric may potentiate or reduce the effect of other medications used at the same time. Among these medications are:

• metoclopramide, used to treat nausea and vomiting;
• antibiotics:tetracycline,rifampicinandrifabutin;
• efavirenzorsome very active protease inhibitorsused to treat HIV;
• warfarinand other anticoagulant medications;
• etoposideused to treat cancer.

?Consult with 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 they are taking it.

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

Taking MalaronePediatric with food and drinks

Administer MalaronePediatricwith food or a lactose drink,if possible. This will increase the amount of Malarone that your child's body can absorb, and make their 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 operating machinery

If you feel dizzy, do not drive.

Malarone Pediatric makes some people feel dizzy. If this happens to you, do not drive, operate machinery or participate 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”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.Consult your doctor or pharmacist again if you are unsure..In case of doubt, consult your doctor or pharmacist again.

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

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

If your child vomits

Malaria prevention:

• If your child vomits within the first hour after taking Malarone Pediatric, administer another dose quickly;,
• It is essential to complete the Malarone Pediatric treatment. If your child needs to take an additional dose due to vomiting, it may be necessary to obtain another prescription;,
• If your child has been vomiting,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:

• If your child has been vomiting and experiencing diarrhea,consult your doctor. Regular blood tests will be necessary. Malarone Pediatric may not be as effective, as the amount absorbed may be reduced. Blood tests will confirm whether the malaria parasite has been eliminated from the blood.

Malaria prevention

The recommended dose for malaria prevention or prophylaxis depends 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-endemic area.
• Continue administering it daily during your stay.
• Continue administering it for another 7 days after returning to a malaria-free area.

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

Malaria treatment

The recommended dose for malaria treatment or therapy depends 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 prescribed

Consult your doctor or pharmacist for advice. 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 at 91.562.04.20, indicating the medication and the amount taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to administer Malarone Pediatric

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

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

Do not administer additional tablets to compensate for a missed dose. Simply administer the next dose when it is due.

Do not interrupt the administration of Malarone Pediatric without consulting your doctor.

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

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

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

Be careful with the following severe adverse reactions. They have occurred in a small number of people, although their exact frequency is unknown.

Severe allergic reactions. The signs include:

• eruption 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.

• Immediately contact your doctorif your child experiences any of these symptoms.Stop giving Malarone Pediatric.

Severe dermatological reactions

• skin eruption, which may present with blisters and appear as small, dark spots (erythema multiforme)(erythema multiforme)
• severe generalized eruption 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 reported side effects have been mild and did not last long.

Very common side effects

These may affectmore than 1 in 10 people:

Common side effects

These may affectup to 1 in 10 people:

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

The common side effects that may appear in blood tests are:

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

Uncommon side effects

These may affectup to 1 in 100 people:

The uncommon side effects that may appear in blood tests are:

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

Rare side effects

These may affectup 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, although their frequency is unknown.

Other side effects that may appear in blood tests:

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 them directly through the Spanish System for 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.

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

Do not use this medication after the expiration datethat appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Pediatric Malaronedoes not require special storage conditions.

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

Malarone Pediatric Composition

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

The other components are:

tablet core:poloxamer 188, microcrystalline cellulose, hydroxypropylmethylcellulose, povidone K30, sodium carboxymethylcellulose (type A), magnesium stearate.

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

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

Appearance of Malarone Pediatric and contents of the package:

Malarone Pediatric is presented in the form of 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 medicine is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

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

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

Italy:Malarone Bambini

Last review date of this leaflet:January 2022.

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