Malarone Pediatric 62.5 mg/25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Malarone Pediatric 62.5 mg/25 mg film-coated tablets

atovaquone/proguanil hydrochloride

Read all of this leaflet carefully before you or your child starts taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you or your child only, and you should not give it to other people, even if they have the same symptoms as you or your child, because it may harm them.

  • If you or your child experience any side effects, talk to your doctor or pharmacist, even if it is a side effect 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 taking Malarone Pediatric
3. How to take Malarone Pediatric
4. Possible side effects
5. How to store Malarone Pediatric
6. Contents of the pack and other information

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

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

What Malarone Paediatric is used for

Malarone Paediatric 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)

Dosage instructions for each use are provided in section 3, How to administer Malarone Paediatric.

Although this medicine is typically 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 bloodstream. Malarone Paediatric prevents malaria by killing this parasite. In individuals already infected with malaria, Malarone Paediatric also eliminates these parasites.

Protect your child from getting malaria

Anyone, at any age, can contract malaria. It is a serious illness, but it is preventable.

Even while taking Malarone Paediatric, it is very important to take precautions to avoid mosquito bites.

• Use mosquito repellent on all exposed areas of skin.
• Wear light-coloured 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 vaporiser) to clear the room of insects or prevent them from entering.

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

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

? Seek immediate medical advice if your child develops 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:

• if your child is allergic to atovaquone, proguanil hydrochloride, or any of the other components of this medicine (listed in section 6).
• for malaria prevention if your child has severe renal impairment.

? Consult your doctor if any of these situations 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 given Malarone Pediatric for malaria prevention and weighs less than 11 kg.

? Consult your doctor or pharmacist if any of these situations apply to your child.

Other medicines and Malarone Pediatric

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how Malarone Pediatric works, or Malarone Pediatric itself 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, and rifabutin;
• efavirenz or some potent protease inhibitors used in the treatment of HIV;
• warfarin and other anticoagulant medicines;
• etoposide, used in cancer treatment.

? Consult your doctor if your child is taking any of these medicines. Your doctor may decide that Malarone Pediatric is not suitable for your child or may recommend additional monitoring while taking it.

? Remember to consult your doctor if your child starts taking any other medicine while taking Malarone Pediatric.

Taking Malarone Pediatric with food and drinks

Administer Malarone Pediatric with food or a milk drink, if possible. This will increase the amount of Malarone absorbed by your child's body and make the treatment more effective.

Pregnancy and breastfeeding

If you or your daughter is pregnant, do not take Malarone Pediatric unless recommended by your doctor.

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 may cause dizziness in some people. If this occurs, you should not drive, operate machinery, or engage in activities that could put you or others at risk.

Malarone Pediatric contains sodium

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

3. How to take Malarone Paediatric

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

Administer Malarone Paediatric with food or a milky drink, if possible. The tablets should be swallowed whole. However, for children who have difficulty swallowing, the tablets may be split or crushed immediately before administration and mixed with food or a milky drink.

It is best to give Malarone Paediatric at the same time each day.

If your child vomits

For prevention of malaria:

• if your child vomits within one hour of taking Malarone Paediatric, give another dose immediately;
• it is important to complete the full course of Malarone Paediatric. If your child needs additional doses due to vomiting, you may require another prescription;
• if your child has been vomiting, it is especially important to use additional protective measures such as repellents and mosquito nets. Malarone Paediatric may be less effective, as the amount absorbed may have been reduced.

For treatment of malaria:

• if your child has been vomiting and has diarrhoea, consult your doctor. Regular blood tests will be needed. Malarone Paediatric may be less effective due to reduced absorption. Blood tests will determine whether the malaria parasite has been cleared from the blood.

Prevention of malaria

The recommended dose for prevention of malaria depends on the child's weight.

11 - 20 kg: 1 tablet daily

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

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

• Start giving Malarone Paediatric 1 or 2 days before travelling to a malaria-risk area
• Continue daily during the stay in the area
• Continue for a further 7 days after returning to a malaria-free area.

For maximum protection, your child must complete the full course of treatment.

Treatment of malaria

The recommended dose for treatment of malaria depends on the child's weight.

5 - 8 kg: 2 tablets once daily for 3 consecutive days.

9 - 10 kg: 3 tablets once daily for 3 consecutive days.

If your child takes more Malarone than they should

Contact your doctor or pharmacist for advice. If possible, show them the Malarone Paediatric packaging.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91.562.04.20, stating the name of the medicine and the amount taken.

It is recommended to bring the medicine packaging and patient information leaflet to the healthcare professional.

If you forget to give Malarone Paediatric

It is very important that your child completes the full course of Malarone Paediatric tablets.

If you forget to give a dose, do not worry. Give it as soon as you remember. Then continue with the treatment as before.

Do not give extra tablets to make up for a missed dose. Simply give the next dose at the usual time.

Do not stop giving Malarone Paediatric without consulting your doctor.

Continue giving Malarone Paediatric for 7 days after returning to a malaria-free area. Completing the full course is essential for maximum protection. Stopping early puts the child at risk of developing malaria, as 7 days are needed to ensure all parasites from an infected mosquito bite are eliminated from the body.

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

4. Possible adverse effects

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

Be cautious of the following serious adverse reactions. These have occurred in a small number of people; however, 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 eyes, face, lips, tongue, or any other part of the body.

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

Severe skin reactions

• skin rash, which may blister and resemble small targets (dark spots in the center surrounded by a paler area with a dark ring around the edge) (erythema multiforme)
• severe widespread 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 reported adverse effects have been mild and short-lived.

Very common adverse effects

These may affect more than 1 in 10 people:

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

Common adverse effects

These may affect up to 1 in 10 people:

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

Common adverse effects that may appear in blood tests include:

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

Uncommon adverse effects

These may affect up to 1 in 100 people:

• anxiety
• unusual sensation of irregular heartbeat (palpitations)
• swelling and redness of the mouth
• hair loss
• raised, itchy rash (hives).

Uncommon adverse effects that may appear in blood tests include:

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

Rare adverse effects

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

• seeing or hearing things that are not real (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 raised red or purple spots on the skin, but may also affect other parts of the body
• seizures
• panic attacks, crying
• nightmares
• severe mental disorder in which the person loses touch with reality and is unable to think or judge clearly
• indigestion
• mouth ulcers
• blisters
• skin peeling
• increased sensitivity of the skin to sunlight.

Other adverse effects that may appear in blood tests:

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

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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Malarone Pediatric

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

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

Malarone Pediatric does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Malarone Paediatric

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

Other components are:

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

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

? Consult your doctor before administering Malarone Paediatric to your child if you suspect an allergy to any of these components.

Appearance of Malarone Paediatric and contents of the pack:

Malarone Paediatric is presented as film-coated tablets, pink in colour, round in shape, and is supplied in blister packs containing 12 tablets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 authorised in the European Economic Area Member States and 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 Paediatric

Italy: Malarone Bambini

Date of most recent review of this leaflet: January 2022.

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