Malarone 250 mg/100 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Malarone 250 mg/100 mg film-coated tablets
atovaquone/proguanil hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Malarone is and what it is used for
- What you need to know before taking Malarone
- How to take Malarone
- Possible side effects
- How to store Malarone
- Contents of the pack and other information
1. What Malarone is and what it is used for
Malarone belongs to a group of medicines known as antimalarials or antipaludic agents. It contains two active substances: atovaquone and proguanil hydrochloride.
What Malarone is used for
Malarone has two uses:
- Prevention of malaria
- Treatment of malaria
Dosage instructions for each use are provided in section 3, How to take Malarone.
Malaria is transmitted through the bite of an infected mosquito, which introduces the malaria parasite (Plasmodium falciparum) into the bloodstream. Malarone prevents malaria by eliminating this parasite. In individuals already infected with malaria, Malarone also eliminates these parasites.
Protect yourself from contracting malaria
Anyone, regardless of age, can contract malaria. It is a serious illness, but it is preventable.
Even when taking Malarone, it is very important to take precautions to avoid mosquito bites.
- Use mosquito repellent on all exposed areas of skin.
- Wear light-colored 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 otherwise protected.
- Consider using an insecticide (tablet, spray, electric device) to clear the room of insects or prevent them from entering.
? If you need any clarification, speak with your doctor or pharmacist.
Even when 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, the illness may not start until several days, weeks, or even months after returning from travel.
? Seek immediate medical advice if you experience symptoms such as: fever, headache, chills, or fatigue, after returning from abroad.
2. What you need to know before taking Malarone
Do not take Malarone:
- if you are allergic to atovaquone, proguanil hydrochloride, or any of the other ingredients of this medicine (listed in section 6).
- for the prevention of malaria if you have severe renal impairment.
? Consult your doctor if either of these situations applies to you.
Warnings and precautions
Consult your doctor or pharmacist before taking Malarone if:
- you have severe kidney disease
- your child is being treated for malaria and weighs less than 11 kg. Another formulation of this medicine is available for treating children weighing less than 11 kg (see section 3).
? Consult your doctor or pharmacist if either of these situations applies to you.
Other medicines and Malarone
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine, including those obtained without a prescription.
Some medicines may affect how Malarone works, or Malarone may enhance or reduce the effect of other medicines taken at the same time as Malarone. 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 the treatment of cancer.
? Consult your doctor if you are taking any of these medicines. Your doctor may decide that Malarone is not suitable for you or may require additional monitoring while you are taking it.
? Remember to consult your doctor if you start taking any other medicine while you are on Malarone.
Taking Malarone with food and drinks
Take Malarone with food or a milky drink, if possible. This will increase the amount of Malarone absorbed by your body and make your treatment more effective.
Pregnancy and breastfeeding
If you are pregnant, do not take Malarone unless your doctor recommends it.
? Consult your doctor or pharmacist before using any medicine.
Do not breastfeed while taking Malarone, as the components of Malarone may pass into breast milk and harm your baby.
Driving and using machines
If you feel dizzy, do not drive.
Malarone may cause dizziness in some people. If this happens to you, you should not drive, operate machinery, or engage in activities that could put you or others at risk.
Malarone contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; essentially "sodium-free".
3. How to take Malarone
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Take Malarone with food or a milk drink, if possible.
It is best to take Malarone at the same time each day.
If you vomit
Malaria prevention:
- if you vomit within one hour after taking Malarone tablets, take another dose as soon as possible;
- it is important to complete the entire course of Malarone. If you need to take an additional dose due to vomiting, you may require another prescription;
- if you have been vomiting, it is especially important to use additional protective measures, such as repellents and mosquito nets. Malarone may be less effective, as the amount absorbed may have been reduced.
Treatment of malaria:
- if you have been vomiting and have diarrhoea, consult your doctor. You will need regular blood tests. Malarone may be less effective, as the amount absorbed may have been reduced.
These tests allow confirmation that the malaria parasite has been eliminated from the blood.
Malaria prevention
The recommended dose for adults is 1 tablet daily, taken as indicated below.
It is not recommended for malaria prevention in children, or in adults weighing less than 40 kg. Malarone Pediatric tablets are recommended for malaria prevention in adults or children weighing less than 40 kg.
To prevent malaria in adults:
- start taking Malarone 1 or 2 days before travelling to a malaria-risk area;
- continue taking it daily during your stay;
- continue taking it for another 7 days after returning to a malaria-free area.
Treatment of malaria:
The recommended dose for adults is 4 tablets once daily for 3 days.
For children, the dose depends on body weight:
- 11–20 kg – 1 tablet daily for 3 days
- 21–30 kg – 2 tablets daily for 3 days
- 31–40 kg – 3 tablets daily for 3 days
- over 40 kg – same dose as for adults.
It is not recommended for the treatment of malaria in children weighing less than 11 kg.
For children weighing less than 11 kg, consult your doctor. A different type of Malarone tablet for children may be available in your country.
If you take more Malarone than you should
Contact your doctor or pharmacist for advice on what to do. If possible, show them the Malarone packaging.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount ingested.
It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Malarone
It is very important that you complete the full course of Malarone.
If you miss a dose, do not worry. Take the next dose as soon as you remember. Then continue with your treatment as before.
Do not take extra tablets to make up for a missed dose. Simply take the next dose at the usual time.
Do not stop treatment with Malarone without consulting your doctor.
Continue taking Malarone for 7 days after returning to a malaria-free area. Complete the full course of Malarone to achieve maximum protection. If you stop treatment early, you risk contracting malaria, as 7 days are needed to ensure the elimination of any parasites that may have entered your body from the bite of an infected mosquito.
If you have any further questions about the use of 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 you experience any of these symptoms. Stop taking Malarone.
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 which 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 fatigue, 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 in the mouth
- hair loss
- itchy raised 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 there (hallucinations).
Adverse effects with unknown frequency:
Their frequency cannot be determined from the available data
- 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, although it may also affect other parts of the body
- seizures
- panic attacks, crying
- nightmares
- severe mental disorder in which the person loses contact with reality and is unable to think or judge clearly
- indigestion
- mouth ulcers
- blisters
- peeling of the skin
- 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 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 via 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
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 is the last day of the month indicated.
Malarone does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Malarone
The active substances are: 250 mg of atovaquone and 100 mg of proguanil hydrochloride per tablet.
Other components:
tablet core: poloxamer 188, microcrystalline cellulose, hydroxypropylcellulose, povidone K30, sodium carboxymethylstarch (type A) (from potato), magnesium stearate.
tablet coating: hypromellose, titanium dioxide (E171), iron oxide red (E172), macrogol 400, polyethylene glycol 8000 (see section 2).
? Consult your doctor before taking Malarone if you may be allergic to any of these components.
Appearance of the product and contents of the pack
Malarone tablets are film-coated, pink-colored, round tablets, marked on one side with “GX CM3”. They are supplied in a 12-tablet blister pack.
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
Manufacturer:
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36
23843 Bad Oldesloe
Germany
or
Glaxo Wellcome S.A.
Avenida de Extremadura, 3
09400 Aranda de Duero (Burgos)
This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany, Austria, Belgium, Slovenia, Slovakia, Spain, Finland, Greece, Hungary, Ireland, Iceland, Italy, Latvia, Lithuania, Luxembourg, Malta, Norway, Netherlands, Poland, Portugal, United Kingdom (Northern Ireland), Czech Republic and Sweden: Malarone
Date of the most recent review of this leaflet: January 2022.
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/