Malarone® tablets are not recommended for malaria prophylaxis in persons under 40 kg bodyweight.4
TREATMENT*
Malarone® is also indicated for treatment of acute uncomplicated Plasmodium falciparum malaria in adults and children.4
TREATMENT IN PERSONS > 40 kg BODY WEIGHT4 :
A single dose of 4 tablets to be taken for three consecutive days.
PRODUCT INFO
The daily dose of Malarone® should be taken with food or milky drink at the same time each day.4
Because Malarone® is effective against drug sensitive and drug resistant P. falciparum it is especially recommended for prophylaxis and treatment of P. falciparum malaria where the pathogen may be resistant to other antimalarials.4
Malarone® has an acceptable safety profile. Most common side effects include headache, nausea, vomiting, diarrhoea and abdominal pain.**
Refer to Malarone® Summary of Product Characteristics (SPC)
* For full details on dosing options, See Malarone® Summary of Product Characteristics (SPC).
** For less frequent undesirable effects, please see Malarone® Summary of Product Characteristics.
MALARONE
– Abbreviated Prescribing Information: Please refer to full Summary of Product Characteristics (SmPC) before prescribing.
COMPOSITION: Each Malarone tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride.
INDICATIONS: Prophylaxis of, and treatment of, acute uncomplicated Plasmodium falciparum malaria. Because Malarone is effective against drug sensitive and drug resistant P. falciparum it is especially recommended for prophylaxis and treatment of P. falciparum malaria where the pathogen may be resistant to other antimalarials. Official guidelines and local information on the prevalence of resistance to antimalarial drugs should be taken into consideration before prescribing.
POSOLOGY AND METHOD OF ADMINISTRATION:Prophylaxis: administration should commence 24 or 48 hours prior to entering a malaria-endemic area, continue during the period of the stay and continue for 7 days after leaving the area. Dosage in Adults (>40kg): 1 tablet daily. Treatment:dosage in Adults: 4 tablets as a single dose for 3 consecutive days. Dosage in Children: please refer to full SmPC.
CONTRAINDICATIONS: Hypersensitivity to any of the ingredients; prophylaxis in patients with severe renal impairment.
SPECIAL WARNINGS AND PRECAUTIONS: Persons taking Malarone for prophylaxis or treatment of malaria should take a repeat dose if they vomit within 1 hour of dosing. In the event of diarrhoea, normal dosing should be continued. In patients with acute malaria who present with diarrhoea or vomiting, alternative therapy should be considered. The concomitant administration of Malarone and efavirenz, boosted protease-inhibitors, rifampicin or rifabutin and metoclopramide should be avoided whenever possible. Caution is advised in concomitant administration of Malarone and warfarin.
PREGNANCY: Use of Malarone in pregnancy should only be considered if the expected benefit to the mother outweighs any potential risk to the foetus. LACTATION: Not recommended.
ABILITY TO DRIVE AND USE MACHINES: Use with caution.
ADVERSE EVENTS:Very Common: Headache, gastrointestinal disturbance including nausea, vomiting, diarrhoea, abdominal pain; Common: anaemia, neutropenia, allergic reactions, hyponatraemia, anorexia, abnormal dreams, depression, insomnia, dizziness, rash and pruritus, fever, cough, elevated liver enzymes. Refer to the SPC for a full list of adverse events.
PRESENTATION: LEGAL CATEGORY: MA HOLDER: MA NUMBER: DATE OF PREPARATION:
Malarone film-coated tablets X 12 tablets. POM. Glaxo Wellcome UK Limited trading as GlaxoSmithKline UK. AA 167/01801. February 2016.
In order to ensure that this product information reflects the most up-to-date clinical and post-marketing surveillance data, please always refer to the latest Summary of Product Characteristics (SPC) which is available from GlaxoSmithKline (Malta) Ltd (Tel: +356 21238131)
REPORTING ADVERSE EVENTS (AEs): If you become aware of any AEs, medication errors and/or use during pregnancy in association with GSK products, please report the event promptly to: GSK (Malta) Limited, 1, De la Cruz Avenue, Qormi QRM 2458, Malta (Tel: +356 21238131) Alternatively, any suspected AEs and medication errors can also be reported via the national Adverse Drug Reactions (ADRs) reporting system: Report forms can be downloaded from www.medicinesauthority.gov.mt/adrportal and posted to the Malta Medicines Authority, Post-licensing Directorate, 203, Level 3, Rue D’Argens, Gżira GŻR 1368, MALTA, or sent by email to postlicensing. medicinesauthority@gov.mt
