Artesunate/ Mefloquine Tablets 400 mg / 500 mg

● Treatment of uncomplicated malaria; active against all Plasmodium parasites that cause malaria in humans (e.g. P. falciparum) [1] ● Not indicated for severe malaria according to the WHO definition [1] ● Treatment regimens should follow the most recent official treatment guidelines and local data on antimalarial resistanc

● Oral use: take once daily for 3 consecutive days; swallow the tablets whole with water, preferably with food or milk [1][2] ● If vomiting occurs within 30 minutes of a dose, give a repeat dose; if a dose is missed, take it as soon as realised and continue the course [1] ● Do not repeat a course within 60 days (increased risk of neuropsychiatric reactions); if malaria occurs within 60 days, use a different ACT [1]

The recommended daily dose range of artesunate/mefloquine is 2–10 mg of artesunate and 7–11 mg of mefloquine per kg body weight, given once daily for 3 consecutive days [1]. The WHO reference weight-based schedule is shown below (tablet counts refer to the reference products)

● Contraindicated in known hypersensitivity to artesunate, mefloquine or related compounds (e.g. quinine, quinidine) or any excipient; in severe malaria; in patients taking QTc-prolonging medicines (e.g. class IA/III antiarrhythmics, neuroleptics and antidepressants, macrolides, fluoroquinolones, azole antifungals, halofantrine); in a history of blackwater fever; and in severe hepatic impairment [1] ● Neuropsychiatric reactions: mefloquine may cause anxiety, paranoia, depression, hallucinations or psychosis; abnormal dreams and insomnia are common. Stop treatment at warning signs and seek medical advice; do not use within 2 months of a previous therapeutic mefloquine dose [1] ● Cardiac caution: risk of QTc prolongation with QT-prolonging medicines; halofantrine is contraindicated for at least 15 weeks after its last dose [1] ● Hepatic impairment: mefloquine elimination may be prolonged, increasing adverse reactions; caution is required and the product should not be used in severe hepatic impairment [1] ● Neuropathy: stop mefloquine at symptoms such as pain, burning, tingling, numbness or weakness; refer any visual disorder to a physician [1] ● Interactions: avoid with halofantrine, carbamazepine, phenytoin, rifampicin and ketoconazole; caution with quinine and HIV antiretrovirals; CYP3A4 inducers may reduce efficacy [1] ● Pregnancy: can be used in the second and third trimesters; may be used in the first trimester when artemether-lumefantrine is not suitable or available. Breastfeeding: use is possible in line with WHO guidelines [1] ● Common side effects: abnormal dreams, insomnia, dizziness, headache, nausea, vomiting, diarrhoea, abdominal pain, vertigo, visual disturbance, bradycardia, hypotension, rash, pruritus, transient rises in liver transaminases, anaemia and post-treatment delayed haemolysis [1] ● May cause dizziness or fatigue — do not drive or operate machinery if affected [1] ● Store below 25 °C in a dry place, protected from light and moisture (product label; reference SmPC: do not store above 30 °C); keep out of the reach of children; prescription-only medicine [1][2] For full prescribing information, refer to the approved package insert (Summary of Product Characteristics) of the product concerned [1].