Artesunate/ Pyonaridine Tablets 20mg/60mg

● Treatment of acute, uncomplicated malaria infection caused by Plasmodium falciparum or Plasmodium vivax [1] ● In the reference product, the 20 mg/60 mg strength is indicated in children and infants weighing 5 kg to under 20 kg [1] ● Not for malaria prophylaxis and not for the treatment of severe, cerebral or complicated malaria [1]

● Oral use: take once daily for 3 consecutive days, with or without food [1] ● If vomiting occurs within 30 minutes of a dose, give a repeat dose; if the repeat dose is also vomited, use an alternative antimalarial [1] ● If a dose is missed, take it as soon as remembered and continue the normal schedule [1]

5 to <8 kg 1 tablet once daily 3 consecutive days 8 to <15 kg 2 tablets once daily 3 consecutive days 15 to <20 kg 3 tablets once daily 3 consecutive days ≥20 kg Use the higher-strength formulation (e.g. 60 mg/180 mg tablets per the approved SmPC) 3 consecutive days

● Contraindicated in known hypersensitivity to pyronaridine, artesunate or any excipient; in patients with clinical signs or symptoms of hepatic injury (e.g. nausea and/or abdominal pain with jaundice) or known severe liver disease; and in severe renal impairment [1] ● Not for malaria prophylaxis and not for severe, cerebral or complicated malaria [1] ● Monitor for signs of hepatotoxicity, especially in the first two weeks (fatigue, nausea, abdominal pain, dark urine, jaundice, itching); check liver function if suspected [1] ● Cardiac caution in at-risk patients: congenital QTc prolongation, hypokalaemia, dehydration, arrhythmia, heart failure, or concomitant QT-prolonging medicines (e.g. macrolides, fluoroquinolones, azole antifungals) [1] ● Interactions: caution with valproate, antiretroviral drugs, herbal medicines and other hepatotoxic drugs (e.g. rifampicin, carbamazepine, isoniazid, paracetamol); monitor CYP2D6 substrates (metoprolol, flecainide, propafenone) and P-gp substrates (digoxin, dabigatran) [1] ● Pregnancy: not recommended in the first trimester unless treatment is life-saving and no alternative exists; use in the second and third trimesters only if other treatments are unsuitable. Breastfeeding: weigh the benefit against the potential risk to the infant [1] ● Common side effects: headache, vomiting, abdominal pain, nausea, bradycardia, somnolence, insomnia, vertigo, cough, asthenia, rash; transient elevations of liver transaminases (usually returning to normal by Day 28) and falls in haemoglobin may occur [1] ● May cause dizziness, tiredness or sleepiness — do not drive or use machines if affected [1] ● Store below 30 °C (product label: in a cool, dry place, protected from light and moisture); keep out of the reach and sight 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].