RIAMET Tablet Ref.[6220] Active ingredients: Artemether Artemether and Lumefantrine Lumefantrine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

Product name and form

Riamet 20 mg/120 mg tablets.

Pharmaceutical Form

Tablet.

Light yellow, round tablet with “NC” debossed on one side and “CG” on the other.

Qualitative and quantitative composition

One tablet contains 20 mg artemether and 120 mg lumefantrine.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Artemether

Artemether is an antimalarial agent used to treat acute uncomplicated malaria. It is administered in combination with lumefantrine for improved efficacy. This combination therapy exerts its effects against the erythrocytic stages of Plasmodium spp. and may be used to treat infections caused by P. falciparum and unidentified Plasmodium species, including infections acquired in chloroquine-resistant areas.

Artemether and Lumefantrine

Artemether/lumefantrine fixed-dose combination comprises a fixed ratio of 1:6 parts of artemether and lumefantrine, respectively. The site of antiparasitic action of both components is the food vacuole of the malarial parasite, where they are thought to interfere with the conversion of haem, a toxic intermediate produced during haemoglobin breakdown, to the nontoxic haemozoin, malaria pigment. Both artemether and lumefantrine have a secondary action involving inhibition of nucleic acid and protein synthesis within the malarial parasite.

Lumefantrine
List of Excipients

Polysorbate 80
Hypromellose
Microcrystalline cellulose
Colloidal anhydrous silica
Croscarmellose sodium
Magnesium stearate

Pack sizes and marketing

PVC/PE/PVDC/aluminium blisters.

Packs of 24.

No specific pack for the treatment of children and infants is available. The 24-tablets pack should be used for this patient population and the parent or care giver should be given the necessary information (see section 6.6).

Marketing authorization holder

Novartis Ireland Limited, Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4, Ireland

Marketing authorization dates and numbers

PL 23860/0024

30 November 1999 / 29 November 2009

Drugs

Drug Countries
RIAMET Austria, Australia, France, Japan, Netherlands, New Zealand, United Kingdom

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