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

Posology

Adults and children weighing 35 kg and above

For patients 12 years of age and above and 35 kg body weight and above, a course of treatment comprises six doses of four tablets i.e. total of 24 tablets, given over a period of 60 hours as follows: the first dose of four tablets, given at the time of initial diagnosis, should be followed by five further doses of four tablets given at 8, 24, 36, 48 and 60 hours thereafter.

Children and infants weighing 5 kg to less than 35 kg

A six-dose regimen is recommended with 1 to 3 tablets per dose, depending on bodyweight:

5 to less than 15 kg bodyweight: the first dose of one tablet, given at the time of initial diagnosis, should be followed by five further doses of one tablet given at 8, 24, 36, 48 and 60 hours thereafter.

15 to less than 25 kg bodyweight: the first dose of two tablets, given at the time of initial diagnosis, should be followed by five further doses of two tablets given at 8, 24, 36, 48 and 60 hours thereafter.

25 to less than 35 kg bodyweight: the first dose of three tablets, given at the time of initial diagnosis, should be followed by five further doses of three tablets given at 8, 24, 36, 48 and 60 hours thereafter.

Infants weighing less than 5 kg

The safety and efficacy of Riamet tablets have not been established in infants weighing less than 5 kg and no dosing recommendations can be made. Currently available data are described in section 5.1 and 5.2.

Older people

There is no information suggesting that the dosage in patients over 65 years of age should be different than in younger adults.

Method of administration

Tablets for oral administration.

To increase absorption, Riamet should be taken with food or a milky drink (see section 5.2). If patients are unable to tolerate food, Riamet should be administered with water, but the systemic exposure may be reduced. Patients who vomit within 1 hour of taking the medication should repeat the dose.

For administration to small children and infants, the tablet/s may be crushed.

In cases of suspected overdosage symptomatic and supportive therapy should be given as appropriate, which should include ECG and blood potassium monitoring.

2 years.

Do not store above 30°C.

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).

For the treatment of children and infants, the 24-tablets pack should be prescribed. The prescriber and pharmacist should instruct the parent or care giver on the posology for their child and that a variable number of tablets (depending on the child’s body weight) will be requested for the full treatment. Therefore, the whole pack may not be used. After successful treatment the remaining tablets should be discarded or returned to the pharmacist.