1.   IDENTIFICATION OF MEDICINE:

• PHARMACEUTICAL FORM AND PRESENTATION:

Artemether / lumefantrine 20/120MG :  Pack of 24 tablets

Artemether / lumefantrine 40/240MG :  Pack of 12 tablets

Artemether / lumefantrine 80/480MG :  Pack of 6 tablets

Artemether / lumefantrine FOR ORAL SUSPENSION : Bottle of 60ml

• QUALITATIVE AND QUANTITATIVE COMPOSITION:

Artemether / lumefantrine TABLETS :

-ARTEMETHER   20 MG  40 MG  80 MG

-LUMEFANTRINE 120 MG  240 MG  480 MG

Artemether / lumefantrine FOR ORAL SUSPENSION :

-ARTEMETHER 180 MG/60 ML   240 MG/60 ML

-LUMEFANTRINE 1080 MG/60 ML  1440 MG/60 ML

EXCIPIENTS: q.s.

• THERAPEUTIC CLASS: Antimalarial

2.   PHARMACOLOGICAL PROPERTIES:

• Pharmacodynamics:

Both components of Artemether / lumefantrine Tablets and Artemether / lumefantrine for oral suspension have their own action site in the malarial parasite. The presence of the endoperioxide bridge is Artemether (generating singlet oxygen and free radicals: those are very cytotoxic to the plasmodia). It appears to be essential for antimalarial activity. Morphological changes of the parasitic membranes induced by Artemether have been described, being the result of free-radical action. Lumefantrine interferes more in the polymerization processes.

Other in-vitro tests suggest that both cause a marked diminution of nucleic acid synthesis. Inhibition of protein synthesis as the basic mechanism of action is suggested in the studies which showed morphological changes in ribosomes as well as in the endoplasmic reticulum, although Artemether acts essentially as a blood schizonticide, Artemether / lumefantrine Tablets and Artemether / lumefantrine for oral suspension did clear gametocytes in comparative clinical trials.

• Pharmacokinetics:

Orally administered Artemether is rapidly absorbed reaching therapeutic levels within 60-90 minutes. Artemether is metabolized in the liver to the demethylated derivate dihydroartemisinin (DHA). The elimination is rapid, with a T 1/2 of 2-4 hours. Dihydroartemisinin, being a potent antimalarial itself, has a T 1/2 of 2-4 hours. The degree of binding to plasma proteins varies markedly according to the species studied. The binding of Artemether with plasma protein in man is about 50%. Radioactivity distribution of Artemether was found to be equal between cells and plasma.

The absorption of Lumefantrine is highly influenced by lipids and food intake (from 10% by fasting to 100% at normal diet). Therefore patients should be encouraged to take the medication with some fatty food as soon as it can be tolerated.

Lumefantrine is N-debutylated in human liver microsomes . This metabolite has 5 to 8 fold higher antiparasitic effects than lumefantrine. Lumefantrine is found to be highly protein bound (95%). The elimination half life in malarial attaint patients will be 4 to 6 days. Lumefantrine and its metabolites are found in bile and faeces.

3.   WHEN SHOULD THIS MEDICINE BE USED?

This medicine is used for the curative treatment of the mixed infections of malaria, including plasmodium falciparum resistant to other classic antimalarials, particularly to adults and children more than 5 kg body weight in endemic area.

It is also recommended for the treatment of the apparent emergence of malaria.

4.   CAUTION!

• WHEN SHOULD THIS MEDICINE NOT BE USED ?

This medicine should not be used in case of allergy to one of its components or excipients. It is contraindicated during the first 3 months of pregnancy and also for prophylaxis.

In case of doubt, do not hesitate to consult a physician or a pharmacist.

• WARNINGS AND PRECAUTIONS FOR USE:

The patients who have permanent aversion to food during the treatment should be watched carefully, because there is a possible majoration of risk of upsurge. This drug was not evaluated in the complicated treatment of malaria including cerebral malaria and kidney insufficiency. On the other hand, an elongation of interval of qtc without clinical effects has been observed in some patients been treated with this drug, in particular with dehydratation or an ionic discord. No correlation was found between elongation of qtc interval and high concentration to the patients.

• PREGNANCY AND LACTATION:

Do not use this medicine to pregnant woman without medical advice. Concerning lactation, no data is available today about its excretion in the maternal milk.

Do not hesitate to seek the advice of your physician or your pharmacist.

• EFFECT ON DRIVING AND OPERATING MACHINERY:

Patients should know that dizziness or fatigue may occur, and so should stop driving and operating machinery during the treatment.

• DRUG INTERACTIONS AND OTHER INTERACTIONS:

In order to avoid possible interactions between several medicines, you should always inform your physician or pharmacist about any other treatment that you are taking. No specific study of interaction was conducted with LUMETA. However patients with LUMETA have taken at the same time antipyretics, antibiotics and a hydroelectric equilibration without bad tolerance.

5. HOW TO USE THIS MEDICINE?

• DOSAGE AND ADMINISTRATION :

·Artemether / lumefantrine TABLETS 20/120MG FOR ADULTS &CHILDREN:

Artemether / lumefantrine TABLETS 40/240MG FOR ADULTS:

Artemether / lumefantrine TABLETS 80/480MG FOR ADULTS:

6.UNDESIRABLE AND UNPLEASANT EFFECTS:

Like all active ingredients, this medicine may cause side effects but the recording of the side effects during the clinical tests with LUMETA are less frequent and of less intensity than other anti-malarials. Common side effects that may occur are nausea, abdominal pain, vomiting, loss of appetite, dizziness, headache, trouble in sleeping, fatigue and general weakness, rarely rash and itching of the skin may occur. Some of these symptoms also accompany a malarial attack and so it may be difficult to distinguish whether these are malarial symptoms or the adverse effects of the drug.

In case of doubt, don't hesitate to consult a physician or a Pharmacist.

7.STORAGE:

Store below 30°C. Protect from light.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

8. SHELF LIFE:

3 Years