1. Name of the medicinal product
Malarone® 250 mg/100 mg film-coated tablets

2. Qualitative and quantitative composition
Each Malarone tablet contains 250 mg atovaquone and 100 mg proguanil hydrochloride.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form
Film coated tablet.

Round, biconvex, pink tablets engraved 'GX CM3' on one side.

4. Clinical particulars
4.1 Therapeutic indications
Malarone is a fixed dose combination of atovaquone and proguanil hydrochloride which acts as a blood schizonticide and also has activity against hepatic schizonts of Plasmodium falciparum. It is indicated for:

Prophylaxis of Plasmodium falciparum malaria.

Treatment of acute, uncomplicated Plasmodium falciparum malaria.

Because Malarone is effective against drug sensitive and drug resistant P. falciparum it is especially recommended for prophylaxis and treatment of P. falciparum malaria where the pathogen may be resistant to other antimalarials.

Official guidelines and local information on the preva lence of resistance to antimalarial drugs should be taken into consideration. Official guidelines will normally include WHO and public health authorities' guidelines.

4.2 Posology and method of administration
Method of administration

The daily dose should be taken with food or a milky drink (to ensure maximum absorption) at the same time each day.

If patients are unable to tolerate food, Malarone should be administered, but systemic exposure of atovaquone will be reduced. In the event of vomiting within 1 hour of dosing a repeat dose should be taken.

Posology

Prophylaxis:

Prophylaxis should

• commence 24 or 48 hours prior to entering a malaria-endemic area,

• continue during the period of the stay

• continue for 7 days after leaving the area.

In residents (semi-immune subjects) of endemic areas, the safety and effectiveness of Malarone has been established in studies of up to 12 weeks.

In non-immune subjects, the average duration of exposure in clinical studies was 27 days.

Dosage in Adults

One Malarone tablet daily.

Malarone tablets are not recommended for malaria prophylaxis in persons under 40 kg bodyweight.

Malarone paediatric tablets are recommended for malaria prophylaxis in persons weighing <40 kg

Treatment

Dosage in Adults

Four Malarone tablets as a single dose for three consecutive days.

Dosage in Children

11-20 kg bodyweight.
 One tablet daily for three consecutive days.
 
21-30 kg bodyweight.
 Two tablets as a single dose for three consecutive days.
 
31-40 kg bodyweight.
 Three tablets as a single dose for three consecutive days.
 
>40 kg bodyweight.
 Dose as for adults.
 

Dosage in the Elderly

A pharmacokinetic study indicates that no dosage adjustments are needed in the elderly (See Section 5.2).

Dosage in Hepatic Impairment

A pharmacokinetic study indicates that no dosage adjustments are needed in patients with mild to moderate hepatic impairment. Although no studies have been conducted in patients with severe hepatic impairment, no special precautions or dosage adjustment are anticipated (See Section 5.2).

Dosage in Renal Impairment

Pharmacokinetic studies indicate that no do