It is indicated in the following cases

· Prophylaxis of Plasmodium falciparum malaria in adults and children over 40 kg

· Treatment of uncomplicated malarial access to Plasmodium falciparum in adults and children of 11 kg or more

Official and local recommendations on the local prevalence of resistance to antimalarial drugs should be taken into account, the official recommendations will normally include the recommendations issued by the World Health Organization (WHO) and the recommendations Of the local health authorities

Mode of administration

The recommended daily dosage should be administered at the same time each day and with a meal or drink to promote the absorption of atovaquone.
If meals can not be taken, the patient should take ATOVAQUONE / PROGUANIL EG, but the bioavailability of atovaquone will be reduced. In the event of vomiting within one hour of administration, a new dose must be administered.
Dosage

Prophylaxis

The prophylactic treatment will be

· Started 24 or 48 hours before the day of arrival, in the endemic zone

· Continued for the duration of the stay, which shall not exceed 28 days

· Continued 7 days after leaving the endemic area

The safety and efficacy of atovaquone / proguanil have been demonstrated, in studies of up to 12 weeks duration, in (semi-immunized) subjects residing in endemic areas. >

Dosage in adults and children over 40 kg body weight

One tablet of ATOVAQUONE / PROGUANIL; EG a day.

ATOVAQUONE / PROGUANIL EG 250 mg / 100 mg is not recommended for the prophylaxis of malaria in subjects with a body weight less than 40 kg
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Processing

Dosage in adults

4 tablets of ATOVAQUONE / PROGUANIL, EG in a single dose for 3 consecutive days

Dosage in children weighing 11 kg or more body weight

· 11 to

Breastfeeding

In a spleen study, concentrations of atovaquone in milk were 30%, maternal plasma concentrations. It is not known whether atovaquone is excreted in breast milk in women

Proguanil is excreted in breast milk in small quantities

The combination of atovaquone / proguanil should not be used during breastfeeding.
In the clinical trials conducted with atovaquone / proguanil in the treatment of malaria, the most commonly reported adverse reactions were: abdominal pain, headache, anorexia, nausea, vomiting, diarrhea and cough. In the clinical trials conducted with atovaquone / proguanil in the prophylactic treatment of malaria, the most commonly reported adverse events were headache, abdominal pain and diarrhea.

Reported undesirable events with a suspected (or at least possible) causal link as well as spontaneous post-marketing notifications are summarized in the following table
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The following convention was used to classify frequencies: very common (≥1 / 10), frequent (≥1 / 100, to