Medicinal Products

ATOVAQUONE / PROGUANIL 250 mg / 100 mg

Generic drug of Malarone
Therapeutic class: Infectiology - Parasitology
Active ingredients: Atovaquone, Proguanil
laboratory: EG Labo

Coated tablet
Box of 12
All forms

Indication

It is indicated in the following cases:

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

· Treatment of uncomplicated Plasmodium falciparum malaria in adults and children 11 kg or more.

Official and local recommendations for local prevalence of antimalarial drug resistance should be considered; official recommendations will normally include recommendations issued by the World Health Organization (WHO) and those of local health authorities.

Dosage ATOVAQUONE / PROGUANIL 250 mg / 100 mg film-coated tablet Box of 12

Administration mode

The recommended daily dosage should be given at the same time each day and with a meal or milk drink to promote the absorption of atovaquone.

If it is not possible to take a meal, the patient should take ATOVAQUONE / PROGUANIL EG but the bioavailability of atovaquone will be reduced. If vomiting occurs within one hour after administration, a new dose should be given.

Dosage

Prophylaxis:

The prophylactic treatment will be:

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

· Continued for the duration of the stay, which should 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-immune) subjects residing in endemic areas.

Dosage in adults and children over 40 kg body weight:

One tablet of ATOVAQUONE / PROGUANIL EG per day.

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

Treatment :

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

·> 11 to <20 kg: 1 tablet daily for 3 consecutive days.

·> 20 to <30 kg: 2 tablets taken once daily for 3 consecutive days.

·> 30 to <40 kg: 3 tablets taken once a day for 3 consecutive days at 24 hours intervals.

·> 40 kg: The dosage will be that of the adult.

Dosage in the elderly

Pharmacokinetic data indicate that dosage adjustment in the elderly is not necessary (see section 5.2 ).

Dosage in case of hepatic insufficiency

Available pharmacokinetic data indicate that dose adjustment in mild to moderate hepatic impairment is not necessary Although no studies have been performed in patients with severe hepatic impairment, no precautions or no dose adjustment is considered (see section 5.2 ).

Dosage in case of renal failure

Pharmacokinetic data indicate that dosage adjustment in patients with mild to moderate renal impairment is not necessary. In cases of severe renal impairment (creatinine clearance <30 ml / min), to treat malaria access to Plasmodium falciparum, alternative treatment should be used as far as possible (see sections caution and precautions for use and pharmacokinetic properties ). For the prophylactic treatment of Plasmodium falciparum malaria in patients with severe renal impairment, refer to Contraindications section .

Against indications

Hypersensitivity to the active substances or to any of the excipients listed under Composition .

Atovaquone / proguanil is contraindicated in the prophylaxis of Plasmodium falciparum malaria in patients with severe renal impairment (creatinine clearance <30 ml / min).

Atovaquone / Proguanil EG side effects

In clinical trials 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 clinical trials with atovaquone / proguanil for the prophylaxis of malaria, the most commonly reported adverse events were: headache, abdominal pain, and diarrhea.

Adverse events reported with suspected (or at least potential) causality and spontaneous post-marketing reports are summarized in the following table:

The following convention was used to classify frequencies: very common (≥1 / 10), frequent (≥1 / 100 to <1/10), uncommon (≥1 / 1000 to <1/100), frequency not known (can not be estimated based on available data).

Long-term safety data for children is limited. In particular, the long-term effects of atovaquone / proguanil on growth, puberty and general development have not been studied.

Class of organ system

Very common

( 1/10)

Frequent

( 1/100 to <1/10)

Rare

( 1/1000 to < 1/100)

Not known

(can not be estimated on the basis of available data)

Blood and lymphatic system disorders

Anemia

Neutropenia 1

pancytopenia

Immune system disorders

Allergic reactions

edema of quincke 3 Anaphylaxis (see section Warnings and precautions for use )

Vasculitis 3

Metabolism and nutrition disorders

Hyponatremia 1

Anorexia

Hyperamylasemia 1

Psychiatric disorders

Abnormal dreams

Depression

Anxiety

panic attacks

Tears

hallucinations

nightmares

Nervous system disorders

headaches

Insomnia

Dizziness

convulsions

Heart conditions

palpitations

tachycardia

Gastrointestinal disorders

Nausea 1 Vomiting Diarrhea Abdominal pain

stomatitis

Gastric intolerance 3

Oral ulcers 3

Hepatobiliary disorders

Elevation of liver enzymes 1

Hepatitis

Cholestasis 3

Skin and subcutaneous tissue disorders

itching

Rashes

Hair loss

Urticaria

Stevens Johnson Syndrome

Erythema multiforme

Formation of vesicles 3

Skin exfoliation

Photosensitivity reactions

General disorders and administration site conditions

Fever

Respiratory, thoracic and mediastinal disorders

Cough

1 . Frequency according to the atovaquone instructions. Patients who participated in clinical trials with atovaquone received higher doses and often had complications from advanced HIV (Human Immunodeficiency Virus) infection. These events may have been observed at a lower frequency or not seen at all in clinical trials with atovaquone / proguanil.

2. Observation from spontaneous post-marketing notifications. The frequency is not known.

3 . Observed under proguanil.

Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. She permits
continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

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