Medicinal Products

ATOVAQUONE / PROGUANIL SIGMA-TAU 250 mg / 100 mg

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

Coated tablet
Box of 12
All forms

Indication

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

· Prophylaxis of Plasmodium falciparum malaria in adults and children over 40 kg, particularly in areas of resistance to other antimalarials.

Official recommendations from the World Health Organization (WHO) and local health authorities regarding the local prevalence of drug resistance in endemic areas for appropriate antimalarial use should be considered.

Dosage ATOVAQUONE / PROGUANIL SIGMA-TAU 250 mg / 100 mg Film-coated tablet Box of 12

Administration mode

Oral way

The tablets will be administered daily at a fixed time with a meal or a milk drink to promote the absorption of atovaquone.

In case of digestive intolerance, the tablets may be administered on an empty stomach, but the systemic exposure of atovaquone may be less. In case of vomiting within one hour after taking, the dose will be repeated.

It is best not to crush the tablets.

Dosage

Prophylaxis of Plasmodium falciparum malaria:

Treatment will be started the day before or the day of arrival in the endemic area. It will be continued for the duration of the risk of malnutrition and 7 days after leaving the endemic area.

Adult, teenager and child over 40 kg body weight (approximately 12 years of age):

1 tablet per day at a fixed time.

ATOVAQUONE / PROGUANIL SIGMA-TAU film-coated tablets 250 mg / 100 mg film-coated tablets are not suitable for persons under 40 kg.

Curative treatment of malaria access to Plasmodium falciparum:

Adults and children over 40 kg body weight (approximately 12 years of age):

4 tablets in a single dose per day for 3 consecutive days at 24 hour intervals.

Subjects with 11 kg or more of body weight:

· 11 to 20 kg: 1 tablet daily for 3 consecutive days at 24 hours intervals.

· 21 to 30 kg: 2 tablets taken once a day for 3 consecutive days at 24 hours intervals.

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

· More than 40 kg body weight: see adult dosage.

Elderly

The kinetics data show that there is no need for special precautions or dose adjustments in the elderly (see section 5.2 ).

Dosage in case of hepatic insufficiency

The available pharmacokinetic data indicate that there is no need for special precautions or dosage adjustments in mild to moderate hepatic impairment.

In patients with severe hepatic impairment, although no studies have been performed, there is no need for special precautions or dosage adjustments (see section 5.2 ).

Dosage in case of renal failure

The available pharmacokinetic data indicate that there is no need for dose adjustment in individuals with mild to moderate renal impairment.

In patients with severe renal impairment (creatinine clearance <30 ml / min) prophylactic treatment with ATOVAQUONE / PROGUANIL SIGMA-TAU 250 mg / 100 mg film-coated tablet is contraindicated (see Contraindications section). To treat malaria in this situation, alternative treatment should be used as far as possible (see sections Warnings and Precautions and Pharmacokinetic Properties ).

Against indications

Hypersensitivity to the active substances or to any of the excipients.

Severe renal insufficiency (creatinine clearance <30 ml / min) for prophylactic use of malaria.

Atovaquone / Proguanil side effects Sigma-Tau

Adverse reactions reported with atovaquone / proguanil, atovaquone or proguanil in clinical studies or spontaneous pharmacovigilance reports are listed below by organ system and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 and <1/10), rare (≥ 1/1000 and <1/100), undetermined frequency: frequency can not be determined from the available data.

In clinical studies with atovaquone / proguanil as curative treatment for malaria, the most commonly reported adverse events, independent of accountability, were: abdominal pain, headache, anorexia, nausea, vomiting, diarrhea, and cough; they were generally reported with the same frequency in patients receiving the atovaquone / proguanil combination or the comparator antimalarial comparator.

In clinical trials of atovaquone / proguanil for malaria prophylaxis, the most commonly reported adverse events, independent of accountability, were: headache, abdominal pain, and diarrhea; they were reported with similar frequency in patients receiving atovaquone / proguanil or placebo.

Classes of organ systems

Very common

Frequent

Rare

Not known frequency

(≥1 / 10)

(≥1 / 100 to <1/10)

(≥1 / 1000 to <1/100)

(can not be estimated from the available data)

Blood and lymphatic system disorders

Anemia 1
Neutropenia 2

Pancytopenia in patients with severe renal insufficiency 4

Immune system disorders

Allergic reactions

Quincke's edema 3 anaphylaxis 3, vasculitis 4

Metabolism and nutrition disorders

Hyponatremia 2
Anorexia 1

Elevation of amylase level 2

Psychiatric disorders

Abnormal dreams 1

Anxiety 1

Panic crisis 3

Depression 1

Crying 3

Hallucinations 3

Nightmares 3

Nervous system disorders

Headache 1

Insomnia 1

Seizures 3

Dizziness 1

Cardiac disorders

Palpitations 3

Tachycardia 3

Gastrointestinal disorders

Nausea 2

Stomatitis 1

Gastric intolerance 4

Vomiting 1

Oral ulcers 4

Diarrhea 1

pains
abdominal 1

Hepatobiliary disorders

Elevation of liver enzymes 2.5

Hepatitis 3

Cholestasis 4

Skin and subcutaneous disorders

Eruption 1

Alopecia 1

Stevens-Johnson Syndrome 3

Urticaria 1

Erythema multiforme 3

Phlyctenes 3

Skin exfoliation 3

General disorders and administration site conditions

Fever 1

Respiratory, thoracic and mediastinal disorders

Cough 1

1. Frequency according to clinical studies of ATOVAQUONE / PROGUANIL SIGMA-TAU 250 mg / 100 mg film-coated tablets.

2. Estimated frequency based on initial studies conducted with atovaquone. Atovaquone doses used in studies with atovaquone were higher than those used in malaria, and reported complications were most often related to the underlying HIV-related pathology. As a result, the causal relationship between adverse effects and atovaquone is difficult to measure. These effects could be noted at a lower frequency or not noted at all in clinical trials with atovaquone / proguanil.

3. Effects reported by spontaneous post-marketing pharmacovigilance notifications. The frequency can not be determined.

4. Effects reported with proguanil. The frequency can not be determined.

5. Hepatic abnormalities reported during clinical trials with atovaquone / proguanil were reversible and without clinical consequences.

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