Source: European Medicines Agency (EU) Revision Year: 2009 Publisher: sanofi-aventis, 174 Avenue de France, F-75013, Paris, France
As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥30 kg/m²), or overweight patients (BMI >27 kg/m²) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1).
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast.
The treatment should be introduced with a mildly reduced calorie diet.
The safety and efficacy of rimonabant have not been evaluated beyond 2 years.
No dosage adjustment is required in elderly (see section 5.2). ACOMPLIA should be used with caution in patients over 75 years of age (see section 4.4).
No dosage adjustment is required for patients with mild or moderate hepatic impairment. ACOMPLIA should be used with caution in patients with moderate hepatic impairment. ACOMPLIA should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2).
No dosage adjustment is required for patients with mild and moderate renal impairment (see section 5.2). ACOMPLIA should not be used in patients with severe renal impairment (see section 4.4 and 5.2).
ACOMPLIA is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
Experience with rimonabant in overdosage is limited. In a single-dose tolerability study, doses up to 300 mg were administered to a limited number of subjects with only minor symptoms reported. These included headache, euphoria, fatigue and insomnia. The pharmacokinetic profile demonstrates that a plateau in exposures is reached at 180 mg. There is no specific antidote for rimonabant; therefore, appropriate supportive measures should be initiated in case of overdose. Treatment should consist of the general measures employed in the management of overdoses, such as keeping airways unobstructed, monitoring cardiovascular function and general symptomatic and supportive measures.
Shelf-life: 3 years.
This medicinal product does not require any special storage conditions.
PVC-aluminium blister packs containing 14, 28, 30, 56, 84, 90 and 98 film-coated tablets.
70 × 1 film-coated tablets in PVC-aluminium perforated unit dose blister packs.
Opaque white HDPE bottles containing 28, 98 and 500 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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