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ACOMPLIA Film-coated tablet (2009)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ACOMPLIA 20 mg film-coated tablets.

Qualitative and quantitative composition

Each tablet contains 20 mg rimonabant. Excipients: The tablets contain approx. 115 mg lactose. For a full list of excipients, see section 6.1.

Pharmaceutical form

Film-coated tablet. Biconvex, teardrop-shaped, white tablets debossed with 20 on one side.

Therapeutic indications

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 ...

Posology and method of administration

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 ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Lactation. Ongoing major depressive illness and/or ongoing antidepressive treatment (see section 4.4).

Special warnings and precautions for use

Depressive disorders Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, and suicidal ideation in up to 1%, of patients receiving rimonabant (see section ...

Interaction with other medicinal products and other forms of interaction

Rimonabant is metabolized by both CYP3A and amidohydrolase (predominantly hepatic) pathways in vitro. Concomitant administration of CYP3A4 inhibitors will lead to increased exposure of rimonabant. Concomitant ...

Pregnancy and lactation

There are no adequate or well-controlled studies in pregnant women. Animal data are inconclusive but suggest possible deleterious effects on embryonal/foetal development (see section 5.3). The potential ...

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. Cognitive investigations in clinical pharmacology studies demonstrated that rimonabant is devoid of any significant ...

Undesirable effects

ACOMPLIA 20 mg has been evaluated for safety in approximately 2500 patients enrolled in studies that examined the metabolic and weight loss effects in overweight and obese patients and in approximately ...

Overdose

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 ...

Pharmacodynamic properties

Pharmaco-therapeutic group: Anti obesity agent ATC code: A08AX01 Rimonabant is a selective cannabinoid-1 receptor (CB1) antagonist that inhibits the pharmacological effects of cannabinoid agonists in vitro ...

Pharmacokinetic properties

Rimonabant pharmacokinetics are fairly dose proportional up to about 20 mg. AUC increased less than in proportion to dose above 20 mg. Absorption Rimonabant displays high in vitro permeability and is not ...

Preclinical safety data

Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: Convulsions were ...

List of excipients

Tablet core: Maize starch Lactose monohydrate Povidone K 30 (E1201) Croscarmellose sodium (E468) Sodium laurilsulfate (E487) Microcrystalline cellulose (E460) Magnesium stearate Tablet coating: Lactose ...

Incompatibilities

Not applicable.

Shelf life

Shelf-life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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 ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

sanofi-aventis, 174 Avenue de France, F-75013, Paris, France

Marketing authorization number(s)

EU/1/06/344/001-011

Date of first authorization / renewal of the authorization

19 June 2006

Πηγαίο έγγραφο

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