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ACOMPLIA (RIMONABANT): PRESCRIBING INFORMATION

DESCRIPTION

Name of the medication

Acomplia (Rimonabant) 20 mg film-coated tablets.

Qualitative and quantitative composition

Each Acomplia tablet contains 20 mg rimonabant.

Tablet core excipients: maize starch, povidone K 30, lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate.
Tablet coating excipients: lactose monohydrate, titanium dioxide, hypromellose, macrogol 3000
Tablet polishing excipients: carnauba wax

Pharmaceutical form

Acomplia: film-coated tablet
Biconvex, teardrop-shaped, white tablets debossed with "20" on one side.


INDICATIONS AND USAGE

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 factors, such as type 2 diabetes or dyslipidaemia.


CONTRAINDICATIONS

  • Hypersensitivity to the active substance of Acomplia (Rimonabant) or to any of the excipients.
  • Lactation.
  • Ongoing major depressive illness and/or ongoing antidepressive treatment.


    DOSAGE AND ADMINISTRATION

    Acomplia dosage and administration


    CLINICAL PHARMACOLOGY

    Acomplia clinical pharmacology


    SPECIAL POPULATIONS

    Acomplia special populations


    PRECLINICAL SAFETY DATA

    Acomplia preclinical safety data


    CLINICAL STUDIES

    Acomplia clinical studies


    WARNINGS AND PRECAUTIONS

    Acomplia warnings and precautions


    DRUG INTERACTIONS

    Acomplia drug interactions


    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. The potential risk for humans is unknown. Use in pregnancy is, therefore, not recommended. Patients should notify their physician if they become pregnant during treatment with Rimonabant (Acomplia) tablets.

    This medicine has been detected in the milk of lactating rats and rimonabant may inhibit the suckling reflex. It is not known if rimonabant is excreted in human milk. Acomplia is contraindicated during breast-feeding.

    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 Acomplia (Rimonabant) is devoid of any significant cognitive or sedative effect.


    ADVERSE REACTIONS

    Acomplia adverse reactions


    OVERDOSE

    Experience with Acomplia (Rimonabant) tablets 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.


    HOW SUPPLIED

    Incompatibilities

    Not applicable.

    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 x 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.

    Special precautions for disposal

    No special requirements.

    Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.

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