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SELINCRO Film-coated tablet (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Selincro 18 mg film-coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride dihydrate). Excipient with known effect: Each film-coated tablet contains 60.68 mg lactose. For the full list of excipients, see section ...

Pharmaceutical form

Film-coated tablet (tablet). White, oval, biconvex, 6.0 8.75 mm film-coated tablet engraved with S on one side.

Therapeutic indications

Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL) [see section 5.1], without physical withdrawal symptoms ...

Posology and method of administration

Posology At an initial visit, the patients clinical status, alcohol dependence, and level of alcohol consumption (based on patient reporting) should be evaluated. Thereafter, the patient should be asked ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients taking opioid agonists (such as opioid analgesics, opioids for substitution therapy with opioid agonists ...

Special warnings and precautions for use

Selincro is not for patients for whom the treatment goal is immediate abstinence. Reduction of alcohol consumption is an intermediate goal on the way to abstinence. Opioid administration In an emergency ...

Interaction with other medicinal products and other forms of interaction

No in vivo drug-drug interaction studies have been conducted. Based on in vitro studies, no clinically relevant interactions between nalmefene, or its metabolites, and concomitantly administered medicinal ...

Fertility, pregnancy and lactation

Pregnancy There are no or limited data (fewer than 300 pregnancy outcomes) from the use of nalmefene in pregnant women. Animal studies have shown reproductive toxicity (see section 5.3). Selincro is not ...

Effects on ability to drive and use machines

Adverse reactions such as disturbance in attention, feeling abnormal, nausea, dizziness, somnolence, insomnia, and headache may occur following administration of nalmefene (see section 4.8). The majority ...

Undesirable effects

Summary of the safety profile The frequencies of the adverse reactions in Table 1 were calculated based on three randomised, double-blind, placebo-controlled studies in patients with alcohol dependence. ...

Overdose

In a study in patients diagnosed with pathological gambling, doses of nalmefene up to 90 mg/day for 16 weeks were investigated. In a study in patients with interstitial cystitis, 20 patients received 108 ...

Pharmacodynamic properties

Pharmacotherapeutic group: Other nervous system drugs, drugs used in alcohol dependence ATC code: N07BB05 Mechanism of action Nalmefene is an opioid system modulator with a distinct μ, δ, and κ receptor ...

Pharmacokinetic properties

Absorption Nalmefene is rapidly absorbed after a single oral administration of 18.06 mg, with a peak concentration (C<sub>max</sub>) of 16.5 ng/ml after approximately 1.5 hours and an exposure (AUC) of ...

Preclinical safety data

Nalmefene was shown to have skin sensitisation potential in the Local Lymph Node Assay in mice after topical application. Studies in animals do not indicate direct harmful effects with respect to fertility, ...

List of excipients

Tablet core: Microcrystalline cellulose Lactose, anhydrous Crospovidone, type A Magnesium stearate Tablet coating: Hypromellose Macrogol 400 Titanium dioxide (E171)

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

Blister: Clear PVC/PVdC-aluminium blisters in cardboard boxes. Pack sizes of 7, 14, 28, 42, 49 and 98 film-coated tablets. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

H. Lundbeck A/S, Ottiliavej 9, DK-2500, Valby, Denmark

Marketing authorization number(s)

EU/1/12/815/001 7 tablets EU/1/12/815/002 14 tablets EU/1/12/815/003 28 tablets EU/1/12/815/004 42 tablets EU/1/12/815/005 98 tablets EU/1/12/815/006 49 tablets

Date of first authorization / renewal of the authorization

Date of first authorisation: 25 February 2013 Date of latest renewal: 10 November 2017

Πηγαίο έγγραφο

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