SELINCRO Film-coated tablet (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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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
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