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  • Selincro 18 mg
    / Lundbeck


    Active Ingredient
    Nalmefene 18.06 mg (as hydrochloride dihydrate)

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    14

    not in the basket chart 44662 9666

    Related information


    Dosage

    The maximum dose is 18.06 mg per day, can be taken with or without food. Method of administration should be adjusted individually for each patient according to its clinical status, alcohol dependence, and level of alcohol consumption.
    See prescribing information for full details.


    Indications

    Reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level (DRL), without physical withdrawal symptoms and who do not require immediate detoxification. This drug should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption. Should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.


    Contra-Indications

    Hypersensitivity to the active substance. Patients taking opioid agonists (such as opioid analgesics, opioids for substitution therapy with opioid agonists (e.g. methadone) or partial agonists (e.g. buprenorphine). Patients with current or recent opioid addiction. Patients with acute symptoms of opioid withdrawal. Patients for whom recent use of opioids is suspected. Patients with severe hepatic impairment (Child-Pugh classification). Patients with severe renal impairment (eGFR<30 ml/min per 1.73 m2). Patients with a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, and delirium tremens).


    Special Precautions

    Nalmefene 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. Caution should be exercised when using medicinal products containing opioids.
    Psychiatric disorders: Caution should be exercised if Nalmefene is prescribed to patients with current psychiatric co-morbidity such as major depressive disorder.
    Seizure disorders: There is limited experience in patients with a history of seizure disorders, including alcohol withdrawal seizures. Caution is advised if treatment aimed at reduction of alcohol consumption is started in such patients.
    Renal or hepatic impairment: Caution should be exercised when prescribing Nalmefene to patients with mild or moderate hepatic or mild or moderate renal impairment.
    See prescribing information for full details.


    Side Effects

    Dizziness, insomnia, and headache. The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration.
    See prescribing information for full details.


    Drug interactions

    Concomitant use with opioid agonists (for example, certain types of cough and cold medicinal products, certain antidiarrhoeal medicinal products, and opioid analgesics), the patient may not benefit from the opioid agonist.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no or limited data (fewer than 300 pregnancy outcomes) from the use of Nalmefene in pregnant women.
    Lactation: It is unknown whether Nalmefene is excreted in human milk.
    See prescribing information for full details.


    Overdose

    Management of an overdose should be observational and symptomatic.
    See prescribing information for full details.


    Important notes

    The film-coated tablet should be swallowed whole. The film-coated tablet should not be divided or crushed because nalmefene may cause skin sensitisation when in direct contact with the skin.
    Storage: Store below 30ºC.


    Manufacturer
    Lundbeck A/S, Denmark
    Licence holder
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