Selincro

Posology At an initial visit, the patient’s clinical status, alcohol dependence, and level of alcohol consumption (based on patient reporting) should be evaluated. Thereafter, the patient should be asked to record his or her alcohol consumption for approximately two weeks.

1) over this two-week period, in conjunction with psychosocial intervention focused on treatment adherence and reducing alcohol consumption.

Selincro is to be taken as-needed:

On each day the patient perceives a risk of drinking alcohol, one tablet should be taken, preferably 1-2 hours prior to the anticipated time of drinking. If the patient has started drinking alcohol without taking Selincro, the patient should take one tablet as soon as possible.

The maximum dose of Selincro is one tablet per day. 2). During pivotal trials the greatest improvement was observed within the first 4 weeks. 1). The physician should continue to assess the patient’s progress in reducing alcohol consumption, overall functioning, treatment adherence, and any potential side effects.

Clinical data for the use of Selincro under randomised controlled conditions are available for a period of 6 to 12 months. Caution is advised if Selincro is prescribed for more than 1 year. 2). 2). 2). Paediatric population The safety and efficacy of Selincro in children and adolescents <18 years of age have not been established.

1). Method of administration Selincro is for oral use. The film-coated tablet should be swallowed whole. 3).

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. The most common adverse reactions were nausea, dizziness, insomnia, and headache.

The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration. Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies. The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration (a few hours to a few days).

Most of these adverse reactions resolved during continued treatment and did not recur upon repeated administration. While these events were generally short- lasting, they could represent alcoholic psychosis, alcohol withdrawal syndrome, or comorbid psychiatric disease.

Tabulated list of adverse reactions Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

7 Table 1. Frequencies of adverse reactions System Organ Class Frequency Adverse Reaction Metabolism and nutrition disorders Common Decreased appetite Psychiatric disorders Very common Insomnia Common Sleep disorder Confusional state Restlessness Libido decreased (including loss of libido) Uncommon Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination) Dissociation Nervous system disorders Very Common Dizziness Headache Common Somnolence Tremor Disturbance in attention Paraesthesia Hypoaesthesia Eye disorders Not known Visual impairment (mostly transient) Cardiac disorders Common Tachycardia Palpitations Gastrointestinal disorders Very Common Nausea Common Vomiting Dry mouth Diarrhoea Skin and subcutaneous tissue disorders Common Hyperhidrosis Not known Angioedema Urticaria Pruritus Rash Erythema Musculoskeletal and connective tissue disorders Common Muscle spasms Not known Myalgia Reproductive system and breast disorder Not known Priapism General disorders and administration site conditions Common Fatigue Asthenia Malaise Feeling abnormal Investigations Common Weight decreased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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. 4 Opioid administration In an emergency situation when opioids must be administered to a patient taking Selincro, the amount of opioid required to obtain the desired effect may be greater than usual.

The patient should be closely monitored for symptoms of respiratory depression as a result of the opioid administration and for other adverse reactions. If opioids are needed in an emergency, the dose must always be titrated individually.

If unusually large doses are required, close observation is necessary. Selincro should be temporarily discontinued for 1 week prior to the anticipated use of opioids, for example, if opioid analgesics might be used during elective surgery.

The prescriber should advise patients that it is important to inform their health care professional of last Selincro intake if opioid use becomes necessary. 5)). 8). If patients develop psychiatric symptoms that are not associated with treatment initiation with Selincro, and/or that are not transient, the prescriber should consider alternative causes of the symptoms and assess the need for continuing treatment with Selincro.

Selincro has not been investigated in patients with unstable psychiatric disease. Caution should be exercised if Selincro is prescribed to patients with current psychiatric comorbidity such as major depressive disorder. The increased suicidal risk in alcohol and substances abusers, with or without accompanying depression, is not reduced by the intake of nalmefene.

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.

1. g. g. 4). 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). 73 m2).

Patients with a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, and delirium tremens).