Posology : מינונים

4.2    Posology and method of administration

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.
At the next visit, Selincro may be initiated in patients who continued to have a high DRL (see section 5.1) 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. Selincro can be taken with or without food (see section 5.2).

During pivotal trials the greatest improvement was observed within the first 4 weeks. The patient’s response to treatment and the need for continued pharmacotherapy should be evaluated on a regular (for example, monthly) basis (see section 5.1). 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.

Special populations
Elderly (≥65 years of age)
No dose adjustment is recommended for this patient population (see sections 4.4 and 5.2).

Renal impairment
No dose adjustment is recommended for patients with mild or moderate renal impairment (see sections 4.4 and 5.2).

Hepatic impairment
No dose adjustment is recommended for patients with mild or moderate hepatic impairment (see sections 4.4 and 5.2).

Paediatric population
The safety and efficacy of Selincro in children and adolescents <18 years of age have not been established. No data are available (see section 5.1).

Method of administration
Selincro is for oral use.
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 (see section 5.3).