SELINCRO Film-coated tablet Ref.[9788] Active ingredients: Nalmefene

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).

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 mg/day of nalmefene for more than 2 years. Intake of a single dose of 450 mg nalmefene has been reported without changes in blood pressure, heart rate, respiration rate, or body temperature.

No unusual pattern of adverse reactions was observed in these settings, but experience is limited.

Management of an overdose should be observational and symptomatic.

Shelf life: 3 years.

This medicinal product does not require any special storage conditions.

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.

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