Special Warning : אזהרת שימוש

4.4   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 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.

Caution should be exercised when using medicinal products containing opioids (for example, cough medicines, opioid analgesics (see section 4.5)).

Comorbidity
Psychiatric disorders
Psychiatric effects were reported in clinical studies (see section 4.8). 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.

Renal or hepatic impairment
Selincro is extensively metabolised by the liver and excreted predominantly in the urine.
Therefore, caution should be exercised when prescribing Selincro to patients with mild or moderate hepatic or mild or moderate renal impairment, for example, by more frequent monitoring.

Caution should be exercised when prescribing Selincro to patients with elevated ALAT or ASAT (>3 times ULN) as these patients were excluded from the clinical development programme.

Elderly patients (≥65 years of age)
Limited clinical data are available on the use of Selincro in patients ≥65 years of age with alcohol dependence.

Caution should be exercised when prescribing Selincro to patients ≥65 years of age (see sections 4.2 and 5.2).

Others
Caution is advised if Selincro is co-administered with a potent UGT2B7 inhibitor (see section 4.5).
Lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

Effects on Driving

4.7   Effects on ability to drive and use machines

Adverse reactions such as disturbance in attention, visual impairment, feeling abnormal, nausea, dizziness, somnolence ,insomnia, and headache may occur following administration of nalmefene (see section 4.8). The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration.
Consequentially, Selincro may have minor to moderate influence on the ability to drive and use machines and patients should exercise caution particular when starting treatment with Selincro.