SELINCRO 18 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

NALMEFENE AS HYDROCHLORIDE DIHYDRATE

Available from:

LUNDBECK ISRAEL LTD.

ATC code:

N07BB05

Pharmaceutical form:

FILM COATED TABLETS

Composition:

NALMEFENE AS HYDROCHLORIDE DIHYDRATE 18.06 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

H.LUNDBECK A/S, DENMARK

Therapeutic area:

NALMEFENE

Therapeutic indications:

Selincro is indicated for the 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.Selincro should only be prescribed in conjunction with continuous psychosocial support focused on treatment adherence and reducing alcohol consumption.Selincro should be initiated only in patients who continue to have a high DRL two weeks after initial assessment.

Authorization date:

2019-01-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH PHARMACIST’S REGULATIONS
(PREPARATIONS)
1986
The medicine is marketed according to doctor’s prescription only.
SELINCRO 18 mg
FILM-COATED TABLETS
COMPOSITION
Each tablet of Selincro contains 18.06 mg nalmefene as hydrochloride
dihydrate.
INACTIVE INGREDIENTS
See section 6.
- READ THE LEAFLET CAREFULLY UNTIL THE END BEFORE USING THE
MEDICATION. This
leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or the pharmacist.
- This medicine was prescribed for you. Do not pass it on to others.
It may harm
them even if their medical condition seems similar to yours.
- The safety and efficacy of this medicine has not been tested in
children and
adolescents below age of 18 years therefore this medicine should not
be used in this
age group .
1.
WHAT IS THE MEDICINE FOR?
Selincro is used for the reduction of alcohol consumption in adult
patients with
alcohol dependence who still have a high level of alcohol consumption
2 weeks after
the first consultation with their doctor.
Alcohol dependence occurs when a person has a physical or
psychological
dependence on the consumption of alcohol.
A high level of alcohol consumption is defined as drinking more than
60 g of pure
alcohol per day for men and more than 40 g of pure alcohol per day for
women. For
example, a bottle of wine (750 ml; 12% alcohol by volume) contains
approximately
70 g alcohol and a bottle of beer (330 ml; 5% alcohol by volume)
contains
approximately 13 g alcohol.
Your doctor has prescribed Selincro because you were not able to
reduce your
alcohol consumption on your own. Your doctor will provide you with
counselling to
help you keep to your treatment and thereby reduce your alcohol
consumption.
Selincro helps to reduce your alcohol consumption by affecting
processes in the
brain that are responsible for your urge to continue drinking.
A high level of alcohol consumption is associated with an increased
risk of health
and social problems.
Selincro can help you reduce the

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Selincro 18mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 18.06 mg nalmefene (as hydrochloride
dihydrate).
Excipient with known effect
Each film-coated tablet contains 60.68 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet)
White, oval, biconvex, 6.0 x 8.75 mm film-coated tablet engraved with
“S” on one side
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Selincro is indicated for the reduction of alcohol consumption in
adult patients with alcohol
dependence who have a high drinking risk level (DRL) [see section
5.1], without physical
withdrawal symptoms and who do not require immediate detoxification.
Selincro should only be prescribed in conjunction with continuous
psychosocial support
focused on treatment adherence and reducing alcohol consumption.
Selincro should be initiated only in patients who continue to have a
high DRL two weeks
after initial assessment.
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 t