Selincro
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
11-12-2018
Charakterystyka produktu
(SPC)
11-12-2018
Sprawozdanie z oceny publicznego
(PAR)
13-03-2013
Składnik aktywny:
Nalmefene hydrochloride dihydrate
Dostępny od:
H. Lundbeck A/S
Kod ATC:
N07BB05
INN (International Nazwa):
nalmefene
Grupa terapeutyczna:
Drugs used in alcohol dependence
Dziedzina terapeutyczna:
Alcohol-Related Disorders
Wskazania:
Selincro is indicated for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking-risk level (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 drinking-risk level two weeks after initial assessment.
Podsumowanie produktu:
Revision: 10
Status autoryzacji:
Authorised
Data autoryzacji:
2013-02-24
Ulotka dla pacjenta
25
B. PACKAGE LEAFLET
26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SELINCRO 18 MG FILM-COATED TABLETS
nalmefene
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Selincro is and what it is used for
2.
What you need to know before you take Selincro
3.
How to take Selincro
4.
Possible side effects
5.
How to store Selincro
6.
Contents of the pack and other information
1.
WHAT SELINCRO IS AND WHAT IT IS USED FOR
Selincro contains the active substance nalmefene.
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 works by affecting processes in the brain that are
responsible for your urge to continue
drinking.
A high level of alcohol consumption is associ
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Selincro 18 mg 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
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