SUBOXONE 8 MG 2 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE

Commercializzato da:

NAOMI SHACO-EZRA LTD

Codice ATC:

N02AE01

Forma farmaceutica:

TABLETS SUBLINGUAL

Composizione:

BUPRENORPHINE HYDROCHLORIDE 8.64 MG; NALOXONE HYDROCHLORIDE DIHYDRATE 2.44 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

INDIVIOR UK LIMITED, UK

Gruppo terapeutico:

BUPRENORPHINE

Area terapeutica:

BUPRENORPHINE

Indicazioni terapeutiche:

Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. The intention of the naloxone component is to deter intravenous misuse.Treatment is intended for use in adults and adolescents over 15 years of age who have agreed to be treated for addiction

Data dell'autorizzazione:

2018-03-31

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
Suboxone 2 mg/0.5 mg
Sublingual tablets
Suboxone 8 mg/2 mg
Sublingual tablets
Active ingredients:
Buprenorphine (as hydrochloride) 2 mg
Naloxone (as hydrochloride dihydrate) 0.5 mg
Buprenorphine (as hydrochloride) 8 mg
Naloxone (as hydrochloride dihydrate) 2 mg
Inactive ingredients and allergens: see section 6 "Further
Information"
and in section 2 “Important
information regarding some of the ingredients of the medicine”
.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed to treat your ailment. Do not pass
it on to others
.
It may harm them
even if it seems to you that their medical condition is similar.
The medicine is intended for use in adults and adolescents over 15
years of age.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Suboxone belongs to a group of medicines that act on the nervous
system and are used to treat addiction
disorders.
Suboxone is used to treat dependence on opioid preparations
(narcotics), such as heroin or morphine, in
drug addicts who have agreed to be treated for their addiction.
Suboxone is used in adults and adolescents
over 15 years of age, who are also receiving medicinal, social and
psychological support.
Therapeutic group:
Buprenorphine - semi-synthetic opioid.
Naloxone - opioid agonist with antagonistic activity.
2.
BEFORE USING THE MEDICINE
2.1 Do not use Suboxone if:

you are sensitive (allergic) to buprenorphine, naloxone (the active
ingredients in Suboxone) or to
any of the other ingredients in the medicine. For the list of inactive
ingredients, see section 6.

you have
serious
breathing problems
.

you have
serious problems with your liver
.

you suffer from intoxication due to alcohol consumption or if you
suffer from trembling, swe

Scheda tecnica

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Suboxone 2 mg/0.5 mg sublingual tablets
Suboxone 8 mg/2 mg sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Suboxone 2 mg/0.5 mg sublingual tablets
Each sublingual tablet contains 2 mg buprenorphine (as hydrochloride)
and 0.5 mg naloxone (as
hydrochloride dihydrate).
Suboxone 8 mg/2 mg sublingual tablets
Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride)
and 2 mg naloxone
(as hydrochloride dihydrate).
Excipients with known effect:
Each Suboxone 2 mg/0.5 mg sublingual tablet contains 42 mg lactose (as
monohydrate)
Each Suboxone 8 mg/2 mg sublingual tablet contains 168 mg lactose (as
monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet
Suboxone 2 mg/0.5 mg sublingual tablets
White hexagonal biconvex tablets of 6.5 mm with “N2” debossed on
one side.
Suboxone 8 mg/2 mg sublingual tablets
White hexagonal biconvex tablets of 11 mm with “N8” debossed on
one side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Substitution treatment for opioid drug dependence, within a framework
of medical, social and
psychological treatment. The intention of the naloxone component is to
deter intravenous misuse.
Treatment is intended for use in adults and adolescents over 15 years
of age who have agreed to be
treated for addiction.
4.2
Posology and method of administration
Treatment must be under the supervision of a physician experienced in
the management of opiate
dependence/addiction.
Posology
Precautions to be taken before induction
Baseline liver function tests and documentation of viral hepatitis
status are recommended prior to
commencing therapy. Patients who are positive for viral hepatitis, on
concomitant medicinal products
(see section 4.5) and/or have existing liver dysfunction are at risk
of accelerated liver injury. Regular
monitoring of liver function is recommended (see section 4.4).
2
Prior to treatment initiation, consideration should be given to the
type