SUBOXONE FILM 2 MG0.5 MG

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

BUPRENORPHINE AS HYDROCHLORIDE; NALOXONE AS HYDROCHLORIDE DIHYDRATE

Commercializzato da:

NAOMI SHACO-EZRA LTD

Codice ATC:

N02AE01

Forma farmaceutica:

SUBLINGUAL FILM

Composizione:

BUPRENORPHINE AS HYDROCHLORIDE 2 MG; NALOXONE AS HYDROCHLORIDE DIHYDRATE 0.5 MG

Via di somministrazione:

BUCCAL, SUBLINGUAL

Tipo di ricetta:

Required

Prodotto da:

AQUESTIVE THERAPEUTICS, USA

Area terapeutica:

BUPRENORPHINE

Indicazioni terapeutiche:

Suboxone sublingual film is indicated for treatment of opioid dependence in adults and adolescents over 15 years of age. Suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Data dell'autorizzazione:

2020-04-07

Foglio illustrativo

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
SUBOXONE film 2 mg/0.5 mg,
for sublingual or buccal use
SUBOXONE film 4 mg/1 mg,
for sublingual or buccal use
SUBOXONE film 8 mg/2 mg,
for sublingual or buccal use
SUBOXONE film 12 mg/3 mg,
for sublingual or buccal use
Active ingredients and their quantities in unit dose:
SUBOXONE film 2 mg/0.5 mg, each film contains:
Buprenorphine (as hydrochloride) 2 mg
Naloxone (as hydrochloride dihydrate) 0.5 mg
SUBOXONE film 4 mg/1 mg, each film contains:
Buprenorphine (as hydrochloride) 4 mg
Naloxone (as hydrochloride dihydrate) 1 mg
SUBOXONE film 8 mg/2 mg, each film contains:
Buprenorphine (as hydrochloride) 8 mg
Naloxone (as hydrochloride dihydrate) 2 mg
SUBOXONE film 12 mg/3 mg, each film contains:
Buprenorphine (as hydrochloride) 12 mg
Naloxone (as hydrochloride dihydrate) 3 mg
Inactive ingredients - see section 6 “Further information” and
section 2 “Important information
about some of the ingredients of the medicine”.
Read the 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 for you. Do not pass it on to
others. It may harm them
even if it seems to you that their medical condition is similar.
Important:
SUBOXONE film should be kept in a safe place away from the reach of
children.
Accidental use by a child is a medical emergency and can result in
death. If a child
accidentally takes SUBOXONE film, contact your doctor or emergency
room immediately.
1. What is the medicine intended for ?
SUBOXONE film is indicated for treatment of opioid dependence in
adults and adolescents
over 15 years of age. SUBOXONE sublingual film should be used as part
of a complete
treatment plan that includes counseling and psychosocial support.
Therapeutic group:
Buprenorphine- partial opioid agonist
Naloxone-

Scheda tecnica

1
1
NAME OF THE MEDICINAL PRODUCT
SUBOXONE FILM 2MG/0.5MG
SUBOXONE FILM 4MG/1MG
SUBOXONE FILM 8MG/2MG
SUBOXONE FILM 12MG/3MG
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SUBOXONE (2 mg buprenorphine/0.5 mg naloxone) FILM contains 2 mg
buprenorphine (as 2.16 mg
buprenorphine HCI) and 0.5 mg naloxone (as 0.61 mg naloxone HCI
dihydrate)
Excipients with known effect
Each film contains 5.87 mg maltitol liquid and 0.01 mg FD&C yellow #6.
Each SUBOXONE (4 mg buprenorphine/1 mg naloxone) FILM contains 4 mg
buprenorphine (as 4.32 mg
buprenorphine HCI) and 1 mg naloxone (as 1.22 mg naloxone HCI
dihydrate)
Excipients with known effect
Each film contains 11.74 mg maltitol liquid and 0.02 mg FD&C yellow
#6.
Each SUBOXONE (8 mg buprenorphine/2 mg naloxone) FILM contains 8 mg
buprenorphine (as 8.64 mg
buprenorphine HCI) and 2 mg naloxone (as 2.44 mg naloxone HCI
dihydrate)
Excipients with known effect
Each film contains 6.02 mg maltitol liquid and 0.02 mg FD&C yellow #6.
Each SUBOXONE (12 mg buprenorphine/3 mg naloxone) FILM contains 12 mg
buprenorphine (as 12.96 mg
buprenorphine HCI) and 3 mg naloxone (as 3.66 mg naloxone HCI
dihydrate)
Excipients with known effect
Each film contains 9.03 mg maltitol liquid and 0.02 mg FD&C yellow #6.
For the full list of excipients, see section 13.
3
PHARMACEUTICAL FORM
Film, for sublingual or buccal use
4
THERAPEUTIC INDICATIONS
SUBOXONE sublingual film is indicated for treatment of opioid
dependence in adults and adolescents over 15
years of age. SUBOXONE sublingual film should be used as part of a
complete treatment plan that includes
counseling and psychosocial support.
5
DOSAGE AND ADMINISTRATION
5.1
Important Dosage and Administration Information
SUBOXONE film is administered sublingually or buccally as a single
daily dose.
Medication should be prescribed in consideration of the frequency of
visits. Provision of multiple refills is not
advised early in treatment or without appropriate patient follow-up
visits.
2
5.2
Induction
Prior to induction, consideration should be given to the t