Sixmo

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Buprenorphine hydrochloride

Available from:

L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A.

ATC code:

N07BC01

INN (International Name):

buprenorphine

Therapeutic group:

Other nervous system drugs

Therapeutic area:

Opioid-Related Disorders

Therapeutic indications:

Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2019-06-19

Patient Information leaflet

40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIXMO 74.2 MG IMPLANT
buprenorphine
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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.
•
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 Sixmo is and what it is used for
2.
What you need to know before you use Sixmo
3.
How to use Sixmo
4.
Possible side effects
5.
How to store Sixmo
6.
Contents of the pack and other information
1.
WHAT SIXMO IS AND WHAT IT IS USED FOR
Sixmo contains the active substance buprenorphine, which is a type of
opioid medicine. It is used to
treat opioid dependence in adults who are also receiving medical,
social and psychological support.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SIXMO
DO NOT USE SIXMO IF YOU:
•
are allergic to buprenorphine or any of the other ingredients of this
medicine (listed in section 6)
•
have severe breathing problems
•
have severly reduced liver function
•
have acute alcoholism or alcohol delirium caused by withdrawal from
alcohol
•
are using naltrexone or nalmefene to treat alcohol or opioid
dependence
•
have history of excessive production of tissue during wound healing
Patients who may not be investigated using a magnetic resonance
imaging (MRI) scan must not be
allowed to receive Sixmo.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Sixmo if you have:
•
asthma or other breathing problems
•
mild or moderate liver problems
•
reduced kidney function
•
head injury or other circumstances where the pressure in the head may

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions
1.
NAME OF THE MEDICINAL PRODUCT
Sixmo 74.2 mg implant
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains buprenorphine hydrochloride equivalent to 74.2
mg buprenorphine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Implant
White/ff-white to pale yellow, rod-shaped implant, 26.5 mm long and
2.4 mm in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sixmo is indicated for substitution treatment for opioid dependence in
clinically stable adult patients
who require no more than 8 mg/day of sublingual buprenorphine, within
a framework of medical,
social and psychological treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be under the supervision of a healthcare professional
experienced in the management
of opioid dependence/addiction. Insertion and removal of the implants
must be performed by a
physician who is competent in minor surgery and has been trained to
conduct the insertion and
removal procedure. Appropriate precautions, such as the conduct of
patient follow-up visits according
to the patient's needs and the treating physician’s clinical
judgement, should be taken during the
treatment.
Patients previously treated with sublingual buprenorphine or
sublingual buprenorphine + naloxone,
must be on stable doses between 2 to 8 mg/day for at least 30 days and
deemed clinically stable by the
treating healthcare professional.
The following factors should be considered when determining clinical
stability and suitability for
Sixmo treatment:
•
period free from opioid drug abuse
•
stability of living environment
•
participation in a structured activity/job
•
consistency in participation in recommended behavioural therapy/peer
support programme