Buvidal

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

buprenorphine

Available from:

Camurus AB

ATC code:

N07BC01

INN (International Name):

buprenorphine

Therapeutic group:

Other nervous system drugs

Therapeutic area:

Opioid-Related Disorders

Therapeutic indications:

Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

Product summary:

Revision: 8

Authorization status:

Authorised

Authorization date:

2018-11-20

Patient Information leaflet

60
B. PACKAGE LEAFLET
61
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUVIDAL 8 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
BUVIDAL 16 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
BUVIDAL 24 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
BUVIDAL 32 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
BUVIDAL 64 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
BUVIDAL 96 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
BUVIDAL 128 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
BUVIDAL 160 MG PROLONGED-RELEASE SOLUTION FOR INJECTION
buprenorphine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Buvidal is and what it is used for
2.
What you need to know before you receive Buvidal
3.
How Buvidal is given
4.
Possible side effects
5.
How to store Buvidal
6.
Contents of the pack and other information
1.
WHAT BUVIDAL IS AND WHAT IT IS USED FOR
Buvidal contains the active substance buprenorphine, which is a type
of opioid medicine. It is used to
treat opioid dependence in patients who are also receiving medical,
social and psychological support.
Buvidal is intended for use in adults and adolescents aged 16 years or
over.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE BUVIDAL
YOU MUST NOT RECEIVE BUVIDAL
-
if you are allergic to buprenorphine or any of the other ingredients
of this medicine (listed in
section 6)
-
if you have serious breathing problems
-
if you have serious liver problems
-
if you are intoxicated with alcohol or have trembling, sweating,
anxiety, confusion or
hallucinations caused by alcohol.
WARNINGS AND PRECAUTIONS
Talk to your doctor before receiving Buvidal if you have:
-
asthma or other breathing problems
-
any liver disease such as hepatitis
-
s

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Buvidal 8 mg prolonged-release solution for injection
Buvidal 16 mg prolonged-release solution for injection
Buvidal 24 mg prolonged-release solution for injection
Buvidal 32 mg prolonged-release solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Buvidal 8 mg prolonged-release solution for injection
Each pre-filled syringe contains 8 mg buprenorphine
Buvidal 16 mg prolonged-release solution for injection
Each pre-filled syringe contains 16 mg buprenorphine
Buvidal 24 mg prolonged-release solution for injection
Each pre-filled syringe contains 24 mg buprenorphine
Buvidal 32 mg prolonged-release solution for injection
Each pre-filled syringe contains 32 mg buprenorphine
Excipient with known effect
The 8 mg, 16 mg, 24 mg and 32 mg strengths contain 95.7 mg of alcohol
(ethanol) in each mL
(10% w/w).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release solution for injection.
Yellowish to yellow clear liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of opioid dependence within a framework of medical, social
and psychological treatment.
Treatment is intended for use in adults and adolescents aged 16 years
or over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of Buvidal
_ _
is restricted to healthcare professionals. Treatment should be
initiated by
and remain under the supervision of a physician experienced in the
management of opioid dependence
therapies. Appropriate precautions, such as to conduct patient
follow-up visits with clinical monitoring
according to the patient's needs, should be taken when prescribing and
dispensing buprenorphine.
Take-home use or self-administration of the product by patients is not
allowed.
3
Precautions to be taken before initiation of treatment
To avoid precipitating symptoms of withdrawal, treatment with Buvidal
should be started when
objective and clear signs of mild to moderate withdrawal are evident
(see section 4.4).