SUBUTEX SUBLINGUAL 8,0 mg TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Critical Care (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 8,0 mg

Authorization status:

Registered

Authorization date:

2003-03-11

Patient Information leaflet

SUBUTEX TABLETS
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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S6
SUBUTEX SUBLINGUAL 0,4 MG TABLETS
SUBUTEX SUBLINGUAL 2 MG TABLETS
SUBUTEX SUBLINGUAL 8 MG TABLETS
The active substance is buprenorphine.
Contains sugar:
Each 0,4 mg tablet contains 26,626 mg lactose monohydrate and 18,0 mg
mannitol.
Each 2 mg tablet contains 47,94 mg lactose monohydrate and 30,0 mg
mannitol.
Each 8 mg tablet contains 191,76 mg lactose monohydrate and 120,0 mg
mannitol.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
This medicine has been prescribed for you personally and you should
not share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1. What SUBUTEX SUBLINGUAL is and what it is used for
2. What you need to know before you take SUBUTEX SUBLINGUAL
3. How to take SUBUTEX SUBLINGUAL
4. Possible side effects
5. How to store SUBUTEX SUBLINGUAL
6. Contents of the pack and other information
THIS MEDICINE CONTAINS BUPRENORPHINE WHICH IS AN OPIOID, WHICH CAN
CAUSE ADDICTION. YOU CAN
GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING IT SUDDENLY.
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1. WHAT SUBUTEX IS AND WHAT IT IS USED FOR
SUBUTEX SUBLINGUAL tablets are used as a part of a medical, social and
psychological treatment
programme for patients addicted to opiate (narcotic) drugs.
This medicine contains buprenorphine which belongs to a class of
medicines called opioids.
This medicine has been prescribed to you and should not be given to
anyone else. Opioids can cause
addiction and you may get withdrawal symptoms if you stop taking it
suddenly. Your prescriber should
have explained how long you will be taking it for and when it is
appropriate to stop, how to do this
safely.
2. WHAT YOU NEED TO KNOW B

Summary of Product characteristics

SUBUTEX TABLETS
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SCHEDULING STATUS S6
1. NAME OF THE MEDICINE
SUBUTEX SUBLINGUAL 0,4 mg tablets
SUBUTEX SUBLINGUAL 2 mg tablets
SUBUTEX SUBLINGUAL 8 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SUBUTEX SUBLINGUAL 0,4 mg:
Each tablet contains buprenorphine hydrochloride equivalent to 0,4 mg
buprenorphine base.
Excipients with known effect:
Sugar content: Each tablet contains 29,626 mg lactose monohydrate and
18,0 mg mannitol.
SUBUTEX SUBLINGUAL 2 mg:
Each tablet contains buprenorphine hydrochloride equivalent to 2,0 mg
buprenorphine base.
Excipients with known effect:
Sugar content: Each tablet contains 47,94 mg lactose monohydrate and
30,0 mg mannitol.
SUBUTEX SUBLINGUAL 8 mg:
Each tablet contains buprenorphine hydrochloride equivalent to 8,0 mg
buprenorphine base.
Excipients with known effect:
Sugar content: Each tablet contains 191,76 mg lactose monohydrate and
120,0 mg mannitol.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
SUBUTEX SUBLINGUAL 0,4 mg:
Oval, flat, glossy, white to creamy-white tablet with “04” on the
one side.
SUBUTEX SUBLINGUAL 2 mg:
Oval, flat, glossy, white to creamy-white tablet with “B2” on the
one side.
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SUBUTEX SUBLINGUAL 8 mg:
Oval, flat, glossy, white to creamy-white tablet with “B8” on the
one side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Substitution treatment for opioid drug dependence, within a framework
of medical, social and
psychological treatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a
strategy for ending treatment with SUBUTEX SUBLINGUAL in order to
minimise the risk of addiction
and drug withdrawal syndrome (see section 4.4). The decision to
maintain a patient on a long-term
opioid
prescription should be an active decision agreed between the clinician
and patient with review at
regular intervals (usu