Subutex 8mg sublingual tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Buprenorphine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

N07BC01

INN (International Name):

Buprenorphine hydrochloride

Dosage:

8mg

Pharmaceutical form:

Sublingual tablet

Administration route:

Sublingual

Class:

Schedule 3 (CD No Register)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04100300

Patient Information leaflet

21
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUBUTEX 0.4 MG, 2 MG AND 8 MG SUBLINGUAL TABLETS
buprenorphine
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 any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Subutex is and what it is used for
2.
Before you take Subutex
3.
How to take Subutex
4.
Possible side effects
5.
How to store Subutex
6.
Further information
1.
WHAT SUBUTEX IS AND WHAT IT IS USED FOR
Subutex is used to treat dependence on opiate (narcotic) drugs, such
as morphine and heroin
in drug addicts who have agreed to be treated for their addiction.
Subutex is used in adults and adolescents over 16 years of age who are
also receiving
medical, social and psychological support.
2.
BEFORE YOU TAKE SUBUTEX
DO NOT TAKE SUBUTEX:

If you are a child under the age of 16 years.

If
you
are
allergic
(hypersensitive)
to
buprenorphine
or
to
any
of
the
other
ingredients of this medicine (listed in section 6).

If you have SERIOUS BREATHING PROBLEMS.

If you have SERIOUS PROBLEMS WITH YOUR LIVER.

If you are intoxicated due to alcohol or have trembling, sweating,
anxiety confusion
or hallucinations caused by alcohol.

If you are breast feeding a baby.
TAKE SPECIAL CARE WITH SUBUTEX
Tell your doctor before you start taking Subutex if you have:

asthma or other breathing problems

any liver disease such as hepatitis

low blood pressure

recently suffered head injury or brain disease

a urinary disorder (especially linked to enlarged prostate in men)

any kidney disease

thyroid problems

adrenocortical disorder (e.g. Addison’s disease)
22
IMPORTANT THINGS TO BE AWARE OF:
�

Summary of Product characteristics

OBJECT 1
SUBUTEX 8MG SUBLINGUAL TABLETS
Summary of Product Characteristics Updated 23-Jul-2019 | Indivior UK
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Subutex 8mg sublingual tablets
2. Qualitative and quantitative composition
Each tablet contains 8mg buprenorphine (as buprenorphine
hydrochloride).
Excipient(s) with known effect: lactose
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Sublingual tablet
Uncoated oval white flat bevelled edged tablet, nominal dimensions 14
mm x 7 mm, debossed with “B8“
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.
4.2 Posology and method of administration
Posology
Treatment with Subutex sublingual tablets is intended for use in
adults and children aged 16 years or over
who have agreed to be treated for opioid dependence.
_Precautions to be taken before dosing_
Prior to treatment