Suboxone 8mg2mg sublingual tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Naloxone hydrochloride dihydrate; Buprenorphine hydrochloride

Available from:

Indivior UK Ltd

ATC code:

N07BC51

INN (International Name):

Naloxone hydrochloride dihydrate; Buprenorphine hydrochloride

Dosage:

2mg ; 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; GTIN: 5012376031361

Patient Information leaflet

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUBOXONE 8 MG/2 MG SUBLINGUAL TABLETS
buprenorphine / naloxone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
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.

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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Suboxone is and what it is used for
2.
What do you need to know before you take Suboxone
3.
How to take Suboxone
4.
Possible side effects
5
How to store Suboxone
6.
Content of the pack and other information
1.
WHAT SUBOXONE IS AND WHAT IT IS USED FOR
Suboxone is used to treat dependence on opioid (narcotic) drugs such
as heroin or morphine in drug
addicts who have agreed to be treated for their addiction. Suboxone is
used in adults and adolescents
over 15 years of age, who are also receiving medical, social and
psychological support.
2.
WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE SUBOXONE
DO NOT TAKE SUBOXONE

if you are allergic (hypersensitive) to buprenorphine, naloxone or any
of the other ingredients of
this medicine (see section 6)

if you have
SERIOUS BREATHING PROBLEMS

if you have
SERIOUS LIVER PROBLEMS

if you are intoxicated due to alcohol or have trembling, sweating,
anxiety, confusion, or
hallucinations caused by alcohol

if you are taking naltrexone or nalmefene for the treatment of alcohol
or opioid dependence.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING SUBOXONE IF YOU HAVE:

asthma or other breathing problems

any liver disease such as hepatitis

low blood pressure

recently suffered a head injury or brain disease

a urinary disorder (especially linked to enlarge prost

Summary of Product characteristics

OBJECT 1
SUBOXONE TABLETS 8MG/2MG
Summary of Product Characteristics Updated 26-May-2016 | Indivior UK
Limited
1. Name of the medicinal product
Suboxone 8 mg/2 mg sublingual tablets
2. Qualitative and quantitative composition
Each sublingual tablet contains 8 mg buprenorphine (as hydrochloride)
and 2 mg naloxone (as
hydrochloride dihydrate).
Excipients with known effect:
Each sublingual tablet contains 168 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Sublingual tablet
White hexagonal biconvex tablets of 11 mm with “N8“ debossed 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. The intention of the naloxone component is to
deter intravenous misuse.
Treatment is intended for use in adults and adolescents over 15 years
of age who have agreed to be treated
for addiction.
4.2 Posology and method of administration
Treatment must be under the supervision of a physician experienced in
the management of opiate
dependence/addiction.
_Precautions to be taken before induction_
Prior to treatment initiation, consideration should be given to the
type of opioid dependence (i.e. long- or
short-acting opioid), the time since last opioid use and the degree of
opioid dependence. To avoid
precipitating withdrawal, induction with buprenorphine/naloxone or
buprenorphine only should be
undertaken when objective and clear signs of withdrawal are evident
(demonstrated e.g. by a score
indicating mild to moderate withdrawal on the validated Clinical
Opioid Withdrawal Scale, COWS).
o For patients dependent upon heroin or short-acting opioids, the
first dose of buprenorphine/naloxone
should be taken when signs of withdrawal appear, but not less than 6
hours after the patient last used
opioids.
o For patients receiving methadone, the dose of methadone should be
reduced to a maximum of 30
mg/day before beginning buprenorphine/naloxone therapy. The long hal