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SPC, UK: Subutex 2mg sublingual tablets (2012)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
RB Pharmaceuticals Limited
Διεύθυνση :
103 - 105 Bath Road,, Slough, Berkshire, SL1 3UH, UK
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Name of the medicinal product

SUBUTEX 2 mg sublingual tablets.

Qualitative and quantitative composition

Buprenorphine hydrochloride equivalent to buprenorphine base: 2 mg.

Pharmaceutical form

Sublingual tablet.

Therapeutic indications

Substitution treatment for opioid drug dependence, within framework of medical, social and psychological treatment.

Posology and method of administration

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 addiction. Administration is sublingual. Physicians must advise ...

Contraindications

Hypersensitivity to buprenorphine or any other component of the tablet Children less than 16 years of age Severe respiratory insufficiency Severe hepatic insufficiency Acute alcoholism or delirium tremens ...

Special warnings and precautions for use

Warnings SUBUTEX sublingual tablets are recommended only for the treatment of opioid drug dependence. It is also recommended that that treatment is prescribed by a physician who ensures comprehensive management ...

Interaction with other medicinal products and other forms of interaction

SUBUTEX should not be taken together with alcoholic drinks or medications containing alcohol. Alcohol increases the sedative effect of buprenorphine (see 4.7 Effects on the ability to drive vehicles or ...

Pregnancy and lactation

Pregnancy Studies in rats and rabbits have evidenced foetotoxicity including post-implantation loss. In addition, maternal oral administration at high doses during gestation and lactation resulted in a ...

Effects on ability to drive and use machines

SUBUTEX may cause drowsiness, particularly when taken together with alcohol or central nervous system depressants. Therefore, patients should be warned against driving or operation machinery (see 4.5 Interaction ...

Undesirable effects

The onset of side effects depends on the patients tolerance threshold. Which is higher in drug addicts than in general population. The symptoms most frequently observed with buprenorphine administration ...

Overdose

In the event of accidental overdose, general supportive measures should be instituted, including close monitoring of respiratory and cardiac status of patient. The major symptom requiring intervention ...

Pharmacodynamic properties

OPIOID ANALGESIC (N: central nervous system) Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the µ (mu) k (kappa) receptors of the brain. Its activity in opioid maintenance ...

Pharmacokinetic properties

Absorption When taken orally, buprenorphine undergoes first-pass hepatic metabolism with N-dealkylation and glucuroconjungation in the small intestine. The use of this medication by oral route is therefore ...

Preclinical safety data

Acute toxicity of buprenorphine was determined in the mouse and rat following oral and parenteral administration. The median lethal dose (LD<sub>50</sub>) in the mouse were 26, 94 and 261 mg/kg for intravenous, ...

List of excipients

Monohydrated lactose Mannitol Maize starch Povidone excipients k30 Citric Acid Sodium citrate Magnesium stearate

Incompatibilities

None known.

Shelf life

2 Years.

Special precautions for storage

Do not store above 30°C. Store in the original package.

Nature and contents of container

7 or 28 tablets in nylon/aluminium/uPVC blister packs.

Special precautions for disposal and other handling

Not applicable.

Marketing authorization holder

RB Pharmaceuticals Ltd 103 – 105 Bath Road, Slough Berkshire SL1 3UH

Marketing authorization number(s)

Subutex 2 mg, sublingual tablets: PL 36699/0002

Date of first authorization / renewal of the authorization

February 1998 (UK)

Date of revision of the text

7th February 2012