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1. Name of the medicinal product

Subutex 0.4 mg sublingual tablets

Subutex 2 mg sublingual tablets

Subutex 8 mg sublingual tablets

2. Qualitative and quantitative composition

Subutex 0.4 mg sublingual tablets

Each tablet contains 0.4 mg buprenorphine (as buprenorphine hydrochloride).

Excipient(s) with known effect: lactose

For the full list of excipients, see section 6.1

Subutex 2 mg sublingual tablets

Each tablet contains 2 mg buprenorphine (as buprenorphine hydrochloride).

Excipient(s) with known effect: lactose

For the full list of excipients, see section 6.1

Subutex 8 mg sublingual tablets

Each tablet contains 8 mg buprenorphine (as buprenorphine hydrochloride).

Excipient(s) with known effect: lactose

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Sublingual tablet

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Subutex 0.4 mg sublingual tablets

Uncoated oval white flat beveled edged tablet, nominal dimensions 8 mm x 4 mm, debossed with “04” on one side.

Subutex 2 mg sublingual tablets

Uncoated oval white flat beveled-edged tablet, nominal dimensions 10 mm x 5 mm, debossed with “B2” on one side.

Subutex 8 mg sublingual tablets

Uncoated oval white flat beveled edged tablet, nominal dimensions 14 mm x 7 mm, debossed with “B8” on one side.

Clinical particular therapeutic indications

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

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 buprenorphine in order to minimize 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 upon between the clinician and patient with a review at regular intervals (usually at least three-monthly, depending on clinical progress).

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 induction, physicians should be aware of the partial agonist profile of buprenorphine to the opiate receptors, which may precipitate a withdrawal syndrome in opioid-dependent patients and consideration should be given to the types 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 Subutex should be undertaken when objective and clear signs of withdrawal are evident e.g. a score higher than 12 on the Clinical Opioid Withdrawal Scale (COWS).

• For patients dependent on heroin or short-acting opioids: the first dose of buprenorphine should be started when objective signs of withdrawal appear, but not less than 6 hours after the patient last used opioids.

• For patients receiving methadone: before beginning Subutex therapy, the dose of methadone should be reduced to a maximum of 30mg/day. Subutex may precipitate symptoms of withdrawal in patients dependent on methadone. The first dose of buprenorphine should be started only when objective signs of withdrawal appear and generally not less than 24 hours after the patient last used methadone because of the long half-life of methadone.

Baseline liver function tests and documentation of viral hepatitis status is recommended prior to commencing therapy.

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