SUBOXONE

Treatment must be under the supervision of a physician experienced in the management of opiate dependence/addiction. 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 (usually at least three-monthly, depending on clinical progress).

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 by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS).

- For patients dependent upon heroin or short-acting opioids, the first dose of buprenorphine/naloxone must be taken when signs of withdrawal appear, but not less than 6 hours after the patient last used opioids. - For patients receiving methadone, the dose of methadone must be reduced to a maximum of 30 mg/day before beginning buprenorphine/naloxone therapy.

The long half-life of methadone should be considered when starting buprenorphine/naloxone. The first dose of buprenorphine/naloxone should be taken only when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone.

Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone. Posology Initiation therapy (induction) The recommended starting dose in adults and adolescents over 15 years of age is 4 mg/1 mg and can be repeated up to a maximum dose of 12 mg/ 3 mg on day 1 to minimise undue withdrawal symptoms and retain the patient in treatment.

Due to naloxone exposure being somewhat higher following buccal administration than sublingual administration, it is recommended that the sublingual site of administration be used during induction to minimise naloxone exposure and to reduce the risk of precipitated withdrawal.

During the initiation of treatment, daily supervision of dosing is recommended to ensure proper sublingual placement of the dose and to observe patient response to treatment as a guide to effective dose titration according to clinical effect.

Dosage stabilisation and maintenance therapy Following treatment induction on day 1, the patient must be rapidly stabilised on an adequate maintenance dose by titrating to achieve a dose that holds the patient in treatment and suppresses opioid withdrawal effects and is guided by reassessment of the clinical and psychological status of the patient.

e. insomnia, headache, nausea, hyperhidrosis and pain). Some reports of seizure, vomiting, diarrhoea, and elevated liver function tests were considered serious. The most commonly reported treatment-related adverse reactions associated with the sublingual or buccal administration of buprenorphine/naloxone were oral hypoesthesia and oral mucosal erythema, respectively.

Other treatment- related adverse reactions reported by more than one patient were constipation, glossodynia and vomiting. Tabulated list of adverse reactions Adverse reactions reported during post-marketing surveillance are also included.

The frequency of possible undesirable effects listed below is defined using the following convention: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Not known (cannot be estimated from the available data).

4). 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Drug dependence, tolerance, potential for abuse and diversion Prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. , major depression). Overuse or misuse may result in overdose and/or death.

It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction.

The clinical need for continuing opioid substitution therapy should be reviewed regularly. Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit. Some risks of misuse and abuse include overdose, spread of blood-borne viral or localised and systemic infections, respiratory depression and hepatic injury.

Buprenorphine misuse by someone other than the intended patient poses the additional risk of new drug-dependent individuals using buprenorphine as the primary drug of abuse and may occur if the medicinal product is distributed for illicit use directly by the intended patient or if it is not safeguarded against theft.

Suboptimal treatment with buprenorphine/naloxone may prompt misuse by the patient, leading to overdose or treatment dropout. A patient who is underdosed with buprenorphine/naloxone may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.

To minimise the risk of misuse, abuse and diversion, appropriate precautions should be taken when prescribing and dispensing buprenorphine, such as avoiding prescribing multiple refills early in treatment, and conducting patient follow-up visits with clinical monitoring that is appropriate for the patient’s needs.

Combining buprenorphine with naloxone in Suboxone is intended to deter misuse and abuse of the buprenorphine. Intravenous or intranasal misuse of Suboxone is expected to be less likely than with buprenorphine alone since the naloxone in this medicinal product can precipitate withdrawal in individual’s dependent on heroin, methadone, or other opioid agonists.

1 • Severe respiratory insufficiency • Severe hepatic impairment • Acute alcoholism or delirium tremens • Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence