ZUBSOLV

Treatment must be under the supervision of a physician experienced in the management of opioid 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).

Zubsolv is not interchangeable with other buprenorphine products, as different buprenorphine products have different bioavailability. Therefore the dose in mg can differ between products. Once the appropriate dose has been identified for a patient with a specific buprenorphine product, that product should not be exchanged with another product.

2). 2). e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence. g. by ascore 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 should 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 should 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 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.

71 mg a day. 71 mg may be administered on day one depending on the individual patient’s requirement. Dosage adjustment and maintenance therapy Following treatment induction on day one, the patient should be stabilised to a maintenance dose during the next few days by progressively adjusting the dose according to the clinical effect on the individual patient.

Patients should be monitored during dose titration. g. 7 mg). 18mg strength is intended to be used to fine tune the dose for patients especially during tapering of treatment or in case of tolerability issues during titration. Physicians are encouraged to prescribe a single tablet once daily regimen where possible to minimise risk of diversion.

e. insomnia, headache, nausea, hyperhidrosis and pain). Some reports ofseizure, vomiting, diarrhoea, and elevated liver function tests were considered serious. 5 %) reported adverse reactions and adverse reactions reported during post-marketing surveillance.

The frequency of possible undesirable effects listed below is defined using the followingconvention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Not known (cannot beestimated from available data). 4).

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product isimportant. It allows continued monitoring of the benefit/risk balance of the medicinalproduct. 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. g. 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 bloodborne 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 primarydrug 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.

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

To minimize 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 Zubsolv is intended to deter misuse and abuse of the buprenorphine. Intravenous or intranasal misuse of Zubsolv is expected to be less likely than with buprenorphine alone since the naloxone in this medicinal product can precipitate withdrawal in individuals dependent on heroin, methadone, or other opioidagonists.

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.