BUNOV

Posology Bunov should be administered every 7th day.

Patients aged 18 years and over:

The lowest Bunov dose (Bunov 5 microgram/hour transdermal patch) should be used as the initial dose. 5) as well as to the current general condition and medical status of the patient. 5) as needed until analgesic efficacy with Bunov is attained.

During the titration process, the dose of Bunov may be adjusted every 3 days (72 hours). Thereafter, the 7-day dosing interval should be maintained. Subsequent dosage increases may then be titrated based on the need for supplemental pain relief and the patient's analgesic response to the patch.

To increase the dose, a larger patch should replace the patch that is currently being worn, or a combination of patches should be applied in different places to achieve the desired dose. It is recommended that no more than two patches are applied at the same time, up to a maximum total dose of 40 microgram/hour buprenorphine.

2). Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment. 4). A Bunov dose reduction or discontinuation of Bunov treatment or treatment review may be indicated. Conversion from opioids Bunov can be used as an alternative to treatment with other opioids.

5) during titration, as required. Elderly No dosage adjustment of Bunov is required in elderly patients. Renal impairment No special dose adjustment of Bunov is necessary in patients with renal impairment. Hepatic impairment There is no need for dosage adjustment of Bunov in patients with mild to moderate hepatic impairment.

Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function. Therefore, such patients should be carefully monitored during treatment with Bunov. Patients with severe hepatic impairment may accumulate buprenorphine during Bunov treatment.

Consideration of alternate therapy should be considered, and Bunov should be used with caution, if at all, in such patients. Paediatric population The safety and efficacy of Bunov in children below 18 years of age has not been established.

No data are available. Method of administration Route of administration Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces. The patch should not be used if the seal is broken. 4), the following directions of use should be followed: Bunov should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars.

4).

The following undesirable effects have occurred:

Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). 4), Mood swings Depersonalisation rvous stem orders Headache, Dizziness, Somnolence Tremor Sedation, Dysgeusia, Dysarthria, Hypoaesthesia, Memory impairment, Migraine, Syncope, Abnormal co- ordination, Disturbance in attention, Paraestheia Balance disorder, Speech disorder Involuntary muscle contractions Seizures Sleep apnoea syndrome Hyperalgesia e disorders Dry eye, Blurred vision Visual disturbance, Eyelid oedema, Miosis r and yrinth Tinnitus,Verti go Ear pain orders rdiac orders Palpitations, Tachycardia Angina pectoris scular orders Hypotension, Circulatory collapse, Hypertension, Flushing Vasodilatatio n, Orthostatic hypotension spiratory, racic and diastinal orders Dyspnoea Cough, Wheezing, Hiccups Respiratory depression, Respiratory failure, Asthma aggravated, Hyperventila tion, Rhinitis strointestinal orders Constipation, Nausea, Vomiting Abdominal pain, Diarrhoea, Dyspepsia, Dry mouth Flatulence Dysphagia, Ileus Diverticulitis patobiliary orders Biliary colic in and bcutaneous sue disorders Pruritus, Erythema Rash, Sweating, Exanthema Dry skin, Urticaria, Face oedema Pustules, Vesicles Dermatitis contact, Application skin discolouration usculoskeletal d connective sue disorders Muscular weakness Myalgia, Muscle spasms nal and nary orders Urinary incontinence, Urinary retention, Urinary hesitation productive tem and ast disorders Erectile dysfunction, Sexual dysfunction neral orders and ministration e conditions Application site reaction1* Tiredness, Asthenic conditions, Peripheral oedema Fatigue, Pyrexia, Rigors, Oedema, Drug withdrawal syndrome, Chest pain Influenza like illness Drug withdrawal syndrome neonatal Drug tolerance estigations Alanine aminotransfera se increased, Weight decreased ury, isoning and cedural mplications Accidental injury, Fall 1Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritus, rash, vesicles, painful/burning sensation at the application site.

2) - Constipation. Respiratory depression Significant respiratory depression has been associated with buprenorphine, particularly by the intravenous route. A number of overdose deaths have occurred when addicts have intravenously abused buprenorphine, usually with benzodiazepines concomitantly.

9). Caution should be exercised when prescribing Bunov to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness. Concomitant use of Bunov opioids such as Buprenorphine and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe buprenorphine concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). 5). If concomitant treatment with other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

Symptoms of serotonin syndrome may include mental-status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. If serotonin syndrome is suspected, a dose reduction or discontinuation of therapy should be considered depending on the severity of the symptoms.

1). Long-term treatment effects and tolerance In all patients, tolerance to the analgesic effects, hyperalgesia, physical dependence, and psychological dependence may develop upon repeated administration of opioids, whereas incomplete tolerance is developed for some side effects like opioid induced constipation.

5) - patients suffering from myasthenia gravis - patients suffering from delirium tremens.