SEVODYNE

4). Posology Sevodyne should be administered every 7th day.

Patients aged 18 years and over:

The lowest Sevodyne dose (Sevodyne 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 Sevodyne is attained.

During the titration process, the dose 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 Sevodyne dose reduction or discontinuation of Sevodyne treatment or treatment review may be indicated. Duration of administration Sevodyne should under no circumstances be administered for longer than absolutely necessary.

If long-term pain treatment with Sevodyne is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.

Discontinuation After removal of the patch, buprenorphine serum concentrations decrease gradually and thus the analgesic effect is maintained for a certain amount of time. This should be considered when therapy with Sevodyne is to be followed by other opioids.

As a general rule, a subsequent opioid should not be administered within 24 hours after removal of the patch. 5). Conversion from opioids Sevodyne can be used as an alternative to treatment with other opioids. 5) during titration, as required.

Special populations Elderly No dosage adjustment of Sevodyne is required in elderly patients. Renal impairment No special dose adjustment of Sevodyne is necessary in patients with renal impairment. Hepatic impairment There is no need for dosage adjustment of this medicine in patients with mild to moderate hepatic impairment.

4). 4), Mood swings Depersona lisation Nervous system disorders Headache, Dizziness, Somnolen ce Tremor Sedation, Dysgeusia , Dysarthria , Hypoaesth esia, Memory impairme nt, Migraine, Syncope, Abnormal co- ordination , Disturban ce in attention, Paraesthei a Balance disorder, Speech disorder Involuntar y muscle contractio ns Seizures, Sleep apnoea syndrome , Hyperalge sia Eye disorders Dry eye, Blurred vision Visual disturbanc e, Eyelid oedema, Miosis Ear and labyrinth disorders Tinnitus, Vertigo Ear pain Cardiac disorders Palpitatio ns, Tachycard ia Angina pectoris Vascular disorders Hypotensi on, Circulator y collapse, Hypertens ion, Flushing Vasodilata tion, Orthostati c hypotensi on Respirator y, thoracic and mediastin al disorders Dyspnoea Cough, Wheezing , Hiccups Respirator y depression , Respirator y failure, Asthma aggravate d, Hypervent ilation, Rhinitis Gastrointe stinal disorders Constipati on, Nausea, Vomiting Abdomina l pain, Diarrhoea, Dyspepsia , Dry mouth Flatulence Dysphagia , Ileus Diverticul itis Hepatobili ary disorders Biliary colic Skin and subcutane ous tissue disorders Pruritus, Erythema Rash, Sweating, Exanthem a Dry skin, Urticaria, Face oedema Pustules, Vesicles Contact dermatitis, Applicati on skin discolour ation Musculos keletal and connectiv e tissue disorders Muscular weakness Myalgia, Muscle spasms Renal and urinary disorders Urinary incontinen ce, Urinary retention, Urinary hesitation Reproduct ive system and breast disorders Erectile dysfunctio n, Sexual dysfunctio n General disorders and administra tion site conditions Applicatio n site reaction1* Tiredness, Asthenic conditions , Peripheral oedema Fatigue, Pyrexia, Rigors, Oedema, Drug withdrawa l syndrome, Chest pain Influenza like illness Neonatal drug withdraw al syndrome , Drug tolerance Investigati ons Alanine aminotran sferase increased, Weight decreased Injury, poisoning and procedural complicati ons Accidenta l injury, Fall 1 Includes common signs and symptoms of contact dermatitis (irritative or allergic): erythema, oedema, pruritus, rash, vesicles, painful/burning sensation at the application site.

2) - Constipation Do not use for acute post-operative pain owing to the increased risk of persistent post-operative opioid use (PPOU) and opioid-induced ventilatory impairment (OIVI). 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 Sevodyne to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness.

Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.

, as an increase in absorption of buprenorphine may occur. When treating febrile patients, one should be aware that fever may also increase absorption resulting in increased plasma concentrations of buprenorphine and thereby increased risk of opioid reactions.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Sevodyne 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 Sevodyne 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.

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