BUFTRIX

Posology Patients over 18 years of age The Hapoctasin dosage should be adapted to the condition of the individual patient (pain intensity, suffering, individual reaction). The lowest possible dosage providing adequate pain relief should be given.

5 microgram/h and Hapoctasin 70 microgram/h. Treatment goals and discontinuation Before initiating treatment with Hapoctasin, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with Hapoctasin, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4).

Initial dose selection:

Patients who have previously not received any analgesics should start with the lowest transdermal patch strength Hapoctasin 35 microgram/h Patients previously given a WHO step-I analgesic (non-opioid) or a step-II analgesic (weak opioid) should also begin with Hapoctasin 35 microgram/h.

According to the WHO recommendations, the administration of a non-opioid analgesic can be continued, depending on the patient's overall medical condition. When switching from a step-III analgesic (strong opioid) to Hapoctasin and choosing the initial transdermal patch strength, the nature of the previous medication, administration and the mean daily dose should be taken into account in order to avoid the recurrence of pain.

In general it is advisable to titrate the dose individually, starting with the lowest transdermal patch strength (Hapoctasin 35 microgram/h). 1). To allow for individual dose adaptation in an adequate time period sufficient supplementary immediate release analgesics should be made available during dose titration.

The necessary strength of Hapoctasin must be adapted to the requirements of the individual patient and checked at regular intervals. After application of the first Hapoctasin transdermal patch the buprenorphine serum concentrations rise slowly both in patients who have been treated previously with analgesics and in those who have not.

The following adverse reactions were reported after administration of Buprenorphine patches in clinical studies and from postmarketing surveillance. 000) Not known (cannot be estimated from the available data) a) The most commonly reported systemic adverse reactions were nausea and vomiting.

b) The most commonly reported local adverse reactions were erythema and pruritus. g. g. pricking or burning skin sensation) Very rare: muscle fasciculation, parageusia Eye disorders Rare: visual disturbance, blurring of vision, eyelid oedema Very rare: miosis Ear and labyrinth disorders Very rare: ear pain Cardiac/Vascular disorders Uncommon: circulatory disorders (such as hypotension or, rarely, even circulatory collapse) Rare: hot flushes Respiratory, thoracic and mediastinal disorders Common: dyspnoea Rare: respiratory depression Very rare: hyperventilation, hiccups Gastrointestinal disorders Very common: nausea Common: vomiting, constipation Uncommon: dry mouth Rare: pyrosis Very rare: retching Skin and subcutaneous tissue disorders Very common: erythema, pruritus Common: exanthema, diaphoresis Uncommon: rash Rare: urticaria Very rare: pustules, vesicles Not known: dermatitis contact, application skin discolouration Musculoskeletal and connective tissue disorders Common: arthralgia Renal and urinary disorders Uncommon: urinary retention, micturition disorders Reproductive system and breast disorders Rare: decreased erection General disorders and administration site conditions Common: oedema, tiredness Uncommon: weariness Rare: withdrawal symptoms*, administration site reactions Very rare: thoracic pain *see section c) Drug dependence Repeated use of Hapoctasin can lead to drug dependence, even at therapeutic doses.

4). c) In some cases delayed allergic reactions occurred with marked signs of inflammation. In such cases treatment with Hapoctasin should be terminated. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Hapoctasin must only be used with particular caution in acute alcohol intoxication, convulsive disorders, in patients with head injury, shock, a reduced level of consciousness of uncertain origin, increased intracranial pressure without the possibility of ventilation.

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)”. Buprenorphine occasionally causes respiratory depression. Therefore care should be taken when treating patients with impaired respiratory function or patients receiving medicinal products which can cause respiratory depression.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Hapoctasin 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 Hapoctasin 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). Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Hapoctasin.

Repeated use of Hapoctasin can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Buprenorphine may result in overdose and/or death. g. major depression, anxiety and personality disorders).

2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician. g. too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines).

6)