RELETRANS

Posology Reletrans should be administered every 7th day. Patients aged 18 years and over The lowest dose of 5 microgram/hour buprenorphine transdermal patch should be used as the initial dose. 5) as well as to the current general condition and medical status of the patient.

Reletrans should not be used at higher doses than recommended. Treatment goals and discontinuation Before initiating treatment with Reletrans, 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 Reletrans, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). 5) as needed until analgesic efficacy with buprenorphine transdermal patches is attained. During the titration process ,the dose may be adjustedevery 3 days (72 hours). Thereafter, the 7-day dosing interval should be maintained. Subsequent dose increases may then be titrated based on the need for supplemental pain relief and the patient’s analgesic response to the transdermal patch.

To increase the dose, a patch with a higher strength should replace the transdermal 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 transdermal patches are applied at the same time, up to a maximum total dose of 40 microgram/hour buprenorphine.

Patients should be carefully and regularly monitored to assess the optimum dose and duration of treatment. 4). A dose reduction or discontinuation of the buprenorphine transdermal patch treatment or treatment review may be indicated.

Conversion from opioids Buprenorphine transdermal patches can be used as an alternative to treatment with other opioids. 5) during titration, as required. Duration of administration Reletrans should under no circumstances be administered for longer than absolutely necessary.

If long-term pain treatment with Reletrans 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.

4). 4), mood swings Depersonal isation Nervous system disorders Headache, dizziness, somnolenc e Tremor, Sedation, dysgeusia, dysarthria, hypoaesthe sia, memory impairment , migraine, syncope, abnormal coordinatio n, disturbance in attention, paraesthesi a Balance disorder, speech disorder Involuntar y muscle contraction s Seizures, sleep apnoea syndrome, hyperalgesi a Eye disorders Dry eye, blurred vision Visual disturbance , eyelid oedema, miosis Ear and labyrinth disorders Tinnitus, vertigo Ear pain Cardiac disorders Palpitation s, tachycardia Angina pectoris System organ class Very common Common Uncommo n Rare Very rare Frequency not known Vascular disorders Hypotensio n, circulatory collapse, hypertensi on, flushing Vasodilata- tion, orthostatic hypotensio n Respiratory, thoracic and mediastinal disorders Dyspnoea Cough, wheezing, hiccups Respirator y depression, respiratory failure, asthma aggravated , hyperventil -ation, rhinitis Gastrointestina l disorders Constipatio n, nausea, vomiting Abdominal pain, diarrhoea, dyspepsia, dry mouth Flatulence Dysphagia, ileus Diverticulit is Hepatobiliary disorders Biliary colic Skin and subcutaneous tissue disorders Pruritus, erythema Rash, sweating, exanthema Dry skin, urticaria Face oedema Pustules, vesicles Dermatitis contact, application site skin discolourat ion Musculoskeleta l and connective tissue disorders Arthralgia, Muscular weakness Myalgia, muscle spasms Renal and urinary disorders Urinary incontinenc e, urinary retention, urinary hesitation System organ class Very common Common Uncommo n Rare Very rare Frequency not known Reproductive system and breast disorders Erectile dysfunctio n, sexual dysfunctio n General disorders and administration site conditions Applicatio n site reaction including erythema, oedema, pruritus, rash Tiredness, asthenia, peripheral oedema, Fatigue, pyrexia, rigors, oedema, drug withdrawal syndrome, application site dermatitis* , chest pain Influenza like illness Drug withdrawal syndrome neonatal, drug tolerance Investigations Alanine aminotrans ferase increased, Weight decreased Injury, poisoning and procedural complications 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 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). 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 Reletrans.

Repeated use of Reletrans 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 Reletrans 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).

For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered. 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, decreasing the total opioid dose should be considered. 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. 5). Caution should be exercised when prescribing Reletrans to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness.

1). Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of buprenorphine and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death.

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