THORBUP

Posology Patients aged 18 years and over:

The lowest ThorBup 20 microgram/hour transdermal patch dose ThorBup 20 microgram/hour transdermal patch 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 ThorBup 20 microgram/hour transdermal patch is attained. The dose of ThorBup 20 microgram/hour transdermal patch may be titrated upwards as indicated after 3 days, when the maximum effect of a given dose is established.

Subsequent dose 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.

ThorBup 20 microgram/hour transdermal patch should be administered every 7th day. Duration of treatment ThorBup 20 microgram/hour transdermal patch should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with ThorBup 20 microgram/hour transdermal patch 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.

Treatment goals and discontinuation Before initiating treatment with ThorBup 20 microgram/hour transdermal patch, 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 ThorBup 20 microgram/hour transdermal patch, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4).

The following undesirable effects have occurred:

System organ class MedDRA Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Very rare (<1/10,000) Not known (cannot be estimated from the available data) Immune system disorders Hypersensiti vity Anaphylactic reaction Anaphylactoid reaction Metabolic and nutritional disorders Anorexia Dehydration Psychiatric disorders Confusion, Depression, Insomnia, Nervousness, Anxiety Sleep disorder, Restlessness, Agitation, Euphoric mood, Affect liability, Hallucination s, Nightmares, Decreased libido, Aggression Psychotic disorder Drug dependence, Mood swings Depersonalisation Nervous system disorders Headache, Dizziness, Somnolenc e Tremor Sedation, Dysgeusia, Dysarthria, Hypoaesthesi a, Memory impairment, Migraine, Balance disorder, Speech disorder Involuntary muscle contractions Convulsions Syncope, Abnormal co- ordination, Disturbance in attention, Paraestheia Eye disorders Dry eye, Blurred vision Visual disturbance, Eyelid oedema, Miosis Ear and labyrinth disorders Tinnitus,Vert igo Ear pain Cardiac disorders Palpitations, Tachycardia Angina pectoris Vascular disorders Hypotension, Circulatory collapse, Hypertension , Flushing Vasodilatatio n, Orthostatic hypotension Respiratory , thoracic and mediastinal disorders Dyspnoea Cough, Wheezing, Hiccups Respiratory depression, Respiratory failure, Asthma aggravated, Hyperventilat ion, Rhinitis Gastrointes tinal disorders Constipatio n, Nausea, Vomiting Abdominal pain, Diarrhoea, Dyspepsia, Dry mouth Flatulence Dysphagia, Ileus Diverticulitis Hepatobilia ry disorders Biliary colic Skin and subcutaneo us tissue disorders Pruritus, Erythema Rash, Sweating, Exanthema Dry skin, Urticaria Face oedema Pustules, Vesicles Dermatitis contact, Application site discolouration Musculosk eletal and connective tissue disorders Muscular weakness Myalgia, Muscle spasms Renal and urinary disorders Urinary retention, Micturition disorder Reproducti ve system Erectile dysfunction, and breast disorders Sexual dysfunction General disorders and administrati on site conditions Application site reaction1 Tiredness, Asthenic conditions, Peripheral oedema Fatigue, Pyrexia, Rigors, Oedema, Drug withdrawal syndrome, Application site dermatitis*, Chest pain Influenza like illness Drug withdrawal syndrome neonatal Investigatio ns Alanine aminotransfe rase increased, Weight decreased Injury, poisoning and procedural complicatio ns Accidental injury, Fall * In some cases delayed local allergic reactions occurred with marked signs of inflammation.

2). Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of this product 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 this product 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). 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.

Additional overdose deaths due to ethanol and benzodiazepines in combination with buprenorphine have been reported. 5), patients already treated with CYP3A4 inhibitors should have their dose of ThorBup 20 microgram/hour transdermal patch carefully titrated since a reduced dosage might be sufficient in these patients.

Buprenorphine is not recommended for analgesia in the immediate post-operative period or in other situations characterised by a narrow therapeutic index or a rapidly varying analgesic requirement. Controlled human and animal studies indicate that buprenorphine has a lower dependence liability than pure agonist analgesics.

In humans limited euphorigenic effects have been observed with buprenorphine. This may result in some abuse of the medicinal product and caution should be exercised when prescribing to patients known to have, or suspected of having, a history of drug abuse or alcohol abuse or serious mental illness.

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