BUPRENORPHINE G.L. PHARMA

4). Posology Adults and children over 12 200-400 micrograms to be dissolved under the tongue every 6-8 hours or as required. The recommended starting dose for moderate to severe pain of the type typically presenting in general practice is 200 to 400 micrograms, 8 hourly.

Elderly There is no evidence that dosage needs to be modified for the elderly. L. 5-110 lb): 200-300 micrograms The recommended dose should be administered every 6-8 hours. Sublingual administration is not suitable for children under the age of six years.

L. Pharma may be used in balanced anaesthetic techniques at a dose of 400 micrograms. Special populations Patients with hepatic insufficiency Buprenorphine is metabolised in the liver. The degree and duration of its action may be different in patients with hepatic impairment.

L. 2). Method of administration Sublingual use. The tablet should not be chewed or swallowed whole as this will reduce efficacy. L. Pharma, 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. L. Pharma, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). L. Pharma should not be used longer than necessary.

Nausea, vomiting, dizziness, sweating and drowsiness have been reported and may be more frequent in ambulant patients. Hallucinations and other psychotomimetic effects have occurred although more rarely than with other agonists/antagonists.

Elderly patients would be expected to be more susceptible to these effects. Hypotension leading to syncope may occur. Rashes, headache, urinary retention and blurring of vision have occasionally been reported. Rarely, a serious allergic reaction may occur following a single dose.

L. 4). Cases of dental caries have been reported with frequency not known (cannot be estimated from the available data). 4) and seizures have been reported with frequency not known (cannot be estimated from the available data). Drug withdrawal syndrome has been reported with frequency uncommon (≥1/1,000 to <1/100).

L. Pharma can lead to drug dependence, even at therapeutic doses. 4). Cases of bronchospasm, angioneurotic oedema and anaphylactic shock have also been reported. During use of buprenorphine as substitution treatment the following adverse reactions have also been observed: hepatic necrosis and hepatitis.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

L. Pharma occasionally causes significant respiratory depression and, as with other strong centrally acting analgesics, care should be taken when treating patients with impaired respiratory function or patients who are receiving drugs which can cause respiratory depression.

L. Pharma, clinical experience has shown that Naloxone may be of benefit in reversing a reduced respiratory rate. Respiratory stimulants such as Doxapram are also effective. The intensity and duration of action may be affected in patients with impaired liver failure.

Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products Concomitant use of 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 of the sedative medicines 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.

Seizures Buprenorphine may lower the seizure threshold in patients with a history of seizure disorder. L. Pharma. L. Pharma can lead to OUD. A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. L.

1 or to other opiates.