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BUPRENORPHINE ZENTIVA is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Buprenorphine patches are not suitable for the treatment of acute pain. Buprenorphine patches are indicated in adults.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Buprenorphine patches should be administered every 7th day. Patients aged 18 years and over The lowest Buprenorphine patch (5 μg/h 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 the Buprenorphine patches 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 Buprenorphine dose reduction or discontinuation of treatment with Buprenorphine patches or treatment review may be indicated.
Conversion from opioids Buprenorphine patches can be used as an alternative to treatment with other opioids. 5) during titration, as required. Paediatric population The safety and efficacy of Buprenorphine patches in children below 18 years of age has not been established.
No data are available. Elderly No dosage adjustment of Buprenorphine patches is required in elderly patients. Renal impairment No special dose adjustment of Buprenorphine patches is necessary in patients with renal impairment. Hepatic impairment There is no need for dosage adjustment of Buprenorphine patches in patients with mild to moderate hepatic impairment.
Buprenorphine is metabolised in the liver. The intensity and duration of its action may be affected in patients with impaired liver function. Therefore, such patients should be carefully monitored during treatment with Buprenorphine patches.
Patients with severe hepatic impairment may accumulate buprenorphine during Buprenorphine patches treatment. Consideration of alternate therapy should be considered, and Buprenorphine patches should be used with caution, if at all, in such patients.
4).
The following undesirable effects have occurred:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). 4) Depersonalisation Nervous system disorders Headache Dizziness Somnolence Tremor Sedation Dysgeusia Dysarthria Hypoaesthesia Memory impairment Migraine Syncope Abnormal co-ordination Disturbance in attention Paraesthesia Balance disorder Speech disorder Involuntary muscle contractions Seizures Sleep apnoea syndrome Hyperalgesia Eye disorders Dry eye Blurred vision Visual disturbance Eyelid oedema Miosis Ear and labyrinth disorders Tinnitus Vertigo Ear pain Cardiac disorders Palpitations Tachycardia Angina pectoris Vascular disorders Hypotension Circulatory collapse Hypertension Flushing Vasodilatation Orthostatic hypotension Respiratory, thoracic and mediastinal disorders Dyspnoea Cough Wheezing Hiccups Respiratory depression Respiratory failure Asthma aggravated Hyperventilation Rhinitis Gastrointestinal disorders Constipation Nausea Vomiting Abdominal pain Diarrhoea Dyspepsia Dry mouth Flatulence Dysphagia Ileus Diverticulitis Hepatobiliary disorders Biliary colic Skin and subcutaneous tissue disorders Pruritus Erythema Rash Sweating Exanthema Dry skin Urticaria Face oedema Pustules Vesicles Dermatitis contact Application skin discolouration Musculoskeletal and connective tissue disorders Muscular weakness Myalgia Muscle spasms Arthralgia Renal and urinary disorders Urinary incontinence Urinary retention Urinary hesitation Reproductive system and breast disorders Erectile dysfunction Sexual dysfunction General disorders and administration site conditions Application site reactions1 * Tiredness Asthenic conditions Peripheral oedema Fatigue Pyrexia Rigors Oedema Drug withdrawal syndrome Chest pain Influenza like illness Drug withdrawal syndrome neonatal Drug tolerance Investigations Alanine aminotransferase increased Weight decreased Injury, poisoning and procedural complications Accidental 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 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 Buprenorphine patches to patients known to have, or suspected of having, problems with drug or alcohol abuse or serious mental illness. Concomitant use of opioids such as 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 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.
1). 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 Buprenorphine patches even at therapeutic doses.
Repeated use of Buprenorphine patches 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 patches may result in overdose and/or death.
5), • patients suffering from myasthenia gravis, • patients suffering from delirium tremens.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Buprenorphine in United Kingdom.
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Method of administration Route of administration Transdermal patch to be worn for 7 days. The patch must not be divided or cut into pieces. 4), the following directions of use should be followed: Buprenorphine patches should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest, but not to any parts of the skin with large scars.
Buprenorphine patches should be applied to a relatively hairless or nearly hairless skin site. If none are available, the hair at the site should be cut with scissors, not shaven. If the application site must be cleaned, it should be done with clean water only.
Soaps, alcohol, oils, lotions or abrasive devices must not be used. The skin must be dry before the patch is applied. The Buprenorphine patch should be applied immediately after removal from the sealed sachet. Following removal of the protective layer, the transdermal patch should be pressed firmly in place with the palm of the hand for approximately 30 seconds, making sure the contact is complete, especially around the edges.
If the edges of the patch begin to peel off, the edges may be taped down with suitable skin tape to ensure a 7 day period of wear. The patch should be worn continuously for 7 days. Bathing, showering, or swimming should not affect the patch.
If a patch falls off, a new one should be applied and worn for 7 days. Treatment goals and discontinuation Before initiating treatment with Buprenorphine patches, 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 Buprenorphine patches it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). 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 Buprenorphine patches 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). Duration of treatment Buprenorphine patches should not be used for longer than necessary. If long-term pain treatment with […]
*In some cases delayed local allergic reactions (allergic contact dermatitis) occurred with marked signs of inflammation. g. laceration) are also possible in patients with fragile skin. Chronic inflammation may lead to long-lasting sequelae, such as post inflammatory hyper- and hypopigmentation, as well as dry and thick scaly skin lesions, which may closely resemble scars.
4). Drug dependence Repeated use of Buprenorphine patches can lead to drug dependence, even at therapeutic doses. 4). After discontinuation of Buprenorphine patches, withdrawal symptoms are unlikely. This may be due to the very slow dissociation of buprenorphine from the opioid receptors and to the gradual decrease of buprenorphine plasma concentrations (usually over a period of 30 hours after removal of the last patch).
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.
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.
A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.
Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death.
It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse or addiction.
The clinical need for analgesic treatment should be reviewed regularly. Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with buprenorphine.
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimize symptoms of withdrawal. Tapering from a high dose may take weeks to months.
The opioid drug withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, […]