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TEPHINE is a brand name for Buprenorphine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tephine is used as astrong analgesic for the relief of severe pain, e.g. following surgery or injuries, myocardial infarction and in cancer. Use of Tephine is NOT indicated in the treatment of headache, toothache, migraine or other conditions involving pain which can be treated using peripherally active analgesics…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults The dose of Tephine should generally be adjusted to the intensity of the pain and the individual sensitivity of the patient. The recommended single dose in patients with a bodyweight greater than 45 kg is 1 sublingual tablet of Tephine 400 microgram.
The onset of effects generally occurs within 30 minutes after sublingual administration. The average duration of effects is 6 – 8 hours. If necessary, 1 sublingual tablet of Tephine 400 microgram may be administered every 6 – 8 hours.
In severe chronic pain, the dose of Tephine should be adjusted to the intensity of the pain and administered regularly in accordance with a fixed schedule corresponding to the duration of effects. Children Tephine 400 microgram should not be used in children.
Renal impairment Caution is recommended in patients with severe renal insufficiency (creatinine clearance <30 ml / min). Hepatic impairment Buprenorphine is metabolised in the liver. The degree and duration of its effects in patients with impaired hepatic function may therefore be altered.
It is thus advisable to appropriately adjust the dose of Tephine in this patient group. 3). Method of administration The sublingual tablets are placed under the tongue, where they will dissolve within 5 – 10 minutes. If the oral mucosa is very dry, a few drops of liquid will accelerate the dissolution process.
The sublingual tablets must not be sucked, chewed or swallowed. At the beginning of treatment, ambulatory patients should rest during and for 1 – 2 hours after administration of Tephine. Treatment goals and discontinuation Before initiating treatment with Tephine, 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 Tephine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). Duration of use Tephine should not be used for longer than is absolutely necessary. If longer term pain management is required, it is advisable to reassess at regular and frequent intervals (with administration pauses, if applicable) whether and at what dose Tephine should continue to be administered.
Summary of the safety profile The most commonly reported adverse reactions in clinical studies were sedation, vertigo, dizziness and nausea. Tabulated list of adverse events The evaluation of undesirable effects is based on the following frequency conventions: Very common (≥ 1/10) Common (≥ 1/100 to <1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from the available data) Table 1.
Adverse drug reactions reported in clinical studies and/or post marketing studies System Organ Class Very Common Common Uncommon Rare Not known Immune system disorders Hypersensiti vity Anaphylactic shock1 Metabolism and nutrition disorders Decreased appetite Psychiatric disorders Confusion Euphoria Disorientatio n Nervousness Depression Psychosis Hallucinatio ns Depersonalis ation Dysphoria Agitation Drug dependence Nervous system Disorders Sedation Dizziness Tiredness Insomnia Headache Dysarthria Paraesthesia Coma Tremor Exhaustion Slurred speech Lack of muscle coordination Seizures Coordination abnormal Somnolence Eye disorders Miosis Vision blurred Diplopia Visual impairment Conjunctiviti s System Organ Class Very Common Common Uncommon Rare Not known Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Tachycardia Bradycardia Cyanosis Atrioventricu lar block second degree Vascular disorders Hypotension Hypertension Pallor Respiratory, thoracic and mediastinal disorders Hypoventilat ion Dyspnoea Apnoea Respiratory depression Bronchospas m Gastrointestin al disorders Nausea Vomiting Dry mouth Constipation Dyspepsia Flatulence Diarrhoea Dental caries Skin and subcutaneous tissue disorders Hyperhidrosi s Pruritus Rash Urticaria Angioedema (Quincke‘s oedema)1 Renal and urinary disorders Micturition disorders Urinary retention General disorders and administration site conditions Asthenia Fatigue Malaise Flushing Drug ineffective Drug interactions 1 Adverse reactions reported post-marketing with less than 1% but included because they are serious.
Respiratory depression As with other potent opioids, clinically significant respiratory depression may occur in patients receiving buprenorphine within the therapeutic dose range. g. in chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia or pre-existing respiratory depression).
Particular caution should be exercised if buprenorphine is administered to patients who receive or have recently received medicinal products with CNS / respiratory impairment. Patients with the above mentioned physical and / or pharmacological risk factors should be monitored and dose reduction should be considered.
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.
Because of these risks, concomitant prescribing with these sedative medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe buprenorphine concomitantly with sedative medicinal products 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 • Opioid-dependent patients and for drug-substitution treatment • Severe respiratory insufficiency • Severe hepatic impairment
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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There is currently insufficient clinical experience of longer term use of buprenorphine in children.
The following undesirable effects have also been reported during use of buprenorphine in drug-substitution treatment: Nervous system: insomnia, sleepiness Cardiovascular system: fainting, fall in blood pressure Respiratory tract: respiratory depression Liver: hepatic necrosis and hepatitis Circulatory dysregulation may occur on initial use of buprenorphine.
Local irritation of the oral mucosa (in some cases with the development of mouth ulcers and haemorrhagic diathesis) can occur after use of buprenorphine sublingual tablets. Drug dependence Repeated use of Tephine can lead to drug dependence, even at therapeutic doses.
4). In opioid-dependent patients, first administration of buprenorphine may induce withdrawal symptoms comparable to those seen after use of naloxone. The safety profile of buprenorphine in children is comparable with that in adults.
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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 Tephine. Repeated use of Tephine 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 Tephine 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.
Dependency Buprenorphine is a partial agonist at the μ-opiate receptor and chronic administration produces dependence of the opioid type. Buprenorphine has certain opioid properties that can lead to an opioid-like euphoria. Controlled human and animal studies indicate that buprenorphine has a substantially lower dependence liability than pure agonist analgesics, such as morphine.
Abrupt discontinuation of treatment is not recommended as it may result in a withdrawal syndrome that may be delayed in onset. Withdrawal symptoms include agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders.
Buprenorphine should be used to relieve pain and not as preventive treatment. In susceptible patients dependence may lead to self-administration of the medicinal product although pain no longer exists. Patients should not exceed the prescribed dose and it is strongly advised to contact their physician if other prescription medicinal products are administered concurrently or in the future.
Use in opioid-dependent patients Buprenorphine analgesics may cause withdrawal symptoms in opioid-dependent patients receiving pure agonist analgesics such as methadone or heroin. Accordingly, caution should be exercised when prescribing buprenorphine to patients who are known to be drug addicted or with a history of drug abuse.
Minor euphoric effects of buprenorphine have been observed in humans. This could result in abuse of the substance to some extent. The current level of dependence should be evaluated in patients with opioid addiction or abuse prior to initiation of treatment with buprenorphine.
Diversion of buprenorphine has been reported. Diversion refers to the introduction of buprenorphine into the illicit market either by patients or by individuals who obtain the medicinal product through theft from patients or pharmacies.
This diversion may lead to new addicts using buprenorphine as the primary drug of abuse, with the risks of overdose, spread of blood borne viral infections and respiratory depression. Hepatic impairment The effect of hepatic impairment on […]