Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany
TRANSTEC is contraindicated in:
TRANSTEC must only be used with particular caution in acute alcohol intoxication, convulsive disorders, in patients with head injury, shock, a reduced level of consciousness of uncertain origin, increased intracranial pressure without the possibility of ventilation.
Buprenorphine occasionally causes respiratory depression. Therefore care should be taken when treating patients with impaired respiratory function or patients receiving medicinal products which can cause respiratory depression.
Buprenorphine has a substantially lower dependence liability than pure opioid agonists. In healthy volunteer and patient studies with TRANSTEC, withdrawal reactions have not been observed. However, after long-term use of TRANSTEC withdrawal symptoms, similar to those occurring during opiate withdrawal, cannot be entirely excluded (see section 4.8). These symptoms are: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal disorders.
In patients abusing opioids, substitution with buprenorphine may prevent withdrawal symptoms. This has resulted in some abuse of buprenorphine and caution should be exercised when prescribing it to patients suspected of having drug abuse problems.
Buprenorphine is metabolised in the liver. The intensity and duration of effect may be altered in patients with liver function disorders. Therefore such patients should be carefully monitored during TRANSTEC treatment.
Athletes should be aware that this medicine may cause a positive reaction to sports doping control tests.
Concomitant use of TRANSTEC and sedating medicinal products such as benzodiazepines or related substances may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedating medicinal products should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe TRANSTEC concomitantly with sedating medicinal products, the lowest effective dose of TRANSTEC should be used, and the duration of the concomitant treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
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, consider decreasing the total opioid dosage.
Concomitant administration of TRANSTEC and other serotonergic agents, such as selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants may result in serotonin syndrome, a potentially life-threatening condition (see section 4.5).
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.
Paediatric population
As TRANSTEC has not been studied in patients under 18 years of age, the use of the medicinal product in patients below this age is not recommended.
Fever and the presence of heat may increase the permeability of the skin. Theoretically in such situations buprenorphine serum concentrations may be raised during TRANSTEC treatment. Therefore on treatment with TRANSTEC, attention should be paid to the increased possibility of opioid reactions in febrile patients or those with increased skin temperature due to other causes.
On administration of MAO inhibitors in the last 14 days prior to the administration of the opioid pethidine life-threatening interactions have been observed affecting the central nervous system and respiratory and cardiovascular function. The same interactions between MAO inhibitors and TRANSTEC cannot be ruled out (see section 4.3).
When TRANSTEC is applied together with other opioids, anaesthetics, hypnotics, sedatives, antidepressants, neuroleptics, and in general, medicinal products that depress respiration and the central nervous system, the CNS effects may be intensified. This applies also to alcohol.
TRANSTEC should be used cautiously when co-administered with:
Administered together with inhibitors or inducers of CYP 3A4 the efficacy of TRANSTEC may be intensified (inhibitors) or weakened (inducers).
The concomitant use of opioids with sedating medicinal products such as benzodiazepines or related substances increases the risk of sedation, respiratory depression, coma and death because of an additive CNS depressant effect. The dose of TRANSTEC and the duration of the concomitant use should be limited (see section 4.4).
There are no adequate data from the use of TRANSTEC in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Towards the end of pregnancy high doses of buprenorphine may induce respiratory depression in the neonate even after a short period of administration. Long-term administration of buprenorphine during the last three months of pregnancy may cause a withdrawal syndrome in the neonate.
Therefore TRANSTEC is contraindicated during pregnancy.
Buprenorphine is excreted in human milk. In rats, buprenorphine has been found to inhibit lactation.
TRANSTEC should not be used during lactation.
The effect of buprenorphine on human fertility is unknown. Buprenorphine did not affect fertility in animal studies (see section 5.3).
TRANSTEC has major influence on the ability to drive and use machines.
Even when used according to instructions, TRANSTEC may affect the patient’s reactions to such an extent that road safety and the ability to operate machinery may be impaired.
This applies particularly at the beginning of treatment, at any change of dosage and when TRANSTEC is used in conjunction with other centrally acting substances including alcohol, tranquillisers, sedatives and hypnotics.
Patients who are affected (e.g. feeling dizzy or drowsy or experience blurred or double vision) should not drive or use machines while using TRANSTEC and for at least 24 hours after the patch has been removed.
Patients stabilized on a specific dosage will not necessarily be restricted if the above mentioned symptoms are not present.
This medicine can impair cognitive function and can affect a patient’s ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told:
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://www.gov.uk/drug-driving-law.
The following adverse reactions were reported after administration of TRANSTEC in clinical studies and from postmarketing surveillance.
The frequencies are given as follows: Very common (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (≤1/10,000), Not known (cannot be estimated from the available data).
a) The most commonly reported systemic adverse reactions were nausea and vomiting.
The most commonly reported local adverse reactions were erythema and pruritus.
b)
Very rare: serious allergic reactions*
Rare: appetite lost
Uncommon: confusion, sleep disorder, restlessness
Rare: psychotomimetic effects (e.g. hallucinations, anxiety, nightmares), decreased libido
Very rare: dependence, mood swings
Common: dizziness, headache
Uncommon: sedation, somnolence
Rare: concentration impaired, speech disorder, numbness, dysequilibrium, paraesthesia (e.g. pricking or burning skin sensation)
Very rare: muscle fasciculation, parageusia
Rare: visual disturbance, blurring of vision, eyelid oedema
Very rare: miosis
Very rare: ear pain
Uncommon: circulatory disorders (such as hypotension or, rarely, even circulatory collapse)
Rare: hot flushes
Common: dyspnoea
Rare: respiratory depression
Very rare: hyperventilation, hiccups
Very common: nausea
Common: vomiting, constipation
Uncommon: dry mouth
Rare: pyrosis
Very rare: retching
Very common: erythema, pruritus
Common: exanthema, diaphoresis
Uncommon: rash
Rare: urticaria
Very rare: pustules, vesicles
Uncommon: urinary retention, micturition disorders
Rare: decreased erection
Common: oedema, tiredness
Uncommon: weariness
Rare: withdrawal symptoms*, administration site reactions
Very rare: thoracic pain
* see section c)
c) In some cases delayed allergic reactions occurred with marked signs of inflammation. In such cases treatment with TRANSTEC should be terminated.
Buprenorphine has a low risk of dependence. After discontinuation of TRANSTEC, withdrawal symptoms are unlikely. This is due to the very slow dissociation of buprenorphine from the opiate receptors and to the gradual decrease of buprenorphine serum concentrations (usually over a period of 30 hours after removal of the last transdermal patch). However, after long-term use of TRANSTEC withdrawal symptoms, similar to those occurring during opiate withdrawal, cannot be entirely excluded. These symptoms include: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastro-intestinal disorders.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
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