Fentora Special Precautions

Patients and their carers must be instructed that Fentora contains an active substance in an amount that can be fatal, especially to a child. Therefore they must keep all tablets out of the sight and reach of children.
In order to minimise the risks of opioid-related undesirable effects and to identify the effective dose, it is imperative that patients be monitored closely by health professionals during the titration process.
It is important that the long acting opioid treatment used to treat the patient's persistent pain has been stabilised before Fentora therapy begins and that the patient continues to be treated with the long acting opioid treatment whilst taking Fentora.
Respiratory depression: As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl. Improper patient selection (e.g., use in patients without maintenance opioid therapy) and/or improper dosing have resulted in fatal outcome with Fentora as well as with other fentanyl products.
Fentora should only be used for conditions specified in Indications/Uses.
Chronic obstructive pulmonary disease: Particular caution should be used when titrating Fentora in patients with non-severe chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression, as even normally therapeutic doses of Fentora may further decrease respiratory drive to the point of respiratory failure.
Increased intracranial pressure, impaired consciousness: Fentora should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO₂ retention, such as those with evidence of increased intracranial pressure or impaired consciousness. Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted.
Cardiac disease: Fentanyl may produce bradycardia. Fentanyl should be used with caution in patients with previous or pre-existing bradyarrythmias.
Hepatic or renal impairment: In addition, Fentora should be administered with caution to patients with hepatic or renal impairment. The influence of hepatic and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated, however, when administered intravenously the clearance of fentanyl has been shown to be altered in hepatic and renal impairment due to alterations in metabolic clearance and plasma proteins. After administration of Fentora, impaired hepatic and renal function may both increase the bioavailability of swallowed fentanyl and decrease its systemic clearance, which could lead to increased and prolonged opioid effects. Therefore, special care should be taken during the titration process in patients with moderate or severe hepatic or renal impairment.
Careful consideration should be given to patients with hypovolaemia and hypotension.
Serotonin Syndrome: Caution is advised when Fentora is coadministered with drugs that affect the serotoninergic neurotransmitter systems.
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose.
Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea).
If serotonin syndrome is suspected, treatment with Fentora should be discontinued.
Tolerance, dependence: Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl. However, iatrogenic addiction following therapeutic use of opioids is rare.
Controlled sodium diet: This medicinal product contains 10 mg sodium (for Fentora 100mcg) or 20mg sodium (for Fentora 200mcg, 400mcg, 600mcg and 800mcg) per tablet. To be taken into consideration by patients on a controlled sodium diet.
Anaphylaxis and hypersensitivity: Anaphylaxis and hypersensitivity have been reported in association with the use of oral transmucosal fentanyl products (see Adverse Reactions).
Effects on ability to drive and use machines: No studies of the effects on the ability to drive and use machines have been performed. However, opioid analgesics impair the mental and/or physical ability required for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). Patients should be advised not to drive or operate machinery if they experience somnolence, dizziness, or visual disturbance while taking Fentora and not to drive or operate machinery until they know how they react.