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Exercise caution before administering Fentanyl 50 micrograms/ml Solution for Injection if the patient: is pregnant, planning to become pregnant or is breast-feeding; has an underactive thyroid gland; is suffering from lung disease; suffers from myasthenia gravis; is suffering from liver or kidney disease; is receiving opioid therapy or has a history of opioid abuse; suffers from alcoholism; is suffering from severe undiagnosed headaches or has recently suffered a head injury; is suffering from low blood volume; has pain in right upper side of the abdomen (bile duct); has been administered during labour (Fentanyl Injection may affect the baby's breathing).
Special Monitoring: Repeated use of fentanyl can result in tolerance and addiction.
Take special care when giving this medicine if the patient is elderly or weak due to ill health or if the patient is in labour.
Fentanyl Injection may make breathing slower than usual or can cause shortness of breath. This medicine will only be given where the patient can be carefully monitored until breathing returns to normal.
Blood pressure and heart rate may also be monitored.
Exercise caution in patients with history of abuse of or dependence to opioids, alcohol, prescription medicines, or illegal drugs.
Repeated use of the product may result in the drug being less effective or becoming dependent on it.
If treatment is stopped, withdrawal symptoms may occur. Monitor patients who may be experiencing withdrawal symptoms (see also Side Effects).
Fentanyl Injection contains sodium: If salt intake needs to be controlled (controlled sodium diet), be aware that: Fentanyl Injection contains 3.5 mg sodium in each ml of solution (equivalent to 0.18% of the recommended maximum daily dietary intake of sodium for an adult); The contents of the ampoule may be diluted in a salt solution before being administered to the patient (this salt solution also contains sodium).
Driving and using machines: The patient should not drive or use any tools or machines for at least 24 hours after having Fentanyl Injection. Alertness may be lessened than usual. This medicine can affect the ability to drive as it may cause sleepiness or dizziness.
The patient should not drive while taking this medicine until he/she knows how it affects him/her. It is an offence to drive if this medicine affects the ability to drive.
However, the patient would not be committing an offence if: The medicine has been prescribed to treat a medical or dental problem; The patient has taken it according to the instructions given by the prescriber or in the information provided with the medicine; It was not affecting the ability to drive safely.
The patient should be advised if he/she is unsure whether it is safe to drive while taking this medicine.
