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Fentanyl 50 micrograms/ml Solution for Injection
Fentanyl 50 micrograms/ml Solution for Injection
1. What Fentanyl 50 micrograms/ml, Solution for Injection is and what it is used for
2. What you need to know before you are given Fentanyl 50 micrograms/ml, Solution for Injection
3. How Fentanyl 50 micrograms/ml, Solution for Injection is given
4. Possible side effects
5. How to store Fentanyl 50 micrograms/ml, Solution for Injection
6. Contents of the pack and other information
Fentanyl belongs to a group of medicines called opioid analgesics, often used in anaesthesia or as a painkiller.
Fentanyl Injection can be used in the following situations:
Talk to your doctor or nurse before you receive Fentanyl 50 micrograms/ml, Solution for Injection if you:
Repeated use of opioid painkillers may result in the drug being less effective (you become accustomed to it). It may also lead to dependence and abuse which may result in life-threatening overdose. If you have concern that you may become dependent on Fentanyl 50 micrograms/ml, Solution for Injection, it is important that you consult your doctor.
If any of the above apply to you or your child, please consult your doctor.
If your treatment is stopped withdrawal symptoms may occur. Please tell your doctor or nurse if you think this is happening to you (see also section 4. Possible side effects).
Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible. However if your doctor does prescribe fentanyl together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor. Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms. Tell your doctor or nurse if you are using or have recently used or might use any other medicines, including medicines obtained without a prescription.
Fentanyl Injection must not be used with drugs used to treat severe depression, such as phenelzine or moclobemide, or if you have stopped taking them within the last 2 weeks. These drugs are known as Monoamine Oxidase Inhibitors (MAOI’s).
Please tell your doctor or nurse if you:
Medicines which may interact with Fentanyl Injection include:
The dose of etomidate and midazolam may need to be reduced if given together with Fentanyl Injection.
If you are taking any of the above medicines, please tell your doctor as Fentanyl Injection may increase the effects of these drugs or prevent them from working properly.
You should not drink alcohol during your treatment with Fentanyl Injection.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Fentanyl Injection should not be used during childbirth as it can affect the baby’s breathing.
Fentanyl is excreted into breast milk. Do not breastfeed or use breast milk that has been expressed for 24 hours after having Fentanyl Injection.
Do not drive or use any tools or machines for at least 24 hours after having Fentanyl Injection. You may be less alert than usual. This medicine can affect your ability to drive as it may make you sleepy or dizzy.
However, you would not be committing an offence if:
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
If you need to control your salt intake (controlled sodium diet) be aware that:
This medicine is an injection and will be given to you by your doctor. Your doctor will determine the dose you need based on your age, body weight, general health and whether you are taking any other medicines.
Fentanyl Injection is given into a vein either by injection or infusion (drip). Under some circumstances your doctor may prescribe a dose higher than those stated here.
During surgery if you are able to breathe on your own
The usual initial dose is between 50 and 200 micrograms, followed by a further dose of 50 micrograms if needed.
During surgery if your breathing is assisted
The usual initial dose is between 300 and 3500 micrograms, followed by a further dose of 100-200 micrograms if needed.
By Infusion (drip)
The usual initial dose is 1 microgram per kilogram every minute for the first 10 minutes, followed by a further dose of 0.1 microgram per kilogram every minute for the duration of your operation. The drip will normally be stopped 40 minutes before the end of your operation.
If you are elderly you will be given a reduced dose.
During surgery if your child is able to breathe on their own
The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of 1-1.25 micrograms per kilogram of body weight if needed.
During surgery if your child’s breathing is assisted
The usual initial dose is between 1 and 3 micrograms per kilogram of body weight, followed by a further dose of between 1-1.25 micrograms per kilogram of body weight if needed.
As Fentanyl Injection will be given to you in hospital by a doctor it is unlikely you will be given too much, however tell your doctor or nurse if you think you have been given too much of this medicine or you begin to experience breathing difficulties, dizziness or symptoms of low blood pressure or muscle stiffness.
An overdose may also result in a brain disorder known as toxic leukoencephalopathy.
Like all medicines, Fentanyl Injection can cause side effects, although not everybody gets them.
If any of the following symptoms occur tell your doctor or nurse immediately. These are symptoms of a serious allergic reaction.
Very common side effects (affect more than 1 in 10 people) include:
Common side effects (affect less than 1 in 10 people)
Uncommon side effects (affect less than 1 in 100 people) include:
Other side effects (frequency not known) include:
Other side effects can occur when Fentanyl Injection is used with a type of medicine called neuroleptics. These include:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and ampoule label after ‘EXP’.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice any discoloration or there are particles in it. If only part of the solution is used, the remainder should be discarded.
Do not store above 25°C and keep container in the outer carton to protect from light.
Active ingredient: fentanyl citrate 78.5 microgramsl equivalent to 50 micrograms fentanyl.
Other ingredients: sodium chloride, sodium hydroxide (for pH-adjustment), water for injections
The clear colourless solution is presented in 2 or 10 ml clear glass ampoules in packs of 10 ampoules.
Not all pack sizes maybe marketed.
Marketing Authorisation Holder
This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark: Fentanyl Ethypharm
Finland: Fentanyl Ethypharm 50 mikrog / ml injektioneste, liuos
France: Fentanyl Ethypharm 50 mcg/ml solution for injection
Germany: Fentanyl Ethypharm 50 Mikrogramm / ml Injektionslösung
Italy: Fentanil Ethypharm
Norway: Fentanyl Ethypharm
Spain: Fentanilo Ethypharm 50 microgramos/ml solución inyectable
Sweden: Fentanyl Ethypharm 50 mcg/ml injektionsvätska, lösning
United Kingdom: Fentanyl 50 micrograms/ml Solution for Injection
This leaflet was last revised in February 2023