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FENTANYL INJECTION 50MCG/ML
Active substance(s): FENTANYL CITRATE / FENTANYL CITRATE / FENTANYL CITRATE
Fentanyl Injection 50 microgram/ml
(referred to as Fentanyl Injection in this leaflet)
Read all of this leaflet carefully before you are given
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
• If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
In this leaflet:
What Fentanyl Injection is and what it is used for
Before having Fentanyl Injection
How Fentanyl Injection is given
Possible side effects
Storing Fentanyl Injection
• ritonavir, (a medication used to treat or prevent infection by
viruses) and other protease inhibitors e.g. itraconazole
• droperidol (a drug used to treat anxiety and sickness)
• muscle relaxants
• medicines used to treat fungal infections such as fluconazole
• midazolam (a medicine used to make you feel relaxed and
sleepy before an operation
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.
Very common side effects (affect more than 1 in 10 people)
• muscle stiffness
• feeling or being sick
Common side effects (affect less than 1 in 10 people)
• feeling agitated
• jerky or uncoordinated movements
• blurred vision, blind spots or haloes around lights (visual
• a slow or irregular heartbeat
• unusually low or high blood pressure
• pain along your veins
• choking caused by cramping (spasm) of the muscles of your
• wheezing or difficulty breathing
• stopping breathing for a short period of time. If necessary
your breathing will be helped by a machine (ventilator).
• an itchy rash or redness of the skin
Uncommon side effects (affect less than 1 in 100 people) include:
• a feeling of extreme happiness (euphoria)
• swelling and clotting along a vein
• changes in blood pressure
• breathing faster than usual
• decrease in body temperature or chills
• breathing complications
Other side effects (frequency not known) include:
• a serious allergic reaction (see symptoms above)
• loss of consciousness
• muscle twitching
• stopping of the heart (cardiac arrest)
• slow or shallow breathing
• itching of the skin
Other side effects can occur when Fentanyl Injection is used with
a type of medicine called neuroleptics. These include:
• chills or shivering
• seeing or hearing things that aren't real (hallucinations)
• Unusual movements, including trembling and shaking of the
hands and fingers, twisting movements of the body, shuffling
walk and stiffness of the arms and legs
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.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
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.
5. Storing Fentanyl Injection
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 citrate may increase the effects of these drugs
or prevent them from working properly.
Using Fentanyl Injection with food and drink:
You are advised not to drink alcohol during your treatment with
Pregnancy and breast-feeding:
Tell your doctor if you are pregnant, or think you may be
pregnant or if you are breast-feeding, before being given
1. What Fentanyl Injection is and what it is used
Effects on the ability to drive and use machines:
Fentanyl citrate may affect your ability to drive or operate
machinery, if you are discharged soon after receiving Fentanyl
Injection and plan to resume these activities, ask your doctor
when it will be safe to do so.
Fentanyl citrate belongs to a group of medicines called opioid
analgesics, often used in anaesthesia or as a painkiller.
3. How Fentanyl Injection is given
Fentanyl Injection 50 micrograms/ml can be used in the following
• In low doses it is used to provide pain relief during short
• Where breathing is assisted it is used in higher doses as an
anaesthetic and analgesic
• It may also be given in combination with a tranquilliser to
induce both calmness and pain relief
• For the treatment of severe pain.
2. Before having Fentanyl Injection
You should not be given Fentanyl Injection if you:
• are allergic (hypersensitive) to fentanyl citrate or other opioid
medicines, or any of the other ingredients listed in section
6 of this leaflet
• suffer from asthma, shallow breathing or other breathing
• are taking or have recently (within the last two weeks) taken
any drugs used to treat depression known as Monoamine
Oxidase Inhibitors (MAOI’s) (see ‘Taking other medicines)
• you are in labour or before the cord is clamped during a
Caesarean section. Fentanyl injection may affect the baby’s
Take special care with Fentanyl Injection
Tell your doctor if you:
• are pregnant, planning to become pregnant or are
• have an under active thyroid gland
• are suffering from lung disease
• suffer from a muscle disorder known as myasthenia gravis
• are suffering from liver or kidney disease
• are receiving opioid therapy or have a history of opioid abuse
• suffer from alcoholism
• are suffering from severe undiagnosed headaches or if you
have recently suffered a head injury
• have been told you are suffering from low blood volume
If any of the above apply to you or your child, please consult your
• Your doctor will take take special care when giving you this
medicine if you are elderly or weak due to ill health or if you
are in labour.
• Fentanyl Injection may make you breathe more slowly than
usual. You will only be given this medicine where you can be
carefully monitored until your breathing returns to normal.
• Your blood pressure and heart rate may also be monitored.
Taking other medicines:
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including those obtained without
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).
Medicines which may interact with Fentanyl Injection include:
• CNS depressants (drugs that act on the brain and make
you feel drowsy or faint). These include sleeping pills,
anti-histamines (medicines used to treat allergies) that make
you drowsy, medicines used to treat certain mental disorders,
other pain killers or a general anaesthetic.
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 muscle or into a vein either by
injection or infusion (drip). Under some circumstances your
doctor may prescribe a dose higher than those stated here.
As pre-medication before surgery
The usual dose is between 50 and 100 micrograms given into a
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
microgram 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.
If you are given more Fentanyl Injection than you should be:
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
immediately if you think you have been given too much Fentanyl
Injection or you begin to experience breathing difficulties,
dizziness or symptoms of low blood pressure or muscle stiffness.
4. Possible side effects
Like all medicines, Fentanyl Injection can causeContinued
although not everybody gets them.
Keep all medicines out of the reach and sight of children.
This product has an expiry date on the ampoule label. The doctor
or nurse will check that the product has not passed this date. If
only part of the solution is used, the remainder should be
Do not store above 25°C and keep container in the outer carton
to protect from light.
6. Further Information
What Fentanyl Injection contains
Active ingredient: Fentanyl Citrate 78.5 micrograms/ml
equivalent to 50 micrograms/ml.
Other ingredients: sodium chloride, sodium hydroxide, water for
What Fentanyl Injection looks like and the contents of the
The clear colourless sterile solution is presented in 50ml clear
Product Licence Holder and Manufacturer:
Aurum Pharmaceuticals Ltd
Romford Essex RM3 8UG, UK
Product licence numbers: PL 12064/0078
Fentanyl 50 micrograms/ml Solution for Injection
Leaflet approved: xx/xxxx
Date of revision: August 2010
Repeated use of fentanyl can result in tolerance and
If any of the following symptoms occur tell your doctor or nurse
immediately. These are symptoms of a serious allergic reaction.
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
PACKAGE LEAFLET: INFORMATION FOR THE USER
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.