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FENTANYL 50 MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): FENTANYL CITRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Fentanyl 50 micrograms/ml
Solution for Injection
Fentanyl Citrate
(referred to as Fentanyl Injection in this leaflet)

D03296

Read all of this leaflet carefully before you are given
Fentanyl Injection.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or
nurse.
• If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Fentanyl Injection is and what it is used for
What you need to know before having Fentanyl Injection
How Fentanyl Injection is given
Possible side effects
How to store Fentanyl Injection
Contents of the pack and other information

1. What Fentanyl Injection is and what it is used
for
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:
• In low doses it is used to provide pain relief during short
surgical procedures
• 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. What you need to know 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)
• suffer from asthma, shallow breathing or other breathing
difficulties
• 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
breathing
Take special care with Fentanyl Injection
Tell your doctor if you:
• are pregnant, planning to become pregnant or are
breast-feeding
• 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 doctor.
Special Monitoring
• Your doctor will 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.
Other medicines and Fentanyl Injection:
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including those obtained without
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).

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 such as etomidate.
• ritonavir, (a medication used to treat or prevent infection by
viruses such as HIV) and other protease inhibitors such as
itraconazole
• droperidol (a drug used to treat anxiety and sickness)
• muscle relaxants
• medicines used to treat fungal infections such as fluconazole
or voriconazole
• midazolam (a medicine used to make you feel relaxed and
sleepy before an operation)
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.
Using Fentanyl Injection with food and drink:
You are advised not to drink alcohol during your treatment with
Fentanyl Injection.
Pregnancy and breast-feeding:
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 Injection is excreted into breast milk. Do not breastfeed or use breast milk that has been expressed for 24 hours
after having Fentanyl Injection.
Effects on the ability to drive and use machines:
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.
•Do not drive while taking this medicine until you know how
it affects you.
• It is an offence to drive if this medicine affects your ability to
drive.
However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or
dental problem and
• You have taken it according to the instructions given by the
prescriber or in the information provided with the medicine
and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it
is safe for you to drive while taking this medicine.
Fentanyl Injection contains sodium
If you need to control your salt intake (controlled sodium diet)
be aware that:
• Each millilitre of Fentanyl Injection contains 3.5 mg of sodium
• The contents of the ampoule may be diluted in a salt solution
before being given to you. This salt solution also contains
sodium

3. How Fentanyl Injection is given
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.
Adults and children over 12 years of age:
As pre-medication before surgery
The usual dose is between 50 and 100 micrograms given into a
muscle.
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.
Elderly:
If you are elderly you will be given a reduced dose.
Use in children under 12 years of age:
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.
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 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.

4. Possible side effects
Like all medicines, Fentanyl Injection can cause side effects,
although not everybody gets them.
Repeated use of fentanyl can result in tolerance and
addiction
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
• collapse
Very common side effects (affect more than 1 in 10 people)
include:
• muscle stiffness
• feeling sick (nausea), or being sick (vomiting)
Common side effects (affect less than 1 in 10 people)
• feeling agitated
• jerky or uncoordinated movements
• drowsiness
• dizziness
• blurred vision, blind spots or haloes around lights (visual
disturbances)
• 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
throat
• 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
• confusion
Uncommon side effects (affect less than 1 in 100 people)
include:
• a feeling of extreme happiness (euphoria)
• headache
• swelling and clotting along a vein
• changes in blood pressure
• breathing faster than usual
• hiccups
• decrease in body temperature or chills
• breathing complications

• 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
Reporting of side effects
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. By reporting
side effects you can help provide more information on the
safety of this medicine.

5. How to store Fentanyl Injection
Keep all medicines out of the sight and reach 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 discarded.
Do not store above 25°C and keep container in the outer carton
to protect from light.

6. Contents of the pack and other
What Fentanyl Injection contains
Active ingredient: Fentanyl Citrate 78.5 micrograms/ml
equivalent to 50 micrograms/ml Fentanyl.
Other ingredients: sodium chloride, sodium hydroxide, water
for injections
What Fentanyl Injection looks like and the contents of the
pack
The clear colourless sterile solution is presented in 2 or 10 ml
clear glass ampoules in packs of 10 ampoules.
Not all pack sizes maybe marketed.
Product Licence Holder:
Martindale Pharmaceuticals Ltd T/A Martindale Pharma
Bampton Road
Romford Essex RM3 8UG, UK
Manufacturer:
MaCarthy’s Laboratories Limited
Bampton Road
Romford
Essex, RM3 8UG
Product licence number: PL 0156/0038
This leaflet was last revised in: March 2016


Other side effects (frequency not known) include:
• a serious allergic reaction (see symptoms above)
• convulsions (fits or seizures)
• 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
• restlessness
• seeing or hearing things that aren’t real (hallucinations)

Continued overleaf

100mm Measurement Verification Bar
D03296

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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.

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