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Package leaflet: Information for the patient


Fentanyl 50 micrograms/ml Injection
fentanyl citrate

Important information about your medicine
Your doctor or nurse will give you the injection
► If this injection causes you any problems talk to your doctor, nurse or pharmacist
► Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to
any of the ingredients of this medicine
► Please tell your doctor or pharmacist, if you are taking any other medicines

• Read all of this leaflet carefully before you start using this medicine because it

contains important information for you.

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.

What is in this leaflet
1. What Fentanyl 50 micrograms/ml Injection is and what it is used for
2. What you need to know before you use Fentanyl 50 micrograms/ml Injection
3. How to use Fentanyl 50 micrograms/ml Injection
4. Possible side effects
5. How to store Fentanyl 50 micrograms/ml Injection
6. Contents of the pack and other information

1. What Fentanyl 50 micrograms/ml Injection
is and what it is used for
Fentanyl 50 micrograms/ml
analgesic drug. It is used:




in anaesthesia
as a pain relief agent
to induce calmness
as a premedication to sedate and prepare a
patient for general anaesthesia

2. What you need to know before you use
Fentanyl 50 micrograms/ml Injection
Do NOT use Fentanyl 50 micrograms/ml
• if you are sensitive or allergic to Fentanyl
50 micrograms/ml Injection, drugs similar to
morphine or muscle relaxants, or any of
the other ingredients in this injection.
• if you have any breathing problems or a lung
disorder, such as asthma, chronic bronchitis or
• if you are taking, or have taken, monoamine
oxidase inhibitor (MAOI) drugs for depression,
in the last 2 weeks.
• if you have brain trauma.

Warnings and precautions
Talk to your doctor or nurse before using
Fentanyl 50 micrograms/ml Injection:
• if you have myasthenia gravis
• if you have reduced blood volume or low
blood pressure
• if you have a thyroid gland deficiency
• if you have liver or kidney disease
• if you have increased intracranial pressure
• if you have a history of alcohol or opioid
• if you are elderly or weak due to ill health

Other medicines and
micrograms/ml Injection:



Tell your doctor or nurse if you are
using or have recently used or might
medicines obtained without a prescription.
This is especially important with the following
medicines as they may interact with your Fentanyl
50 micrograms/ml Injection:

pain relieving drugs

any other medicines that depress the activity
of the brain or spinal cord

• naloxone
• antifungal and antiviral medicines
• medicines for depression (such as
citalopram, duloxetine, escitalopram, fluoxetine,
fluvoxamine, paroxetine, sertraline, venlafaxine)

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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 pharmacist for advice before
using this medicine. The doctor will then decide
if the injection is suitable for you. Fentanyl 50
micrograms/ml Injection should not be used during
childbirth as it can affect the baby’s breathing.
Fentanyl 50 micrograms/ml Injection may get into
breast milk. Do not breast-feed for 24 hours after
having Fentanyl 50 micrograms/ml Injection.

Driving and using machines:
You should not drive or use machinery if you
are affected by the administration of Fentanyl
50 micrograms/ml Injection.
Details regarding a new driving offence
concerning driving after drugs have been taken in
the UK may be found here:

The 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
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.

3. How to use Fentanyl 50 micrograms/ml
Your nurse or doctor will give you the
Your doctor will decide the correct dosage for
you and how and when the injection will be

If you use more Fentanyl 50 micrograms/
ml Injection than you should:

Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too
much. If you think you have been given too
much or you begin to experience breathing
difficulties, dizziness or symptoms of low
blood pressure and a slower heartbeat,
you must tell the person giving you the injection

If you stop using Fentanyl 50 micrograms/
ml Injection:
Repeated use of fentanyl may lead to drug
dependence, with withdrawal symptoms on
stopping the drug.

31/07/2014 12:19:36

If you have any further questions on the use of this
medicine, ask your doctor, nurse or pharmacist.

5. How to store Fentanyl 50 micrograms/ml

4. Possible side effects

Keep this medicine out of the sight and reach of
Your injection will be stored at less than 25°C and
protected from light.
Do not use this medicine after the expiry date
which is stated on the label/ carton after “EXP:”
The expiry date refers to the last day of that

Like all medicines, Fentanyl 50 micrograms/ml
Injection can cause side effects, although not
everybody gets them. The following side effects
are serious and should you suffer any of the
following please contact your doctor immediately/
go to the nearest accident & emergency unit:
• Anaphylaxis which can include shortness of
breath, difficulty breathing, skin rash, irregular
skin patches and itching
• Bronchospasm - spasms in the throat
• Perception of seeing or hearing things
• Slow heartbeat
The following side effects have been reported:
Very common (affects more than 1 in 10
• feeling sick (nausea), being sick (vomiting)
• muscle stiffness (which may involve your chest
Common (in less than 1 in 10, but more than
1 in 100 patients)
• agitation
• drowsiness
• dizziness
• problems with vision
• asthma-like symptoms
• low or high blood pressure
• irregular heartbeat (slow or fast)
• pain in your veins
• skeletal muscle rigidity
• confusion after the operation
Uncommon (in less than 1 in 100, but more
than 1 in 1000 patients)
• changes in blood pressure
• breathing complications
• breathing faster than normal
• fall in body temperature below normal or chills
• headache
• swelling and clotting in a vein
• sweating
• hiccups
• cough
• feeling of extreme happiness
Rare (in less than 1 in 1000, but more than
1 in 10000 patients)
• spasm of the sphincter of Oddi (pain in stomach/
• problems with urination
• restlessness
• involuntary trembling and quivering
Other side effects (frequency not known)
• serious allergic reaction which may cause
difficulty in breathing or dizziness, and hives or
nettle rash (urticaria)
• convulsions (fits or seizures)
• loss of consciousness
• muscle twitching
• stopping of the heart
• slow or shallow breathing
• itching of the skin

6. Contents of the pack and other information
Injection contains:

50 micrograms/ml

The active substance is fentanyl citrate. In
Fentanyl 50 micrograms/ml Injection each 1 ml of
solution contains the equivalent of 50 micrograms
of fentanyl.
The other ingredients are sodium chloride, water
for injections, and hydrochloric acid or sodium

50 micrograms/ml
Injection looks like and contents of the
Fentanyl 50 micrograms/ml Injection is a clear,
colourless and sterile solution for injection.
The following pack sizes are available for Fentanyl
50 micrograms/ml Injection:
• 2 ml clear glass ampoules: packs of 5 or 10
• 10 ml clear glass ampoules: packs of 5 or 10
• 50 ml clear glass vial, closed with a bromobutyl
rubber stopper: packs of 1
The marketing authorisation number of this
medicine is: PL 01502/0062

Marketing Authorisation Holder:
hameln pharmaceuticals ltd
United Kingdom

hameln pharmaceuticals gmbh
Langes Feld 13
31789 Hameln
hameln rds a.s.
Horná 36
900 01 Modra
Slovak Republic
HBM Pharma s.r.o.
03680 Martin
Sklabinská 30
Slovak Republic

medicine, please contact the Marketing
Authorisation Holder
This leaflet was last approved July 2014

Other side effects when Fentanyl 50
micrograms/ml Injection is used together with
medicines called neuroleptics, which can be
given before or during an operation:
• shivering and restlessness
• seeing things that aren‘t there (hallucinations)
• unusual movements, including trembling and
shaking of the hands and fingers, twisting
movements of the body, a shuffling walk and
stiffness of the arms and legs.
If you think this injection is causing you any
problems, or you are at all worried, talk to
your doctor, nurse or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or
nurse: This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme
Alternatively you can call Freephone 0808 100
3352 (available from 10 a.m. to 2 p.m. Mondays
to Fridays) or fill in a paper form available from
your local pharmacy. By reporting side effects you
can help provide more information on the safety
of this medicine.

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Expand Transcript

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.