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Fentanyl Injection BP

Fentanyl citrate
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Fentanyl Injection BP. It does not contain all the information that is known about Fentanyl Injection BP. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What FENTANYL is for

Fentanyl is a powerful drug used to relieve pain and produce sleepiness.
It can be used as a premedication before an operation, or with a general anaesthetic during an operation. It can also be used after painful operations to reduce the pain that you feel.
Fentanyl belongs to a group of medicines called opioid (narcotic) analgesics.
Fentanyl works by changing the messages that are sent to the brain about pain.
Your doctor will have explained why you are being treated with Fentanyl and told you what dose you will be given. Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.
Fentanyl can be addictive, but when it is used only to relieve or prevent pain it is unlikely to become habit forming.

Before you are given FENTANYL

When you must not use it

You should not be given Fentanyl if you are pregnant or breastfeeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved.
We do not know if it is safe for you to be given Fentanyl while you are pregnant.
It may affect your baby if it is given early in pregnancy or in the last weeks before your baby is due.
We do not know if your baby can take in Fentanyl from breast milk if you are breastfeeding.
Fentanyl injection will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed.

Before you are given it

You must tell your doctor if:

1. you have been given Fentanyl before and had any problems with it

2. you have any allergies to

any ingredients listed at the end of this leaflet
other strong analgesics (pain killers) eg. morphine or pethidine.
any other substances
If you have an allergic reaction, you may get a skin rash, hay fever or an asthma attack.

3. you have any of these medical conditions

problems with your breathing such as severe asthma, severe bronchitis or emphysema.
a history of fits or head injuries.
myasthenia gravis (muscle weakness)
heart problems
liver or kidney problems
It may not be safe for you to be given Fentanyl if you have any of these conditions.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription at the chemist, supermarket or health food shop.
These medicines may affect the way Fentanyl works.
Your doctor or pharmacist can tell you what to do if you are taking any other medicines.
If you have not told your doctor about any of these things, tell them before you are given any Fentanyl.

How FENTANYL is given

Fentanyl will be given to you by injection by your doctor or specially trained nurse.
The injection may be given into a vein or into a muscle.

Overdose

The doctor or nurse giving you Fentanyl will be experienced in its use, so it is extremely unlikely that you will be given too much.
However, the first sign of overdosage is often muscle spasm, followed by a marked slowing of your breathing, accompanied by a bluish tinge on the skin. You will probably lose consciousness.
Fentanyl doses should be carefully worked out, so problems with overdosage are unlikely. There are other drugs, eg. naloxone or nalorphine, which can be used if needed to reverse the effects of too much Fentanyl.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well after you have been given Fentanyl.
Fentanyl helps most people suffering severe pain, but it may have unwanted side-effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
After you have been given Fentanyl you will probably feel light-headed, dizzy, sleepy and you may feel quite strange, especially if you are not lying down.
Tell your doctor or nurse if you notice any of the following side effects and they worry you.
Fentanyl may cause
slowing down of breathing
muscle spasm
Fentanyl sometimes causes
changes in blood pressure (higher or lower)
dizziness
nausea (feeling sick)
vomiting
blurred vision
itching
euphoria (exaggerated sense of well-being)
Some people may get other side effects after being given Fentanyl.
Tell your doctor if you notice anything else that is making you feel unwell.

Storage

If you are storing Fentanyl at home they should be kept in the original pack in a cool dry place where the temperature stays below 30 degrees C.
Do not store it or any other medicine in the bathroom or near a sink.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Do not leave it in the car on hot days.

Disposal

Make sure that you return to your doctor or pharmacist any injections that have passed the use by (expiry) date marked on the pack, or if you have any left over when your doctor says you no longer need to be given Fentanyl injections.

Product description

Fentanyl injection is a clear, colourless solution.
Each Fentanyl injection contains fentanyl citrate 50mcg/mL as the active ingredient in Water for Injection BP plus
Citric acid - anhydrous (E330)
Sodium citrate (E331)
Sodium chloride
Sodium hydroxide (for pH adjustment).
Fentanyl is available in
Polyamp® Duo Fit® 10 x 2 mL and 10 x 10mL

Manufacturer

AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113
Tel: 1800 805 342
This leaflet was prepared in February 2008.
Australian Registration Numbers:
100mcg/2mL 12100
500mcg/10mL 48369
® Trade Marks herein are the property of the AstraZeneca group