Alfentanil Hydrochloride Injection (equivalent to 0.5 mg/mL alfentanil)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about RAPIFEN. It does
not contain all the information that is known about RAPIFEN.
It does not take the place of talking to your doctor, anaesthetist or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you being
given RAPIFEN against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor, anaesthetist
Keep this leaflet. You may need to read it again.
What RAPIFEN is for
RAPIFEN is a drug used to relieve pain and produce anaesthesia.
It can be used as a premedication before an operation, or with a general anaesthetic
during an operation.
RAPIFEN belongs to a group of medicines called opioid analgesics.
RAPIFEN works by changing the messages that are sent to the brain about pain.
Your doctor will have explained why you are being given RAPIFEN.
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
RAPIFEN 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 RAPIFEN
When you must not use it
RAPIFEN should not be used for pain relief after surgery has taken place.
RAPIFEN should not be used if you have an allergy, intolerance or hypersensitivity
any ingredients listed at the end of this leaflet
other opioid analgesics (pain killers) e.g. morphine or pethidine.
Symptoms of an allergic or hypersensitivity reaction may include:
rash, itching or hives on the skin
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body.
RAPIFEN is not generally given to children under 12 years of age.
RAPIFEN 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 passed.
Before you are given it
You must tell your doctor if you:
are pregnant or planning to become pregnant. Your doctor will decide if you can take
RAPIFEN. It may affect your baby if it is given early in pregnancy or in the last
weeks before your baby is due.
are breastfeeding or wish to breastfeed. RAPIFEN may be excreted in breast milk. Breast-feeding
is not advisable for 24 hours after RAPIFEN has been given.
Tell your doctor if you have any of the following medical conditions:
problems with your breathing such as severe asthma, severe bronchitis or emphysema
a history of fits or head injury
myasthenia gravis (muscle weakness)
liver or kidney problems
are overweight or obese
Tell your doctor if you take any medicine that slows down your reactions (CNS depressants),
especially benzodiazepines or related drugs or have problems with alcohol.
It may not be safe for you to be given RAPIFEN or you may be given a reduced dose
if you have any of these conditions.
If you have not told your doctor about any of the above, tell them before you are
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines you can
buy without a prescription from a pharmacy, supermarket or health food store.
Tell your doctor immediately and do not take RAPIFEN if you are taking:
medicines for depression called Monoamine Oxidase (MAO) Inhibitors. These medicines
must not be taken in the 14 days before RAPIFEN is given.
Also tell your doctor if you are taking:
any anaesthetic agents such as propofol
any medicine that slows down your reactions (CNS depressants) such as benzodiazepines
or related drugs, sleeping pills, tranquillizers, medicines for mental disorders,
alcohol, some illegal drugs.
If you receive a strong pain killer or other CNS depressant after receiving RAPIFEN
during surgery, the dose of the painkiller or other CNS depressants may need to be
lowered to reduce the risk of potentially serious side effects such as breathing difficulties,
with slow or shallow breathing, severe drowsiness and decreased awareness, coma and
an antibiotic called erythromycin
an antifungal called fluconazole, voriconazole, ketoconazole or itraconazole
a medicine for the stomach called cimetidine
an antiviral called ritonavir
a heart medicine called diltiazem
medicines for depression known as selective serotonin re-uptake inhibitors (SSRIs)
or serotonin norepinephrine re-uptake inhibitors (SNRIs)
RAPIFEN can increase the effects of alcohol. Tell your doctor about your consumption
of alcohol and follow the doctor's advice.
If you have not told your doctor about any of these things, tell them before you are
These medicines may be affected by RAPIFEN or may affect how well RAPIFEN works. Your
doctor can tell you what to do if you are taking any of these medicines.
How RAPIFEN is given
RAPIFEN will be given to you by injection by a specially trained anaesthetist.
The injection is given into the vein (intravenous use).
Your doctor will decide how much RAPIFEN you will need.
Elderly people may be given a smaller dose.
The doctor or nurse giving you RAPIFEN will be experienced in its use, so it is extremely
unlikely that you will be given too much.
In the unlikely event that an overdose occurs, your doctor or the anaesthetist will
take the necessary actions. The symptoms of overdose could include:
lowering of blood pressure
lowering of heart rate
If these symptoms occur, you may be administered another medicine (e.g. naloxone)
to help reverse the effects.
If you think you or anybody else has been given too much RAPIFEN, contact your doctor
or nurse immediately.
Tell your doctor or nurse as soon as possible if you do not feel well after you have
been given RAPIFEN. RAPIFEN 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 RAPIFEN 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
nausea and vomiting
drowsiness or sleepiness
injection site pain or pain during the procedure
Tell your doctor or nurse as soon as possible if you have any of the following as
you may need medical attention:
feeling of extreme happiness (euphoric mood)
visual disturbance such as blurred vision
Tell your doctor or nurse immediately if you experience:
breathing difficulties, which can last longer than its pain-killing effect.
slow, fast or irregular heartbeat.
tightening of the chest or heart attack
low or high blood pressure
muscle stiffness or involuntary muscle movements, including slow, stiff or jerking
spasm of the larynx (voice box)
RAPIFEN may affect your alertness and ability to drive. Therefore you should not drive
or operate machinery until your doctor advised that you can.
Some people may get other side effects after being given RAPIFEN.
Tell your doctor or nurse if you notice anything else that is making you feel unwell.
RAPIFEN should be kept in a cool dry place, protected from light, where the temperature
stays below 25 degrees C.
RAPIFEN will be kept in a locked cupboard in the hospital pharmacy or operating theatre.
RAPIFEN should not be used after the date (month and year) printed after "EXP". The
anaesthetist will inspect RAPIFEN before use to determine that it is still within
its use by date.
The hospital staff looking after you will dispose of any remaining RAPIFEN appropriately.
RAPIFEN injection is a clear, colourless solution.
The active ingredient in RAPIFEN is alfentanil.
RAPIFEN contains 0.5 mg/mL of alfentanil, as the active ingredient
RAPIFEN also contains sodium chloride and water for injection.
RAPIFEN is available in two size glass ampoules: a 2 mL and a 10 mL ampoule.
A carton of RAPIFEN contains 5 ampoules.
5 x 2 mL and 5 x 10mL
The 2 mL ampoule contains 1 mg of alfentanil.
The 10 mL ampoule contains 5 mg of alfentanil.
JANSSEN-CILAG Pty Ltd
1-5 Khartoum Rd
Macquarie Park NSW 2113 Australia
Tel: 1800 226 334
Australian Registration Numbers:
1mg/2 mL ampoule AUSTR 50506
5 mg/10 mL ampoule AUSTR 50508
This leaflet was prepared in
®RAPIFEN is the registered trademark of JANSSEN PHARMACEUTICA for alfentanil hydrochloride