RAPIFEN™

alfentanil hydrochloride

0.5 mg/mL injection

What is in this leaflet

This leaflet answers some of the common questions about RAPIFEN injection. It
does not contain all of the available information. It does not take the place of
talking to your doctor, pharmacist or anaesthetist.

If you have any concerns about using RAPIFEN, ask your doctor, pharmacist or
anaesthetist. Your doctor, pharmacist or anaesthetist have more information.

Keep this leaflet after your treatment has finished. You may need to read it
again.

What RAPIFEN is used for

RAPIFEN is used to produce loss of feeling and consciousness in surgical
procedures, and to prevent pain and discomfort during surgery.

RAPIFEN belongs to the group of strong painkillers called opioid analgesics.
These medicines relieve pain by blocking the nerves in the brain that recognise
pain messages from the body.

Your doctor may have prescribed RAPIFEN for another reason. Ask your doctor
if you have any questions about why this medicine has been prescribed for you.

Before you are given RAPIFEN

When you must not be given it

Do not use RAPIFEN if you know you are allergic to any of the ingredients.
(See the last section of this leaflet for a list of ingredients). Signs of
allergy include a skin rash, itching, shortness of breath and/or a swollen face.

Do not use RAPIFEN if you know you cannot tolerate opioid painkillers, for
example, morphine and pethidine.

Do not use RAPIFEN if the packaging is torn or shows signs of tampering. Do
not use RAPIFEN beyond the expiry date (month and year) printed on the pack.

Before you are given it

Certain people must use RAPIFEN with caution. Ask your doctor for advice.

Driving and Operating Machinery

RAPIFEN can affect your alertness and ability to drive and operate machinery.
It is therefore advisable to wait up to 24 hours after RAPIFEN has been given
before performing these tasks. However, you should first ask your doctor or
pharmacist for advice.

You must tell your doctor if:

• you are pregnant or planning to become pregnant
• you are breast-feeding or wish to breastfeed
• you have or have ever had liver or kidney problems
• you have heart problems
• you have a history of fits or have ever had a head injury or brain tumour
• you have problems with your breathing such as severe asthma, severe
  bronchitis or emphysema
• you have a thyroid gland that is underactive
• you drink alcohol on a regular basis.

If you have not told your doctor or pharmacist about any of the above, tell
them before you are given RAPIFEN.

Your doctor will decide whether or not to treat you with RAPIFEN or whether
to adjust the dose or adapt your treatment.

Other medicines and alcohol

Tell your doctor or pharmacist if you are taking any other medicines,
including medicines you can buy from a pharmacy, supermarket or health food
shop.

In particular, tell your doctor or pharmacist if you are taking any of the
following:

• medicines which make you feel drowsy or cause you to be slow to react,
  such as sleeping tablets, tranquillisers or strong pain-killers
• certain medicines used to treat heart disease such as diltiazem
• medicines used as antidepressants. In particular, antidepressants
  belonging to a group called called monoamine oxidase inhibitors (MAOIs), which
  should be stopped for 2 weeks before RAPIFEN is used.
• certain medicines used to treat mental disorders
• macrolide antibiotics such as erythromycin
• azole antifungals such as fluconazole, ketoconazole or itraconazole
• a medicine for the stomach called cimetidine
• an antiviral called ritonavir
• alcohol

RAPIFEN can speed up and increase the sedative effects of alcohol and
sleeping tablets. Be careful and tell your doctor if you are taking any of these
products with RAPIFEN.

There may also be some other medicines that may cause problems if used
together with RAPIFEN. So, make a point of telling your doctor or pharmacist
which medicines you are using at the moment, and before you start taking any new
medicines. They will tell you which medicines should not be used or what other
measures (for example, a change of dose) are necessary.

Using RAPIFEN

How it is given

Adults

The usual dose of RAPIFEN ranges from 7 micrograms per kilogram to 150
micrograms per kilogram depending on what it is being used for. Repeated doses
may be given in some cases.

If you are elderly, you may be given a lower dose of RAPIFEN.

Children 1 to 12 years

The usual dose of RAPIFEN for children is the same as that used in adults.
However, in some cases a higher dose or more frequent dosing may be required, as
RAPIFEN has a shorter duration of action in children.

RAPIFEN is not recommended for use in children younger than 1 year, as the
safety of RAPIFEN in this age group is not known.

If you are given too much (overdose)

In the unlikely event that an overdose has been given, your doctor or
anaesthetist will take the necessary actions. There are specific agents that can
reverse the effects from an overdose of RAPIFEN.

Tell your doctor immediately if you experience any breathing difficulties.

Side Effects

All medicines have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some side effects. Do
not be alarmed by this list of possible side effects. You may not experience any
of them.

Ask your doctor, pharmacist or anaesthetist to answer any questions you may
have.

Tell your doctor if you experience any of the following:

• nausea and vomiting
• low blood pressure which may cause headache, weakness or dizziness
• high blood pressure
• dizziness
• headache
• pain at injection site
• shivering
• sleepiness
• disorientation
• agitation
• feeling of extreme happiness
• cough
• hiccup
• itching
• sweating

Tell your doctor immediately if you notice any of the following as you may
need urgent medical care:

• abnormally slow and/or weak breathing
• muscle stiffness or sudden muscle twitches
• slow or fast heart beat
• changes in the heart rate (fast, slow or irregular)
• blurred or double vision
• a feeling of choking which is caused by the spasm of the muscles around
  the voice box
• allergic reactions such as skin rash, shortness of breath, or swelling of
  the face, neck and throat

You will be closely monitored for side effects during and after a RAPIFEN
injection.

Other side effects not listed above may also occur in some people. Do not
hesitate to report any other side effects to your doctor or pharmacist.

Product Description

What it looks like

RAPIFEN is a clear, colourless solution contained in 2 mL glass ampoules. A
carton of RAPIFEN contains 5 ampoules.

Ingredients

The 2 mL ampoule contains 1 mg of alfentanil, together with sodium chloride
and water.