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RAPIFEN 0.5MG/ML

Active substance(s): ALFENTANIL HYDROCHLORIDE / ALFENTANIL HYDROCHLORIDE / ALFENTANIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2017

GB-IE - AW_123421

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500 micrograms/ml
solution for injection or infusion
Alfentanil hydrochloride
Rapifen is a registered trademark

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
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their signs of illness
are the same as yours
• 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 Rapifen is and what it is
used for
2 What you need to know before
you are given Rapifen
3 How Rapifen is given
4 Possible side effects
5 How Rapifen is stored
6 Contents of the pack and other
information

1 What Rapifen is and what it is used for
Rapifen contains a medicine called
alfentanil hydrochloride. It belongs to
a group of medicines called ‘opioid
analgesics’. Rapifen is a strong painkiller
that works for a short period of time.

Rapifen is used to prevent or relieve
pain during different types of surgery in
adults and children of all ages, including
babies. It can be used for:
• Short operations, where you go home
on the same day
• Longer operations, where you may
stay in hospital for a number of days
In children, Rapifen can also be used to
induce ‘sleep’ for surgery when used
with a sedative.

2 What you need to know before you are given Rapifen
Do not have Rapifen if:

• You are allergic to alfentanil
hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
• You are allergic to strong medicines
for pain called ‘opioid analgesics’
• You suffer from breathing difficulties
called ‘obstructive airway disease’ or
‘respiratory depression’. You may only
be able to have Rapifen if your
breathing is helped by a machine
called a ventilator
• You are in labour or before the cord is
clamped during a Caesarean section.
Rapifen may affect the baby’s breathing
Do not use this medicine if any of the
above applies to you. If you are not sure,
talk to your doctor or nurse before
having Rapifen.

Warnings and precautions

Talk to your doctor or nurse before being
given this medicine if you have ever had:
• Problems with your lungs, liver or kidneys
• Problems with alcohol (alcoholism)
• Long-term treatment with strong
painkillers
Your doctor will carefully monitor the
amount of Rapifen given to you. If you
are not sure if any of the above applies
to you, talk to your doctor or nurse before
having Rapifen.

Special monitoring

• Rapifen may make you breathe more
slowly. Your breathing will be carefully
monitored until it returns to normal
• Your blood pressure and heart rate will
also be monitored

Babies, children and adolescents
Rapifen can cause breathing difficulties,
especially in babies and very young
children. When babies and very young
children are given Rapifen:
• Their breathing will be carefully
monitored during the operation and for
some time afterwards.
• The doctor may give a medicine to
relax the muscles and to prevent them
becoming stiff.

Other medicines and Rapifen

Tell your doctor or nurse if you are
taking, have recently taken or might
take any other medicines. This includes
medicines that you buy without
a prescription or herbal medicines.
In particular, do not have this medicine
and tell your doctor or nurse if you
have taken:
• Medicines for depression called
‘monoamine oxidase inhibitors’
(MAOIs) in the past two weeks
If this applies to you, do not have Rapifen.
It is especially important to talk to
your doctor or nurse if you are
taking any of the following:
• ‘Selective Serotonin Reuptake
Inhibitors’ (SSRIs) or ‘Serotonin
Norepinephrine Reuptake Inhibitors’
(SNRIs)
The effects of Rapifen may last
longer if you are taking:
• Cimetidine - for ulcers, stomach ache
and heartburn
• Erythromycin - an antibiotic
• Diltiazem - for a heart problem
Talk to your doctor before having Rapifen
if you are taking any of these medicines.
The effects of Rapifen or any of
these medicines may be increased
when they are taken together
• Other strong medicines for pain, for
example ‘opioid analgesics’ such as
morphine or codeine
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• Medicines for high blood pressure or
heart problems called ‘beta-blockers’
• Medicines for putting you to sleep
called ‘anaesthetic agents’
• Medicines for anxiety or to help you sleep
such as tranquillisers or sleeping pills
• Medicines that affect your central
nervous system (CNS depressants)
such as medicines for mental
disorders
• Medicines for epilepsy such as
clobazam, clonazepam or phenobarbital
Talk to your doctor before having
Rapifen if you are taking any of these
medicines. They may have to change
the amount of Rapifen or the other
medicines you are given.
Certain medicines may affect the
way Rapifen works
• Medicines for fungal infections called
fluconazole, voriconazole,
ketoconazole or itraconazole
• Medicines for HIV infection (called
antiviral protease inhibitors) such as
ritonavir, indinavir or saquinivir
Talk to your doctor before having
Rapifen if you are taking any of these
medicines. They may have to change
the amount of Rapifen you are given.

Rapifen with alcohol

Tell your doctor or nurse if you use
alcohol regularly, because the effect of
Rapifen may be increased or last longer.

Pregnancy and breast-feeding

You must tell your doctor before having
Rapifen if you are pregnant, think you
may be pregnant or might become
pregnant.
Rapifen is not recommended during
childbirth as it crosses the placenta and
can affect your baby’s breathing.
You may still be able to have Rapifen
if your doctor thinks you need to.
Rapifen may get into breast milk. Do not
breast-feed or use breast milk that has
been expressed during 24 hours after
having Rapifen.
Ask your doctor or pharmacist for advice
before taking any medicine if you are
pregnant or breast-feeding.

Driving and using machines

Do not drive or use any tools or machines
for at least 24 hours after having Rapifen.
You may be less alert than usual.
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:
o The medicine has been prescribed to
treat a medical or dental problem and
You
have taken it according to the
o
instructions given by the prescriber
or in the information provided with
the medicine and
o 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.

Rapifen contains sodium chloride
If you need to control your salt intake
(controlled sodium diet) be aware that:
• Each Rapifen ampoule (10 ml)
contains 1.55 mmol sodium (35.4 mg)
• The contents of the ampoule may be
diluted in a salt solution before
being given to you. This salt
solution also contains sodium

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3 How Rapifen is given
Rapifen is given by a doctor experienced
in using this type of medicine. Check
with your doctor or nurse if you are not
sure about anything.

How Rapifen is given

• Rapifen is given as a drip (infusion) or
an injection into a vein
• You may be given an anaesthetic at
the same time

How much Rapifen is given

Your doctor will decide how much
Rapifen you need. This may depend on:
• Your body weight in kilograms
• Your general health
• Your age
• The type of operation you are having

Adults

Rapifen given as a drip (infusion)
• The dose of Rapifen is based on body
weight in kilograms
• You will usually be given an initial dose
of 50 to 100 micrograms per kilogram
• If necessary, this may be followed by
0.5 to 1 micrograms per kilogram
during each minute of your operation
• The drip will normally be stopped
30 minutes before the end of your
operation
Rapifen given by injection
If you are to breathe by yourself
• You will usually be given an initial dose
of 500 micrograms
• It will be given slowly, over about
30 seconds
• If necessary, you will be given further
injections of 250 micrograms during
the operation
When your breathing is helped by
a machine (ventilator)
• The dose of Rapifen is based on body
weight in kilograms
• The initial dose will be
30-50 micrograms per kilogram

• If necessary, further injections of
15 micrograms per kilogram will be
given during the operation
• The last injection will be given no later
than 10 minutes before the end of the
operation

Babies, children and adolescents
Rapifen is used with other medicines
(anaesthetics or sedatives) in babies,
children and adolescents.

• In children
When Rapifen is given by injection
as an anaesthetic or to relieve pain
o You will usually be given an initial
dose 10 to 20 micrograms per
kilogram of body weight
If
o necessary, you will be given further
injections of 5 to 10 micrograms per
kilogram of body weight
When Rapifen is given as a drip
(infusion) to maintain pain relief
during surgery
o You will usually be given a dose
of 0.5 to 2 micrograms per kilogram
of body weight per minute.
o If the Rapifen drip is combined with
an anaesthetic, you will usually be
given a dose of approximately
1 microgram per kilogram of body
weight per minute.
• In newborn babies, a lower dose of
Rapifen may be given.
• Adolescents will usually be given
a similar dose to adults.

Elderly or ill patients

Less Rapifen may be used in patients
that are elderly or weak due to ill health.

If you have been given too much
Rapifen
It is unlikely that you will be given too
much Rapifen. This will be monitored
during your operation.

4 Possible side effects
Like all medicines, this medicine can
cause side effects, although not everybody
gets them. Your doctor will monitor these
effects during your operation.
Very common (affects more than
1 in 10 people)
• Feeling sick (nausea) or being sick
(vomiting)
Common (affects fewer than
1 in 10 people)
• Slower or weaker breathing or your
breathing may stop for a short period
of time. If necessary, your breathing
will be helped by a machine (ventilator)
• Muscle twitching or stiffness, which
may involve your chest muscles
• Dizziness and fainting. These are signs
of lowered blood pressure
• Raised blood pressure
• Feeling tired or sleepy
• Feeling cold or shivering
• Feeling excited or unusually carefree
• Feeling calm and relaxed
• Fast or slow heartbeat
• Blurred or double vision
• Pain where the injection was given
• Unusual movements
Uncommon (affects fewer than
1 in 100 people):
• Choking caused by cramping (spasm)
of the muscles in your throat
• Slower or weaker breathing returning
• Feeling sleepy or unresponsive
• Breathing faster possibly with flushing
of the skin
• An irregular heartbeat
• Feeling agitated or disoriented
• Sweating or skin rash
• Headache
• Hiccups
• General body aches and pains

Rare (affects fewer than
1 in 1,000 people)
• Difficulty in breathing, wheezing or
shortness of breath
• Nose bleeds
• Itchy skin
• Feeling agitated
• Crying
Other possible side effects:
• Serious allergic reaction which may
cause difficulty in breathing, wheezing
or coughing, and hives or nettle rash
(urticaria)
• Breathing can stop completely,
which may be fatal
• Heart attack
• Fits or seizures
• Loss of consciousness after your
operation
• Pupils of the eye much smaller than
normal
• Fever or high temperature
• Redness of the skin or rash
• Feeling disorientated
• Muscle twitches

Side effects in babies, children
and adolescents

The frequency and type of side effects
in children and adolescents are similar
to those described above. Muscle
twitching or stiffness may occur more
commonly in newborn babies than in
older people given Rapifen.

Reporting of side effects

If you get any side effects, talk to your
doctor, pharmacist 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 at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.

5 How Rapifen is stored
Rapifen is kept out of the reach and
sight of children. It is stored in
a Controlled Drug Store in the hospital
pharmacy. This medicinal product does
not require any special storage
conditions. Rapifen ampoules are for
single use only. Any unused contents
should be discarded.

When Rapifen is given, it can be mixed
with:
• Sodium chloride solution
• Dextrose solution
• Compound sodium lactate solution
(Hartmann’s solution)
These mixtures are used within 24 hours
of preparation.
Rapifen will not be used after the expiry
date stated on the label. The expiry date
refers to the last day of that month.

6 Contents of the pack and other information
What Rapifen contains

• The active substance is alfentanil
hydrochloride. Each millilitre (ml)
contains 500 micrograms of alfentanil
(as the hydrochloride).
• The other ingredients are sodium
chloride and water.

What Rapifen looks like and
contents of the pack

Rapifen is supplied in a clear glass
ampoule containing 2 ml (packs of 10)
or 10 ml (packs of 5 and 10) of liquid.
Marketing Authorisation Holder:
JANSSEN-CILAG LTD, 50-100 Holmers
Farm Way, High Wycombe,
Buckinghamshire HP12 4EG, UK
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Manufacturer:
GlaxoSmithKline Manufacturing S.p.A.,
Strada Provinciale Asolana N. 90
(loc San Polo), 43056 Torrile (PR), Italy
OR
McGregor Cory Ltd, Middleton Close,
Banbury, OX16 4RS, UK

For information in large
print, tape, CD or Braille,
telephone 0800 7318450.
This leaflet was last revised in
February 2017.
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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.

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