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RAPIFEN INTENSIVE CARE 5MG/ML

Active substance(s): ALFENTANIL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

GB - AW_96598
© J-C 2014

intensive care

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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
The name of your medicine is Rapifen
intensive care. It is called ‘Rapifen’ in this
leaflet.

Rapifen is used to give pain relief and
control breathing when using an artificial
breathing machine in intensive care.

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.

2 What you need to know before you are given Rapifen
You will not be given 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 are pregnant
• You are in labour or before the cord is
clamped during a Caesarean section.
Rapifen may affect the baby’s breathing.

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
• An underactive thyroid gland
• Problems with alcohol (alcoholism)
• Long-term treatment with strong
painkillers
Your doctor will carefully monitor the
amount of Rapifen you are given.

Special monitoring

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

Other medicines and Rapifen

• Your doctor or nurse will need to know
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 the intensive care unit, your doctor
may stop any medicines that you
usually take and may give you different
medicines
• In particular, your doctor or nurse
needs to know if you have taken
medicines for depression called
“monoamine oxidase inhibitors” in the
past 2 weeks
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
The effects of Rapifen or any of these
medicines may be increased when
they are taken together
• Other strong medicines for pain called
‘opioid analgesics’ such as morphine
or codeine
• 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 for epilepsy such
as clobazam, clonazepam
or phenobarbital
Your doctor 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
Your doctor 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.
You may still be able to have Rapifen
if your doctor thinks you need to.
Rapifen should not be used during
childbirth as it can affect the baby's
breathing.
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:
- 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 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 5 mg dose contains less than
1 mmol sodium (23 mg) so it is
essentially ‘sodium-free’
• 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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© J-C 2014

GB - AW_96598

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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)
• You will usually be given an initial dose
of 2 mg per hour
• If necessary, this may be followed
by extra doses during short painful
procedures
• The drip will normally be stopped
within 4 days

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
• Any other medicines you are being
given at the same time

Elderly patients and people with
liver problems or underactive
thyroid

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

If you have too much Rapifen

It is unlikely that you will be given too
much Rapifen. This will be monitored
while you are in intensive care.

4 Possible side effects
Like all medicines, this medicine can
cause side effects, although not everybody
gets them. Your doctor will monitor these
effects while you are in intensive care.
Very common (affects more than
1 in 10 people)
• Feeling sick (nausea), being sick
(vomiting)
Common (affects less than
1 in 10 people)
• Slower or weaker breathing or your
breathing may stop for a short period
of time. Your breathing will be helped
by a machine (ventilator) until you are
able to breathe by yourself
• 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
• Muscle twitching or stiffness (which
may involve your chest muscles)
• Fast or slow heartbeat
• Blurred or double vision
• Pain where the injection was given

Other possible side effects:
• Serious allergic reaction which may
cause difficulty in breathing, wheezing
or coughing, and hives or nettle rash
(urticaria)
• Heart attack
• Fits or seizures
• Pupils of the eye much smaller than
normal
• Loss of consciousness after your
operation
• Fever or high temperature
• Breathing can stop completely, which
may be fatal
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.

Uncommon (affects less than
1 in 100 people)
• Hiccups
• Choking caused by cramping (spasm)
of the muscles in your throat
• Headache
• Sweating or skin rash
• An irregular heartbeat
• Feeling agitated or disoriented
• Slower or weaker breathing returning

5 How Rapifen is stored
Rapifen is kept out of the sight
and reach of children. It is stored
in a Controlled Drug Store in the hospital
pharmacy. Rapifen is stored at or below
25oC. Rapifen Intensive Care ampoules
are for single use only. Any unused
contents should be discarded.

When Rapifen is given, it can be mixed
with:
• Sodium chloride solution
• Glucose 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 5 milligrams of alfentanil
(as the hydrochloride).
• The other ingredients are sodium
chloride and water. It may also contain
small amounts of sodium hydroxide or
hydrochloric acid.

What Rapifen looks like and
contents of the pack

Rapifen is supplied in a clear glass
ampoule containing 1ml of liquid in
packs of 5 or 10 ampoules.

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
September 2014.

Marketing Authorisation Holder:
Janssen-Cilag Ltd
50-100 Holmers Farm Way,
High Wycombe, Buckinghamshire
HP12 4EG, UK.

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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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