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MARCAIN POLYAMP STERIPACK 0.25%

Active substance: BUPIVACAINE HYDROCHLORIDE

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PS05229

Package leaflet: Information for the user

Marcain® Polyamp Steripack 0.25% and 0.5%
bupivacaine hydrochloride

Read all of this leaflet carefully before this
medicine is given to you 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.
• 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.

In particular, tell your doctor if you are taking
any of the following medicines:
• Medicines used to treat an uneven heart beat
(arrhythmia) such as lidocaine, mexiletine or
amiodarone.
• Medicines used to stop blood clots
(anti-coagulants).
Your doctor needs to know about these
medicines to be able to work out the correct
dose of Marcain Polyamp Steripack for you.

What is in this leaflet:
1. What Marcain Polyamp Steripack is and
what it is used for
2. What you need to know before Marcain
Polyamp Steripack is given to you
3. How Marcain Polyamp Steripack is given
to you
4. Possible side effects
5. How to store Marcain Polyamp Steripack
6. Contents of the pack and other information

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think that
you may be pregnant or are planning to have a
baby, ask your doctor for advice before taking
this medicine.

1. What Marcain Polyamp Steripack is and
what it is used for
Marcain Polyamp Steripack contains a medicine
called bupivacaine hydrochloride. It belongs to a
group of medicines called local anaesthetics.
Marcain Polyamp Steripack is used to numb
(anaesthetise) parts of the body. It is used to
stop pain happening or to provide pain relief.
It can be used to:
• Numb parts of the body during surgery in
adults and children above 12 years.
• Relieve pain in adults, infants and children
above 1 year of age.
2. What you need to know before Marcain
Polyamp Steripack is given to you
You must not be given Marcain Polyamp
Steripack:
• If you are allergic to bupivacaine
hydrochloride or any of the other ingredients
of this medicine (listed in section 6).
• If you are allergic to any other local
anaesthetics of the same class (such as
lidocaine or ropivacaine).
• If you have a skin infection near to where
the injection will be given.
• If you have something called cardiogenic
shock (a condition where the heart is unable
to supply enough blood to the body).
• If you have something called hypovolaemic
shock (very low blood pressure leading
to collapse).
• If you have problems with clotting of your blood.
• If you have diseases of the brain or spine
such as meningitis, polio or spondylitis.
• If you have a severe headache caused
by bleeding inside the head (intracranial
haemorrhage).
• If you have problems with your spinal cord
due to anaemia.
• If you have blood poisoning (septicaemia).
• If you have had a recent trauma, tuberculosis
or tumours of the spine.
You must not be given Marcain Polyamp Steripack
if any of the above apply to you. If you are not
sure, talk to your doctor or nurse before you are
given Marcain Polyamp Steripack.
Warnings and precautions
Talk to your doctor or nurse before having
Marcain Polyamp Steripack:
• If you have heart, kidney or liver problems.
This is because your doctor may need to
adjust the dose of Marcain Polyamp Steripack.
• If you have a swollen stomach due to more
fluid than normal.
• If you have a stomach tumour.
• If you have been told that you have
decreased volume of blood (hypovolaemia).
• If you have fluid in your lungs.
Children
• In children aged less than 12 years as some
injections of Marcain Polyamp Steripack
in order to numb parts of the body during
surgery are not established in younger
children. The use of Marcain Polyamp
Steripack is not established in children
less than 1 year of age.
If you are not sure if any of the above apply to
you, talk to your doctor or nurse before you are
given Marcain Polyamp Steripack.
Other medicines and Marcain Polyamp
Steripack
Tell your doctor if you are taking, have recently
taken or might take any other medicines.
This includes medicines that you buy without
a prescription and herbal medicines. This
is because Marcain Polyamp Steripack can
affect the way some medicines work and some
medicines can have an effect on Marcain
Polyamp Steripack.

Driving and using machines
Marcain Polyamp Steripack may make you feel
sleepy and affect the speed of your reactions.
After you have been given Marcain Polyamp
Steripack, you should not drive or use tools or
machines until the next day.
Marcain Polyamp Steripack contains sodium
Marcain Polyamp Steripack contains up
to 3.15 milligrams (mg) of sodium in each
millilitre (ml), equivalent to 31.4 mg per 10 ml
ampoule. Your doctor will take this into account
if you are on a sodium controlled diet.
3. How Marcain Polyamp Steripack is
given to you
Marcain Polyamp Steripack will be given to you
by a doctor. Your doctor will know the correct
way to give you this medicine.
The dose that your doctor gives you will depend
on the type of pain relief that you need and
the part of your body that the medicine will be
injected into. It will also depend on your body
size, age, and physical condition. Usually one
dose will last long enough but more doses may
be given if the surgery takes a long time.
Marcain Polyamp Steripack will be given to you
as an injection. The part of the body where you
are injected will depend on why you are being
given Marcain Polyamp Steripack. Your doctor
will give you Marcain Polyamp Steripack in one
of the following places:
• Near to the part of the body that needs to
be numbed.
• In an area away from the part of the body
that needs to be numbed. This is the
case if you are given an epidural injection
(an injection around the spinal cord).
When Marcain Polyamp Steripack is injected
into the body in one of these ways, it stops the
nerves from being able to pass pain messages
to the brain. It will slowly wear off when the
medical procedure is over.
If you have been given too much
Marcain Polyamp Steripack
Serious side effects from getting too much
Marcain Polyamp Steripack are unlikely.
They need special treatment and the doctor
treating you is trained to deal with these situations.
The first signs of being given too much Marcain
Polyamp Steripack are usually as follows:
• Feeling dizzy or light-headed
• Numbness of the lips and around the mouth.
• Numbness of the tongue.
• Hearing problems.
• Problems with your sight (vision).
To reduce the risk of serious side effects, your
doctor will stop giving you Marcain Polyamp
Steripack as soon as these signs appear.
This means that if any of these happen to
you, or you think you have received too much
Marcain Polyamp Steripack, tell your doctor
immediately.
More serious side effects from being given
too much Marcain Polyamp Steripack include
twitching of your muscles, fits (seizures), and
loss of consciousness.
If you have any further questions on the use
of this medicine, ask your doctor, pharmacist
or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Severe allergic reactions (rare, may affect
up to 1 in 1,000 people)
If you have a severe allergic reaction, tell your
doctor immediately. The signs may include
sudden onset of:
• Swelling of your face, lips, tongue or throat.
This may make it difficult to swallow.
• Severe or sudden swelling of your hands,
feet and ankles.
• Difficulty breathing.
• Severe itching of the skin (with raised lumps).

Other possible side effects:
Very common (may affect more than 1 in
10 people)
• Low blood pressure. This might make you
feel dizzy or light-headed.
• Feeling sick (nausea).
Common (may affect up to 1 in 10 people)
• Being sick (vomiting).
• Feeling dizzy.
• Pins and needles.
• High blood pressure (hypertension).
• Slow heart beat.
• Problems passing water.
Uncommon (may affect up to 1 in 100 people)
• Feeling light-headed.
• Fits (seizures).
• Numbness of the tongue or around the mouth.
• Ringing in the ears or being sensitive to sound.
• Difficulty speaking.
• Blurred sight (vision).
• Loss of consciousness.
• Shaking (tremors).
• Twitching of your muscles.
Rare (may affect up to 1 in 1,000 people)
• Double vision.
• Nerve damage that may cause changes in
sensation or muscle weakness (neuropathy).
This may include peripheral nerve damage.
• A condition called arachnoiditis (inflammation
of the membrane that surrounds the spinal
cord). The signs include a stinging or burning
pain in the lower back or legs and tingling,
numbness or weakness in the legs.
• Weak or paralysed legs.
• Uneven heart beat (arrhythmias). This could
be life-threatening.
• Slowed or stopped breathing or stopped
heart beat. This could be life-threatening.
Possible side effects seen with other local
anaesthetics which might also be caused by
Marcain Polyamp Steripack include:
• Problems with your liver enzymes. This may
happen if you have long-term treatment with
this medicine.
• Damaged nerves. Rarely this may cause
permanent problems.
• Blindness which is not permanent or
problems with the muscles of the eyes that
are long-lasting. This may happen with some
injections given around the eyes.
Do not be concerned by this list of possible side
effects. You may not get any of them.
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 to store Marcain Polyamp Steripack
• Keep this medicine out of the sight and reach
of children.
• Do not use this medicine after the expiry
date which is stated on the container after
EXP. The expiry date refers to the last day
of that month.
• Store below 30°C. Do not freeze.
• Your doctor or the hospital will normally
store Marcain Polyamp Steripack and they
are responsible for the quality of the product
when it has been opened if it is not used
immediately. They are also responsible for
disposing of any unused Marcain Polyamp
Steripack correctly.
6. Contents of the pack and other information
What Marcain Polyamp Steripack contains
The active ingredient is bupivacaine
hydrochloride. Marcain Polyamp Steripack
comes in two strengths: 2.5 mg or 5 mg of
bupivacaine hydrochloride per ml of solution.
The other ingredients are sodium chloride,
sodium hydroxide, hydrochloric acid and water
for injections.
What Marcain Polyamp Steripack looks like
and contents of the pack
Marcain Polyamp Steripack is a solution for
injection. It comes in 10 ml or 20 ml plastic
ampoules in cartons of 5 or 10. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisations for Marcain
Polyamp Steripack 0.25% and 0.5% are held
by AstraZeneca UK Ltd, 600 Capability Green,
Luton, LU1 3LU, UK.
Marcain Polyamp Steripack 0.25% and 0.5%
is manufactured by AstraZeneca UK Limited,
Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK and AstraZeneca AB,
S-151 85 Södertälje, Sweden.

To listen to or request a copy of
this leaflet in Braille, large print
or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the
following information:
Product name
Reference number
Marcain Polyamp Steripack 0.25%
17901/0144
Marcain Polyamp Steripack 0.5%
17901/0145
This is a service provided by
the Royal National Institute of
Blind People.
This leaflet was last revised in November 2014.
© AstraZeneca 2014.
Marcain is a trade mark of the AstraZeneca
group of companies.
PAI 14 0034

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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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