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Naropin

Ropivacaine hydrochloride
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Naropin. It does not contain all the information that is known about Naropin. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What NAROPIN is for

NAROPIN is a local anaesthetic (an-a-set-ik). It is injected into the body where it makes the nerves unable to pass messages to the brain. Depending on the amount used, NAROPIN will either totally stop pain or will cause a partial loss of feeling.
NAROPIN is used as an anaesthetic to stop the pain of surgery and/or to make childbirth less painful. NAROPIN is also used after surgery to treat post-operative pain.
Your doctor will have explained why you are being treated with NAROPIN and told you what dose you will be given.
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 more information.
NAROPIN is not addictive.

Before you are given NAROPIN

When you must not use it

NAROPIN must not be used if:

1. you have any allergies to

any ingredient listed at the end of this leaflet
any other local anaesthetics

2. you have problems controlling your low blood pressure

3. you have inflammation and/or an infection at the site of injection

Before you start to use it

You must tell your doctor if:

1. you have any allergies to other substances

2. you have any of these medical conditions

problems with your blood pressure or circulation
blood poisoning
problems with the clotting of your blood
acidosis, or too much acid in the blood
nerve problems
liver, kidney or heart problems
disease of the brain or spine, including meningitis, polio, cancer or infections.
muscle disease or weakness (e.g. myasthenia gravis)

3. you are pregnant, are breast feeding or intend to breast-feed.

Your doctor will discuss the possible risks and benefits of using NAROPIN during pregnancy and breast-feeding.
It may not be safe for you to be given NAROPIN if you have any of these conditions.
NAROPIN 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 been passed.

Taking other medicines

You must tell your doctor if you are taking any other medicines, including
medicines that control your heart beat
medicines used to thin the blood, including aspirin
low molecular weight heparin or other medicines used to prevent blood clots
fluvoxamine, a medicine used to treat depression.
enoxacin, a medicine used to treat bacterial infections.
ketoconazole, a medicine used to treat fungal infections
cimetidine, a medicine used to treat stomach ulcers or heartburn
medicines for depression
medicines that you buy at the pharmacy, supermarket or health food shop.
These medicines may affect the way NAROPIN works.
Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.
If you have not told your doctor about any of these things, tell them before you are given any NAROPIN.

Using NAROPIN

How it will be given

NAROPIN will be injected by your doctor into the skin, near a single nerve, or into an area which contains a large number of nerves. Naropin may also be directed into a surgical incision after surgery by a tube.
This will result in an area of numbness at or near the site of administration, or in an area that may seem unrelated to the site of administration. The latter will be the case if you are given an EPIDURAL injection (an injection around the spinal cord).
NAROPIN should not be injected directly into the blood.
The dosage you will be given will depend on your body size, age and the type of pain relief required. Your doctor will have had a lot of experience using NAROPIN or other local anaesthetics and will choose the best dose for you. They will be willing to discuss this decision with you.

Overdose

The doctor giving you NAROPIN will be experienced in the use of local anaesthetics, so it unlikely that you will be given too much.
However, if you are particularly sensitive to NAROPIN, or the dose is accidentally injected directly into your blood, you may develop problems with your sight, hearing, and get a numb feeling in or around the mouth, feel dizzy or stiff, or have twitchy muscles.
In rare cases, these effects may be followed by drowsiness and fits. In extreme cases you may have problems with your breathing or your heart and you may become unconscious.

While you are being given it

Things to be careful of

Be careful driving or operating machinery after you have been given NAROPIN.
You may be drowsy and your reflexes may be slow.
Do not drink alcohol while you are being given NAROPIN.
If you drink alcohol while you are being given NAROPIN your blood pressure may drop making you feel dizzy and faint.
Please talk to your doctor or pharmacist about these possibilities if you think they may bother you.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking NAROPIN.
NAROPIN will help relieve pain in most people, but it may have unwanted side-effects. 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 or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
nausea (feeling sick)
vomiting
headache
dizziness
irregular or slow heart beat
fever
a tingling feeling ("pins and needles")
shivering
difficulty passing urine
These are all mild side effects of NAROPIN.
Tell your doctor or a nurse immediately if you notice any of the following:
stiff or twitching muscles
painful joints
difficulty breathing
extreme dizziness
slow heart beat
pain in the chest
fits
On rare occasions you may lose consciousness.
These are all serious side effects. You may need urgent medical attention
Serious side effects are rare.
Tell your doctor if you notice anything else that is making you feel unwell.
Some people may get other side effects while taking NAROPIN.

After using it

Storage

NAROPIN will be stored by your doctor or pharmacist under the recommended storage conditions.
It should be kept in a cool dry place where the temperature stays below 30°C.

Disposal

Any NAROPIN which is not used, and which is left in the container, will be disposed of in a safe manner by your doctor, nurse or pharmacist.

Product description

NAROPIN is a clear colourless solution for injection or infusion.
The active ingredient is ropivacaine hydrochloride, plus
sodium chloride
hydrochloric acid or
sodium hydroxide for pH adjustment
water for injections.
Naropin® 0.2% (2.0 mg/mL), 0.75% (7.5 mg/mL) and 1% (10.0 mg/mL) are available in
10 mL and 20 mL polypropylene ampoules (Polyamp® DuoFit®)
Naropin® 0.2% (2.0 mg/mL) is also available in 100mL and 200mL polypropylene infusion bags (Polybag®)

Manufacturer

AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
North Ryde NSW 2113
This leaflet was prepared in March 2010.
Australian Registration numbers:
0.2% (2mg/mL)
10mL 52406
20mL 52405
100mL 52396
200mL 52395
0.75% (7.5mg/mL)
10mL 52400
20mL 52399
1% (10mg/mL)10mL 52398
20mL 52397
Naropin, Polyamp Duofit and Polybag are trademarks of the AstraZeneca group of companies.