Ropivacaine hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some of the common questions people ask about ROPIVACAINE-AFT. It does not contain all the information that is known about ROPIVACAINE-AFT.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor will have weighed the risks of you using ROPIVACAINE-AFT against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What ROPIVACAINE-AFT is for
ROPIVACAINE-AFT 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, ROPIVACAINE-AFT will either totally stop pain or will cause a partial loss of feeling.
ROPIVACAINE-AFT is used as an analgesic to make childbirth less painful. ROPIVACAINE-AFT is also used after surgery to treat post-operative pain.
Your doctor will have explained why you are being treated with ROPIVACAINE-AFT 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.
ROPIVACAINE-AFT is not addictive.
Before you are given ROPIVACAINE-AFT
When you must not use it
ROPIVACAINE-AFT must not be used if:
- you have any allergies to
- any ingredient listed at the end of this leaflet
- any other local anaesthetics
- you have problems controlling your low blood pressure
- you have inflammation and/or an infection at the site of injection
Before you start to use it
You must tell your doctor if:
- you have any allergies to other substances
- 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)
- you are pregnant, are breast feeding or intend to breast-feed.
Your doctor will discuss the possible risks and benefits of using ROPIVACAINE-AFT during pregnancy and breast-feeding.
It may not be safe for you to be given ROPIVACAINE-AFT if you have any of these conditions.
ROPIVACAINE-AFT 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 ROPIVACAINE-AFT 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 ROPIVACAINE-AFT.
Using ROPIVACAINE-AFT
How it will be given
ROPIVACAINE-AFT may be injected by your doctor into the skin, or infused near a single nerve, or into an area which contains a large number of nerves. ROPIVACAINE-AFT 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 infusion (an infusion around the spinal cord).
ROPIVACAINE-AFT 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 ROPIVACAINE-AFT 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 ROPIVACAINE-AFT 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 ROPIVACAINE-AFT, 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 ROPIVACAINE-AFT. You may be drowsy and your reflexes may be slow.
Do not drink alcohol while you are being given ROPIVACAINE-AFT. If you drink alcohol while you are being given ROPIVACAINE-AFT 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 ROPIVACAINE-AFT.
ROPIVACAINE-AFT will help relieve pain in most people, but it may have unwanted side-effects. All medicines can have side-effects but sometimes they are serious, but 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 ROPIVACAINE-AFT.
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 ROPIVACAINE-AFT
After using it
Storage
ROPIVACAINE-AFT 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 25°C. Do not refrigerate. Do not freeze.
Disposal
Any ROPIVACAINE-AFT 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
ROPIVACAINE-AFT is a clear colourless solution for infusion.
The active ingredient isropivacaine hydrochloride, plus
sodium chloride
hydrochloric acid or
sodium hydroxide for pH adjustment
water for injections.
ROPIVACAINE-AFT 0.2% (2.0 mg/mL) is available in 100 mL and 200 mL polyolefin bag
Sponsor
AFT Pharmaceuticals Pty Ltd
113 Wicks Road, North Ryde
Sydney, NSW 2113
Australia
Free Phone: 1800 238 74276
Email:customer.service@aftpharm.com
Date of Preparation
This leaflet was prepared on 20 December 2019.
Published by MIMS October 2022