Details for: NAROPIN
Company: ASPEN PHARMACARE CANADA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02229411 | NAROPIN | ROPIVACAINE HYDROCHLORIDE | 2 MG / ML | SOLUTION | BLOCK/INFILTRATION |
| 02229411 | NAROPIN | ROPIVACAINE HYDROCHLORIDE | 2 MG / ML | SOLUTION | EPIDURAL |
| 02229415 | NAROPIN | ROPIVACAINE HYDROCHLORIDE | 5 MG / ML | SOLUTION | BLOCK/INFILTRATION |
| 02229415 | NAROPIN | ROPIVACAINE HYDROCHLORIDE | 5 MG / ML | SOLUTION | EPIDURAL |
| 02229418 | NAROPIN | ROPIVACAINE HYDROCHLORIDE | 10 MG / ML | SOLUTION | EPIDURAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
NAROPIN is used as an anaesthetic and for pain relief. It can be used:
- to anaesthetise the area of the body where surgery is performed;
- to provide pain relief in labour and after surgery or acute injury.
What it does
NAROPIN temporarily prevents the nerves in the injected area from transmitting feelings of pain, heat or cold. You may still feel pressure and touch. In many cases the nerves to the muscles in the area will also be blocked. This may cause temporary weakness or paralysis. The duration of pain relief depends on the dose and how it is given.
When it should not be used
NAROPIN should not be used in patients who:
- are allergic to ropivacaine, any other “-caine” type anaesthetics, or any of the nonmedicinal ingredients in the product
What the medicinal ingredient is
ropivacaine hydrochloride
What the non-medicinal ingredients are
sodium chloride, hydrochloric acid and/or sodium hydroxide and water for injection.
What dosage form it comes in
NAROPIN 2mg/mL for infusion is available in 100 and 200 mL infusion bags.
NAROPIN 5 mg/mL for injection is available in 20 mL ampoules.
NAROPIN 10 mg/mL for injection is available in 10 mL and 20 mL ampoules
Warnings and precautions
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NAROPIN. Talk about any health conditions or problems you may have, including:
- about all health problems you have now or have had in the past;
- about other medicines you take, including ones you can buy without a prescription;
- if you are taking drugs used to treat irregular heart activity (anti-arrhythmics, such as amiodarone);
- if you have ever had a bad, unusual allergic reaction to ropivacaine or any other medicines ending with “-caine”;
- if you have a heart, liver or kidney disease, since the dose of NAROPIN may have to be adjusted;
- if you are pregnant, plan to become pregnant or are breastfeeding;
- if you have been diagnosed with porphyria, a rare hereditary disorder.
Other warnings you should know about:
- NAROPIN could cause irreversible joint damage if it is used to manage your pain after joint surgery.
- NAROPIN may temporarily interfere with your ability to drive or operate tools or machinery.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication
The following may interact with NAROPIN:
- drugs that treat heart rhythm problems (e.g. mexiletine, amiodarone);
- other local anaesthetics;
- sedative drugs;
- if using NAROPIN for a long time:
- fluvoxamine or imipramine, used to treat depression
- enoxacin, an antibiotic
- theophylline, used to treat lung diseases
Proper use of this medication
Usual Dose
NAROPIN should be administered by a doctor. It can be administered by an anaesthesia
professional under the supervision of a doctor.
The dose to be given is decided by the doctor, based on the clinical need and your physical
condition.
Overdose
You can have serious side effects from getting too much NAROPIN. You may need treatment to deal with the side effects from the overdose. The doctor treating you is trained to deal with these situations. The first signs of being given too much NAROPIN are usually as follows:
- Feeling dizzy or light-headed.
- Numbness of the lips and around the mouth.
- Numbness of the tongue.
- Hearing problems.
- Tingling in the ears.
- Problems with your sight (vision).
- problems with speech
- twitching muscles
- tremors
- trembling
- seizures
- loss of consciousness
- change in heart rhythm
- heart attack
- decrease in blood pressure
Missed Dose
Side effects and what to do about them
These are not all the possible side effects you may feel when taking NAROPIN. If you
experience any side effects not listed here, contact your healthcare professional.
Medicines affect different people in different ways. Just because side effects have occurred in
some patients, does not mean that you will get them.
Tell your doctor as soon as possible if you do not feel well during treatment with NAROPIN.
Possible side effects include: Numbness, due to nerve irritation caused by the needle or the
injection. This does not usually last for long.
Possible side effects seen with other local anaesthetics which might also be caused by
NAROPIN include:
Damaged nerves. Rarely (affecting less than 1 in 1,000 people), this may cause permanent
problems.
If too much NAROPIN is given into the spinal fluid, the whole body may become numbed
(anaesthetised).
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Very Common | |||
| Low blood pressure: feeling dizzy or light-headed | ✘ | ||
| Nausea | ✘ | ||
| Common | |||
| Pins and needles | ✘ | ||
| Feeling dizzy | ✘ | ||
| Headache | ✘ | ||
| Slow or fast heart beat | ✘ | ||
| High blood pressure | ✘ | ||
| Vomiting | ✘ | ||
| Difficulty in passing urine | ✘ | ||
| High temperature (fever) or stiffness (rigor) | ✘ | ||
| Back Pain | ✘ | ||
| Uncommon | |||
| Anxiety | ✘ | ||
| Decreased sensitivity or feeling in the skin | ✘ | ||
| Fainting | ✘ | ||
| Difficulty breathing | ✘ | ||
| Low body temperature | ✘ | ||
| Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much NAROPIN: seizures, feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with sight, problems with speech, stiff muscles, and trembling | ✘ | ||
| Numbness | ✘ | ||
| Nerve Damage | ✘ | ||
| Rare | |||
| Heart attack | ✘ | ||
| Severe allergic reaction (anaphylaxis): sudden onset of rash, itching or lumpy rash (hives); swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing. | ✘ | ||
| Uneven heart beat | ✘ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
How to store
Your doctor or the hospital will normally store NAROPIN. The staff is responsible for storing,
dispensing and disposing of NAROPIN in the correct way.
NAROPIN will be kept out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
If you want more information about NAROPIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.apsenpharma.ca, or by calling 1-844-330-1213.
This leaflet was prepared by: Aspen Pharmacare Canada Inc,
1155 North Service Road, Suite 8,
Oakville, ON, L6M 3E3
Trademarks are owned by or licensed to the Aspen Group of companies.
© 2019 Aspen Group of companies or its licensor. All rights reserved.
Last Revised: March 25, 2019