Naropin 2 mg/ml, 7.5 mg/ml, 10 mg/ml solution for injection
Naropin 2 mg/ml solution for infusion
Ropivacaine hydrochloride
Read all of this leaflet carefully before Naropin is given to 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 symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
- 1. What Naropin is and what it is used for
- 2. Before Naropin is given to you
- 3. How Naropin is given to you
- 4. Possible side effects
- 5. How to store Naropin
- 6. Further information
What Naropin is and what it is used for
The name of your medicine is "Naropin solution for injection" or "Naropin solution for infusion".
- It contains a medicine called ropivacaine hydrochloride.
- It belongs to a group of medicines called local anaesthetics.
- It will be given to you either as an injection or as an infusion, depending on what it is being used for.
Naropin 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, including having a baby by Caesarean section.
- Relieve pain during childbirth, after surgery, or after an accident.
Before Naropin is given to you
You must not be given Naropin:
- If you are allergic (hypersensitive) to ropivacaine hydrochloride or any of the other ingredients of Naropin (see Section 6: Further information).
- If you are allergic to any other local anaesthetics of the same class (such as lidocaine or bupivacaine).
- If you have been told that you have decreased volume of blood (hypovolaemia).
- Into a blood vessel to numb a specific area of your body, or into the neck of the womb to relieve pain during childbirth.
If you are not sure if any of the above apply to you, talk to your doctor before you are given Naropin.
Take special care with Naropin:
- If you have heart, liver or kidney problems. Tell your doctor if you have any of these problems because your doctor may need to adjust the dose of Naropin.
- If you have ever been told that you have a rare disease of the blood pigment called "porphyria" or if anyone in your family has it. Tell your doctor if you or a family member has porphyria because your doctor may need to give you a different anaesthetic medicine.
- Tell your doctor before treatment about any diseases or medical conditions that you have.
Taking other medicines
Please tell your doctor if you are taking, or have recently taken, any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Naropin can affect the way some medicines work and some medicines can have an effect on Naropin.
In particular, tell your doctor if you are taking any of the following medicines:
- Other local anaesthetics.
- Strong pain killers, such as morphine or codeine.
- Drugs used to treat an uneven heart beat (arrhythmia), such as lidocaine and mexiletine.
Your doctor needs to know about these medicines to be able to work out the correct dose of Naropin for you.
Also tell your doctor if you are taking any of the following medicines:
- Medicines for depression (such as fluvoxamine)
- Antibiotics to treat infections caused by bacteria (such as enoxacin).
This is because your body takes longer to get rid of Naropin if you are taking these medicines. If you are taking either of these medicines, prolonged use of Naropin should be avoided.
Pregnancy and breast-feeding
Before you are given Naropin, tell your doctor if you are pregnant, planning to get pregnant, or if you are breast-feeding. It is not known if ropivacaine hydrochloride affects pregnancy or passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Naropin may make you feel sleepy and affect the speed of your reactions. After you have been given Naropin, you should not drive or use tools or machines until the next day.
Important information about some of the ingredients of Naropin
Naropin contains up to 3.7 milligrams (mg) of sodium in each millilitre (ml) of solution. If you are on a sodium controlled diet you will need to take this into account.
How Naropin is given to you
Naropin will be given to you by a doctor. The dose that your doctor gives you will depend on the type of pain relief that you need. It will also depend on your body size, age, and physical condition.
Naropin will be given to you as an injection or as an infusion. The part of the body where it will be used will depend on why you are being given Naropin. Your doctor will give you Naropin in one of the following places:
- The part of the body that needs to be numbed.
- 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 or infusion (into the area around the spinal cord).
When Naropin is used in one of these ways, it stops the nerves from being able to pass pain messages to the brain. It will stop you feeling pain, heat or cold in where it is used however you may still have other feelings like pressure or touch.
Your doctor will know the correct way to give you this medicine.
If you have been given too much Naropin
Serious side effects from getting too much Naropin need special treatment and 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.
- Problems with your sight (vision).
To reduce the risk of serious side effects, your doctor will stop giving you Naropin as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Naropin, tell your doctor immediately.
More serious side effects from being given too much Naropin include problems with your speech, twitching of your muscles, tremors, trembling, fits (seizures), and loss of consciousness.
Possible side effects
Like all medicines, Naropin may cause side effects although not everybody gets them.
Important side effects to look out for:
Sudden life-threatening allergic reactions (such as anaphylaxis) are rare, affecting less than 1 in 1,000 people. Possible symptoms include 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. If you think that Naropin is causing an allergic reaction, tell your doctor immediately.
Other possible side effects:
Very common (affects more than 1 in 10 people)
- Low blood pressure (hypotension). This might make you feel dizzy or light-headed.
- Feeling sick (nausea).
Common (affects less than 1 in 10 people)
- Pins and needles.
- Feeling dizzy.
- Being sick (vomiting).
- Slow or fast heart beat (bradycardia, tachycardia).
- High blood pressure (hypertension).
- High temperature (fever) or stiffness (rigor).
- Back pain.
- Headache.
- Difficulty in passing urine.
Uncommon (affects less than 1 in 100 people)
- Anxiety.
- Fainting.
- Difficulty breathing.
- Decreased sensitivity or feeling in the skin.
- Low body temperature (hyporthermia.)
- Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much Naropin (see also "If you have been given too much Naropin" above). These include fits (seizures), feeling dizzy or light-headed, numbness of the lips and around the mouth, numbness of the tongue, hearing problems, problems with your sight (vision), problems with your speech, stiff muscles, and trembling.
Rare (affects less than 1 in 1,000 people)
- Heart attack (cardiac arrest).
- Uneven heart beat (arrhythmias).
Other 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).
Children
In children, the side effects are the same as in adults except for low blood pressure which happens less often in children (affecting less than 1 in 10 children) and being sick which happens more often in children (affecting more than 1 in 10 children).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How to store Naropin
- Keep out of the reach and sight of children.
- Do not use after expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
- Do not store above 30°C. Do not freeze.
- Your doctor or the hospital will normally store Naropin 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 Naropin correctly.
Further information
What Naropin contains
The active ingredient is ropivacaine hydrochloride. Naropin comes in the following strengths: 2 mg, 7.5 mg or 10 mg of ropivacane hydrochloride per ml of solution.
The other ingredients are sodium chloride, hydrochloric acid and/or sodium hydroxide, and water for injections.
What Naropin looks like and contents of the pack
Naropin is a clear, colourless solution for injection or infusion.
Naropin solution for injection 2 mg/ml, 7.5 mg/ml and 10 mg/ml is available as follows:
- 10 ml polypropylene ampoules (Polyamp) in packs of 5 or 10.
- 20 ml polypropylene ampoules (Polyamp) in packs of 5 or 10.
Naropin solution for infusion 2 mg/ml is available as follows:
- 100 ml polypropylene bags (Polybag) in packs of 5.
- 200 ml polypropylene bags (Polybag) in packs of 5.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisations for Naropin are held by
The manufacturer responsible for batch release is
and
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria, Belgium, Denmark, Germany, Greece, Ireland, Luxembourg, Netherlands, Spain, United Kingdom: Naropin.
France, Portugal: Naropeine.
Italy: Naropina.
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 Naropin 2 mg/ml infusion & 2, 7.5, 10 mg/ml injection
Reference number 17901/0149, 0150, 0151, 0152
This is a service provided by the Royal National Institute of Blind People
Leaflet updated: September 2008
© AstraZeneca 2008.
Naropin is a trade mark of the AstraZeneca group of companies.
PAI 08 0056
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