Ropivacaine hydrochloride 2 mg/ml solution for injection

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

1. What Ropivacaine solution for injection is and what it is used for
2. What you need to know before you take Ropivacaine solution for injection
3. How to take Ropivacaine solution for injection
4. Possible side effects
5. How to store Ropivacaine solution for injection
6. Contents of the pack and other information

• If you are allergic (hypersensitive) to ropivacaine hydrochloride or any of the other ingredients of Ropivacaine solution for injection (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 Ropivacaine solution for injection.

Talk to your doctor or pharmacist before taking Ropivacaine solution for injection:

• if you have heart, liver or kidney problems. Your doctor may need to adjust the dose of ropivacaine.
• if you have ever been told that you or anyone in your family has a rare disease of the blood pigment called "porphyria". Your doctor may need to give you a different anaesthetic medicine.
• about any diseases or medical conditions that you have.

Special care should be given:

• in newborn children as they are more susceptible to ropivacaine.
• in children up to and including 12 years as some injections to numb parts of the body are not established in younger children.
• in children up to and including 12 years as the use of Ropivacaine 7.5 mg and 10 mg/ml injections to numb parts of the body is not established. The strengths of Ropivacaine 2mg/ml and 5 mg/ml may be more appropriate

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 ropivacaine can affect the way some medicines work and some medicines can have an effect on ropivacaine.

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 ropivacaine 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 ropivacaine if you are taking these medicines. If you are taking either of these medicines, prolonged use of ropivacaine should be avoided.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine. It is not known if ropivacaine hydrochloride affects pregnancy or passes into breast milk.

Ropivacaine may make you feel sleepy and affect the speed of your reactions. After you have been given Ropivacaine solution for injection, you should not drive or use tools or machines until the next day.

2mg/ml:

Naropin contains 33.87mg sodium (main component of cooking/table salt) in each 10ml ampoule. This is the equivalent to 1.69% of the recommended maximum daily dietary intake of sodium for an adult.

Naropin contains 67.74mg sodium (main component of cooking/table salt) in each 20ml ampoule. This is the equivalent of 3.39% of the recommended maximum daily dietary intake of sodium for an adult.

7.5mg/ml:

Naropin contains 29.54mg sodium (main component of cooking/table salt) in each 10ml ampoule. This is the equivalent to 1.48% of the recommended maximum daily dietary intake of sodium for an adult.

Naropin contains 59.08mg sodium (main component of cooking/table salt) in each 20ml ampoule. This is the equivalent of 2.95% of the recommended maximum daily dietary intake of sodium for an adult.

10mg/ml:

Naropin contains 27.96mg sodium (main component of cooking/table salt) in each 10ml ampoule. This is the equivalent to 1.40% of the recommended maximum daily dietary intake of sodium for an adult.

Naropin contains 55.92mg sodium (main component of cooking/table salt) in each 20ml ampoule. This is the equivalent of 2.80% of the recommended maximum daily dietary intake of sodium for an adult.

Serious side effects from getting too much ropivacaine need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Ropivacaine 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 ropivacaine as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much ropivacaine, tell your doctor immediately.

More serious side effects from being given too much ropivacaine include problems with your speech, twitching of your muscles, tremors, trembling, fits (seizures), and loss of consciousness.

Sudden life-threatening allergic reactions (such as anaphylaxis, anaphylactic shock) are rare, affecting 1 to 10 users in 10,000. Possible symptoms include sudden onset of rash, itching or lumpy rash (hives); swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing; a feeling of loss of consciousness. If you think that Ropivacaine solution for injection is causing an allergic reaction, tell your doctor immediately.

Very common (affects more than 1 user in 10)

• Low blood pressure (hypotension). This might make you feel dizzy or light-headed.
• Feeling sick (nausea).

Common (affects 1 to 10 users in 100)

• Pins and needles.
• Feeling dizzy.
• Headache.
• Slow or fast heart-beat (bradycardia, tachycardia).
• High blood pressure (hypertension).
• Being sick (vomiting).
• Difficulty in passing urine.
• High temperature (fever) or shivering (chills).
• Back pain.

Uncommon (affects 1 to 10 users in 1,000)

• Anxiety.
• Decreased sensitivity or feeling in the skin.
• Fainting.
• Difficulty breathing.
• Low body temperature (hypothermia).
• Some symptoms can happen if the injection was given into a blood vessel by mistake, or if you have been given too much ropivacaine (see also “If you have been given too much Ropivacaine solution for injection” 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 1 to 10 users in 10,000)

• Heart attack (cardiac arrest).
• Uneven heart beat (arrhythmias).

Not known (frequency cannot be estimated from the available data)

• Horner's Syndrome.

• Numbness, due to nerve irritation caused by the needle or the injection. This does not usually last for long.
• Involuntary muscle movements (dyskinesia).

• Damaged nerves. Rarely (affecting 1 to 10 users in 10,000), this may cause permanent problems.
• If too much ropivacaine is given into the spinal fluid, the whole body may become numbed (anaesthetised).
• Receiving an epidural injection (injection into the space around your spinal nerves) may cause a disruption of a nerve pathway from the brain to the head and neck, especially in pregnant women, which may sometimes result in a condition called Horner’s syndrome. This is characterized by decrease in the size of the pupil, drooping of the upper eyelid, and failure of the sweat glands to make sweat. It will resolve on its own when the treatment is stopped.

In children, the side effects are the same as in adults except for low blood pressure which happens less often in children (affecting 1 to 10 children in 100) and being sick which happens more often in children (affecting more than 1 in 10 children).

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is ropivacaine hydrochloride. Ropivacaine solution for injection comes in the following strengths: 2 mg, 7.5 mg or 10 mg of ropivacaine hydrochloride per ml of solution.

The other ingredients are sodium chloride, hydrochloric acid and/or sodium hydroxide, and water for injections.

Ropivacaine is a clear, colourless solution for injection.

Ropivacaine 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.

Not all pack sizes may be marketed.

The Marketing Authorisations for Ropivacaine are held by

The manufacturers responsible for batch release are:

And