Chirocaine 5mg/ml solution for injection/concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• 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 Chirocaine is and what it is used for
2. What you need to know before you are given Chirocaine
3. How you will be given Chirocaine
4. Possible side effects
5. How to store Chirocaine
6. Contents of the pack and other information

Chirocaine is used as a local anaesthetic to numb parts of the body before major surgery (for example as an epidural for caesarean section) and minor surgery (such as on the eye and mouth).

It is also used for pain relief:

• after major surgery
• during childbirth

Chirocaine can also be used with children to numb parts of the body before surgery and for pain relief after minor surgery, such as the repair of a groin hernia.

Chirocaine has not been tested in children less than 6 months of age.

• if you are allergic (hypersensitive) to levobupivacaine, to any similar local anaesthetics or to any of the other ingredients of this medicine (listed in section 6)
• if you have very low blood pressure
• as a type of pain relief given by injection into the area around the neck of the womb (the cervix) during the early stage of labour (paracervical block)
• to numb an area by injecting Chirocaine into a vein

Talk to your doctor or nurse before you are given Chirocaine if you have any of the diseases or conditions below. You may need to be checked more closely or given a smaller dose.

• if you have a heart condition
• if you suffer from diseases of the nervous system
• if you are weak or ill
• if you are elderly
• if you have liver disease.

Tell your doctor or nurse if you are taking or have recently taken or might take any other medicines.

In particular, tell them if you are taking medicines for:

• irregular heartbeats (such as mexiletine)
• fungal infections (such as ketoconazole) since this may affect how long Chirocaine stays in your body
• asthma (such as theophylline) since this may affect how long Chirocaine stays in your body.

If you are pregnant, breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nursefor advice before taking this medicine.

Chirocaine must not be a given for pain relief by injection into the area around the neck of the womb or cervix during childbirth (paracervical block).

The effect of Chirocaine on the child during the early stages of pregnancy is not known. Therefore, Chirocaine should not be used during the first three months of your pregnancy, unless your doctor thinks it is necessary.

It is not known if levobupivacaine passes into breast milk, however from the experience with a similar drug, only small amounts of levobupivacaine are expected to pass into breast milk. Breast-feeding is therefore possible after having a local anaesthetic.

The use of Chirocaine can have a considerable effect on the ability to drive or use machines. You must not drive or operate machinery until all the effects of Chirocaine and the immediate effects of surgery have worn off. Make sure you get advice about this matter from the doctor or nurse who is treating you, before leaving hospital.

This medicinal product contains 3.5 mg/mL sodium in the bag or ampoule solution to be taken into consideration by patients on a controlled sodium diet.

The amount of Chirocaine you will be given and how often it is given will depend on why it is being used and also on your health, age and weight. The smallest dose that can produce numbness in the required area will be used. The dose will be carefully worked out by your doctor.

When Chirocaine is used for pain relief during labour or for childbirth by caesarean section (an epidural), the dose used should be particularly carefully controlled.

If you get more Chirocaine than you should, you may have numbness of the tongue, dizziness, blurred vision, muscle twitching, severe breathing difficulties (including stopping breathing) and even fits (convulsions). If you notice any of these symptoms, tell your doctor immediately. Sometimes too much Chirocaine may also cause low blood pressure, fast or slow heartbeats and changes in your heart rhythm. Your doctor may need to give you other medicines to help stop these symptoms.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

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Ireland

The active substance is levobupivacaine (as hydrochloride).

Chirocaine 2.5 mg/ml solution for injection/concentrate for solution for infusion: One ml contains 2.5 mg levobupivacaine (as hydrochloride). Each ampoule contains 25 mg in 10 ml.

Chirocaine 5 mg/ml solution for injection/concentrate for solution for infusion: One ml contains 5 mg levobupivacaine (as hydrochloride). Each ampoule contains 50 mg in 10 ml.

The other ingredients are water for injections, sodium chloride, sodium hydroxide and a small quantity of hydrochloric acid.

Chirocaine solution for injection / concentrate for solution for infusion is available in strengths containing 2.5 mg or 5.0 mg of levobupivacaine per ml. It is a clear, colourless solution, in polypropylene ampoules. Each ampoule contains 25 mg or 50 mg levobupivacaine in a 10 ml ampoule. It is supplied in packs of 5, 10 or 20 ampoules. Not all pack size may be marketed.

United Kingdom

Ireland

This medicinal product is authorised in the Member States of the EEA under the following names:

Chirocaine: Sweden, Latvia, Netherlands, France, UK, Ireland, Finland, Greece, Slovenia, Belgium, Bulgaria, Czech Republic, Luxembourg, Italy, Croatia, Slovakia.

Chirocane: Spain