Levobupivacaine 7.5 mg/ml solution for injection/infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or pharmacist.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4

1. What Levobupivacaine 7.5 mg/ml is and what it is used for
2. What you need to know before you use Levobupivacaine 7.5 mg/ml.
3. How to use Levobupivacaine 7.5 mg/ml
4. Possible side effects
5. How to store Levobupivacaine 7.5 mg/ml
6. Contents of the pack and other information

Levobupivacaine is used as a local anaesthetic to make numb parts of the body before a major surgery (except in cases ofcaesarean section) and in minor surgery (such as on the eye and mouth.)

It is also used for:

• pain relief after major surgery

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

Levobupivacaine 7.5 mg/ml 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.
• To numb an area of the body by injecting Levobupivacaine 7.5 mg/ml into a vein.
• As a type of pain relief during delivery.

Talk to your doctor, pharmacist or nurse before you are given Levobupivacaine 7.5 mg/ml if you have any of the following diseases or conditions below. You may need to be checked more closely or be given a smaller dose.

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

Tell your doctor, pharmacist or nurse if you are taking, using or have recently taken or might take any other medicines even those that may be acquired without a medical prescription. Particularly, if you are taking medicines for:

• Irregular heartbeats (such as mexiletine)
• Fungal infections (such as ketoconazole) since this may affect how long Levobupivacaine 7.5 mg/ml stays in your body
• Asthma (such as theophylline) since this may affect how long Levobupivacaine 7.5 mg/ml stays in your body.

If you are pregnant, breastfeeding or think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.

Levobupivacaine 7.5 mg/ml must not be givenas pain relief during labour or as a labour or as a local anaesthetic during caesarean section.

The effect of Levobupivacaine 7.5 mg/ml on the child during the early stage of pregnancy is not known. Therefore, Levobupivacaine 7.5 mg/ml 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 similar drugs, 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 Levobupivacaine can have a considerable effect on the ability to drive or use machiness. You must not drive or operate machinery until the effects of Levobupivacaine 7.5 mg/ml and the inmediate 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 which shall be taken into consideration with patients on a controlled sodium diet.

The amount of Levobupivacaine 7.5 mg/ml 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.

If you get more Levobupivacaine 7.5 mg/ml 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 Levobupivacaine 7.5 mg/ml may also cause low blood pressure, bradycardia or tachycardia 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system 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 substance is levobupivacaine (as hydrochloride).

A milliliter of solution contains 7.5 mg of levobupivacaine (as hydrochloride). Each 10 ml ampoule contains 75 mg.

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

Levobupivacaine 7.5 mg/ml is a clear, colourless solution which comes in type-1 glass ampoules.

Each ampoule contains 75 mg of levobupivacaine in one 10 ml ampoule. It is supplied in packages of 5 and 10 ampoules.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Manufacturing Responsible:

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