Levobupivacaine 1.25 mg/ml solution for 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4

1. What Levobupivacaine 1.25 mg/ml is and what it is used for
2. What you need to know before you are given Levobupivacaine 1.25 mg/ml
3. How to use Levobupivacaine 1.25 mg/ml
4. Possible side effects
5. How to store Levobupivacaine 1.25 mg/ml
6. Contents of the pack and other information

• 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 Levobupivacaine 1.25 mg/ml into a vein.

Talk to your doctor, pharmacist or nurse before you are given Levobupivacaine 1.25 mg/ml if you have any of the following diseases or conditions. You may need to be checked more closely or be given a smaller dose.

• 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, pharmacist or nurse if you are taking, or have recently taken or might take any other medicines even those that may be acquired without a medical prescrition. Particulary,tell them if you are taking medicines for:

• Irregular heartbeats (such as mexiletine)
• Fungal infections (such as ketoconazole) since this may affect how long Levobupivacaine 1.25 mg/ml stays in your body
• Asthma (such as theophylline) since this may affect how long Levobupivacaine 1.25 mg/ml stays in your body.

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

Levobupivacaine 1.25 mg/ml 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 Levobupivacaine 1.25 mg/ml in child during the early stage of pregnancy is not known. Therefore, Levobupivacaine 1.25 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 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 Levobupivacaine 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 Levobupivacaine and the inmmediate 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 15 mmol (3.5 mg/ml) sodium per 100 ml bag and 30 mmol (3.5 mg/ml) sodium per 200 ml bag which shall be taken into consideration by patients on a controlled sodium diet.

Adults:

The amount of Levobupivacaine 1.25 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.

When Levobupivacaine 1.25 mg/ml is used for pain relief during childbirth, the dose used should be carefully controlled.

Children:

Not recommended.

If you get more Levobupivacaine 1.25 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 convulsions. If you notice any of these symptoms, tell your doctor immediately. Sometimes too much Levobupivacaine 1.25 mg/ml may also cause low blood pressure, bradycardia or tachicardia 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).

Levobupivacaine 1.25 mg/ml: 1 ml contains 1.25 mg levobupivacaine (as hydrochloride).

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

Levobupivacaine 1.25 mg/ml is a clear, colourless solution. Each Polypropylene or PVC-free polyolefin bags contains 100 ml or 200 ml solution. It is supplied in packs of 5 and 24 bags of 100ml solution and 12 bags of 200 ml solution.

Not all pack sizes may be marketed

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