Bupivacaine 0.5% w/v with glucose solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, 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 Bupivacaine with glucose solution for injection is and what it is used for
2. What you need to know before Bupivacaine with glucose solution for injection is given to you
3. How Bupivacaine with glucose solution for injection is given to you
4. Possible side effects
5. How to store Bupivacaine with glucose solution for injection
6. Contents of the pack and other information

• If you are allergic to bupivacaine hydrochloride or any of the other ingredients of this medicine (listed in Section 6).
• If you are allergic to any other local anaesthetics of the same class (such as lidocaine or ropivacaine).
• If you have a skin infection near to where the injection will be given.
• If you have blood poisoning (septicaemia).
• If you have something called cardiogenic shock (a serious condition where the heart is unable to supply enough blood to the body).
• If you have something called hypovolaemic shock (very low blood pressure leading to collapse).
• If you have problems with clotting of your blood.
• If you have diseases of the brain or spine such as meningitis, polio or spondylitis.
• If you have a severe headache caused by bleeding inside the head (intracranial haemorrhage).
• If you have problems with your spinal cord due to anaemia.
• If you have had a recent trauma, tuberculosis or tumours of the spine.

You must not be given this medicine if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given this medicine.

Talk to your doctor or nurse before having Bupivacaine injection:

• If you have heart, liver or kidney problems. This is because your doctor may need to adjust the dose of Bupivacaine injection.
• If you have been told that you have decreased volumes of blood (hypovolaemia).
• If you have fluid in your lungs.

If you are not sure if any of the above apply to you, talk to your doctor or nurse before you are given this medicine.

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

In particular, tell your doctor if you are taking any of the following medicines:

• Other local anaesthetics.
• Medicines used to treat an uneven heart beat (arrhythmia), such as amiodarone.

Your doctor needs to know about these medicines to be able to work out the correct dose of Bupivacaine injection for you.

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

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

This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule. This is considered essentially sodium free.

Bupivacaine injection is injected slowly into the spinal channel (part of the spine) by a doctor experienced in paediatric anaesthetic techniques. Dosage depends on the age and weight of the patient and will be determined by the doctor.

When Bupivacaine injection is injected, it stops the nerves from being able to pass pain messages to the brain.

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

More serious side effects from being given too much Bupivacaine injection include tremors, fits (seizures) and heart problems.

Very common (may affect more than 1 in 10 people)

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

Common (may affect up to 1 in 10 people)

• Headache.
• Being sick (vomiting).
• Difficulty in passing urine or being incontinent.

Uncommon (may affect up to 1 in 100 people)

• Itching, numbness, burning or tingling of the skin.
• Back pain.
• Muscle weakness for a short time.

Rare (may affect up to 1 in 1,000 people)

• Heart attack.
• Difficulty breathing.
• Weakness or loss of feeling or loss of movement in your lower body.
• Long-lasting pain in your back or legs.
• Reduced or strange sensation or feeling in the skin.

Some symptoms can happen if the injection was given in the wrong way by mistake, or if you have been given it with other local anaesthetics. These include fits (seizures), feeling dizzy or light-headed, trembling and numbness of the tongue.

Possible side effects seen with other local anaesthetics which might also be caused by Bupivacaine injection include:

• Damaged nerves. Rarely (affecting less than 1 in 1,000 people), this may cause permanent problems.
• If too much Bupivacaine injection is given into the spinal fluid, the whole body may become numbed (anaesthetised).

Side effects in children are similar to those in adults.

Do not be concerned by this list of possible side effects. You may not get any of them.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active ingredient is bupivacaine hydrochloride anhydrous. Each millilitre (ml) of solution contains 5 mg of bupivacaine hydrochloride anhydrous.

The other ingredients are glucose anhydrous and/or glucose monohydrate, sodium hydroxide and water for injections.

Bupivacaine injection is a clear, colourless solution for injection. It comes in glass ampoules containing 4 ml of solution.

Bupivacaine with glucose solution for injection is manufactured by

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Product name Bupivacaine 0.5% w/v with glucose solution for injection

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