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Bupivacaine 5mg/ml Solution for Injection

Active Ingredient:
bupivacaine hydrochloride
Company:  
Baxter Healthcare Ltd See contact details
ATC code: 
N01BB01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 04 Dec 2025
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 00116/0671.

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Bupivacaine 2.5mg/ml & 5mg/ml Solution for Injection

Package Leaflet: Information for the User

Bupivacaine 2.5mg/ml Solution for Injection

Bupivacaine 5 mg/ml Solution for Injection

bupivacaine hydrochloride monohydrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist or nurse.
  • If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Bupivacaine is and what it is used for

Bupivacaine contains the active substance Bupivacaine hydrochloride monohydrate.

It belongs to a group of medicines called local anaesthetics.

Bupivacaine is used to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:

  • Numb parts of the body during surgery in adults and children above 12 years.
  • Relieve pain in adults, infants and children above 1 year of age

2. What you need to know before you use Bupivacaine
Do not use Bupivacaine:
  • If you are allergic to bupivacaine hydrochloride monohydrate, 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.

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.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Bupivacaine.

  • If you have heart, liver or kidney problems. This is because your doctor may need to adjust the dose of Bupivacaine. Problems with your liver enzymes may occur, particularly if you have long-term treatment with this medicine.
  • If you have epilepsy.
  • If you have been told that you have decreased volume of blood (hypovolaemia).

Children

In children aged less than12 years as some injections of Bupivacaine in order to numb parts of the body during surgery are not established in younger children. The use of Bupivacaine is not established in children less than 1 year of age.

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.

Other medicines and Bupivacaine

Tell your doctor or pharmacist 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 can affect the way some medicines work and some medicines can have an effect on Bupivacaine.

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

  • Medicines used to treat an uneven heart beat (arrhythmia) such as lidocaine, mexiletine or amiodarone.

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

Pregnancy, breast-feeding and fertility

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

Pregnancy

There are no or limited amount of data from the use of bupivacaine in pregnant women.

Breast-feeding

Bupivacaine enters the mother’s milk, if you are breast-feeding you should discuss options with your doctor.

Fertility

There are no data on the effect of bupivacaine on human fertility.

Driving and using machines

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

Bupivacaine Solution contains sodium

This medicinal product contains 3.15 mg/ml (0.14 mmol) sodium per dose. Your doctor will take this into account if you are on a sodium controlled diet.

3. How to use Bupivacaine

Bupivacaine will be given to you by your doctor. Your doctor will know the correct way to give you this medicine.

The dose that your doctor gives you will depend on the type of pain relief that you need and the part of your body that the medicine will be injected into. It will also depend on your body size, age, and physical condition. Usually one dose will last long enough but more doses may be given if the surgery takes a long time.

Bupivacaine will be given to you as an injection or infusion. The part of the body where you are injected will depend on why you are being given Bupivacaine. Your doctor will give you Bupivacaine in one of the following places:

  • Near to the part of the body that needs to be numbed.
  • In an area away from the part of the body that needs to be numbed. This is the case if you are given an epidural injection (an injection around the spinal cord).

When Bupivacaine is injected into the body in one of these ways, it stops the nerves from being able to pass pain messages to the brain. It will slowly wear off when the medical procedure is over.

Use in children and adolescents

Depending on the type of required analgesia Bupivacaine is injected slowly either into the epidural space (part of the spine) or other parts of the body 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.

If you use more Bupivacaine than you should

Serious side effects from getting too much Bupivacaine are unlikely. They need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Bupivacaine 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 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, tell your doctor immediately.

More serious side effects from being given too much Bupivacaine include twitching of your muscles, fits (seizures), being sick (vomiting) and loss of consciousness.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have also been reported:

Severe allergic reactions (rare, may affect up to 1 in 1,000 people)

If you have a severe allergic reaction, tell your doctor immediately. The signs may include sudden onset of:

  • Swelling of your face, lips, tongue or throat. This may make it difficult to swallow.
  • Severe or sudden swelling of your hands, feet and ankles.
  • Difficulty breathing.
  • Severe itching of the skin (with raised lumps).

Other possible side effects:

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).

Common (may affect up to 1 in 10 people)

  • Being sick (vomiting).
  • Feeling dizzy.
  • Pins and needles.
  • High blood pressure (hypertension).
  • Slow heart beat.
  • Problems passing water.

Uncommon (may affect up to 1 in 100 people)

  • Feeling light-headed.
  • Fits (seizures).
  • Numbness of the tongue or around the mouth.
  • Ringing in the ears or being sensitive to sound.
  • Difficulty in speaking.
  • Blurred sight or double vision.
  • Loss of consciousness.
  • Shaking (tremors).
  • Twitching of your muscles.

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

  • Nerve damage that may cause changes in sensation or muscle weakness (neuropathy). This may include peripheral nerve damage.
  • A condition called arachnoiditis (inflammation of the membrane that surrounds the spinal cord). The signs include a stinging or burning pain in the lower back or legs and tingling, numbness or weakness in the legs.
  • Weak or paralysed legs.
  • Uneven heart beat (arrhythmias). This could be life-threatening.
  • Slowed or stopped breathing or stopped heart beat. This could be life-threatening.

Possible side effects seen with other local anaesthetics which might also be caused by Bupivacaine include:
  • Damaged nerves. Rarely this may cause permanent problems.
  • Blindness which is not permanent or problems with the muscles of the eyes that are long-lasting. This may happen with some injections given around the eyes.

Additional side effects in children and adolescents

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report any side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland

HPRA Pharmacovigilance
Website:www.hpra.ie

Malta

ADR Reporting
Website: https://medicinesauthority.gov.mt/adrportal

5. How to store Bupivacaine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and the box after “EXP”. The expiry date refers to the last day of that month.

Store below 30°C. Do not refrigerate or freeze.

Shelf life after dilution:

Chemical and physical in use stability has been demonstrated for 36 hours at 25°C.

From a microbiological point of view the product should be used immediately.

After first opening: to be used immediately

Only clear solutions practically free from particles should be used. Do not use if container is damaged.

Any unused solution should be discarded.

Do not throw away any medicines via waste-water or with household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Bupivacaine contains

The active substance is bupivacaine hydrochloride monohydrate.

For 2.5mg/ml

Each ml contains 2.5 mg of Bupivacaine hydrochloride monohydrate

Each 10 ml glass vial contains 25 mg of bupivacaine hydrochloride monohydrate.

Each 20 ml glass vial contains 50 mg of bupivacaine hydrochloride monohydrate.

For 5 mg/ml

Each ml contains 5 mg of bupivacaine hydrochloride monohydrate

Each vial with 10 ml contains 50 mg of bupivacaine hydrochloride monohydrate.

Each vial with 20 ml contains 100 mg of bupivacaine hydrochloride monohydrate.

Other ingredients are Sodium Chloride, 0.4% Sodium hydroxide, 0.85% hydrochloric acid and Water for injections.

What Bupivacaine looks like and content of the pack:

Bupivacaine is a clear, colourless, aqueous, sterile solution for injection supplied in 10ml and 20 ml glass vial.

Pack sizes:

5, 10 X 10 ml solution for injection

1, 5, 10 X 20 ml solution for injection

Not all packs sizes may be marketed.

Marketing Authorization Holder:
United Kingdom:
Baxter Healthcare Limited
Caxton way
Thetford
Norfolk
IP24 3SE

Ireland & Malta:
Baxter Holding B.V.
Kobaltweg 49
3542CE Utrecht
Netherlands

Manufacturer:
Baxter
Boulevard René Branquart, 80
7860 Lessines
Belgium

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom(Northern Ireland) under the following names:

Germany Bupivacain-Baxter 2,5 mg/ml Injektionslösung

Bupivacain-Baxter 5 mg/ml Injektionslösung

Estonia Bupivacaine Baxter 5 mg/ml süstelahus

Ireland Bupivacaine 2.5mg/ml Solution for Injection

Bupivacaine 5mg/ml Solution for Injection

Latvia BUPIVACAINE BAXTER 5 mg/ml šķīdums injekcijām

Lithuania Bupivacaine Baxter 5mg/ml injekcinis tirpalas

Malta Bupivacaine 2.5mg/ml Solution for Injection

Bupivacaine 5.0mg/ml Solution for Injectio

Netherlands Bupivacaine HCl Baxter 2,5 mg/ml oplossing voor injectie

Bupivacaine HCl Baxter 5 mg/ml oplossing voor injectie

United Kingdom Bupivacaine 2.5mg/ml Solution for Injection

Bupivacaine 5.0mg/ml Solution for Injection

This leaflet was last revised in August 2025.

1400008718

Baxter Healthcare Ltd
Company image
Address
Caxton Way, Thetford, Norfolk, IP24 3SE, UK
Medical Information e-mail
[email protected]
Medical Information Direct Line
0800 0260516
WWW
https://www.baxterhealthcare.co.uk/
Medical Information Website
https://medinfo.baxterhealthcare.co.uk
Customer Care direct line
0800 028 9881
E-mail
[email protected]