- bupivacaine hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0564.
Bupivacaine Hydrochloride 0.25% w/v and 0.5% w/v Solution for Injection
PATIENT INFORMATION LEAFLET
Bupivacaine Hydrochloride 0.25%w/v solution for Injection and 0.5% w/v solution for Injection
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This product will be referred to as Bupivacaine Hydrochloride Injection from here on.
In this leaflet:
1. What Bupivacaine Hydrochloride Injection is and what it is used for
2. Before you are given Bupivacaine Hydrochloride Injection
3. How Bupivacaine Hydrochloride Injection is given to you
4. Possible side effects
5. How to store Bupivacaine Hydrochloride Injection
6. Further information
1. WHAT BUPIVACAINE HYDROCHLORIDE INJECTION IS AND WHAT IT IS USED FOR
Bupivacaine belongs to a group of medicines called amide-type anaesthetics.
Bupivacaine Hydrochloride injection 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:
Bupivacaine Hydrochloride Injection may be used as follows:
2. BEFORE YOU ARE GIVEN BUPIVACAINE HYDROCHLORIDE INJECTION
You should not be given this medicine if:
You should not be given this Injection as an epidural if:
Speak to your doctor or midwife if one of these applies to you before you are given this medicine.
Take special care and tell your doctor or midwife if:
Taking other medicines:
Tell your doctor or midwife before you are given this medicine if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some drugs can interact with Bupivacaine Hydrochloride Injection which can significantly alter their effects. These drugs include:
Some drugs may increase the risk of side effects with Bupivacaine Hydrochloride Injection in certain situations. These drugs include:
If you are already taking one of these medicines, speak to you doctor or midwife before you receive Bupivacaine Hydrochloride Injection.
Pregnancy and breastfeeding:
Tell your doctor/midwife before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant, or are breastfeeding. There is no evidence of harmful effects in pregnancy or breastfeeding. However, as with all drugs Bupivacaine Hydrochloride Injection should only be given in early pregnancy if absolutely necessary.
In children < 12 years as some injections of Bupivacaine Hydrochloride injection in order to numb parts of the body during surgery are not established in younger children. Bupivacaine Hydrochloride injection is not established in children < 1 year.
Driving and using machines:
Certain areas of your body will be numb for about 2-4 hours after having this medicine.
If this is likely to affect your ability to drive or use machinery you should wait for the effect to wear off. In general, it is wise to ask your doctor whether it is safe to drive.
3. HOW BUPIVACAINE HYDROCHLORIDE INJECTION IS GIVEN TO YOU
Bupivacaine Hydrochloride Injection should only be administered by a doctor who will, in the case of an epidural injection, have the necessary knowledge and experience in the technique of epidural anaesthesia.
Before administrating an epidural Injection, your doctor may inject a test dose of Bupivacaine Hydrochloride Injection to ensure that the solution is not directed into a blood vessel.
Your doctor will decide on the most suitable dosage for your particular case and may decide to reduce the dose if you are young, or elderly, or in a weak condition. If you are concerned about how much of this medicine you have received, speak to your doctor immediately.
Use in children and adolescents
Depending on the type of required analgesia Bupivacaine Hydrochloride Injection is injected slowly either into the epidural space (part of the spine) or other parts of the body by an anaesthesiologist experienced in paediatric anaesthetic techniques. Dosage depends on the age and weight of the patient and will be determined by the anaesthesiologist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Bupivacaine Hydrochloride Injection can sometimes cause side effects, although not everyone gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately.
Other serious side effects are also rare, but may occur if too much Bupivacaine Hydrochloride Injection is given or if the drug is unintentionally injected into a blood vessel.
If you notice any of the following effects inform your doctor immediately.
Other possible side effects:
Very common (affects more than 1 in 10 people):
Common (affects 1 to 10 people in 100)
Uncommon (affects 1 to 10 people in 1000)
Rare (affects 1 to 10 people in 10,000)
Possible side effects seen with other local anaesthetics which might also be caused by Bupivacaine include:
Additional side effects in children and adolescents
Adverse drug reactions 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 any of the side effects get serious or you notice any side effects not listed in this leaflet, please tell your doctor or midwife.
Reporting of side effects
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.
5. HOW TO STORE BUPIVACAINE HYDROCHLORIDE INJECTION
Keep this medicine out of sight and reach of children.
The solution should not be used after the expiry date printed on the ampoule and carton. The expiry date refers to the last day of that month.
Do not store above 25°C.
Keep the container in the outer carton in order to protect from light.
This medicine should not be mixed with any other drugs unless compatibility is known.
The solution must not be stored in contact with metals e.g. needles or metal parts of syringes, as dissolved metal ions may cause swelling at the site of the injection.
If only part of an ampoule is used, the remaining solution should be discarded.
The solution should not be used if it is discoloured in any way.
6. FURTHER INFORMATION
The active substance is bupivacaine hydrochloride.
The other ingredients are sodium chloride and sodium hydroxide and water for Injection.
What Bupivacaine Hydrochloride Injection looks like and contents of pack
Bupivacaine Hydrochloride Injection is a colourless or almost colourless, aqueous, sterile solution for injection and is available in two strengths:
Bupivacaine Hydrochloride Injection 0.25%w/v. Each 1ml contains 2.5mg of anhydrous bupivacaine hydrochloride.
Bupivacaine Hydrochloride Injection 0.5%w/v. Each 1ml contains 5mg of anhydrous bupivacaine hydrochloride.
Both product strengths are available as either:
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in: December 2018.
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