- 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 12762/0563.
Bupivacaine & Adrenaline (Epinephrine) Injection BP 0.25% and 0.5% w/v, 1 in 200,000
PATIENT INFORMATION LEAFLET
Bupivacaine & Adrenaline (Epinephrine) Injection 0.25%w/v, 1 in 200,000
Bupivacaine & Adrenaline (Epinephrine) Injection 0.5%w/v, 1 in 200,000
Anhydrous Bupivacaine Hydrochloride and Adrenaline
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.
The product is known by the above name but will be referred to as Bupivacaine & Adrenaline Injection throughout the rest of this leaflet.
In this leaflet:
1. What Bupivacaine & Adrenaline Injection is and what it is used for
2. Before you are given Bupivacaine & Adrenaline Injection
3. How Bupivacaine & Adrenaline Injection is given to you
4. Possible side effects
5. How to store Bupivacaine & Adrenaline Injection
6. Further information
1. WHAT BUPIVACAINE & ADRENALINE INJECTION IS AND WHAT IT IS USED FOR
Bupivacaine & Adrenaline Injection contains two active ingredients.
Bupivacaine & Adrenaline Injection is used in adults and children above 12 years to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:
It may also be used to give prolonged relief of pain when it is injected around the spinal cord, e.g. as an epidural injection in labour.
2. BEFORE YOU ARE GIVEN BUPIVACAINE & ADRENALINE INJECTION
Do not use
Adrenaline containing Bupivacaine & Adrenaline injection for special techniques (e.g. penile block, Oberst block) to numb parts of the body where areas with end arteries are affected.
You should not be given this medicine if:
Because the solution contains adrenaline, which narrows the blood vessels, this injection should not be used in areas such as fingers, toes, ears, nose or penis, as the blood supply to these areas might become inadequate.
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.
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.
A large number of drugs can interact with Bupivacaine & Adrenaline Injection which can significantly alter their effects. These drugs include:
If you are already taking one of these medicines, speak to you doctor or midwife before you receive Bupivacaine & Adrenaline Injection.
Pregnancy and breast-feeding:
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 breast-feeding.
As with all drugs Bupivacaine & Adrenaline Injection should only be given in pregnancy if absolutely necessary.
The safety and efficacy of Bupivacaine & Adrenaline injection 0.5%w/v, 1 in 200,000 in children aged < 12 years of age have not been established. Other strengths may be more appropriate.
The safety and efficacy of Bupivacaine & Adrenaline injection 0.25%w/v, 1 in 200,000 in children aged < 1 year of age have not been established.
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.
Important information about some of the ingredients of Bupivacaine & Adrenaline Injection:
This medicine contains sodium metabisulphite, a preservative. This may rarely cause severe allergic (hypersensitivity) reactions and wheezing.
This medicinal product contains less than 1mmol sodium (23mg) per dose (essentially ‘sodium-free’).
3. HOW BUPIVACAINE & ADRENALINE INJECTION IS GIVEN TO YOU
Bupivacaine & Adrenaline 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 & Adrenaline 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 & Adrenaline 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 & Adrenaline 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 & Adrenaline Injection is given or if the drug is unintentionally injected into a blood vessel.
Tell your doctor straight away if you notice any of the following side effects:
Very common - (affects more than 1 in 10 people)
Common - (affects less than 1 in 10 people)
Uncommon - (affects less than 1 in 100 people)
Rare - (affects less than 1 in 1,000 people)
Other possible side effects include:
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.
Additional side effects in children and adolescents:
Adverse drug reactions in children are similar to those in adults.
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 & ADRENALINE INJECTION
Keep this medicine out of the 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.
The solution should not be used if it is discoloured in any way.
This medicine should not be mixed with any other drugs.
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.
6. FURTHER INFORMATION
The active substances are bupivacaine hydrochloride and adrenaline.
The other ingredients are sodium metabisulphite (E223), sodium chloride and sodium acetate in water for injections.
What Bupivacaine & Adrenaline Injection looks like and contents of pack
Bupivacaine & Adrenaline Injection is a colourless or almost colourless, aqueous, sterile solution for injection and is available in two strengths:
1. Bupivacaine & Adrenaline Injection 0.25% w/v, 1 in 200,000. Each 10ml of this solution contains 25mg of anhydrous bupivacaine hydrochloride and 50 micrograms of adrenaline.
2. Bupivacaine & Adrenaline Injection 0.5% w/v, 1 in 200,000. Each 10ml of this solution contains 50mg of anhydrous bupivacaine hydrochloride and 50 micrograms of adrenaline.
Both product strengths are available as 10ml glass ampoules in boxes of 10 or individually sterile wrapped in packs of 10.
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This leaflet was last revised in: November 2018.
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