- bupivacaine hydrochloride anhydrous
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 02848/0197.
Bupivacaine Hydrochloride 0.1% w/v and 0.125%w/v Solution for Infusion
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Bupivacaine Hydrochloride 0.1% w/v Solution for Infusion
Bupivacaine Hydrochloride 0.125% w/v Solution for Infusion
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.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
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.
The name of your medicine is Bupivacaine Hydrochloride 0.1% w/v Solution for Infusion, Bupivacaine Hydrochloride 0.125% w/v Solution for Infusion. It will be referred to as Bupivacaine Hydrochloride Infusion Solution for ease hereafter.
In this leaflet:
1. What Bupivacaine Hydrochloride Infusion Solution is and what it is used for
2. What you need to know before you are given Bupivacaine Hydrochloride Infusion Solution
3. How to take Bupivacaine Hydrochloride Infusion Solution is given to you
4. Possible side effects
5. How to store Bupivacaine Hydrochloride Infusion Solution
6. Contents of the pack and other information
1. WHAT BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION IS AND WHAT IT IS USED FOR
Bupivacaine Hydrochloride is a local anaesthetic; it produces loss of feeling or sensation that is confined to one part of the body. Bupivacaine belongs to a group of medicines called amide-type anaesthetics.
Bupivacaine Hydrochloride Infusion Solution may be used to prevent or give prolonged relief of pain when it is injected around the spinal cord, e.g. as an epidural in labour or after a surgical operation.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION
Do not take Bupivacaine Hydrochloride Infusion Solution if:
You should not be given this Infusion Solution as an epidural if:
Speak to your doctor or nurse if one of these applies to you before you are given this medicine.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Bupivacaine Hydrochloride Infusion Solution
Other medicines and Bupivacaine Hydrochloride Infusion Solution:
Tell your doctor or nurse 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 Infusion Solution which can significantly alter their effects. These drugs include:
If you are already taking one of these medicines, speak to you doctor or nurse before you receive Bupivacaine Hydrochloride Infusion Solution.
Pregnancy, breastfeeding and fertility:
Tell your doctor/ nurse before you are given this medicine if you are pregnant, think you may be pregnant or are planning to become pregnant, or are breastfeeding. However, as with all drugs Bupivacaine Hydrochloride Infusion Solution should only be given in early pregnancy if absolutely necessary.
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.
Bupivacaine Injection contains Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per dosag, that is to say essentially ‘sodium-free’.
3. HOW TO TAKE BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION IS GIVEN TO YOU
Bupivacaine Hydrochloride Infusion Solution should only be administered by a doctor who will, in the case of an epidural infusion, have the necessary knowledge and experience in the technique of epidural anaesthesia.
Before administrating an epidural Infusion Solution, your doctor may inject a test dose of Bupivacaine Hydrochloride Infusion Solution 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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can 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 Infusion Solution 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 less than 1 in 10 people):
Uncommon (affects less than 1 in 100 people)
Rare (affects less than 1 in 1000 people):
Possible side effects seen with other local anaesthetics which might also be caused by Bupivacaine include:
Do not be concerned by this list of possible side effects. You may not get any of them.
If any of the side effect get serious or you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
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 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.
5. HOW TO STORE BUPIVACAINE HYDROCHLORIDE INFUSION SOLUTION
Keep this medicine out of the sight and reach of children.
The solution should not be used after the expiry date printed on the infusion bag.
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 infusion.
If only part of an ampoule is used, the remaining solution should be discarded.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
The active substance is bupivacaine hydrochloride.
The other ingredients are sodium chloride, sodium hydroxide and water for injection.
What Bupivacaine Hydrochloride Infusion Solution looks like and contents of pack
Bupivacaine Hydrochloride Infusion Solution is a colourless or almost colourless, aqueous, sterile solution for infusion and is available in two strengths:
Bupivacaine Hydrochloride Infusion Solution 0.1%w/v. Each 1ml contains 1mg of anhydrous bupivacaine hydrochloride.
Bupivacaine Hydrochloride Infusion Solution 0.125%w/v. Each 1ml contains 1.25mg of anhydrous bupivacaine hydrochloride.
Both product strengths are available as 100ml or 250ml plastic (polypropylene) bags for infusion in packs of 10 and 5 respectively. Not all pack sizes may be marketed.
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Company responsible for Manufacture:
This leaflet was last revised in: July 2019
Capital House, 1st Floor, 85 King William Street, London, EC4N 7BL, UK
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