Bupivacaine Hydrochloride 1mg/Ml And Fentanyl 2microgram/Ml Solution For Injection/Infusion
PACKAGE LEAFLET: INFORMATION FOR THE USER D00499
Bupivacaine Hydrochloride Fentanyl (as citrate)
(Referred to as Bupivacaine and Fentanyl Injection in this leaflet)
Read all of this leaflet carefully before you use Bupivacaine and Fentanyl Injection.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
1. What Bupivacaine and Fentanyl Injection is and what it is used for
2. Before having Bupivacaine and Fentanyl Injection
3. How Bupivacaine and Fentanyl Injection is given
4. Possible side effects
5. Storing Bupivacaine and Fentanyl Injection
6. Further information
This medicine is a mixture of two active ingredients: Bupivacaine, which is a local anaesthetic, a medicine used to numb areas of your body in order to relieve pain and Fentanyl, which is used to treat pain.
Bupivacaine and Fentanyl Injection is a medicine that is used to treat pain during labour and after operations. It will be given to you in hospital under supervision of an anaesthetist.
You should not be given Bupivacaine and Fentanyl Injection if you:
• are allergic to bupivacaine, fentanyl or any of the other ingredients listed in section 6 of this leaflet
• are currently having difficulty breathing
• suffer from alcoholism
• are suffering from severe stomach pain
• have suffered a head injury or have severe and undiagnosed headaches
• suffer from a tumour of the adrenal gland known as phaeochromocytoma
• are currently taking drugs used to treat depression known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks
• have been given a type of local anaesthesia known as Biers block
• have been told you have a low blood volume in your body (hypovolaemia)
• have a heart problem known as complete heart block
• are suffering from a disease that affects the brain or the nerves in your spine such as meningitis, poliomyelitis, brain or spinal tumours, tuberculosis of the spine or bleeding in the brain
• are suffering from a blood disorder known as pernicious anaemia
• are suffering from a serious skin infection of your lower back that is producing pus
• are suffering from shock caused by a lack of blood or problems with your blood circulation. The symptoms of this include feeling weak, cold or pale skin, breathing quickly and feelings of anxiety
• have problems with your blood clotting or you are taking medicines to stop your blood clotting.
Special care will be taken with Bupivacaine and Fentanyl Injection. Tell your doctor if you suffer from:
• low or high blood pressure
• problems with your thyroid
• asthma or other breathing problems
• problems with your prostate
• a disorder that causes fits such as epilepsy
• problems with your adrenal glands
• liver or kidney problems
• heart disease.
Special care will be taken when this medicine is being given to the elderly and ill.
If any of the above apply to you or your child, please consult your doctor.
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without prescription.
You must not be given Bupivacaine and Fentanyl Injection if you are taking:
• drugs used to treat severe depression, such as phenelzine or moclobemide, or if you have stopped taking them within the last 2 weeks. These drugs are known as Monoamine Oxidase Inhibitors (MAOI's).
• medicines used to stop your blood clotting (anticoagulants)
Tell your doctor if you are taking any of the following medicines that may interact with Bupivacaine and Fentanyl Injection:
• medicines used to treat mental disorders (antipsychotics) such as droperidol
• medicines used to help you to relax (anxiolytics) such as diazepam, buspirone and barbiturates
• medicines used to help you to sleep (hypnotics) such as temazepam, zolpidem and chloral hydrate
• medicines used to treat feeling or being sick and other stomach problems like heartburn and acid reflux, such as cisapride, domperidone and metoclopramide
• medicines used to treat high blood pressure (beta-blockers and calcium channel blockers) such as propranolol
If you have any doubts about whether this medicine should be given to you, consult your doctor or nurse.
Pregnancy & breast-feeding
Bupivacaine and Fentanyl Injection is thought to be safe for use during pregnancy and breast-feeding. However if you are pregnant, trying to become pregnant or breast-feeding you should ask your doctor for advice before taking any medicine.
Effects on the ability to drive and use machines
Bupivacaine and Fentanyl Injection may affect your ability to drive or operate machinery. If you are discharged from hospital soon after receiving this medicine and plan to resume these activities, ask your doctor when it will be safe to do so.
Having this medicine with food and drink
You should not drink alcohol during your treatment with Bupivacaine and Fentanyl Injection
Bupivacaine and Fentanyl Injection will be given to you as an injection into your lower back (epidural). The injection will be given to you either as several single doses or as a continuous infusion (drip). In certain circumstances the doctor may give you a different dose to those stated here.
By infusion (drip)
The usual initial dose is a slow injection of 10-20ml, followed by a continuous dose of 5-20ml per hour if necessary.
The usual initial dose is a slow injection of 10-20ml, followed by further injections of 3-20ml if necessary.
If you are given too much Bupivacaine and Fentanyl Injection
As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or nurse if you have any concerns.
Like all medicines, Bupivacaine and Fentanyl Injection can cause side effects, although not everybody gets them.
If any of the following symptoms occur tell your doctor or nurse immediately. These are symptoms of a serious allergic reaction:
• sudden wheeziness and tightness of chest
• swelling of eyelids, face or lips
• skin lumps or hives
• skin rash (red spots), itchiness, fever
Other possible side effects include:
• feeling or being sick
• feeling very cold, shivering
• difficulty passing urine
• dry mouth
• facial flushing
• an unusually slow or irregular heartbeat
• a feeling of dizziness or spinning (vertigo)
• feeling faint on standing up from a seated position
• low blood pressure
• changes in mood
• seeing or hearing things that aren't real (hallucinations)
• pin-point pupils or unusually large pupils
• muscle damage, weakness or stiffness
• slowed breathing
• lack of oxygen in the body (hypoxia), the symptoms of which include dizziness and feeling faint
• water on the lungs.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
Keep out of the reach and sight of children.
You should not be given Bupivacaine and Fentanyl Injection after the expiry date which is printed on the carton and vial label. The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep container in the outer carton.
What Bupivacaine and Fentanyl Injection contains
The active substances are bupivacaine hydrochloride and fentanyl (as citrate).
The other ingredients are sodium chloride, dilute hydrochloric acid, water for injection.
What Bupivacaine and Fentanyl Injection looks like and contents of the pack
Bupivacaine and Fentanyl Injection is a clear, colourless solution supplied in a 10ml clear glass vial. Each vial contains 20 micrograms of fentanyl and 10mg of bupivacaine hydrochloride.
Marketing Authorisation Holder: Manufacturer:
Aurum Pharmaceuticals Ltd., Bampton Road,
RM3 8UG UK
Burton Hospital NHS Trust, Belvedere Road,
Burton on Trent,
If you would like any more information, or would like the leaflet in a different format e.g. large print, please contact Medical Information at the Marketing Authorisation Holder's address.
Product licence number: PL 12064/0062
Date of last revision: October 2009
Bampton Road, Harold Hill, Romford RM3 8UG, United Kingdom
Au R U M
100mm Measurement Verification Bar