BUPIVACAINE HYDROCHLORIDE 1MG/ML AND FENTANYL 2MICROGRAM/ML SOLUTION FOR INJECTION/INFUSION
Active substance(s): BUPIVACAINE HYDROCHLORIDE / FENTANYL CITRATE
Bupivacaine Hydrochloride 1mg/ml and Fentanyl
2microgram/ml Solution for Injection/Infusion
Fentanyl (as citrate)
(Referred to as Bupivacaine and Fentanyl Injection in this leaflet)
Read all of this leaflet carefully before you use Bupivacaine and
• 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.
In this leaflet:
What Bupivacaine and Fentanyl Injection is and what it is used for
Before having Bupivacaine and Fentanyl Injection
How Bupivacaine and Fentanyl Injection is given
Possible side effects
Storing Bupivacaine and Fentanyl Injection
1. What Bupivacaine and Fentanyl Injection is and
what it is used for
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
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.
2. Before having Bupivacaine and Fentanyl
You should not be given Bupivacaine and Fentanyl Injection if
• 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
• suffer from a tumour of the adrenal gland known as
• 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
• 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
• 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
Taking other medicines
Please tell your doctor or nurse if you are taking or have recently
taken any other medicines, including those obtained without
You must not be given Bupivacaine and Fentanyl Injection if you are
• 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
• 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
• 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
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
3. How Bupivacaine and Fentanyl Injection is given
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.
4. Possible side effects
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.
5. Storing Bupivacaine and Fentanyl Injection
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.
6. Further Information
What Bupivacaine and Fentanyl Injection contains
The active substances are bupivacaine hydrochloride and fentanyl (as
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:
Aurum Pharmaceuticals Ltd.,
RM3 8UG UK
Burton Hospital NHS Trust,
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
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.
100mm Measurement Verification Bar