Patient Leaflet Updated 19-Aug-2019 | ADVANZ Pharma
BUFYL Solution for Infusion 1mg/ml; 1.25mg/ml and 2 micrograms/ml
Package leaflet: Information for the user
BUFYL® 1mg/ml and 2 microgram/ml Solution for infusion
BUFYL® 1.25mg/ml and 2 microgram/ml Solution for infusion
Bupivacaine Hydrochloride/Fentanyl Citrate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
The name of your medicine is BUFYL® 1mg/ml and 2 microgram/ml Solution for infusion and BUFYL® 1.25mg/ml and 2 microgram/ml Solution for infusion. It will be referred to as Bufyl for ease hereafter.
What is in this leaflet
1. What Bufyl is and what it is used for
2. What you need to know before you are given Bufyl
3. How Bufyl will be given to you
4. Possible side effects
5. How to store Bufyl
6. Contents of the pack and other information
1. WHAT BUFYL 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 (as citrate), which is used to treat pain.
Bufyl is a medicine that is used to treat pain during labour and after operations. It will be given to you in hospital under the supervision of an anaesthetist, in an epidural (injection into the lower back).
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN BUFYL
You should not be given Bufyl by an epidural
Warnings and precautions
Talk to your doctor or nurse before you are given Bufyl if you have:
Tell your doctor if you have ever abused or been dependent on opioids, alcohol, prescription medicines, or illegal drugs.
Repeated use of the product may result in the drug being less effective (you become accustomed to it) or becoming dependent on it.
If your treatment is stopped withdrawal symptoms may occur. Please tell your doctor or nurse if you think this is happening to you (see also section 4. Possible side effects).
Special care will be taken when this medicine is being given to the elderly and ill.
If any of the above apply to you, please consult your doctor.
Other medicines and Bufyl
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including those obtained without prescription.
You must not be given Bufyl if you are taking:
Tell your doctor if you are taking any of the following medicines that may interact with Bufyl:
However, if your doctor does prescribe Bufyl together with sedative medicines the dose and duration of concomitant treatment should be limited by your doctor.
Please tell your doctor about all sedative medicines you are taking and follow your doctor’s dose recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and symptoms stated above. Contact your doctor when experiencing such symptoms.
If you have any doubts about whether this medicine should be given to you, consult your doctor, nurse or pharmacist.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine.
Driving and using machines
Bufyl 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.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while you are given this medicine.
3. HOW BUFYL WILL BE GIVEN TO YOU
Bufyl 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 Bufyl 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 elderly or in a weak condition or if you have liver or kidney problems. If you are concerned about how much of this medicine you have received, speak to your doctor immediately.
Use in children:
Bufyl is not recommended for use in children.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause severe potentially life-threatening 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), shock should be reported to a doctor immediately.
If you notice any of the following side effects speak to your doctor, nurse or pharmacist as soon as possible:
Other possible side effects include:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
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.
Reporting of side effects
If you get any side effects, talk to your doctor 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 BUFYL
Keep this medicine out of the sight and reach of children.
You should not be given Bufyl after the expiry date which is stated on the container label after EXP.
The doctor or nurse will check that the expiry date on the label has not been passed before administering the infusion to you. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bufyl contains
What Bufyl looks like and contents of the pack:
Bufyl is a clear, colourless aqueous sterile solution for infusion and is available in two strengths:
Both product strengths are available as 250ml or 500ml plastic (polypropylene) bags for infusion in packs of 5, not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last revised in July 2019.
Bufyl is the registered trademark of Mercury Pharma Group Ltd.
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