BUPIVACAINE HYDROCHLORIDE 1 MG / ML AND FENTANYL CITRATE 2 MICROGRAMS / ML SOLUTION FOR INFUSION, BUFYL 1 MG / ML AND 2MICROGRAMS / ML SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

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 nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

This medicine contains fentanyl which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.

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.

This medicine has been prescribed for you for the treatment of pain during labour and after operations.

It contains the fentanyl which belongs to a class of medicines called opioids, which are ‘pain relievers’. This medicine has been provided to you and should not be given to anyone else.

Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely. 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

• if you are allergic to bupivacaine, fentanyl or any of the other ingredients of this medicine (listed in section 6)
• if you have been given a type of local anaesthesia known as a Biers block
• if you have been given a type of local anaesthesia that numbs the cervix during childbirth
• if you are suffering from inflammation or skin infection at the site of the proposed injection
• if you have problems with blood clotting or you are taking medicines to stop your blood clotting
• if you have a heart problem known as complete heart block
• if you are currently having difficulty breathing or you suffer from asthma
• if you have suffered a head injury or are suffering from a disease that affects the brain or the nerves in your spine such as meningitis, poliomyelitis, brain or spinal tumours, developmental spinal problems such as spina bifida, tuberculosis of the spine, blood vessel malformations or bleeding in the brain
• if you are suffering from shock caused by a lack of blood or problems with your blood circulation (symptoms of this include feeling weak, cold or pale skin, breathing quickly and anxiety)
• if you are currently taking drugs used to treat depression known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks
• if you have consumed excessive amounts of alcohol
• if you are suffering from a blood disorder known as pernicious anaemia.

Warnings and precautions

Talk to your doctor or nurse before you are given Bufyl if you have:

• a disorder that causes fits such as epilepsy
• any heart problems including, low or high blood pressure, fast or slow heartbeats
• liver or kidney problems
• problems with your adrenal glands
• problems with your thyroid
• prostate enlargement in men
• disease of the nervous system, such as Myasthenia gravis (a disorder with weak muscles)
• breathing problems
• you are taking any medicine from the group of medicines known as benzodiazepines. Taking these medicines with Bufyl may result in sedation, difficulties in breathing (respiratory depression), coma and may be fatal. Even if benzodiazepines are prescribed, your doctor may need to change the dose, the duration of treatment or monitor you regularly.

Talk to your prescriber before taking this medicine if you:

• are or have ever been addicted to opioids, alcohol, prescription medicines, or illegal drugs.
• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating, when you have stopped taking alcohol or drugs.
• feel you need to take more of Bufyl to get the same level of pain relief, this may mean you are becoming tolerant to the effects of this medicine or are becoming addicted to it. Speak to your prescriber who will discuss your treatment and may change your dose or switch you to an alternative pain reliever.

Taking this medicine regularly, particularly for a long time, can lead to addiction. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.

Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your prescriber about your treatment.

Addiction can cause withdrawal symptoms when you stop taking this medicine. Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your prescriber will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.

Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid, may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.

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:

• 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 (MAOIs)
• medicines used to stop your blood clotting (anticoagulants).

Tell your doctor if you are taking any of the following medicines that may interact with Bufyl:

• medicines used to treat irregular heartbeats such as amiodarone
• medicines that depress the nervous system such as sleeping pills or those that may cause drowsiness or are used to help you to relax (anxiolytics) such as barbiturates
• medicines used to treat mental disorders (antipsychotics) such as chlorpromazine and droperidol
• medicines used to treat high blood pressure such as propranolol
• general anaesthetics such as propofol and nitrous oxide
• strong painkillers such as morphine and codeine
• cimetidine which is used to treat stomach ulcers
• the antiviral drug ritonavir
• concomitant use of Bufyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

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.

Pregnancy

Do not take Bufyl if you are pregnant or think you might be pregnant unless you have discussed this with your prescriber and the benefits of treatment are considered to outweigh the potential harm to the baby.

If you use Bufyl during pregnancy, your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.

Breastfeeding

Do not take Bufyl while you are breastfeeding as fentanyl passes into breast milk and will affect your baby.

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.

• do not drive while using this medicine until you know how it affects you
• it is an offence to drive if this medicine affects your ability to drive
• however, you would not be committing an offence if:
• the medicine has been prescribed to treat a medical or dental problem and
• you have received it according to the instructions given by the prescriber or in the information provided with the medicine and
• it was not affecting your ability to drive safely.

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

Your prescriber should have discussed with you, how long the course will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.

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 stop taking Bufyl

Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your prescriber first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.

4. POSSIBLE SIDE EFFECTS

Rare: may affect up to 1 in 1,000 people

• weakness, loss of sensation (persistent anasthesia), bowel incontinence (loss of sphincter control), weakness or numbness in peripheral nerves (neuropathy), peripheral nerve injury, a pain disorder caused by inflammation of one of the membranes that surrounds and protects the nerves of the spinal cord. It is characterized by severe stinging, burning pain, and neurological problems (arachnoiditis), muscular weakness caused by nerve damage (paresis), paralysis of legs and lower body (paraplegia)
• double vision (diplopia).

Not known: frequency cannot be estimated from the available data

• loss of consciousness, involuntary twitching of a muscle (myoclonus), impairment of voluntary movement (Dyskinesia), rise in the pressure inside the skull that can result from or cause brain injury (raised intracranial pressure)
• cough
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbance, nightmares)
• dependence and addiction (see section “How do I know if I am addicted?”).

How do I know if I am addicted?

If you notice any of the following signs whilst taking Bufyl, it could be a sign that you have become addicted.

• – You need to take the medicine for longer than advised by your prescriber

• – You feel you need to use more than the recommended dose

• – You are using the medicine for reasons other than prescribed

• – When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again.

If you notice any of these signs, it is important you talk to your prescriber

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: 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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Mercury Pharmaceuticals Limited, Capital House,

85 King William Street, London EC4N 7BL, UK

Manufacturer

Mercury Pharmaceuticals Ltd., Capital House, 85 King William

Street, London EC4N 7BL, UK

This leaflet was last revised in December 2020.

Bufyl is the registered trademark of Mercury Pharma Group Ltd.

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