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Bufyl 1.25mg/Ml And 2microgram/Ml Solution For Infusion

Informations for option: Bufyl 1.25mg/Ml And 2microgram/Ml Solution For Infusion, show other option
Document: leaflet MAH BRAND_PL 02848-0237 change

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Date of Approval: N/A

PROOF

MercuryPharma

To be implemented by: N/A

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23/09/2014

Product Description:

Originated by Date:

Tech Approved

Date:

Bufyl Infusion 1 mg/ml & 1,25mg/ml

10/04/2012

No

Component:

Revised by

Version: 101728/LF/3, 101729/LF/3,

Leaflet

101730/LF/3, 101731/LF/3

Manufacturer:

File Name:

CRFNo.:

Sintetica Bioren

101728-29-30-31LF Bufyl Infusion V3_1

AMCo.CRF.081.2014

Market:

Software Package:

Barcode:

UK

Quark Xpress 10

N/A

Minimum Font Size & Typeface:

Dimensions:

Pharma Code:

9pt Swiss 721BT

148 x 210 mm

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Colours:

Key Line:

Uncommonly (affecting less than 1 in 1000 people)

•    headache

•    a feeling of spinning (vertigo)

•    restlessness

•    pin point pupils

•    hiccups

•    dry mouth, constipation

•    feeling cold or excessive sweating.

Rarely (affecting less than 1 in 10000 people)

•    weakness.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

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

By reporting side effects you can help provide more information on the safety of this medicine.

5. STORING BUFYL

Keep this medicine out of the sight and reach of children.

You should not be given Bufyl after the expiry date which is printed on the container label. 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.

6. FURTHER INFORMATION

What Bufyl contains:

The active substances are bupivacaine hydrochloride and fentanyl (as citrate).

The other ingredients are sodium chloride, sodium hydroxide and water for injections. 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:

Bufyl 1mg/ml and 2microgram/ml Solution for Infusion: Each 1ml contains 1mg of bupivacaine hydrochloride and 2 micrograms of fentanyl.

Bufyl 1.25mg/ml and 2microgram/ml Solution for Infusion: Each 1ml contains 1.25mg of bupivacaine hydrochloride and 2 micrograms of fentanyl.

Both product strengths are available as 250ml or 500ml plastic (polypropylene) bags for infusion.

Marketing Authorisation Holder:

Mercury Pharma International Ltd.,

4045, Kingswood Road, City West Business Park, Co Dublin, Ireland Manufacturer:

Mercury Pharmaceuticals Ltd.,

101728/LF/3 101729/LF/3 101730/LF/3 101731/LF/3


No. 1 Croydon, 12-16 Addiscombe Road, Croydon CRO OXT, UK This leaflet was last revised in September 2014.

Bufyl is the registered trademark of Mercury Pharma Group Ltd.

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MercuryPharma

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.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, please ask your doctor, nurse, or pharmacist.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

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.

In this leaflet:

1.    What Bufyl is and what it is used for

2.    Before having Bufyl

3.    How Bufyl is given

4.    Possible side effects

5.    Storing Bufyl

6.    Further 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. BEFORE HAVING BUFYL

You should not be given Bufyl by an epidural if you:

•    are allergic to bupivacaine, fentanyl or any of the other ingredients listed in section 6 of this leaflet

• have been given a type of local anaesthesia known as a Biers block

• have been given a type of local anaesthesia that numbs the cervix during childbirth

•    are suffering from inflammation or skin infection at the site of the proposed injection

•    have problems with blood clotting or you are taking medicines to stop your blood clotting

•    have a heart problem known as complete heart block

•    are currently having difficulty breathing or you suffer from asthma

•    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

•    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)

•    are currently taking drugs used to treat depression known as monoamine oxidase inhibitors (MAOIs) or have taken them in the last 2 weeks

•    have consumed excessive amounts of alcohol

•    are suffering from a blood disorder known as pernicious anaemia.

Special care will be taken with Butyl. Tell your doctor if you suffer from:

•    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.

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.

Taking other medicines:

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken 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.

If you have any doubts about whether this medicine should be given to you, consult your doctor, nurse or pharmacist.

Pregnancy & breast-feeding:

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:

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 taking this medicine until you know how it affects you

•    it is an offence to drive if this medicine affects your ability to drive

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• however, you would not be committing an offence if:

-    the medicine has been prescribed to treat a medical or dental problem and

-    you have taken 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 taking this medicine.

Important information about some of the ingredients of Bufyl:

This medicine contains approximately 3.5 mg sodium per ml. This should be taken into consideration by patients on a controlled sodium (salt) diet.

3. HOW BUFYL IS GIVEN

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.

Bufyl is not recommended for use in children.

If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bufyl can cause side effects, although not everybody 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.

If you notice any of the following side effects speak to your doctor, nurse or pharmacist as soon as possible:

•    an unusually slow, fast or irregular heartbeat

•    feelings of great elation or disorientation, epileptic fits, numbness of the tongue or mouth, a ringing noise in your ear (tinnitus) or light headedness. All of these are possible signs of toxicity

•    changes in mood

•    seeing or hearing things (hallucinations)

•    uncontrolled spasm of your vocal chords

•    slowed breathing.

Other possible side effects include:

Very Commonly (affecting 1 in 10 people)

•    low blood pressure

•    feeling sick (nausea) or being sick (vomiting)

•    muscle stiffness.

Commonly (affecting less than 1 in 100 people)

•    nervousness, dizziness, drowsiness or confusion

•    high blood pressure

•    difficulty in passing urine

•    feeling agitated

•    problems with your eyesight.

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