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BREVIBLOC PREMIXED 20MG/ML SOLUTION FOR INFUSION

Active substance(s): ESMOLOL

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Brevibloc Premixed 20 mg/ml solution for infusion
UK/H/2864/001/II/003

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BREVIBLOC Premixed 20 mg/ml Solution for Infusion
Esmolol hydrochloride
Read all of this leaflet carefully before you are given this medicine. 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, nurse or pharmacist
 If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any
possible side effects not listed in this leaflet.
Throughout this leaflet, BREVIBLOC Premixed 20 mg/ml Solution for Infusion will be
called Brevibloc.
In this leaflet:
1. What Brevibloc is and what it is used for
2. What you need to know before you are given Brevibloc
3. How you will be given Brevibloc
4. Possible side effects
5. How to store Brevibloc
6. Contents of the pack and other information
1. What Brevibloc is and what it is used for
Brevibloc contains a medicine called esmolol. It belongs to a group of medicines called
‘beta-blockers’. It works by controlling the rate and force of your heartbeat. It can also
help to reduce your blood pressure.
It is used to treat:
 Heartbeat problems, when your heart beats too fast
 Heartbeat problems and an increase in your blood pressure if this happens during or
straight after an operation.
2. What you need to know before you are given Brevibloc
2. Before you are given

Your doctor will not give you Brevibloc if:


You are allergic (hypersensitive) to esmolol, to other beta-blocker medicine, or any of
the other ingredients of this medicine (listed in section 6). The signs of an allergic

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reaction include shortness of breath, wheezing, rash, itching or swelling of your face
and lips
You have a very slow heartbeat (less than 50 beats per minute)
You have a fast or alternating fast and slow heartbeat
You have something called “severe heart block”. Heart block is a problem with the
electrical messages that control your heartbeat
You have low blood presure
You have a problem with the blood supply to your heart
You have serious heart failure symptoms
You are receiving or have recently received verapamil. You must not be given
Brevibloc within 48 hours of when you stop receiving verapamil
You have a gland disease called phaeochromocytoma which has not been treated.
Phaeochromocytoma arises from the adrenal gland and may cause a sudden increase
in blood pressure, severe headache, sweating and increased heartbeat
You have increased blood pressure in the lungs (pulmonary hypertension)
You have asthma symptoms that are worsening rapidly
You have increased levels of acids in your body (metabolic acidosis)

You will not be given Brevibloc if any of the above applies to you. If you are not sure if
you have any of these conditions, talk to your doctor, nurse or pharmacist before having
Brevibloc.
Warnings and Precautions
Talk to your doctor, nurse or pharmacist before being given Brevibloc. Your doctor will
take special care with this medicine if:
 You are being treated for certain heart rhythm disorders called supraventricular
arrhythmias and you:
- Have other heart problems or
- Are taking other heart medicines
Use of Brevibloc in this way can lead to severe reactions which may be fatal
including:
- Loss of consciousness
- Shock (when your heart does not pump enough blood)
- Heart attack (cardiac arrest)
 You develop low blood pressure (hypotension). The signs of this may be feeling
dizzy or light headed, especially when standing up. Low blood pressure usually gets
better within 30 minutes of the end of your Brevibloc treatment
 You have a low heart rate before treatment
 Your heart rate decreases to less than 50 to 55 beats per minute. If this happens your
doctor may give you a lower dose or stop treatment with Brevibloc
 You have heart failure

You have problems with the electrical messages that control your heartbeat (heart
block)
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You have a gland disease called phaeochromocytoma which has been treated with
medicines called alpha-receptor blockers
You are being treated for high blood pressure (hypertension) which has been caused
by low body temperature (hypothermia)
You have narrowing of your airways or wheezing, such as with asthma
You have diabetes or low blood sugar. Brevibloc can increase the effects of your
diabetes medicines
You develop skin problems. These can be caused by the solution leaking around the
site of the injection. If this happens your doctor will use a different vein for your
injection
You have a particular type of angina (chest pain) called ‘Prinzemetal’s angina’
You have low blood volume (with low blood pressure). You could develop
circulatory collapse more easily
You have circulation problems, such as paleness of your fingers (Raynaud’s disease)
or aching, tired and sometimes burning pains in your legs
You have kidney problems. If you have kidney disease or you need kidney dialysis
you could develop high blood potassium levels (hyperkalemia). This can cause
serious heart problems
You have any allergies or are at risk of anaphylactic reactions (severe allergic
reactions). Brevibloc can make allergies more severe and more difficult to treat
You or any of your family have a history of psoriasis (where your skin produces scaly
patches)
You have a disease called hyperthyroidism (an overactive thyroid gland).

Changing the dose is not usually necessary if you have liver problems.
If any of the above apply to you (or you are not sure) check with your doctor, nurse or
pharmacist before being given this medicine. You may need to be checked carefully and
your treatment may be changed.
Other medicines and Brevibloc
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines that you have obtained yourself, without a
prescription, including herbal medicines and natural products. Your doctor will check
that any other medicines you are taking will not alter the way that Brevibloc works.
In particular, tell your doctor, nurse or pharmacist if you are taking any of the following:
 Medicines that can lower the blood pressure or slow the heart rate
 Medicines used to treat heart rhythm problems or chest pain (angina) such as
verapamil and diltiazem. You should not receive Brevibloc within 48 hours of
stopping verapamil
 Nifedipine, which is used to treat chest pain (angina), high blood pressure and
Raynaud’s disease
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Medicines used to treat heart rhythm problems (such as quinidine, disopyramide,
amiodarone) and heart failure (such as digoxin, digitoxin, digitalis)
Medicines used to treat diabetes, including insulin and medicines taken by mouth
Medicines known as ganglion blocking agents (such as trimetaphan)
Medicines used as pain killers, such as non-steroidal anti-inflammatory drugs known
as NSAIDs
Floctafenine, which is a pain killer
Amisulpride, a medicine that is used to treat mental problems
‘Tricyclic’ antidepressant medicines (such as imipramine and amitriptyline) or any
other drugs for mental health problems
Barbiturates (such as phenobarbital, used to treat epilepsy) or phenothiazines (such as
chlorpromazine, used to treat mental disorders)
Clozapine which is used to treat mental disorders
Epinephrine, which is used to treat allergic reactions
Medicines used to treat asthma
Medicines used to treat colds or a blocked nose, called ‘nasal decongestants’
Reserpine, which is used to treat high blood pressure
Clonidine, which is used to treat high blood pressure and migraine
Moxonidine, which is used to treat high blood pressure
Ergot derivates, medicines mainly used to treat Parkinson's disease
Warfarin, which is used to thin your blood
Morphine, which is a strong pain killer
Suxamethonium chloride (also known as succinylcholine or scoline) or mivacurium,
which are used to relax your muscles, usually during an operation.
Your doctor will also take special care when using Brevibloc during operations, when
you will be having anaesthetics and other treatments.

If you are not sure if any of the above applies to you, talk to your doctor, nurse or
pharmacist before having Brevibloc.
Tests you may have while Brevibloc is used
The use of medicines such as Brevibloc over a long period of time can cause a reduction
in the force of your heartbeat.
Since Brevibloc is only used for a limited time, this is unlikely to happen to you. During
treatment you will be carefully monitored and Brevibloc treatment will be reduced or
stopped if the force of your heartbeat is reduced.
Your doctor will also check your blood pressure while you are being treated with
Brevibloc.
Pregnancy and breast-feeding

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Ask your doctor or pharmacist for advice before taking any medicine.
You should not be given Brevibloc if you are pregnant, or if you think you may be
pregnant.
Tell your doctor if you are breast-feeding. Brevibloc may pass into breast milk so you
should not be given Brevibloc if you are breast-feeding.
Important information about some of the ingredients of Brevibloc
Brevibloc contains approximately 209 mg of sodium per bag. This may be important if
you are controlling the sodium in your diet.
3. How you will be given Brevibloc
The recommended dose
Your doctor will decide how much of the medicine you will need and for how long it will
be given to you.
Brevibloc will not normally be given for longer than 24 hours.
This medicine is particularly useful if your fluid intake needs to be controlled.
How Brevibloc is given
Brevibloc is ready to use. You will be given Brevibloc by a slow injection (infusion)
through a needle inserted into a vein in your arm.
Brevibloc must not be mixed with sodium bicarbonate or other medicinal products
The treatment is given in two stages:
- Stage one: a large dose is given over one minute. This increases the levels in your
blood quickly
- Stage two: a smaller dose is then given over four minutes
- Stage one and two may then be repeated and adjusted according to your heart’s
response. As soon as an improvement has happened, stage one (the large dose)
will be stopped and stage two (the small dose) will be reduced as necessary
- After reaching a stable condition, you may be given another heart drug, while
your dose of Brevibloc is gradually reduced.
If your heart rate or blood pressure increases during an operation or straight after
recovering from it, you will be given larger doses of Brevibloc for a short time.

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The elderly
Your doctor will start your treatment with a lower dose.
Children
Children up to the age of 18 years should not receive Brevibloc.
If you have too much Brevibloc
As you are being given Brevibloc by trained and qualified person, it is unlikely that you
will have too much. However if this happens, the doctor will stop Brevibloc and give you
additional treatment, if necessary.
If you think that a dose of Brevibloc has been forgotten
As you are being given Brevibloc by a trained and qualified person, it is unlikely that you
will miss a dose. However, if you think that you have missed a dose, talk to your doctor,
nurse or pharmacist as soon as possible.
If you stop having Brevibloc
Suddenly stopping Brevibloc may cause symptoms of rapid heartbeat (tachycardia) and
high blood pressure (hypertension) to return. To avoid this your doctor should stop your
treatment gradually. If you are known to have coronary artery disease (this may be
associated with a history of angina or heart attack) your doctor will take special care
when stopping treatment with Brevibloc.
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, this medicine can cause side effects, although not everybody gets
them. Most side effects disappear within 30 minutes of stopping treatment with
Brevibloc. The following side effects have been reported with Brevibloc:
Tell your doctor, nurse or pharmacist straight away if you notice any of the
following side effects, which can be serious. The infusion may also need to be
stopped.
Very common (may affect more than 1 in 10 people)

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Fall in blood pressure. This can be rapidly corrected by reducing the dose of
Brevibloc or stopping the treatment. Your blood pressure will be measured often
during treatment
Excessive sweating.

Common (may affect less than 1 in 10 people)
 Loss of appetite
 Feeling anxious or depressed
 Dizziness
 Feeling sleepy
 Headache
 Tingling or ‘pins and needles’
 Difficulty concentrating
 Feeling confused or agitated
 Feeling or being sick (nausea and vomiting)
 Feeling weak
 Feeling tired (fatigue)
 Irritation and hardening of your skin where Brevibloc was injected.
Uncommon (may affect less than 1 in 100 people)
 Abnormal thoughts
 Sudden loss of consciousness
 Feeling faint or fainting
 Fits (seizures or convulsions)
 Problems with speech
 Problems with eyesight
 Slow heart rate
 Problems with the electrical messages that control your heartbeat
 Increased pressure in the arteries of the lungs
 Inability of the heart to pump enough blood (heart failure)
 A disruption in the rhythm of the heart sometimes known as palpitations (ventricular
extrasystoles)
 A heartbeat disorder (nodal rhythm)
 Chest discomfort caused by poor blood flow through the blood vessels of the heart
muscle (angina pectoris)
 Poor circulation in your arms or legs
 Looking pale or flushed
 Fluid on your lungs
 Shortness of breath or tightness of the chest making it difficult to breathe
 Wheezing
 Blocked nose
 Abnormal rattling/crackling sounds when breathing
 Changes in your sense of taste
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Indigestion
Constipation
Dry mouth
Pain in your stomach area
Discoloured skin
Reddening of the skin
Pain in your muscles or tendons, including around the shoulder blades and ribs
Problems passing urine (urinary retention)
Feeling cold or high temperature (fever)
Pain and swelling (oedema) of your vein where Brevibloc was injected
Burning feeling or bruising at the site of injection.

Very rare (may affect less than 1 in 10,000 people)
 Severe reduction in heart rate (sinus arrest)
 No electrical activity in the heart (asystole)
 Tender blood vessels with an area of hot red skin (thrombophlebitis)
 Dead skin caused by the solution leaking around the site of the injection.
Not known (the number of people affected is unknown)
 Increased levels of potassium in the blood (hyperkalemia)
 Increased levels of acids in your body (metabolic acidosis)
 Increased rate of contraction of the heart (accelerated idioventricular rhythm)
 Spasm of the artery in the heart
 Failure of the normal circulation of the blood (cardiac arrest)
 Psoriasis (where your skin produces scaly patches)
 Swelling of the skin of the face, limbs, tongue or throat (angioedema)
 Hives (urticaria)
 Inflammation of a vein or blistering at the site of infusion.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes
any possible side effects not listed in this leaflet.
5. How to store Brevibloc







Keep this medicine out of the sight and reach of children
Do not use Brevibloc after the expiry date which is stated on the label after EXP. The
expiry date refers to the last day of that month
Do not remove the overpouch until ready to use
Do not store above 25ºC
Do not freeze
The opened product is stable for 24 hours at 2 to 8°C. However it should be used
immediately after opening

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Do not use Brevibloc if you notice particles or discolouration of the solution.

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. This measures will help
protect the environment..
6. Contents of the pack and other information
What Brevibloc contains
The active substance is esmolol hydrochloride. One ml contains 20 mg of esmolol
hydrochloride. Each bag contains 2000 mg of esmolol hydrochloride in 100 ml solution.
The other ingredients are: sodium acetate and glacial acetic acid, sodium chloride, sterile
water (called ‘water for injections’). Sodium hydroxide or hydrochloric acid may be
added to ensure the correct pH.
What Brevibloc looks like and contents of the pack
Brevibloc is a clear, colourless to light yellow, sterile solution for intravenous infusion
(slow injection). It is available in 100 ml plastic (latex free) bags.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk, UK
IP24 3SE

Brevibloc is manufactured by:
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
This medicinal product is authorized in the Member States of the EEA under the
following names:
Member State
Cyprus

Name
BREVIBLOC 20 mg/ml Διάλυμα για έγχυση

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Brevibloc Premixed 20 mg/ml solution for infusion
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Greece
Italy
Spain
United Kingdom

BREVIBLOC 20 mg/ml Διάλυμα για έγχυση
BREVINTI
BREVIBLOC 20 mg/ml, Solución para infusión
BREVIBLOC Premixed 20 mg/ml Solution for Infusion

This leaflet was last revised in August 2013

For information about BREVIBLOC or to request this
leaflet in formats such as audio or large print please
contact the Marketing Authorisation Holder: Tel: 01635
206345
Information on the use of this product for medical or healthcare professionals is
provided in the Summary of Product Characteristics included in this presentation.

Baxter and Brevibloc are trademarks of Baxter International Inc.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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