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BREVIBLOC PREMIXED 10MG/ML SOLUTION FOR INFUSION

Active substance(s): ESMOLOL HYDROCHLORIDE

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Throughout this leaflet, BREVIBLOC Premixed 10 mg/ml
Solution for Infusion will be called Brevibloc.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Brevibloc is and what it is used for
What you need to know before you are given Brevibloc
How you will be given Brevibloc
Possible side effects
How to store Brevibloc
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
Your doctor will not give you Brevibloc if:
• You are allergic (hypersensitive) to esmolol, to other
beta-blocker medicines, or any of the other ingredients
of this medicine (listed in section 6). The signs of an
allergic 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 pressure
• 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.

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), talk
to your doctor, nurse or pharmacist before being given this
medicine. You may need to be checked carefully and your
treatment may be changed.

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
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.

Brevibloc contains sodium
Brevibloc contains approximately 700 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

Other medicines and Brevibloc

The recommended dose

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.

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.

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
• 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

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

As you are being given Brevibloc by a 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)
• 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)
BE-30-01-984

DATE 14 May 2015

MARKETING
APPROVED

Date

If you have too much Brevibloc

Signature

Children up to the age of 18 years should not receive
Brevibloc.

Name

Children

RA
PROOFREAD + APPROVED

Your doctor will start your treatment with a lower dose.

Country

• 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.

The Elderly

3rd DRAFT

Read all of this leaflet carefully before you are given this
medicine. It contains important information for you.

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)
• You have a gland disease called phaeochromocytoma
which has been treated with medicines called alphareceptor 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
‘Prinzmetal’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).

– 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.

ARTWORK APPROVAL

Package leaflet:
Information for the patient
BREVIBLOC Premixed 10 mg/ml
Solution for Infusion
Esmolol hydrochloride

• 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.

EUROPEAN LABELLING CENTRE

Warnings and Precautions

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.

This medicinal product is authorised in the Member States
of the EEA under the following names:
Name

Belgium

Brevibloc 10 mg/ml, solution pour
perfusion

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.

Denmark

Brevibloc

Finland

Brevibloc 10 mg/ml infuusioneste, liuos

Germany

Brevibloc 10 mg/ml Infusionslösung

Ireland

Brevibloc Premixed 10 mg/ml, Solution
for Infusion

Luxembourg

Brevibloc 10 mg/ml, solution pour
perfusion

Netherlands

Brevibloc 10 mg/ml, oplossing voor
infusie

Norway

Brevibloc 10 mg/ml, Infusjonsvæske,
oppløsning

Poland

Brevibloc 10 mg/ml, Roztwór do infuzji

Portugal

Brevibloc Premixed 10 mg/ml, Solução
para perfusão

Reporting of side effects

Spain

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

Brevibloc 10 mg/ml, Solución para
perfusión

Sweden

Brevibloc 10 mg/ml, Infusionsvätska,
lösning

Ireland

UK

Brevibloc Premixed 10 mg/ml, Solution
for Infusion

United Kingdom
You can also report side effects 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.

This leaflet was last revised in May 2015
Other sources of information

For information about Brevibloc or to request
this leaflet in formats such as audio or large
print please contact the Marketing Authorisation
Holder: Tel +44 (0) 1635 206345.

5. How to store Brevibloc
Baxter and Brevibloc are trademarks of Baxter International Inc.

• 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 refrigerate or freeze
• The opened product is stable for 24 hours at 2 to 8°C.
However, it should be used immediately after opening
• Do not use Brevibloc if you notice particles or
discolouration of the solution.
Do not throw 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 Brevibloc contains
• The active substance is esmolol hydrochloride. One
ml contains 10 mg of esmolol hydrochloride. Each bag
contains 2500 mg of esmolol hydrochloride in 250 ml
solution.
BE-30-01-984

Date

Signature

Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium

Name

Brevibloc is manufactured by:

Country

Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk, UK
IP24 3SE

RA
PROOFREAD + APPROVED

The Marketing Authorisation holder is:

3rd DRAFT

Marketing Authorisation Holder and Manufacturer

ARTWORK APPROVAL

Brevibloc is a clear, colourless to light yellow, sterile solution
for intravenous infusion (slow injection). It is available in
250 ml plastic (latex free) bags.

Member State

You can also report side effects directly via HPRA
Pharmacovigilance, Earlsfort Terrace,
IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.
Website: www.hpra.ie; Email: medsafety@hpra.ie.

DATE 14 May 2015

What Brevibloc looks like and contents of the pack

MARKETING
APPROVED

• 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.

EUROPEAN LABELLING CENTRE

• 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
• 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.

Expand view ⇕

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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