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ESMOLOL HYDROCHLORIDE 10 MG/ML SOLUTION FOR INJECTION

Active substance(s): ESMOLOL HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Esmolol hydrochloride 10 mg/ml solution for injection
Esmolol hydrochloride
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, ask your doctor or nurse.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Esmolol hydrochloride 10 mg/ml solution for injection is and what it is used for
2. Before you use Esmolol hydrochloride 10 mg/ml solution for injection
3. How to use Esmolol hydrochloride 10 mg/ml solution for injection
4. Possible side effects
5. How to store Esmolol hydrochloride 10 mg/ml solution for injection
6. Further information
1. WHAT ESMOLOL HYDROCHLORIDE
10 MG/ML SOLUTION FOR INJECTION
IS AND WHAT IT IS USED FOR
Esmolol belongs to the group of beta
blockers. These medicines slow down the
heartbeat and reduce blood pressure.
Esmolol is used for short-term treatment if
your heart beats too fast.
Esmolol is also used during or straight after
surgery if your blood pressure gets too high
and/or your heart beats too fast.
2. BEFORE YOU USE ESMOLOL HYDROCHLORIDE 10 MG/ML SOLUTION FOR
INJECTION
Do not use Esmolol hydrochloride
10 mg/ml solution for injection if you
- are allergic (hypersensitive) to esmolol
or any of the other ingredients of esmolol
- have a very slow heart beat
- have a problem with the electrical
messages that control your heartbeat (a
problem called “heart block”).
- have a serious heart failure
- have a fast or alternating fast and slow
heartbeat (a problem called the “Sick
Sinus” syndrome)
- have a phaeochromocytoma not yet
treated. (A phaeochromocytoma is a
condition of the adrenal gland that may
be accompanied by a sudden increase
of blood pressure, severe headache,
sweating and increased heartbeat)
- have a problem with the blood supply to
your heart (a problem called cardiogenic
schock)
- have low blood pressure
- have increased pressure in the vessels
of the lung (pulmonary hypertension)
- have an acute asthmatic attack
- have increased level of acids in your
body (a problem called metabolic
acidosis)
Take special care with Esmolol hydrochloride 10 mg/ml solution for injection
- The most frequently observed side effect
is hypotension (low blood pressure).
The signs of this may be feeling dizzy or
light headed, especially when standing
up. This is rapidly reversible with dosage
reduction or discontinuation. Usually,
your blood pressure and ECG will be
continously monitored if you are treated
with esmolol.
Your doctor will take special care if you
- have diabetes or low blood sugar
(hypoglycaemia). You require special
monitoring because esmolol can mask
the symptoms of a low blood sugar.
- have had heart problems in the past Your
doctor will monitor you very closely for
any heart symptoms. If necessary, the
treatment will be stopped, the dosage
lowered or special treatment initiated.
- have a skin reaction at the injection
site, another injection site should be
used.
- have narrowing of your airways or
wheezing, such as with asthma.
- have psoriasis or healed psoriasis (where
your skin produces scaly patches)
- have any allergies. Esmolol may increase
both your sensitivity toward the cause
of your allergy and the seriousness of
allergic reactions.
- have circulatory problems, such as
paleness of your fingers (Raynaud’s
disease) or aching, tired and sometimes
burning pains in your legs.
- have kidney problems
Taking other medicines
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription, herbal medicines, or
natural products.

Your doctor will check that any medicines
you are taking will not alter the way that
Esmolol hydrochloride 10 mg/ml solution
for injection works.
In particular, tell your doctor, nurse or
pharmacist if you are taking any of the
following:
• Medicines used to treat heart rhythm
problems, chest pain (angina) and high
blood pressure such as verapamil and
diltiazem
• Medicines used to treat both heart
rhythm problems and heart failure, such
as digoxin, digitoxin, digitalis, quinidine,
disopyramide or amiodarone
• Medicines used to treat diabetes,
including insulin and medicines taken by
mouth
• Medicines known as ganglion blocking
agents (such as trimetaphan)
• Medicines used to treat colds or a blocked
nose, called nasal ‘decongestants’
• Medicines used as pain killers, such as
non-steroidal anti-inflammatory drugs
known as NSAIDs
• Medicines used to treat depression,
such as ‘tricyclic’ antidepressants or any
other drugs for mental health problems
• Clonidine, which is used to treat high
blood pressure and migraine
• Nifedipine, which is used to treat chest
pain (angina), high blood pressure and
Raynaud’s disease
• Warfarin, which is used to thin your
blood
• Reserpine, which is used to treat high
blood pressure
• Morphine, which is a strong pain killer
• Floctafenine, which is a pain killer
• Amisulpride, a medicine that is used to
treat mental problems
• Suxamethonium chloride (also known as
succinylcholine or scoline), which is used
to relax your muscles, usually during
an operation. Your doctor will also
take special care when using Esmolol
hydrochloride 10 mg/ml solution for
injection 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 or pharmacist
before
having
Esmolol
hydrochloride
10 mg/ml solution for injection.
Pregnancy and breast-feeding
Insufficient data are available about the
use of esmolol during pregnancy in humans
to prove safety. However, there are no
indicators of increased risk of birth defects in
humans. Because of the lack of experience
the use of Esmolol hydrochloride 10 mg/ml
solution for injection during pregnancy is
not recommended.
Ask your doctor or pharmacist for advice
before taking any medicine.
It is not known whether esmolol is excreted
in the breast milk. Therefore breast-feeding
is not recommended during administration
of esmolol.
Ask your doctor or pharmacist for advice
before taking any medicine.
3. HOW TO USE ESMOLOL HYDROCHLORIDE 10 MG/ML SOLUTION FOR
INJECTION
The dosage must be individually adapted. A
starting dosage followed by a maintenance
dosage should be administered. Your doctor
will determine the dosage scheme and
adapt the dosage as needed based on the
side effects.
Esmolol hydrochloride 10 mg/ml solution
for injection 100 mg/10 ml is administered
as an injection. It is administered into a
vein by a doctor or a nurse.
The duration of use depends on the effect
and possibly occurring side effects. Your

doctor will determine the duration of
treatment.
Changing the dose of esmolol is not usually
necessary if you:
- have liver problems
- are elderly
If you have kidney problems then your
doctor will take appropriate caution.
Children and adolescents
The safety and efficacy of esmolol have
not been established in children and
adolescents.
If you have received more Esmolol
hydrochloride 10 mg/ml solution for
injection than you should
If you have the feeling that you have
received too much esmolol, inform your
doctor or nurse who will then take further
measures.
The following symptoms may occur if there
is an overdosage:
severe drop in blood pressure, slow heart
beat, reduced heart function, shock
occurring because of decreased heart
function, reduced breathing (respiratory
insufficiency), loss of consciousness ranging
to coma, convulsions (cramps), nausea,
vomiting, low blood sugar (hypoglycaemia).
When the use of Esmolol hydrochloride
10 mg/ml solution for injection is
stopped
If you suffer from a heart disease caused
by coronary artery problems (such as
angina pectoris), caution is required when
interrupting treatment with Esmolol
hydrochloride 10 mg/ml solution for
injection. The infusion will be terminated
gradually.
If you have any further questions on the use
of this product, ask your doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Esmolol hydrochloride
10 mg/ml solution for injectioncan cause
side effects, although not everybody gets
them.
Most side effects disappear within 30
minutes of stopping treatment with
Esmolol hydrochloride 10 mg/ml solution
for injection.
Tell your doctor or nurse straight away if
you notice any of the following side effects,
which can be serious. The infusion may
need to be stopped.
Side effects are ranked according to their
frequency:
very common: affects more than 1 user in
10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: Frequency cannot be estimated
from the available data
The following side effects may appear:
Very common: fall in blood pressure,
sweating.
Common:
Feeling
sleepy,
Headache,
Difficulty concentrating, Dizziness, Feeling
lightheaded, Tingling or “pins and needles”,
Feeling or being sick (nausea and vomiting),
Loss of appetite, Irritation and hardening of
your skin where Esmolol hydrochloride 10
mg/ml solution for injectionwas injected,
Feeling weak, Feeling tired (fatigue), Feeling
anxious or depressed, Feeling confused or
agitated
Uncommon: Slow heart rate, Sudden loss
of consciousness, Feeling faint of fainting,
Fits (seizures or convulsions), Changes in
your sense of taste, Problems with speech,
Problems with eyesight, Shortness of breath
or difficulty breathing, Fluids on your lungs,
Wheezing, Blocked nose, Abnormal breath
sounds, Dry mouth, Pain in your stomach
area, Indigestion, Constipation, Problems
passing urine, Discoloured skin, Reddening
of the skin, Pain in your muscles or tendons,
Poor circulation in your arms or legs,
Looking pale or flushed, Chest pain, Feeling
cold or high temperature (fever), Pain
and swelling (oedema) of your vein where
Esmolol hydrochloride 10 mg/ml solution
for injectionwas injected, Burning feeling at
the site of injection, Abnormal thoughts
Very rare: Severe reduction in heart rate,
Cardiac arrest, Tender blood vessels with
an area of hot red skin (thrombophlebitis),
Skin problems caused by the solution
leaking around the site of injection
Not known (the number of people affected
is unknown): Psoriasis (where your skin
produces scaly patches).
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or nurse.

5. HOW
TO
STORE
ESMOLOL
HYDROCHLORIDE
10
MG/ML
SOLUTION FOR INJECTION
Do not store above 25°C. Keep the vial in
the outer carton in order to protect from
light.
Keep out of the reach and sight of children.
Do not use Esmolol hydrochloride 10 mg/
ml solution for injectionafter the expiry date
which is stated on the carton and label of
the vial after EXP. The expiry date refers to
the last day of that month.
The opened product is stable for 24 hours
at 2°C-8 °C. However, it should be used
immediately after opening. If not used
immediately, in-use storage times and
conditions are the responsibility of the user
and would normally not be longer than 24
hours at 2 to 8 °C unless opening has taken
place in controlled and validated aseptic
conditions.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.
6. FURTHER INFORMATION
What Esmolol hydrochloride 10 mg/ml
solution for injection contains
- The active substance is esmolol hydrochloride.
- Each vial of 10 ml solution for injection
contains 100 mg esmolol hydrochloride.
1 ml aqueous solution contains 10 mg
esmolol hydrochloride.
- The other ingredients are sodium acetate
trihydrate, acetic acid 99%, hydrochloric
acid 10% (for pH adjustment), water for
injections.
What Esmolol hydrochloride 10 mg/ml
solution for injection looks like and
contents of the pack
Esmolol hydrochloride 10 mg/ml solution for
injection is clear and colourless, available in
glass vials containing 10 ml solution each.
The vial is of colourless glass (type I) and
has a chlorobutyl rubber stopper.
Marketing Authorisation Holder
Orpha-Devel Handels und Vertriebs GmbH
Wintergasse 85/1B
A-3002 Purkersdorf
Austria
Manufacturer
HIKMA Italia S.p.A.
Viale Certosa 10
Pavia (PV) 27100
Italy
G.L. Pharma GmbH
Arnethgasse 3
1160 Vienna
Austria
This medicinal product is authorised in
the Member States of the EEA under the
following names:
Belgium:
Esmocard
Czech
Republic:
Esmocard
100mg/10ml
injekčni
roztok
Denmark: Esmocard
Estonia:
Esmocard 10 mg/ml süstelahus
Finland:
Esmocard 10 mg/ml injektioneste,
liuos
France:
Esmocard
Germany: Esmocard 100 mg/10 ml Injektionslösung
Greece:
Esmocard
Hungary:
Esmocard 10 mg/ml oldatos injekció
Ireland:
Esmocard
Italy:
Esmocard
Latvia:
Esmocard
Lithuania: Esmocard 100 mg/10 ml injekcinis
tirpalas
Luxembourg: Esmocard
Netherlands: Esmolol HCl Orpha 100 mg/10 ml
oplossing voor injective
Norway:
Esmocard
Poland:
Esmocard 100 mg/10 ml
Portugal:
Esmocard solução injectável
Slovakia:
Esmocard injekčný roztok
Slovenia:
Esmocard
Spain:
ESMOCARD 100 mg/10ml solución
inyectable
Sweden:
Esmocard
United Kingdom: Esmolol hydrochloride 10 mg/ml
solution for injection

This leaflet
31.08.2010.

was

last

approved

in

The information for the use of this
product for medical or healthcare
professionals is available in the
attached SPC.

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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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