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ESMOLOLHYDROCHLORIDE 250 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ESMOLOL HYDROCHLORIDE

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Esmolol hydrochloride 250 mg/ml
UK
package leaflet
19.03.2013 add. manufacturer for finished
product
20.03.2013 comments authority (KKR)

Art.Nr.: GIxxxxxGB xxxx
Weber-Code: xxxx
Format: 148 x 420 mm
colors: black

PACKAGE LEAFLET: INFORMATION FOR THE USER
Esmolol hydrochloride 250 mg/ml concentrate for solution for infusion
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 nurse.
In this leaflet:
1. What Esmolol hydrochloride 250 mg/ml concentrate for solution for infusion is
and what it is used for
2. Before you use Esmolol hydrochloride 250 mg/ml concentrate for solution for infusion
3. How to use Esmolol hydrochloride 250 mg/ml concentrate for solution for infusion
4. Possible side effects
5. How to store Esmolol hydrochloride 250 mg/ml concentrate for solution for infusion
6. Further information
1. WHAT ESMOLOL HYDROCHLORIDE
250 MG/ML CONCENTRATE FOR
SOLUTION FOR INFUSTION IS
AND WHAT IT IS USED FOR
Esmolol hydrochloride 250 mg/ml
concentrate for solution for infusion
belongs to the group of beta-blockers.
These medicines slow down the
heartbeat and reduce blood pressure.
Esmolol hydrochloride 250 mg/ml
concentrate for solution for infusion is
used for short-term treatment if your
heart beats too fast.
Esmolol hydrochloride 250 mg/ml
concentrate for solution for infusion
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 250 MG/ML
CONCENTRATE FOR SOLUTION
FOR INFUSION
Do not use Esmolol hydrochloride
250
mg/ml
concentrate
for
solution for infusion 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
250
mg/ml
concentrate for solution for infusion
- ESMOLOL HYDROCHLORIDE 250 MG/
ML CONCENTRATE FOR SOLUTION
FOR INFUSION MUST BE DILUTED BY
YOUR DOCTOR OR NURSE AND USED
IMMEDIATELY AFTER OPENING (see
section 3).
- 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
hydrochloride 250 mg/ml concentrate
for solution for infusion 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 250 mg/ml concentrate
for solution for infusion 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 250 mg/ml concentrate
for solution for infusion 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 250 mg/ml concentrate
for solution for infusion.
Pregnancy and breast-feeding
Insufficient data are available about
the use of Esmolol hydrochloride
250 mg/ml concentrate for solution for
infusion 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
250 mg/ml concentrate for solution
for infusion during pregnancy is not
recommended.
Ask your doctor or nurse 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 nurse for advice
before taking any medicine.
Important
information
about
some
of
the
ingredients
of
Esmolol hydrochloride 250 mg/ml
concentrate for solution for infusion
Esmolol hydrochloride 250 mg/ml
concentrate for solution for infusion
contains ethanol 96% and propylene
glycol.
In the diluted solution, the content of
ethanol is less than 100 mg.
3. HOW
TO
USE
ESMOLOL
HYDROCHLORIDE 250 MG/ML
CONCENTRATE FOR SOLUTION
FOR INFUSION
ESMOLOL HYDROCHLORIDE 250 MG/
ML CONCENTRATE FOR SOLUTION FOR
INFUSTION MUST BE DILUTED AND
USED IMMEDIATELY AFTER OPENING.
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 250 mg/ml
concentrate for solution for infusion
is administered as an infusion. 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 250 mg/ml
concentrate for solution for infusion
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
250
mg/ml
concentrate
for
solution
for
infusion 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 250 mg/ml
concentrate for solution for infusion. 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
250 mg/ml concentrate for solution for
infusion can cause side effects, although
not everybody gets them.
Most side effects disappear within 30
minutes of stopping treatment with
Esmolol hydrochloride 250 mg/ml
concentrate for solution for infusion.
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 or
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 250 MG/ML
CONCENTRATE FOR SOLUTION
FOR INFUSION
Do not store above 25°C. Keep the
ampoule in the outer carton in order to
protect from light.
Keep out of the reach and sight of
children.
Do not use Esmolol hydrochloride
250 mg/ml concentrate for solution for
infusion after the expiry date which is
stated on the carton and label of the
ampoule 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 diluted and 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 and
dilution have 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
250
mg/ml
concentrate
for
solution for infusion contains
The active substance is esmolol
hydrochloride.
Each ampoule of 10 ml concentrate for
solution for infusion contains 2500 mg
esmolol hydrochloride. 1 ml solution
contains 250 mg esmolol hydrochloride.
The other ingredients are sodium acetate
trihydrate, acetic acid 99 %, propylene
glycol, ethanol 96%, hydrochloric acid
10% (for pH adjustment) and water
for injections.
What
Esmolol
hydrochloride
250
mg/ml
concentrate
for
solution for infusion looks like and
contents of the pack
One ampoule contains 10 ml of a clear
and colourless solution.
The ampoule is of colourless glass
(type I) with a break ring in the small
part of the ampoule.
One pack Esmolol hydrochloride
250 mg/ml concentrate for solution for
infusion contains 1 ampoule.
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 2500mg/10ml


koncentrát pro připravu


infuzního roztoku
Denmark:
Esmocard
Estonia:

Esmocard 250 mg/ml


infusioonilahuse


kontsentraat
Finland:

Esmocard 250 mg/ml


infuusiokonsentraatti,


liuosta varten
France:

Esmocard
Germany:
Esmocard 2500 mg/10ml


Konzentrat zur Herstellung

einer Infusionslösung
Greece:

Esmocard
Hungary:
Esmocard 250 mg/ml


konzentrátum oldatos


infúzióhoz
Ireland:

Esmocard
Italy:

Esmocard
Latvia:

Esmocard
Lithuania:
Esmocard 2500 mg/10 ml


koncentratas infuziniam


tirpalui
Luxembourg:
Esmocard
Netherlands:
Esmolol
HCl
Orpha


2500 mg/10 ml concentraat


voor oplossing voor


intraveneuze infusie
Norway:

Esmocard
Poland:

Esmocard 2500 mg/10 ml
Portugal:
Esmocard concentrado


para solução para perfusão
Slovakia:
Esmocard infúzny


koncentrát
Slovenia:
Esmocard
Spain:

ESMOCARD 2500 mg/10ml


concentrado para


solución para perfusión
Sweden:
Esmocard
United Kingdom: Esmolol hydrochloride


250 mg/ml concentrate


for solution for infusion
This leaflet was
October 2010.

last

approved

in

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

GIxxxxxGB xxxx

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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