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EMCOR 10MG TABLETS

Active substance(s): BISOPROLOL FUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

MC1.0-0417-2012

Emcor® LS 5 mg film coated tablets
Emcor® 10 mg film coated tablets
bisoprolol fumarate
Read all of this leaflet carefully before you start
taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor
or your pharmacist.
- 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 Emcor is and what it is used for
2. Before you take Emcor tablets
3. How to take Emcor tablets
4. Possible side effects
5. How to store Emcor tablets
6. Further information
1. WHAT EMCOR IS AND WHAT IT IS USED FOR
The active substance in Emcor tablets is bisoprolol.
Bisoprolol belongs to a group of medicines called
beta-blockers. These medicines work by affecting
the body`s response to some nerve impulses,
especially in the heart. As a result, bisoprolol slows
down the heart rate and makes the heart more
efficient at pumping blood around the body.
Emcor tablets are used to treat high blood pressure
(hypertension) and to help prevent chest pain
(angina pectoris).
2. BEFORE YOU TAKE EMCOR TABLETS
Do not take Emcor tablets
Do not take Emcor tablets if one of the following
conditions applies to you:
• allergy (hypersensitivity) to bisoprolol or to any
of the other ingredients (see section 6 ‘What
Emcor contains’)
• severe asthma or severe chronic lung disease
• severe blood circulation problems in your limbs
(such as Raynaud’s syndrome), which may cause
your fingers and toes to tingle or turn pale or
blue
• untreated phaeochromocytoma, which is a rare
tumour of the adrenal gland
• metabolic acidosis, which is a condition in which
the blood is too acidic.
Do not take Emcor tablets if you have one of the
following heart problems:
• acute heart failure
• worsening heart failure requiring an injection
of medicines into a vein to increase the force of
contraction of the heart
• low blood pressure
• certain heart conditions causing a very slow
heart rate or irregular heartbeat and you have
not been fitted with a pacemaker
• cardiogenic shock, which is an acute serious
heart condition causing low blood pressure and
circulatory failure.
Take special care with Emcor tablets
If you have any of the following conditions tell
your doctor before taking Emcor tablets; he or she
may want to take special care (for example give
additional treatment or perform more frequent
checks):
• heart failure (although bisoprolol can be used to
treat heart failure the dosage is very different)
• first degree heart block (a condition in which
nerve signals to the heart are disturbed, possibly
causing it occasionally to skip a beat, or beat
irregularly)
• diabetes
• strict fasting
• certain heart diseases such as disturbances
in heart rhythm, or severe chest pain at rest
(Prinzmetal’s angina)
• kidney or liver problems
• less severe blood circulation problems in your
limbs
• less severe asthma or chronic lung disease
• history of allergies
• history of a scaly skin rash (psoriasis)
• tumour of the adrenal gland (phaeochromocytoma)
• thyroid disorder.
In addition, tell your doctor if you are going to
have:
• desensitization therapy (for example for the
prevention of hay fever), because Emcor tablets
may make it more likely that you experience an
allergic reaction, or such a reaction may be more
severe
• anaesthesia (for example for surgery), because
Emcor tablets may influence how your body
reacts to this situation.
Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription
or herbal medicines.
Do not take the following medicines with Emcor
tablets without special advice from your doctor:
• certain medicines used to treat high blood
pressure, angina pectoris or irregular heartbeat
(known as calcium antagonists, such as verapamil
and diltiazem)

• certain medicines used to treat high blood
pressure such as clonidine, methyldopa,
moxonodine, rilmenidine. However, do not stop
taking these medicines without checking with
your doctor first.
Check with your doctor before taking the following
medicines with Emcor tablets; your doctor may
need to check your condition more frequently:
• certain medicines used to treat irregular
or abnormal heartbeat (known as Class I
antiarrhythmic medicines, such as quinidine and
disopyramide)
• certain medicines used to treat high blood
pressure or angina pectoris (known as
dihydropyridine-type calcium antagonists, such
as nifedipine)
• certain medicines used to treat irregular
or abnormal heartbeat known as Class III
antiarrhythmic medicines, such as amiodarone)
• beta-blockers applied locally (such as timolol eye
drops for glaucoma treatment)
• certain medicines used to treat conditions
such as Alzheimer’s disease or glaucoma
(known as parasympathomimetics, such as
tacrine or carbachol) or medicines that are
used to treat acute heart problems (known as
sympathomimetics, such as isoprenaline and
dobutamine)
• antidiabetic medicines including insulin
• anaesthetic agents (for example during surgery)
• digitalis, used to treat heart failure
• non-steroidal anti-inflammatory medicines
(NSAIDs) used to treat arthritis, pain or
inflammation (for example ibuprofen or
diclofenac)
• sympathomimetics such as adrenaline and
noradrenaline which are used in the treatment of
heart attack and low blood pressure. Adrenaline is
also used to treat allergic reactions. Higher doses
of adrenaline may be necessary for treatment of
allergic reactions if Emcor is being taken at the
same time.
• any medicine, which can lower blood pressure
as a desired or undesired effect such as
antihypertensives, certain medicines for
depression (tricyclic antidepressants such as
imipramine or amitriptyline), certain medicines
used to treat epilepsy or during anaesthesia
(barbiturates such as phenobarbital), or certain
medicines to treat mental illness characterized
by a loss of contact with reality (phenothiazines
such as levomepromazine)
• mefloquine, used for prevention or treatment of
malaria
• depression
treatment
medicines
called
monoamine oxidase inhibitors (except MAO-B
inhibitors) such as moclobemide
• moxisylyte, which is used to treat circulatory
problems like Raynaud’s syndrome
Pregnancy and breast-feeding
There is a risk that use of Emcor tablets during
pregnancy may harm the baby. If you are pregnant
or planning to become pregnant, tell your doctor.
He or she will decide whether you can take Emcor
tablets during pregnancy.
It is not known whether bisoprolol passes into
human breast milk. Therefore, breastfeeding is not
recommended during therapy with Emcor tablets.
Driving and using machines
Your ability to drive or use machinery may be
affected depending on how well you tolerate the
medicine. Please be especially cautious at the start
of treatment, when the dose is increased or the
medication is changed, as well as in combination
with alcohol.
Some of the possible side effects listed in section
4 below could affect you when driving. If you feel
tired, dizzy or faint or get any muscle weakness or
cramps you should not drive.
3. HOW TO TAKE EMCOR TABLETS
Always take Emcor tablets exactly as your doctor
has told you. Check with your doctor or pharmacist
if you are not sure.
Take the tablet with some water in the morning, with
or without food. Do not crush or chew the tablet.
Treatment with Emcor tablets is usually long-term.
Adults:
The usual daily dose is 10 mg bisoprolol.
Depending on how well you respond to the
medicine, your doctor may decide to decrease the
dose to 5 mg or he may decide to increase it to 20
mg. The dose should not exceed 20 mg in one day.
Your doctor will tell you what to do. The label will
also tell you how many tablets to take and how
often to take them. Your pharmacist will help if you
are unsure.
If you have to stop treatment entirely, your doctor
will usually advise you to reduce the dose gradually,
as otherwise your condition may become worse.
Children
Emcor tablets are not recommended for use in
children.
If you take more Emcor tablets than you should
If you have taken more Emcor tablets than you
should, tell your doctor or hospital accident and
emergency department immediately. Take your
tablets with you. Your doctor will decide what
measures are necessary.

If you have taken too many tablets you may have
a slowed heart rate, severe difficulty in breathing,
feeling dizzy, or trembling (due to decreased blood
sugar).
If you forget to take Emcor tablets
Do not take a double dose to make up for a forgotten
dose. Take your usual dose the next morning.
If you stop taking Emcor tablets
Never stop taking Emcor unless on your doctor’s
advice. Otherwise your condition could become
much worse. If you have any further questions
on the use of this product, ask your doctor or
pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Emcor tablets can cause side
effects, although not everybody gets them.
To prevent serious side effects, speak to a doctor
immediately if a side effect is severe, occurs
suddenly or gets worse rapidly. Serious side effects
include breathing problems for anyone with asthma
or a lung condition, and allergic reactions such as
itching or rash. Other serious side effects include
changes to heart rate, which can cause dizziness
and weakness, or worsening of heart failure which
can cause a persistent chesty cough due to a build
up of fluid on the lungs. If you get any of these
side effects contact your doctor or seek emergency
assistance immediately as you may need to go to
a hospital.
Known side effects are listed below according to
how frequently they may occur:
Common (affects fewer than 1 person in 10):
• tiredness, dizziness, headache
• feeling of coldness or numbness in hands or feet
• low blood pressure
• stomach or intestine problems such as nausea,
vomiting, diarrhoea, or constipation.
Uncommon (affects fewer than 1 person in 100):
• interference with normal heart rate
• worsening heart failure
• sleep disturbances
• depression
• breathing problems in patients with asthma or
chronic lung disease
• feeling weak, muscle weakness, muscle cramps
• dizziness when standing up.
Rare (affects fewer than 1 person in 1,000):
• hearing problems
• allergic runny nose, sneezing and itching
• reduced tear flow (dry eyes)
• inflammation of the liver which can cause
yellowing of the skin or the whites of the eyes
• certain blood test results for liver function or fat
levels differing from normal
• allergy-like reactions such as itching, flush, rash
• impaired erection
• nightmares, hallucinations
• fainting.
Very rare (affects fewer than 1 person in 10,000):
• irritation and redness of the eye (conjunctivitis)
• hair loss
• appearance or worsening of scaly skin rash
(psoriasis); psoriasis-like rash.
Tell your doctor or your pharmacist if you notice
any of the side effects listed above or any other
unwanted or unexpected effects.

5. HOW TO STORE EMCOR TABLETS
• Keep out of the reach and sight of children.
• Do not use Emcor tablets after the expiry date
which is stated on the blister and the carton after
EXP. The expiry date refers to the last date of that
month.
• Emcor tablets do not require any special storage
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 Emcor tablets contain
Emcor LS 5 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 5 mg.
• The other ingredients are:
Tablet core: Silica, colloidal anhydrous;
magnesium stearate; crospovidone; maize
starch; microcrystalline cellulose; calcium
hydrogen phosphate (anhydrous). Film coating:
Iron oxide yellow (E172); dimethicone; macrogol
400; titanium dioxide (E171); hypromellose.
Emcor 10 mg film-coated tablets
• The active substance is bisoprolol fumarate. Each
film-coated tablet contains 10 mg.
• The other ingredients are:
Tablet core: Silica, colloidal anhydrous;
magnesium stearate; crospovidone; maize starch;
microcrystalline cellulose; calcium hydrogen
phosphate (anhydrous).
Film coating: Iron oxide red (E172); Iron oxide
yellow (E172); dimethicone; macrogol 400;
titanium dioxide (E171); hypromellose.
What Emcor tablets look like and contents of
the pack
Emcor 5 mg film-coated tablets are yellowishwhite and heart-shaped with a break-line on both
sides.
Emcor 10 mg film-coated tablets are pale orange
– light orange and heart-shaped with a break-line
on both sides.
Each pack contains 4, 14 or 28 tablets. Not all pack
sizes may be marketed.
Marketing Authorisation Holder
Merck Serono Ltd
Bedfont Cross
Stanwell Road
Feltham
TW14 8NX
UK
Manufacturer
Merck KGaA & Co. Werk Spittal
Hösslgasse 20
9800 Spittal/DrauAustria

This
leafletwas
waslast
lastapproved
revised in
in month
July 2012.
This leaflet
year.
TW462278

MC1.0-0417-2012

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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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