CONGESCOR 1.25MG FILM-COATED TABLETS

Active substance: BISOPROLOL FUMARATE

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Package leaflet: Information for the user
Congescor 1.25 mg film-coated tablets
Congescor 2.5 mg film-coated tablets
Bisoprolol fumarate
Read all of this leaflet carefully before you start taking this medicine because 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 or your pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Congescor is and what it is used for
What you need to know before you take Congescor
How to take Congescor
Possible side effects
How to store Congescor
Contents of the pack and other information

1.

What CONGESCOR is and what it is used for

The active substance in Congescor 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.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to supply the
body's needs. Congescor is used to treat stable chronic heart failure.
It is used in combination with other medicines suitable for this condition (such as ACE-inhibitors,
diuretics, and heart glycosides).

2.

What you need to know before you take

Do not take Congescor
Do not take Congescor if one of the following conditions applies to you:






allergy (hypersensitivity) to bisoprolol or to any of the other ingredients (see section 6 ‘What
Congescor 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 when there is too much acid in the blood.

Do not take Congescor if you have one of the following heart problems:


acute heart failure
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worsening heart failure requiring injection of medicines into a vein, that increase the force of
contraction of the heart
slow heart rate
low blood pressure
certain heart conditions causing a very slow heart rate or irregular heartbeat
cardiogenic shock, which is an acute serious heart condition causing low blood pressure and
circulatory failure.

Warnings and precautions
If you have any of the following conditions tell your doctor before taking Congescor; he or she may
want to take special care (for example give additional treatment or perform more frequent checks):

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 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 Congescor may
make it more likely that you experience an allergic reaction, or such reaction may be more
severe

anaesthesia (for example for surgery), because Congescor may influence how your body reacts
to this situation.
Children and adolescents
Congescor is not recommended for use in children or adolescents.
Other medicines and Congescor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Do not take the following medicines with Congescor without special advice from your doctor:




certain medicines used to treat irregular or abnormal heartbeat (Class I antiarrhythmic medicines
such as quinidine, disopyramide, lidocaine, phenytoin; flecainide, propafenone)
certain medicines used to treat high blood pressure, angina pectoris or irregular heartbeat
(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 Congescor; your doctor may need
to check your condition more frequently:



certain medicines used to treat high blood pressure or angina pectoris (dihydropyridine-type
calcium antagonists such as felodipine and amlodipine)
certain medicines used to treat irregular or abnormal heartbeat (Class III antiarrhythmic
medicines such as amiodarone)
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beta-blockers applied locally (such as timolol eye drops for glaucoma treatment)
certain medicines used to treat for example Alzheimer’s disease or glaucoma
(parasympathomimetics such as tacrine or carbachol) or medicines that are used to treat acute
heart problems (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)
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.

Pregnancy and breast-feeding
There is a risk that use of Congescor 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 Congescor
during pregnancy.
It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not
recommended during therapy with Congescor.
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.

3.

How to take Congescor

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Treatment with Congescor requires regular monitoring by your doctor. This is particularly necessary at
the start of treatment during dose increase, and when you stop treatment.
Take the tablet with some water in the morning, with or without food. Do not crush or chew the tablet.
The scored tablets can be divided into two equal doses
Treatment with Congescor is usually long-term.
Adults including the elderly
Treatment with bisoprolol must be started at a low dose and increased gradually.
Your doctor will decide how to increase the dose, and this will normally be done in the following way:







1.25 mg bisoprolol once daily for one week
2.5 mg bisoprolol once daily for one week
3.75 mg bisoprolol once daily for one week
5 mg bisoprolol once daily for four weeks
7.5 mg bisoprolol once daily for four weeks
10 mg bisoprolol once daily for maintenance (on-going) therapy.
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The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how well you tolerate the medicine, your doctor may also decide to lengthen the time
between dose increases. If your condition gets worse or you no longer tolerate the drug, it may be
necessary to reduce the dose again or to interrupt treatment. In some patients a maintenance dose
lower than 10 mg bisoprolol may be sufficient.
Your doctor will tell you what to do.
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.
If you take more Congescor than you should
If you have taken more Congescor tablets than you should, tell your doctor immediately. Your doctor
will decide what measures are necessary.
Symptoms of an overdose may include slowed heart rate, severe difficulty in breathing feeling dizzy,
or trembling (due to decreased blood sugar).
If you forget to take Congescor
Do not take a double dose to make up for a forgotten dose. Take your usual dose the next morning.
If you stop taking Congescor
Never stop taking Congescor 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, this medicine can cause side effects, although not everybody gets them.
To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurred
suddenly or gets worse rapidly.
The most serious side effects are related to the heart function:

slowing of heart rate (affects more than 1 person in 10)

worsening of heart failure (affects less than 1 person in 10)

slow or irregular heartbeat (affects less than 1 person in 100)
If you feel dizzy or weak, or have breathing difficulties please contact your doctor as soon as possible.
Further side effects are listed below according to how frequently they may occur:
Common (affects less than 1 person in 10):

tiredness, feeling weak, 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 less than 1 person in 100):

sleep disturbances

depression

dizziness when standing up

breathing problems in patients with asthma or chronic lung disease
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muscle weakness, muscle cramps.

Rare (affects less than 1 person in 1,000):

hearing problems

allergic runny nose

reduced tear flow

inflammation of the liver which can cause yellowing of the skin or 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 less 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.

5.

How to store Congescor


Keep this medicine out of the sight and reach of children

Do not use this medicine 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.
Congescor 1.25 mg film-coated tablets:
Congescor 2.5 mg film-coated tablets:

Do not store above 25°C.
Do not throw away 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 Congescor contains
Congescor 1.25 mg film-coated tablets

The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg.

The other ingredients are:
Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; pregelatinised
maize starch; maize starch; microcrystalline cellulose; calcium hydrogen phosphate
(anhydrous).
Film coating: dimethicone; talcum; macrogol 400; titanium dioxide (E171); hypromellose.
Congescor 2.5 mg film-coated tablets

The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg.

The other ingredients are:
Tablet core: Silica, colloidal anhydrous; magnesium stearate; crospovidone; maize starch;
microcrystalline cellulose; calcium hydrogen phosphate (anhydrous).
Film coating: dimethicone; macrogol 400; titanium dioxide (E171); hypromellose.

What Congescor looks like and contents of the pack
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Congescor 1.25 mg film-coated tablets are white and round.
Congescor 2.5 mg film-coated tablets are white and heart-shaped with a break-line on both sides.
Each pack contains 10, 20, 28, 30, 50, 56, 60, 90, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merck Serono Ltd, Bedfont Cross, Stanwell Road, Feltham, Middlesex, TW14 8NX, UK
Manufacturer
Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany
Merckle GmbH, Ludwig-Merckle Strasse 3, 89143 Blaubeuren, Germany
Tillomed Laboratories Ltd., 3 Howard Road, Eaton Socon, St. Neots, PE19 3ET, United Kingdom
Sanico, Industriezone 4, Veedijk 59, 2300 Turnhout, Belgium
Merck S.L., Poligono Merck, 08100 Mollet des Vallès (Barcelona), Spain
This medicinal product is authorised in the Member States of the EEA under the following
names:
Belgium:
Denmark:
France:
Germany:
Italy:
Netherlands:
Sweden:
United Kingdom:

Isoten *
Congescor
Cardiocor
Bisoprolol-ratiopharm
Congescor
Bisoprololfumaraat Deco Mylan
Congescor
Congescor

*2.5 mg film-coated tablets: Isoten Minor
This leaflet was last revised in April 2013.

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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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