Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Concor Cor 2.5 (Concor Cor 2.5 mg)
2.5 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 2.5 and Concor Cor 2.5 mg are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet for possible future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms appear identical.
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Concor Cor 2.5 is and what it is used for
Important information before taking Concor Cor 2.5
How to take Concor Cor 2.5
Possible side effects
How to store Concor Cor 2.5
Contents of the pack and other information

1. What Concor Cor 2.5 is and what it is used for

The active substance in Concor Cor 2.5 is bisoprolol fumarate. Bisoprolol belongs to a group of medicines called beta-blockers. These medicines affect the body's response to certain nerve impulses, particularly in the heart. As a result, bisoprolol slows down heart activity and thereby improves the heart's efficiency in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weakened and unable to pump sufficient blood to meet the body's needs.
Concor Cor 2.5 is used in the treatment of stable chronic heart failure.

2. Important information before using Concor Cor 2.5

When not to use Concor Cor 2.5
Do not use Concor Cor 2.5 in the following cases:

if the patient is allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6),
if the patient has severe asthma,
if the patient has serious circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness, or blueness of the fingers or toes,
if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland,
if the patient has metabolic acidosis, a condition in which the blood pH is abnormal,
if the patient has acute heart failure,
if the patient's heart failure worsens and intravenous administration of drugs increasing cardiac contractility becomes necessary,
if the patient has symptoms of slow heart function,
if the patient has symptoms of low blood pressure,
if the patient has certain heart diseases causing very slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) in the absence of a pacemaker,
if the patient has cardiogenic shock, an acute, life-threatening disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, speak to your doctor before starting treatment with Concor Cor 2.5; your doctor may decide that special caution is needed (for example, additional medication or more frequent monitoring):

diabetes,
strict fasting,
certain heart diseases (such as heart rhythm disorders or severe chest pain at rest – Prinzmetal's angina),
kidney or liver disorders,
circulatory disorders in the limbs,
mild asthma or chronic lung disease,
presence of scaly skin lesions (psoriasis), even in medical history,
phaeochromocytoma of the adrenal medulla,
thyroid dysfunction.

Additionally, inform your doctor if you are planning:

allergen immunotherapy (e.g. to prevent hay fever), because Concor Cor 2.5 may increase the likelihood of an allergic reaction or intensify such a reaction;
surgery under general anaesthesia, because Concor Cor 2.5 may alter the body's response to administered drugs.

Children and adolescents
Concor Cor 2.5 is not recommended for use in children and adolescents.

Concor Cor 2.5 with other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.

Do not take the following medicines together with Concor Cor 2.5 without specific medical advice:

certain medicines used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
certain medicines used to treat high blood pressure, coronary artery disease, or heart rhythm disorders (calcium antagonists such as verapamil and diltiazem);
certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, do not stop taking these medicines without consulting your doctor.

Before taking any of the following medicines together with Concor Cor 2.5, consult your doctor; your doctor may recommend more frequent medical checks:

certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine-type calcium antagonists such as felodipine and amlodipine);
certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone);
locally applied beta-blockers (such as eye drops used to treat glaucoma);
certain medicines used to treat conditions such as Alzheimer's disease or glaucoma (parasympathomimetics);
medicines used to treat acute heart conditions (adrenergic agonists such as isoprenaline and dobutamine);
insulin and oral antidiabetic medicines;
agents used in general anaesthesia (e.g. during surgery);
digitalis glycosides used to treat heart failure;
non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, relieve pain and inflammation (e.g. ibuprofen and diclofenac);
adrenaline, a medicine used to treat severe, life-threatening allergic reactions and cardiac arrest;
all medicines that may lower blood pressure, either as a desired or adverse effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants), certain antiepileptic drugs or barbiturates used during general anaesthesia, and certain medicines used in psychiatric disorders involving loss of contact with reality (phenothiazine derivatives);
mefloquine, used for prevention and treatment of malaria;
medicines used to treat depression, known as monoamine oxidase inhibitors (MAO inhibitors, except MAO-B inhibitors);
rifampicin, an antibiotic used to treat infections;
ergotamine derivatives, medicines used to treat dementia and migraine headaches.

Pregnancy and breastfeeding
There is a risk that using Concor Cor 2.5 during pregnancy may harm the unborn child.
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Concor Cor 2.5 can be taken during pregnancy.
It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor Cor 2.5.

Driving and using machines
This medicine may, depending on individual tolerance, impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increases, or when changing medications, as well as when combining this medicine with alcohol.

3. How to use Concor Cor 2.5

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Concor Cor 2.5. This is particularly
important at the beginning of treatment, when increasing the dose, and when stopping treatment.
The tablet should be taken in the morning with food or independently of meals, swallowed with water.
Do not chew the tablets. Tablets with a score line may be divided into two equal doses.
The following strengths are available on the market: Concor Cor 1.25 (1.25 mg), Concor Cor 2.5 (2.5 mg), Concor Cor 3.75
(3.75 mg), Concor Cor 7.5 (7.5 mg).
Adults
Your doctor will start treatment with bisoprolol at a low dose, which will be gradually increased – your doctor will decide
how to increase the dose. The recommended initial dose is 1.25 mg once daily. The dose is increased at intervals of two weeks or longer to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once daily.
This is usually done as follows:

1.25 mg bisoprolol once daily for 2 weeks;
2.5 mg bisoprolol once daily for 2 weeks;
3.75 mg bisoprolol once daily for 2 weeks;
5 mg bisoprolol once daily for 2 weeks;
7.5 mg bisoprolol once daily for 2 weeks;
10 mg bisoprolol once daily as maintenance (chronic) therapy.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before the next
dose increase. If the condition worsens or if the medicine is not well tolerated, it may be necessary
to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.
Impaired liver or kidney function
Particular caution is required when increasing the dose of the medicine.
Elderly patients
Dose adjustment is not necessary.
Use in children and adolescents
Concor Cor 2.5 is not recommended for use in children and adolescents.
Duration of treatment
Treatment with Concor Cor 2.5 is usually long-term.
If treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose. Otherwise, the condition may worsen.
Taking more than the recommended dose of Concor Cor 2.5
If you take more Concor Cor 2.5 than prescribed, inform your doctor immediately. The doctor will decide what actions to take.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).
Missed dose of Concor Cor 2.5
Do not take a double dose to make up for a missed dose. Take the next dose as prescribed the following morning.
Stopping Concor Cor 2.5
Never stop taking Concor Cor 2.5 unless instructed by your doctor. Otherwise, your condition may worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Very common (affects at least 1 in 10 people):

bradycardia (slow heart rate).

Common (affects less than 1 in 10 people):

worsening of existing heart failure,
fatigue, asthenia (weakness), dizziness, headache,
feeling of coldness or numbness in hands or feet,
low blood pressure,
gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

Uncommon (affects less than 1 in 100 people):

atrioventricular conduction disorders,
sleep disorders,
depression,
bronchospasm (breathing difficulties) in patients with bronchial asthma or chronic obstructive pulmonary disease,
muscle weakness or muscle cramps.

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

hearing disturbances,
allergic rhinitis,
reduced tear production (should be considered if the patient wears contact lenses),
hepatitis, which may cause yellowing of the skin or eyes,
changes in results of certain blood tests related to liver function (increased AlAT and AspAT activity) or serum triglyceride levels,
allergic reactions such as itching, facial flushing, rash. Immediate medical advice must be sought if more severe allergic reactions occur, which may include swelling of the face, neck, tongue, mouth or throat, or breathing difficulties,
erectile dysfunction,
nightmares, hallucinations,
fainting.

Very rare (affects less than 1 in 10,000 people):

conjunctivitis (eye irritation or redness),
alopecia (hair loss),
occurrence or worsening of scaly skin lesions (psoriasis), psoriasiform eruptions.

Reporting of side effects
If any side effects occur, including any side effects not listed in
this leaflet, inform your doctor, pharmacist or nurse. Side effects can
be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al.
Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website:
https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder or parallel importer.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Concor Cor 2,5

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Concor Cor 2.5 contains

The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg of bisoprolol fumarate.
Other components: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, calcium hydrogen phosphate; tablet coating: dimethicon, polyethylene glycol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 2.5 looks like and contents of the pack
Concor Cor 2.5 is a white, film-coated, heart-shaped tablet with a score line on both sides of the tablet.
The pack contains 30 or 60 film-coated tablets.
For further detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Merck Serono SIA
Duntes iela 23A
LV-1005 Riga
Latvia
Manufacturer:
Merck S.L.
Polígono Merck
Mollet del Vallés
08100 Barcelona
Spain
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
Parallel importer:
Allpharm Sp. z o.o. sp.k.
M. Zdziechowskiego Street 11/4
02-659 Warsaw
Repackaged in:
CEFEA Sp. z o.o. Sp. Synoptis Industrial Sp. z o.o. Shiraz Productions Sp. z o.o.
sp. k. Forteczna Street 35-37 Tymiankowa Street 24/28
Działkowa Street 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in Latvia, country of export: 02-0168
Parallel Import Licence Number: 75/25