Package leaflet: Information for the patient

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

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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, especially 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 weak and unable to pump enough 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 fingers of hands or feet,
if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland,
if the patient has metabolic acidosis, a condition in which blood pH is abnormal,
if the patient has acute heart failure,
if heart failure worsens and intravenous administration of drugs increasing heart contractility is required,
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 bronchial 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 allergic reactions or intensify such reactions;
a surgical procedure under general anaesthesia, because Concor Cor 2.5 may alter the body's response to administered drugs.

Children and adolescents
Use of Concor Cor 2.5 is not recommended in children and adolescents.

Concor Cor 2.5 and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take the following medicines together with Concor Cor 2.5 without specific instruction from your doctor:

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 (calcium antagonists, dihydropyridine derivatives 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, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
medicines used to treat acute heart disorders (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 undesirable effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants), certain antiepileptics or agents used in general anaesthesia (barbiturates), 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 called monoamine oxidase 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you can take Concor Cor 2.5 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 operating machinery
Depending on how it is tolerated, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after increasing the dose, or after changing medications, as well as when combining the medicine with alcohol.

3. How to use Concor Cor 2.5

This medicine should always be taken exactly as prescribed 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 discontinuing 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 and gradually increase it – your doctor will decide how to adjust the dosage. The recommended initial dose is 1.25 mg once daily. The dose should be increased every two weeks or at longer intervals 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 for maintenance therapy (chronic treatment).

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before increasing the dose further. If symptoms worsen 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 of bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.
Impaired liver or kidney function
Exercise particular caution when increasing the dose of this 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 discontinuation of treatment becomes necessary, 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, contact your doctor immediately. Your doctor will decide what actions should be taken.
Symptoms of overdose may include: slowed heart rate, difficulty breathing, a significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar levels).
Missing a dose of Concor Cor 2.5
Do not take a double dose to make up for a missed dose. Take the next dose as scheduled the following morning.
Stopping treatment with Concor Cor 2.5
Never stop taking Concor Cor 2.5 unless your doctor specifically advises you to do so. Otherwise, your condition may worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Very common (affects at least 1 in 10 patients):

bradycardia (slow heart rate)

Common (affects fewer than 1 in 10 patients):

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

Uncommon (affects fewer than 1 in 100 patients):

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

Rare (affects fewer than 1 in 1,000 patients):

hearing disturbances,
allergic rhinitis,
reduced tear secretion (should be considered if the patient uses contact lenses),
hepatitis, which may cause yellowing of the skin or eyes,
changes in the 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. If more severe allergic reactions occur, including swelling of the face, neck, tongue, mouth or throat, or difficulty breathing, contact a doctor immediately,
erectile dysfunction,
nightmares, hallucinations,
fainting.

Very rare (affects fewer than 1 in 10,000 patients):

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

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorisation holder or the parallel importer.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store the medicine Concor Cor 2.5

The medicine should be stored in a place inaccessible and out of sight 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 stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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 are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate; tablet coating: dimethicone, macrogol 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 tablet, heart-shaped, with a score line on both sides of the tablet.
The pack contains 28, 56 or 100 film-coated tablets.
For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Ireland, country of export:
Merck Serono (Ireland) Limited
4045 Kingswood Road, Citywest Business Campus
Dublin D24 V06K
Ireland
Manufacturer:
Merck S.L.
Polígono Merck
Mollet del Vallés
08100 Barcelona
Spain
Parallel Importer:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 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.
spółka komandytowa ul. Forteczna 35-37 ul. Tymiankowa 24/28
ul. Działkowa 56 87-100 Toruń 95-054 Ksawerów
02-234 Warsaw
Marketing Authorisation Number in Ireland, country of export: PA 2286/4/2
Parallel Import Licence Number: 74/25