Concor Cor 2,5

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Concor Cor 2.5 (Concor COR 2.5 mg)

2.5 mg, coated tablets

Bisoprolol fumarate
Concor Cor 2.5 and Concor COR 2.5 mg are different trade names for the same drug.

It is necessary to carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This drug has been prescribed for a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Concor Cor 2.5 and what is it used for
• 2. Important information before using Concor Cor 2.5
• 3. How to use Concor Cor 2.5
• 4. Possible side effects
• 5. How to store Concor Cor 2.5
• 6. Package contents and other information

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

The active substance of Concor Cor 2.5 is bisoprolol fumarate. Bisoprolol belongs to a group of drugs called beta-adrenolytics. These drugs affect the body's response to certain nerve impulses, especially in the heart. As a result, bisoprolol slows down the heart rate and thus increases the efficiency of the heart in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.
Concor Cor 2.5 is used to treat stable, chronic heart failure.

2. Important information before using Concor Cor 2.5

When not to use Concor Cor 2.5

Concor Cor 2.5 should not be used in the following cases:
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• if the patient is allergic to bisoprolol or any of the other ingredients of this drug (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 can cause tingling, paleness, or blueness of the fingers or toes,
• if the patient has an untreated pheochromocytoma, a rare tumor 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 requires intravenous administration of drugs that increase heart contractility,
• if the patient has symptoms of slow heart rate,
• if the patient has symptoms of low blood pressure,
• if the patient has certain heart diseases that cause very slow or irregular heartbeats (second or third degree atrioventricular block, sinoatrial block, sick sinus syndrome) without a pacemaker,
• if the patient has cardiogenic shock, an acute, life-threatening heart disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If any of the following conditions occur, the patient should discuss them with their doctor before starting Concor Cor 2.5; the doctor may consider it necessary to take special precautions (e.g., administer additional drugs or perform more frequent medical check-ups):

• diabetes,
• strict fasting,
• certain heart diseases (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina),
• kidney or liver disorders,
• circulatory disorders in the limbs,
• mild asthma or chronic obstructive pulmonary disease,
• psoriasis (including a history of psoriasis),

Additionally, the patient should inform their doctor if:

• desensitization therapy is planned (e.g., to avoid hay fever), as Concor Cor 2.5 may increase the risk of an allergic reaction or worsen its severity;
• a surgical procedure under general anesthesia is planned, as Concor Cor 2.5 may alter the body's response to the administered drugs.

Children and adolescents

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

The patient should inform their doctor about all drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
The following drugs should not be used with Concor Cor 2.5 without special recommendation by the doctor:

• certain drugs used to treat arrhythmias (class I antiarrhythmic drugs, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain drugs used to treat high blood pressure, coronary artery disease, or arrhythmias (calcium antagonists, such as verapamil and diltiazem);
• certain drugs used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. However, these drugs should not be stopped without consulting a doctor.

Before using the following drugs with Concor Cor 2.5, the patient should discuss them with their doctor, as the doctor may recommend more frequent medical check-ups:

• certain drugs used to treat high blood pressure or coronary artery disease (dihydropyridine calcium antagonists, such as felodipine and amlodipine);
• certain drugs used to treat arrhythmias (class III antiarrhythmic drugs, such as amiodarone);
• locally used beta-adrenolytics (such as eye drops for glaucoma treatment);
• certain drugs used to treat Alzheimer's disease or glaucoma (parasympathomimetics);
• drugs used to treat acute heart disorders (adrenergic drugs, such as isoprenaline and dobutamine);
• insulin and oral antidiabetic drugs;
• drugs used for general anesthesia (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat arthritis, pain, and inflammation (e.g., ibuprofen and diclofenac);
• adrenaline, a drug used to treat severe, life-threatening allergic reactions and cardiac arrest;
• all drugs that may lower blood pressure, either as a desired or undesired effect, such as antihypertensive drugs, certain antidepressants (tricyclic antidepressants), certain antiepileptic drugs, or drugs used during general anesthesia (barbiturates), as well as certain drugs used for psychiatric disorders characterized by loss of contact with reality (phenothiazine derivatives);
• mefloquine, used to prevent and treat malaria;
• drugs used to treat depression, known as monoamine oxidase inhibitors (except for MAO-B inhibitors);
• rifampicin, an antibiotic used to treat infections;
• ergotamine derivatives, drugs 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 fetus.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug. The doctor will decide whether Concor Cor 2.5 can be used during pregnancy.
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It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Concor Cor 2.5.

Driving and operating machinery

The drug may impair the ability to drive or operate machinery, depending on how it is tolerated. The patient should be particularly careful at the beginning of treatment, after increasing the dose, or when changing drugs, as well as when combining the drug with alcohol.

3. How to use Concor Cor 2.5

This drug should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Concor Cor is available in the following doses: 1.25 mg, 2.5 mg, 3.75 mg, 7.5 mg.
Regular medical check-ups are necessary during treatment with Concor Cor 2.5. This is especially important at the beginning of treatment, during dose increases, and when stopping treatment.
The tablet should be taken in the morning with food or independently of food, washed down with water. The tablets should not be chewed. Scored tablets can be divided into two equal doses.

Adults

The doctor will start treatment with bisoprolol at a low dose, which will be gradually increased - the 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 more 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 of bisoprolol once daily for 2 weeks;
• 2.5 mg of bisoprolol once daily for 2 weeks;
• 3.75 mg of bisoprolol once daily for 2 weeks;
• 5 mg of bisoprolol once daily for 2 weeks;
• 7.5 mg of bisoprolol once daily for 2 weeks;
• 10 mg of bisoprolol once daily for maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the drug is tolerated, the doctor may recommend extending the time interval to the next dose increase. If the disease worsens or the drug is not tolerated, it may be necessary to reduce the dose again or stop treatment. In some patients, a maintenance dose lower than 10 mg of bisoprolol may be sufficient.
The doctor will determine the appropriate course of action.

Impaired liver or kidney function

Special caution is necessary when increasing the dose of Concor Cor 2.5.

Elderly patients

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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 stopped, the doctor will usually recommend gradually reducing the dose of the drug; otherwise, the disease may worsen.

Using more than the recommended dose of Concor Cor 2.5

If a dose of Concor Cor 2.5 higher than recommended is taken, the doctor should be informed immediately. The doctor will decide what actions to take.
Symptoms of overdose include: slow heart rate, difficulty breathing, significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar levels).

Missing a dose of Concor Cor 2.5

A double dose should not be taken to make up for a missed dose. The recommended dose should be taken the next morning.

Stopping Concor Cor 2.5 treatment

Concor Cor 2.5 treatment should never be stopped without consulting a doctor; otherwise, the disease may worsen.
In case of any further doubts about using this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, Concor Cor 2.5 can cause side effects, although not everybody gets them.
Very common(occurring in at least 1 in 10 patients):

• bradycardia (slow heart rate).

Common(occurring less frequently than in 1 in 10 patients):

• worsening of existing heart failure,
• fatigue, asthenia (weakness), dizziness, headache,
• feeling of cold or numbness in the hands or feet,
• low blood pressure,
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation.

Uncommon(occurring less frequently than in 1 in 100 patients):

• conduction disorders,
• sleep disorders,

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• depression,
• bronchospasm (difficulty breathing) in patients with asthma or chronic obstructive pulmonary disease,
• muscle weakness or cramps.

Rare(occurring less frequently than in 1 in 1000 patients):

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (should be considered if the patient wears contact lenses),
• hepatitis, which can cause yellowing of the skin or eyes,
• changes in the results of certain blood tests, related to liver function (increased ALT and AST activity) or triglyceride levels in serum,
• allergic reactions, such as itching, flushing, rash. The patient should immediately contact their doctor if they experience more severe allergic reactions, which may include: swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing,
• impotence,
• nightmares, hallucinations,
• fainting.

Very rare(occurring less frequently than in 1 in 10,000 patients):

• conjunctivitis (irritation or redness of the eyes),
• hair loss,
• onset or worsening of psoriatic skin lesions (psoriasis), psoriasis-like lesions.

Reporting side effects
If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al.
Jerozolimskie 181C, 02-222 Warsaw
phone: +48 22 49 21 301, fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the drug.

5. How to store Concor Cor 2.5

The drug should be stored out of sight and reach of children.
Store at a temperature below 25°C.
Do not use this drug after the expiration date stated on the blister pack and the carton. The expiration date refers to the last day of the specified month.
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Translation of some information on the immediate packaging:
Lot/EXP printed - batch number/expiration date see embossing.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Package contents 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.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, calcium hydrogen phosphate; tablet coating: dimeticone 100, macrogol 400, titanium dioxide (E171), hypromellose 2910/15.

What Concor Cor 2.5 looks like and what the package contains

Concor Cor 2.5 is a white, heart-shaped, coated tablet with a score line on both sides of the tablet.
Each package contains 28 or 56 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Merck spol. s r.o.
Na Hřebenech II 1718/10
140 00 Prague 4
Czech Republic

Manufacturer:

Merck, S.L.
Polígono Merck
Mollet del Vallès,
08100 Barcelona
Spain
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany

Parallel importer:

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Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Marketing authorization number in the Czech Republic, the country of export: 77/026/01-C
Parallel import authorization number: 422/24

Date of leaflet approval: 29.11.2024

[Information about the trademark]
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