Concor Cor 2,5

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Concor Cor 2.5 (Emconcor Cor), 2.5 mg, coated tablets
Bisoprolol fumarate
Concor Cor 2.5 and Emconcor Cor 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 to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 taking Concor Cor 2.5
• 3. How to take Concor Cor 2.5
• 4. Possible side effects
• 5. How to store Concor Cor 2.5
• 6. Contents of the packaging 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-adrenergic blockers. 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 within 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 taking Concor Cor 2.5

When not to take Concor Cor 2.5

Concor Cor 2.5 should not be taken in the following cases:

• 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 bluish discoloration 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 heart rhythm (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) without a pacemaker,
• if the patient has cardiogenic shock, a severe and life-threatening circulatory disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If any of the following conditions occur, the patient should talk to their doctor before starting Concor Cor 2.5; the doctor may consider special caution (e.g., additional medication or 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),
• pheochromocytoma of the adrenal gland,
• thyroid dysfunction.

In addition, the patient should tell their doctor if they are planning:

• desensitization treatment (e.g., to avoid hay fever), as Concor Cor 2.5 may increase the risk of an allergic reaction or worsen such a reaction;
• undergoing surgery under general anesthesia, as Concor Cor 2.5 may change 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 and other drugs

The patient should tell their doctor about all drugs they are currently taking or have recently taken, as well as any drugs they plan to take.
Concor Cor 2.5 should not be taken with the following drugs 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 taking the following drugs with Concor Cor 2.5, the patient should talk to 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);
• topically applied beta-adrenergic blockers (such as eye drops for glaucoma treatment);
• certain drugs used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
• drugs used to treat acute heart disorders (adrenergic agonists, 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;
• nonsteroidal 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, called 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 taking 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 taking this drug. The doctor will decide whether Concor Cor 2.5 can be taken during pregnancy.
It is not known whether bisoprolol passes into human milk, so breastfeeding is not recommended during treatment with Concor Cor 2.5.

Driving and using machines

The drug may impair the ability to drive or operate machines, 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 take Concor Cor 2.5

This drug should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
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 in case of treatment discontinuation.
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.
Concor Cor 1.25 (1.25 mg), Concor Cor 2.5 (2.5 mg), Concor Cor 3.75 (3.75 mg), Concor Cor 5 (5 mg), Concor Cor 7.5 (7.5 mg), and Concor Cor 10 (10 mg) are available on the market.

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 discontinue 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

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, the doctor will usually recommend gradual reduction of the dose, otherwise, the disease may worsen.

Taking a higher dose of Concor Cor 2.5 than recommended

In case of taking a higher dose of Concor Cor 2.5 than recommended, the patient should immediately inform their doctor. The doctor will decide what actions to take.
Symptoms of overdose include: slowed heart rate, difficulty breathing, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missing a dose of Concor Cor 2.5

The patient should not take a double dose to make up for a missed dose. The next morning, they should take the recommended dose.

Discontinuing Concor Cor 2.5

The patient should never stop taking Concor Cor 2.5 unless their doctor recommends it. Otherwise, the disease may worsen.
In case of any further doubts about taking 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 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 1 in 100 patients):

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

Rare(occurring less frequently than 1 in 1,000 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 some 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 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 the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 will 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.
Concor Cor 2.5 should not be used after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
Store at a temperature below 25°C.
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. 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 ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, calcium hydrogen phosphate. tablet coating: dimethicone, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 2.5 looks like and what the packaging contains

Concor Cor 2.5 mg is a white, heart-shaped, coated tablet with a score line on both sides of the tablet.
The packaging contains 28, 56, or 100 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Spain, the country of export:

Merck, S.L.
María de Molina, 40
28006 Madrid
Spain

Manufacturer:

Merck Healthcare KGAA
Frankfurter Strasse 250, D-64293 Darmstadt, Germany
Merck, S.L., Polígono Merck, 08100 Mollet del Vallés (Barcelona), Spain
Tjoapack Netherlands B.V., Nieuwe Donk 9, 4879 AC Etten-Leur, Netherlands
Famar Lyon, Avenue du General De Gaulle, F-69230 Saint-Genis Laval, France

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish export authorization number: 869735.9

• 608356.7

Parallel import authorization number: 4/13 Date of leaflet approval: 03.01.2023

[Information about the trademark]