Concor Cor 5

Leaflet attached to the packaging: patient information

WARNING: Keep the leaflet, the information on the immediate packaging in a foreign language.

Concor Cor 5 (Emconcor Cor), 5 mg, film-coated tablets

Bisoprolol fumarate
Concor Cor 5 and Emconcor Cor are different trade names for the same drug.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Concor Cor 5 and what is it used for
• 2. Important information before taking Concor Cor 5
• 3. How to take Concor Cor 5
• 4. Possible side effects
• 5. How to store Concor Cor 5
• 6. Contents of the packaging and other information

1. What is Concor Cor 5 and what is it used for

The active substance of Concor Cor 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 the heart rate and thus increases the efficiency of the heart in pumping blood throughout the body. Bisoprolol at a dose of 5 mg lowers high blood pressure.
Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.
Concor Cor 5 is used to treat stable, chronic heart failure.
Concor Cor 5 is used to treat high blood pressure or angina pectoris (chest pain caused by insufficient blood supply to the heart) .

2. Important information before taking Concor Cor 5

When not to take Concor Cor 5

Concor Cor 5 should not be taken 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 problems 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 medicines 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 heart condition 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 5; the doctor may decide that special caution is necessary (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;
• psoriatic skin lesions, including a history of psoriasis;
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, the patient should tell their doctor if they plan to:

• undergo desensitization treatment (e.g., to avoid hay fever), as Concor Cor 5 may increase the risk of an allergic reaction or worsen such a reaction;
• undergo surgery under general anesthesia, as Concor Cor 5 may alter the body's response to anesthetics.

Children and adolescents

Concor Cor 5 is not recommended for use in children and adolescents.

Concor Cor 5 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concor Cor 5 should not be taken with the following medicines without special recommendation by the doctor:

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

Before taking the following medicines with Concor Cor 5, the patient should talk to their doctor, as the doctor may recommend more frequent medical check-ups:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine calcium antagonists, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class III antiarrhythmics, such as amiodarone);
• topically applied beta-blockers (such as eye drops for glaucoma treatment);
• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetics);
• medicines used to treat acute heart conditions (adrenergic agonists, such as isoproterenol and dobutamine);
• insulin and oral antidiabetic medicines;
• general anesthetics (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 medicine used to treat severe, life-threatening allergic reactions and cardiac arrest;
• all medicines that can lower blood pressure, either as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants), certain antiepileptic medicines, or medicines used during general anesthesia (barbiturates), as well as certain medicines used in psychiatric disorders characterized by loss of contact with reality (phenothiazine derivatives);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, known as monoamine oxidase inhibitors (except for 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 taking Concor Cor 5 during pregnancy may harm the baby.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether Concor Cor 5 can be taken during pregnancy.
It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Concor Cor 5.

Driving and operating machinery

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

3. How to take Concor Cor 5

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
During treatment with Concor Cor 5, regular medical check-ups are necessary. 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.
The medicine is available in the following doses: 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, 10 mg.

Adults

Treatment of stable, chronic heart failure
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 a day.
The dose is increased at intervals of two weeks or more to a dose of 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once a day. This is usually done as follows:

• 1.25 mg of bisoprolol once a day for 2 weeks;
• 2.5 mg of bisoprolol once a day for 2 weeks;
• 3.75 mg of bisoprolol once a day for 2 weeks;
• 5 mg of bisoprolol once a day for 2 weeks;
• 7.5 mg of bisoprolol once a day for 2 weeks;
• 10 mg of bisoprolol once a day for maintenance treatment (chronic).

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, the doctor may recommend extending the time between dose increases. If the disease worsens or the medicine 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.
Treatment of high blood pressure and angina pectoris
In both indications, the usual dose is one Concor Cor 5 tablet (equivalent to 5 mg of bisoprolol fumarate) once a day.
If necessary, the doctor may increase the dose to two Concor Cor 5 tablets (equivalent to 10 mg of bisoprolol fumarate) once a day.
The maximum recommended dose is 20 mg once a day.

Impaired liver or kidney function

Treatment of high blood pressure and angina pectoris
In patients with mild to moderate liver or kidney impairment, there is usually no need to modify the dosage. In patients with severe kidney failure and in patients with severe liver failure, a dose higher than 10 mg of bisoprolol should not be used.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence that the dosage needs to be modified.
Treatment of stable, chronic heart failure
Special caution should be exercised when increasing the dose of the medicine.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor Cor 5 is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Concor Cor 5 is usually long-term.
If treatment needs to be stopped, the doctor will usually recommend gradual reduction of the dose, otherwise, the disease may worsen.

Taking a higher dose of Concor Cor 5 than recommended

In case of taking a higher dose of Concor Cor 5 than recommended, the patient should immediately inform their doctor. The doctor will decide what actions to take.
Symptoms of overdose include: slow heart rate, breathing difficulties, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missing a dose of Concor Cor 5

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

Stopping treatment with Concor Cor 5

The patient should never stop taking Concor Cor 5 unless their doctor recommends it. Otherwise, the disease may worsen.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor Cor 5 can cause side effects, although not everybody gets them.
Very common(occurring in at least 1 in 10 patients):

• bradycardia (slow heart rate) (in patients with stable, chronic heart failure).

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

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

Only for patients with high blood pressure or angina pectoris:
* these symptoms occur mainly at the beginning of treatment. They are usually mild and disappear within 1-2 weeks.
Uncommon(occurring less frequently than 1 in 100 patients):

• conduction disorders, worsening of existing heart failure (in patients with high blood pressure or angina pectoris); bradycardia (slow heart rate) (in patients with high blood pressure or angina pectoris),
• sleep disorders,
• depression,
• asthenia (weakness) (in patients with high blood pressure or angina pectoris),
• bronchospasm (breathing difficulties) in patients with asthma or chronic obstructive pulmonary disease,
• muscle weakness or cramps.

Rare(occurring less frequently than 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 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 in case of severe allergic reactions, which may include: facial swelling, 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 changes.

Reporting side effects
If side effects occur, including any side effects not listed in the leaflet, the patient should tell 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Concor Cor 5

The medicine should be stored 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 month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Concor Cor 5 contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 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: yellow iron oxide (E 172), dimeticone, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 5 looks like and what the pack contains

Concor Cor 5 is a yellowish-white, heart-shaped, film-coated tablet with a score line on both sides of the tablet.
Each pack contains 28 or 56 film-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the 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

Parallel importer:

PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna

Repackaged by:

Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
LABOR Pharmaceutical-Chemical Enterprise Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND Joint-Stock Company, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
Spanish marketing authorization number:869750.2
Parallel import authorization number:352/17
Date of leaflet approval: 20.10.2022
[Information about the trademark]