Concor Cor 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 5 (Emconcor Cor), 5 mg, coated tablets
Bisoprolol fumarate
Concor Cor 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 because it contains
important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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 tell their doctor, pharmacist, or nurse. 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 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 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 drug (listed in section 6),
• if the patient has severe asthma,
• if the patient has severe 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 has worsened 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, a severe, 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 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;
• psoriasis (including a history of psoriasis);
• thyroid dysfunction;
• pheochromocytoma of the adrenal gland.

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

• 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;
• undergoing surgery under general anesthesia, as Concor Cor 5 may alter the body's response to administered drugs.

Children and adolescents

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

Concor Cor 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 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 channel blockers, 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 together with Concor Cor 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 channel blockers, such as felodipine and amlodipine);
• certain drugs used to treat arrhythmias (class III antiarrhythmic drugs, such as amiodarone);

Pregnancy and breastfeeding

There is a risk that taking Concor Cor 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 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 drug, depending on how it is tolerated, may impair the ability to drive vehicles or operate machinery. Special caution should be exercised 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 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.
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.
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

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 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 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.
Treatment of high blood pressure and angina pectoris
In both indications, the usual dose is one Concor Cor 5 tablet (corresponding to 5 mg of bisoprolol fumarate) once a day.
If necessary, the doctor may increase the dose to two Concor Cor 5 tablets (corresponding 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
Patients with mild to moderate liver or kidney impairment usually do not need to modify the dosage. In patients with severe renal impairment and in patients with severe liver impairment, a dose greater than 10 mg of bisoprolol per day should not be used.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence to suggest that the dosage needs to be modified.
Treatment of stable, chronic heart failure
Special caution should be exercised when increasing the dose of Concor Cor 5.

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, difficulty breathing, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missing a dose of Concor Cor 5

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

Stopping treatment with Concor Cor 5

Concor Cor 5 should never be stopped without consulting a doctor.
Otherwise, the disease may worsen.
In case of any further doubts about the use of this drug, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all drugs, 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 often 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 often 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 (difficulty breathing) in patients with asthma or chronic obstructive pulmonary disease,
• muscle weakness or cramps.

Rare(occurring less often 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 the blood,
• allergic reactions, such as itching, flushing, rash. The patient should immediately contact their doctor in case of more severe allergic reactions, which may include: facial swelling, neck, tongue, mouth, or throat, or difficulty breathing,
• impotence,
• nightmares, hallucinations,
• fainting.

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

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

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should tell 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, Tel.: +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 drug.

5. How to store Concor Cor 5

The drug should be stored out of sight and reach of children.
Do not use this drug after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store at a temperature below 30°C.
Drugs should not be thrown into the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused drugs. 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 coated tablet contains 5 mg of bisoprolol fumarate.
• Other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, corn starch, microcrystalline cellulose, calcium hydrogen phosphate. tablet coating: dimethicone, macrogol 400, titanium dioxide (E 171), hypromellose, yellow iron oxide (E 172).

What Concor Cor 5 looks like and what the packaging contains

Concor Cor 5 mg is a yellowish-white, heart-shaped, coated tablet with a dividing 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., Maria de Molina, 40, 28006 Madrid, Spain

Manufacturer:

Merck Healthcare KGAA, Frankfurter Strasse, 250, D-64293 Darmstadt, Germany
TJOAPACK B.V., Columbusstraat, 4, NL-7801 Emmen, Netherlands
P&G Health Austria GmbH & Co.OG, Hosslgasse 20, A-9800 Spittal/Drau, Austria
Merck, S.L., Poligono Merck, E-08100 Mollet del Vallés (Barcelona), Spain
Famar Lyon, 29 Avenue Charles de Gaulle, 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 marketing authorization number, country of export: 869750.2

Parallel import authorization number: 883/12 Date of leaflet approval: 30.11.2022

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