Concor Cor 10

Leaflet accompanying the packaging: patient information

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

Concor Cor 10 (Cardicor)

10 mg, film-coated tablets

Bisoprolol fumarate
Concor Cor 10 and Cardicor are different trade names for the same drug.

The leaflet should be read carefully before taking the medicine, as 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, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for 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 inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Concor Cor 10 and what is it used for
• 2. Important information before taking Concor Cor 10
• 3. How to take Concor Cor 10
• 4. Possible side effects
• 5. How to store Concor Cor 10
• 6. Contents of the packaging and other information

1. What is Concor Cor 10 and what is it used for

The active substance of Concor Cor 10 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 increases the efficiency of the heart in pumping blood throughout the body. Bisoprolol at doses of 5 mg and 10 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 10 is used to treat stable, chronic heart failure.
Concor Cor 5 and Concor Cor 10 are 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 10

When not to take Concor Cor 10

Concor Cor 10 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 blood circulation 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 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 heartbeats (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 disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If any of the following conditions occur, the doctor should be consulted before starting Concor Cor 10; the doctor may consider it necessary to take special precautions (e.g., administer additional medicines or perform more frequent checks):

• diabetes,
• strict fasting,
• certain heart diseases (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina),
• kidney or liver disorders,
• blood circulation 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 doctor should be informed if:

• desensitization treatment is planned (e.g., to avoid hay fever), as Concor Cor 10 may increase the risk of an allergic reaction or worsen such a reaction;
• a surgical procedure under general anesthesia is planned, as Concor Cor 10 may change the body's response to the administered medicines.

Children and adolescents

Concor Cor 10 is not recommended for use in children and adolescents.

Concor Cor 10 and other medicines

The doctor should be informed about all medicines currently being taken or recently taken by the patient, as well as any medicines that the patient plans to take.
Concor Cor 10 should not be taken with the following medicines without special recommendation by the doctor:

• certain medicines used to treat arrhythmias (class I anti-arrhythmic medicines, 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 10, the doctor should be consulted, 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 anti-arrhythmic medicines, such as amiodarone);
• locally used 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 disorders (adrenergic agonists, such as isoprenaline and dobutamine);
• insulin and oral anti-diabetic medicines;
• general anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, 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 can lower blood pressure, either as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants), certain anti-epileptic 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 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 10 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 10 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 10.

Driving and operating machinery

The medicine may affect the ability to drive or operate machinery. Special care should be taken at the beginning of treatment, after a dose increase, or when changing medicines, as well as when combining the medicine with alcohol.

3. How to take Concor Cor 10

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
Regular medical check-ups are necessary during treatment with Concor Cor 10. 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.

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 daily.
The dose is increased at intervals of at least 2 weeks 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 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 or half a Concor Cor 10 tablet (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, the doctor may increase the dose to one Concor Cor 10 tablet or two Concor Cor 5 tablets (equivalent to 10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.

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 adjust the dosage. In patients with severe kidney impairment and severe liver impairment, the dose should not exceed 10 mg of bisoprolol per day.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence that the dosage needs to be adjusted.
Treatment of stable, chronic heart failure
Special care should be taken when increasing the dose of Concor Cor 10.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor Cor 10 is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Concor Cor 10 is usually long-term.
If treatment needs to be stopped, the doctor will usually recommend gradually reducing the dose of the medicine; otherwise, the disease may worsen.

Taking a higher dose of Concor Cor 10 than recommended

If a higher dose of Concor Cor 10 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, breathing difficulties, significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar levels).

Missing a dose of Concor Cor 10

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

Stopping treatment with Concor Cor 10

Treatment with Concor Cor 10 should never be stopped without consulting a doctor; otherwise, the disease may worsen.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Concor Cor 10 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 in 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 usually occur at the beginning of treatment and are generally mild and disappear within 1-2 weeks.
Uncommon(occurring less frequently than in 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 in 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 the blood,
• allergic reactions, such as itching, flushing, rash. The doctor should be contacted immediately in case of more severe allergic reactions, which may include: swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing,

other side effects have also been reported:

• sexual dysfunction,
• 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 changes.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Reporting side effects can help gather more information on the safety of this medicine.

5. How to store Concor Cor 10

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 pharmacist should be asked 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 10 contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 10 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, calcium hydrogen phosphate. tablet coating: red iron oxide (E 172), yellow iron oxide (E 172), dimethicone, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 10 looks like and contents of the packaging

Concor Cor 10 mg is a light orange/bright orange film-coated tablet, heart-shaped, with a score line on both sides of the tablet.
The packaging contains 28 or 56 film-coated tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Ireland, the country of export:

Merck Serono (Ireland) Limited
4045 Kingswood Road, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:

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

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
Ireland export license number: PA2286/004/006

Parallel import license number: 242/24

Translation of day-of-the-week symbols on the packaging:

Mon

• Monday Tue
• Tuesday Wed
• Wednesday Thu
• Thursday Fri
• Friday Sat
• Saturday Sun
• Sunday

Date of leaflet approval: 14.06.2024

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