Concor Cor 5

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

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

Concor Cor 5

5 mg, coated tablets

Bisoprolol fumarate

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 oxygen supply to the heart).

2. Important information before taking Concor Cor 5

When not to take Concor Cor 5

Do not take Concor Cor 5 in the following cases:

• if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6),
• if you have severe asthma,
• if you have 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 you have an untreated pheochromocytoma, a rare tumor of the adrenal gland,
• if you have metabolic acidosis, a condition in which the blood pH is abnormal,
• if you have acute heart failure,
• if your heart failure has worsened and you need to take medicines that increase the heart's contractility intravenously,
• if you have symptoms of slow heart rate,
• if you have symptoms of low blood pressure,
• if you have 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 you have cardiogenic shock, a severe, life-threatening heart disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If you have any of the following conditions, you should talk to your doctor before starting Concor Cor 5; your 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;
• 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, you should tell your doctor if you 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;
• surgery under general anesthesia, as Concor Cor 5 may affect the body's response to the medications used.

Children and adolescents

Concor Cor 5 is not recommended for children and adolescents.

Concor Cor 5 and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Do not take the following medicines with Concor Cor 5 without special recommendation by your doctor:

• certain medicines used to treat arrhythmias (class I antiarrhythmic agents, 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, do not stop taking these medicines without consulting your doctor.

Before taking the following medicines with Concor Cor 5, you should talk to your doctor, as your 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 antiarrhythmic agents, 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 disorders (adrenergic agents, such as isoprenaline and dobutamine);
• insulin and oral antidiabetic agents;
• agents used in general anesthesia (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• nonsteroidal anti-inflammatory agents (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 agents, certain antidepressants (tricyclic antidepressants), certain antiepileptic agents, or agents 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 using Concor Cor 5 during pregnancy may harm the baby. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Concor Cor 5 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 using machines

The medicine, depending on how it is tolerated, may affect your ability to drive or use machines. You 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 exactly as prescribed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.

Concor Cor 5 (5 mg) and Concor Cor 10 (10 mg) are available.

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.

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 (equivalent to 5 mg of bisoprolol fumarate) once daily.

If necessary, the doctor may increase the dose to 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

In patients with mild to moderate liver or kidney disorders, 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 dosage modification is necessary.

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 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

If you have taken a higher dose of Concor Cor 5 than recommended, you should immediately inform your 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

Do not take a double dose to make up for a missed dose. The next day, take the recommended dose in the morning.

Stopping treatment with Concor Cor 5

Never stop taking Concor Cor 5 unless your doctor recommends it. Otherwise, the disease may worsen.

If you have any further doubts about the use of this medicine, you should consult your 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 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 usually occur at the beginning of treatment and 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 production (should be considered if you wear 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. You should immediately contact your doctor if you experience more severe allergic reactions, which may include: facial swelling, neck, tongue, mouth, or throat, or difficulty breathing,
• potency disorders,
• 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 worsening of psoriatic skin lesions (psoriasis), psoriasis-like changes.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. 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

By reporting side effects, you can help provide more information on the safety of this 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 blister pack and carton after EXP. 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. You should ask your 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 coated tablet contains 5 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, calcium hydrogen phosphate;

tablet coating: yellow iron oxide (E 172), dimethicone, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 5 looks like and contents of the pack

Concor Cor 5 is a yellowish-white, heart-shaped, coated tablet with a dividing line on both sides of the tablet.

The pack contains 30 or 60 coated tablets.

For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Merck Romania SRL

Str. Gara Herăstrău Nr. 4D, Clădirea C, Etaj 6

Sector 2, 020334 Bucharest

Romania

Manufacturer:

Merck Healthcare KGaA

Frankfurter Strasse 250

64293 Darmstadt

Germany

P&G Health Austria GmbH & Co. OG

Hösslgasse 20

9800 Spittal/Drau

Austria

Famar Lyon

29 Avenue Charles de Gaulle

69230 Saint-Genis-Laval

France

Merck, S.L.

Polígono Merck

08100 Mollet del Vallès (Barcelona)

Spain

Parallel importer:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

CEFEA Sp. z o.o. Sp. komandytowa

ul. Działkowa 56

02-234 Warsaw

SHIRAZ PRODUCTIONS Sp. z o.o.

ul. Tymiankowa 24/28

95-054 Ksawerów

Marketing authorization number in Romania, the country of export: 6095/2014/02

6095/2014/01

6095/2014/03

6095/2014/04

Parallel import authorization number: 225/23

Date of approval of the leaflet: 11.10.2023

[Information about the trademark]