Concor Cor 1,25

Package Leaflet: Information for the Patient

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

Concor Cor 1.25 (Concor COR), 1.25 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 1.25 Concor CORare different trade names for the same drug.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Concor Cor 1.25 and what is it used for
• 2. Important information before taking Concor Cor 1.25
• 3. How to take Concor Cor 1.25
• 4. Possible side effects
• 5. How to store Concor Cor 1.25
• 6. Package contents and other information

1. What is Concor Cor 1.25 and what is it used for

The active substance of Concor Cor 1.25 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 heart's efficiency in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.
Concor Cor 1.25 is used to treat stable, chronic heart failure.

2. Important information before taking Concor Cor 1.25

When not to take Concor Cor 1.25

Do not take Concor Cor 1.25 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, pallor, or cyanosis 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 worsens and you need intravenous administration of medicines that increase heart contractility,
• 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 disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions

If you have any of the following conditions, talk to your doctor before taking Concor Cor 1.25; your doctor may decide that special caution is needed (e.g., additional medications 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),
• pheochromocytoma of the adrenal gland,
• thyroid dysfunction.

In addition, tell your doctor if you are planning:

• desensitization treatment (e.g., to avoid hay fever), as Concor Cor 1.25 may increase the risk of an allergic reaction or worsen such a reaction;
• general anesthesia surgery, as Concor Cor 1.25 may change the body's response to the medications used.

Children and adolescents

Concor Cor 1.25 is not recommended for children and adolescents.

Concor Cor 1.25 and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Do not take the following medicines with Concor Cor 1.25 without your doctor's special recommendation:

• 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, do not stop taking these medicines without consulting your doctor.

Before taking the following medicines with Concor Cor 1.25, 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 anti-arrhythmic medicines, such as amiodarone);
• topically applied beta-blockers (such as eye drops for glaucoma);
• certain medicines used to treat Alzheimer's disease or glaucoma (parasympathomimetics);
• medicines used to treat acute heart disorders (adrenergic agonists, such as isoproterenol 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, 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 may 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 for 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 1.25 during pregnancy may harm the baby.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Concor Cor 1.25 during pregnancy.
It is not known whether bisoprolol passes into human milk, so breastfeeding is not recommended during treatment with Concor Cor 1.25.

Driving and using machines

The medicine may impair your ability to drive or use machines, depending on how it is tolerated. Be particularly careful at the start of treatment, when increasing the dose, or when changing medicines, as well as when combining the medicine with alcohol.

3. How to take Concor Cor 1.25

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Concor Cor 1.25. This is especially important at the start of treatment, when increasing the dose, and when stopping treatment.
Take the tablet in the morning with food or on an empty stomach, with a glass of water. Do not chew the tablets. The scored tablet 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

Your doctor will start treatment with bisoprolol at a low dose, which will be gradually increased - your doctor will decide how to increase the dose. The recommended initial dose is 1.25 mg once daily.
The dose will be 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, your 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.
Your doctor will determine the appropriate course of action.

Impaired liver or kidney function

Be particularly careful when increasing the dose of Concor Cor 1.25.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor Cor 1.25 is not recommended for children and adolescents.

Duration of treatment

Treatment with Concor Cor 1.25 is usually long-term.
If treatment needs to be stopped, your doctor will usually recommend gradually reducing the dose of the medicine, otherwise, the disease may worsen.

Taking a higher dose of Concor Cor 1.25 than recommended

If you have taken a higher dose of Concor Cor 1.25 than recommended, inform your doctor immediately. Your 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 low blood sugar levels).

Missing a dose of Concor Cor 1.25

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

Stopping treatment with Concor Cor 1.25

Never stop taking Concor Cor 1.25 unless your doctor recommends it. Otherwise, the disease may worsen.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor Cor 1.25 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 often 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 often 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 often than 1 in 1,000 patients):

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (consider if you wear contact lenses),
• liver inflammation, which can cause yellowing of the skin or eyes,
• changes in the results of certain blood tests, related to liver function (increased ALT and AST activity) or triglyceride levels in the blood,
• allergic reactions, such as itching, flushing, rash. If you experience severe allergic reactions, including: facial swelling, throat swelling, or difficulty breathing, contact your doctor immediately,
• impotence,
• nightmares, hallucinations,
• fainting.

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

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

Reporting side effects
If you experience any side effects, including any not listed in this leaflet, 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:
Aleje Jerozolimskie 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, you can help provide more information on the safety of this medicine.

5. How to store Concor Cor 1.25

Keep the medicine 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 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Translation of some information on the immediate packaging:

• Verwendbar bis/Ch.-B. siehe Randprägung - Expiry date/Batch number embossed on the edge of the blister.

6. Package contents and other information

What Concor Cor 1.25 contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized starch, corn starch, microcrystalline cellulose, calcium hydrogen phosphate anhydrous; tablet coating: dimethicone, talc, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 1.25 looks like and what the package contains

Concor Cor 1.25 is a white, round, film-coated tablet.
Each package contains 20, 30, 40, 60, or 100 film-coated tablets.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Merck Serono GmbH, Alsfelder Str. 17, 64289 Darmstadt, Germany

Manufacturer:

Merck Healthcare KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany
P&G Health Austria GmbH & Co. OG, Hösslgasse 20, 9800 Spittal/Drau, Austria
Merck S.L., Polígono Merck, 08100 Mollet del Vallès (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
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
LABOR Przedsiębiorstwo Farmaceutyczno-Chemiczne Sp. z o.o., ul. Długosza 49, 51-162 Wrocław
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CANPOLAND SPÓŁKA AKCYJNA, ul. Beskidzka 190, 91-610 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o., ul. Tymiankowa 24/28, 95-054 Ksawerów
German marketing authorization number:46660.00.00
Parallel import authorization number:23/18
Date of leaflet approval:12.07.2022
[Information about the trademark]