Concor Cor 1,25

Package Leaflet: Information for the Patient

Concor COR 1.25, 1.25 mg, coated tablets
Concor COR 2.5, 2.5 mg, coated tablets
Concor COR 3.75, 3.75 mg, coated tablets
Concor COR 7.5, 7.5 mg, coated tablets
Bisoprolol fumarate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Concor COR and what is it used for

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

2. Important information before taking Concor COR

When not to take Concor COR

Do not take Concor COR 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 severe blood circulation disorders in the limbs (such as Raynaud's syndrome) that may cause tingling, pallor, or cyanosis of the fingers or toes,

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• 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 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 discuss them with your doctor before starting Concor COR; your doctor may decide that special caution is required (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, you should tell your doctor if you are planning:

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

Children and adolescents

Concor COR is not recommended for children and adolescents.

Concor COR and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Do not take the following medicines with Concor COR without special advice from your doctor:

• certain medicines used to treat arrhythmias (class I anti-arrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);

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• certain medicines used to treat high blood pressure, coronary heart 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, you should discuss them with your doctor, as your doctor may recommend more frequent medical check-ups:

• certain medicines used to treat high blood pressure or coronary heart disease (dihydropyridine derivatives, 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);
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
• medicines used to treat acute heart disorders (adrenergic medicines, 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 may lower blood pressure, either as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants), certain antiepileptic medicines or used during general anesthesia (barbiturates) and 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, called 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 during pregnancy may harm the baby.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Concor COR during pregnancy.
It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Concor COR.

Driving and using machines

The medicine may affect your ability to drive or use machines, depending on how it is tolerated. Be particularly careful at the beginning of treatment, when increasing the dose, or when changing medicines, as well as when combining the medicine with alcohol.
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3. How to take Concor COR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Concor COR. This is especially important at the beginning 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. Scored tablets can be divided into two equal doses.

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 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 bisoprolol once daily for 2 weeks;
• 2.5 mg bisoprolol once daily for 2 weeks;
• 3.75 mg bisoprolol once daily for 2 weeks;
• 5 mg bisoprolol once daily for 2 weeks;
• 7.5 mg bisoprolol once daily for 2 weeks;
• 10 mg bisoprolol once daily for maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg 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 bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.

Liver or kidney disorders

Be particularly careful when increasing the dose of the medicine.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor COR is not recommended for children and adolescents.

Duration of treatment

Treatment with Concor COR 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 than recommended

If you have taken more Concor COR than recommended, tell 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).
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Missing a dose of Concor COR

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

Stopping treatment with Concor COR

Never stop taking Concor COR unless your doctor tells you to. Otherwise, the disease may worsen.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor COR 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 frequently 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 frequently 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 frequently than 1 in 1,000 patients):

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (consider 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 the blood,
• allergic reactions, such as itching, flushing, rash. You should immediately contact your doctor if you experience more severe allergic reactions, which may include: swelling of the face, 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, 5
• psoriasis or psoriasis-like skin changes.

Reporting side effects
If you experience any side effects, including those 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Concor COR

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton after EXP and "Expiry Date". The expiry date refers to the last day of the month stated.
Concor COR 1.25 / Concor COR 2.5 / Concor COR 3.75

• Store in a temperature below 25°C.

Concor COR 7.5

• Store in a temperature below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Concor COR contains

Concor COR 1.25 coated tablets

• The active substance is bisoprolol fumarate. Each coated tablet contains 1.25 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, maize starch, microcrystalline cellulose, calcium hydrogen phosphate anhydrous; coating: dimeticone 100, talc, macrogol 400, titanium dioxide (E171), hypromellose.

Concor COR 2.5 coated tablets

• The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg of bisoprolol fumarate.
• The other ingredients are:

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tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate anhydrous;
coating: dimeticone 100, macrogol 400, titanium dioxide (E171), hypromellose.
Concor COR 3.75 coated tablets

• The active substance is bisoprolol fumarate. Each coated tablet contains 3.75 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate anhydrous; coating: yellow iron oxide (E172), dimeticone 100, macrogol 400, titanium dioxide (E171), hypromellose.

Concor COR 7.5 coated tablets

• The active substance is bisoprolol fumarate. Each coated tablet contains 7.5 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate anhydrous; coating: yellow iron oxide (E172), dimeticone 100, macrogol 400, titanium dioxide (E171), hypromellose.

What Concor COR looks like and contents of the pack

Concor COR 1.25 is a white, round, coated tablet.
Concor COR 2.5 is a white, heart-shaped, coated tablet with a score line on both sides of the tablet.
Concor COR 3.75 is a white, heart-shaped, coated tablet with a score line on both sides of the tablet.
Concor COR 7.5 is a light yellow, heart-shaped, coated tablet with a score line on both sides of the tablet.
The pack contains 28, 56, or 100 coated tablets.

Marketing authorization holder

Merck Sp. z o.o.
Jerozolimskie Avenue 142B
02-305 Warsaw, Poland
Logo of the marketing authorization holder

Manufacturer

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

Date of last revision of the leaflet: March 2022

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