Concor Cor 5

Package Leaflet: Information for the Patient

Concor COR 5, 5 mg, Film-Coated Tablets

Concor COR 10, 10 mg, Film-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, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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. 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 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

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 serious blood circulation disorders in the limbs (such as Raynaud's syndrome) that may 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 you have worsening heart failure and 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 and 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 taking 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;
• psoriatic skin lesions, also in the medical history;
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, you should tell your doctor if you are planning:

• desensitization therapy (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 alter the body's response to administered medications.

Children and adolescents

Concor COR is not recommended for use in children and adolescents.

Concor COR 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 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 together 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 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;
• general anesthetics (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 may 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) and certain agents 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 fetus.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, 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, depending on how it is tolerated, may impair the ability to drive or operate machines.

Be particularly careful at the beginning of treatment, after increasing the dose, or when changing medications, as well as when combining the medicine with alcohol.

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.

During treatment with Concor COR, regular medical check-ups are necessary.

This is especially important at the beginning of treatment, during dose increase, and in case of treatment discontinuation.

Take the tablet in the morning with food or independently of food, with a glass of water.

Do not chew the tablets.

Scored tablets can be divided into two equal doses.

Adults

Treatment of stable, chronic heart failure

Your 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 usually happens 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 treatment (chronic).

The maximum recommended daily dose is 10 mg bisoprolol.

Depending on how the medicine is tolerated, the doctor may recommend extending the time interval to the next dose increase.

If the disease worsens or the medicine is not tolerated, it may be necessary to reduce the dose again or discontinue treatment.

In some patients, a maintenance dose lower than 10 mg 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 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 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 impairment, there is usually no need to modify the dosage.

In patients with severe renal impairment and in patients with severe liver impairment, a dose greater than 10 mg bisoprolol per day should not be used.

Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence that dosage adjustment is necessary.

Treatment of stable, chronic heart failure

Particular caution should be exercised 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 use in children and adolescents.

Duration of treatment

Treatment with Concor COR is usually long-term.

If treatment needs to be discontinued, the doctor will usually recommend gradual reduction of the dose of the medicine, otherwise the disease may worsen.

Taking a higher dose of Concor COR than recommended

If you have taken a higher dose of Concor COR than recommended, inform your doctor immediately.

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

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 the use of 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) (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 (consider if the patient wears contact lenses),
• hepatitis, which may 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.

Immediately contact your doctor in case of severe allergic reactions, which may include: facial, neck, tongue, mouth, or throat swelling, 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 you experience any side effects, including those not listed in this leaflet, please inform 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Concor COR

Keep this 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.

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 5 film-coated tablets

• The active substance is bisoprolol fumarate.
• Each film-coated tablet contains 5 mg bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate anhydrous; tablet coating: yellow iron oxide (E172), dimethicone 100, macrogol 400, titanium dioxide (E171), hypromellose.

Concor COR 10 film-coated tablets

• The active substance is bisoprolol fumarate.
• Each film-coated tablet contains 10 mg bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate anhydrous; tablet coating: red iron oxide (E172), yellow iron oxide (E172), dimethicone 100, macrogol 400, titanium dioxide (E171), hypromellose.

What Concor COR looks like and contents of the pack

Concor COR 5 are yellowish-white film-coated tablets, heart-shaped, with a score line on both sides of the tablet.

Concor COR 10 are pale orange/light orange film-coated tablets, heart-shaped, with a score line on both sides of the tablet.

The pack contains 28, 56, or 100 film-coated tablets.

Marketing authorization holder

Merck Sp. z o.o.

Al. Jerozolimskie 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 package leaflet: March 2022