Concor Cor 5

Leaflet attached to the packaging: patient information

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

Concor Cor 5, 5 mg, film-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 necessary.
• In case of 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 increases the heart's efficiency 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 blood supply to the heart).

2. Important information before taking Concor Cor 5

When not to take Concor Cor 5

Concor Cor 5 must 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, pallor, or cyanosis 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 worsens 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 patient should discuss them with their doctor before starting Concor Cor 5; the doctor may decide that special caution is necessary (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);
• thyroid function disorders;
• pheochromocytoma of the adrenal gland.

In addition, the patient should tell their doctor if they plan to undergo:

• 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;
• general anesthesia surgery, as Concor Cor 5 may alter the body's response to administered medications.

Children and adolescents

Concor Cor 5 is not recommended for use in children and adolescents.

Concor Cor 5 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The following medicines must not be taken with Concor Cor 5 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 5, the patient should discuss them with their doctor, 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);
• topically used 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 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, 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 using Concor Cor 5 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 5 can be taken during pregnancy.

It is not known whether bisoprolol passes into breast milk; therefore, breastfeeding is not recommended during treatment with Concor Cor 5.

Driving and using machines

The medicine may affect the ability to drive or use machines, depending on how it is tolerated. The patient 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 the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

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.

Regular medical check-ups are necessary during treatment with Concor Cor 5. 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 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 treatment (chronic).

The maximum recommended daily dose is 10 mg of bisoprolol.

Depending on how the medicine is tolerated, the doctor may recommend extending the time interval until the next dose increase. 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 (corresponding to 5 mg of bisoprolol fumarate) once daily.

If necessary, the doctor may increase the dose to two Concor Cor 5 tablets (corresponding to 10 mg of bisoprolol fumarate) once daily.

The maximum recommended dose is 20 mg once daily.

Disorders of 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 severe liver failure, a dose greater than 10 mg of bisoprolol per day should not be used.

Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence to suggest that the dosage needs to be modified.

Treatment of stable, chronic heart failure

Special caution is necessary 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 use in 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 gradually reducing the dose of the medicine; otherwise, the disease may worsen.

Taking a higher dose of Concor Cor 5 than recommended

If a higher dose of Concor Cor 5 than recommended is taken, the patient should immediately inform their 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

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

Stopping treatment with Concor Cor 5

The patient should never stop taking Concor Cor 5 without consulting their doctor; otherwise, the disease may worsen.

If the patient has any further doubts about the use of this medicine, they should consult their 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 generally 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 (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 patient should immediately contact their doctor if they experience more severe allergic reactions, which may include: facial, neck, tongue, mouth, or throat swelling, 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 the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, more information can be collected on the safety of the 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 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 patient should ask their 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 film-coated tablet contains 5 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, 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 packaging

Concor Cor 5 mg has the form of yellowish-white film-coated tablets, heart-shaped, with a score line on both sides of the tablet.

The packaging contains 30 film-coated tablets.

For more detailed information, the patient 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:

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

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

Parallel import authorization number: 350/18

Date of approval of the leaflet: 24.11.2023

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