Concor Cor 2,5

PATIENT INFORMATION LEAFLET: USER INFORMATION

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

Concor Cor 2.5 (Concor Cor 2.5 mg)

2.5 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 2.5 Concor Cor 2.5 mgare different trade names for the same drug.

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 the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Concor Cor 2.5 and what is it used for
• 2. Important information before taking Concor Cor 2.5
• 3. How to take Concor Cor 2.5
• 4. Possible side effects
• 5. How to store Concor Cor 2.5
• 6. Contents of the pack and other information
• 1. What is Concor Cor 2.5 and what is it used for

The active substance of Concor Cor 2.5 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 within the body.
Heart failure occurs when the heart muscle is weak and cannot pump enough blood to meet the body's needs.
Concor Cor 2.5 is used to treat stable, chronic heart failure.

2. Important information before taking Concor Cor 2.5

When not to take Concor Cor 2.5

Concor Cor 2.5 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 been diagnosed with severe circulatory disorders in the limbs (such as Raynaud's syndrome), which can cause tingling, paleness, or bluish discoloration 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 heart rhythm (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) without a pacemaker,
• if the patient has cardiogenic shock, a severe, 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 talk to their doctor before starting to take Concor Cor 2.5; the doctor may consider 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,
• circulatory disorders in the limbs,
• mild asthma or chronic pulmonary disease,
• psoriasis (including a history of psoriasis),
• pheochromocytoma of the adrenal gland,
• thyroid dysfunction.

In addition, the patient should tell their doctor if they are planning:

• desensitization treatment (e.g., to avoid hay fever), as Concor Cor 2.5 may increase the risk of an allergic reaction or worsen such a reaction;
• undergoing surgery under general anesthesia, as Concor Cor 2.5 may change the body's response to the medications administered.

Children and adolescents

Concor Cor 2.5 is not recommended for use in children and adolescents.

Concor Cor 2.5 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.
Concor Cor 2.5 must not be taken with the following medicines without special recommendation by the 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, the patient should not stop taking these medicines without consulting their doctor.

Before taking the following medicines together with Concor Cor 2.5, the patient should talk to 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 antiarrhythmic agents, 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 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 drugs (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 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 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 2.5 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 2.5 can be taken during pregnancy.
It is not known whether bisoprolol passes into human milk, so breastfeeding is not recommended during treatment with Concor Cor 2.5.

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 2.5

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 mg, Concor Cor 2.5 mg, Concor Cor 3.75 mg, Concor Cor 5 mg, and Concor Cor 7.5 mg, Concor Cor 10 mg are available.
Regular medical check-ups are necessary during treatment with Concor Cor 2.5. This is especially important at the beginning of treatment, during dose increase, 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

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 two 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 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 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 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.

Impaired liver or kidney function

Special caution is necessary when increasing the dose of Concor Cor 2.5.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor Cor 2.5 is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Concor Cor 2.5 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.

Overdose of Concor Cor 2.5

In case of overdose of Concor Cor 2.5, the patient should immediately inform their doctor. The doctor will decide what actions to take.
Overdose symptoms include: slow heart rate, difficulty breathing, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missed dose of Concor Cor 2.5

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 2.5

The patient should never stop taking Concor Cor 2.5 unless their doctor recommends it. Otherwise, the disease may worsen.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor Cor 2.5 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 coldness 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 (should be considered if the patient wears contact lenses),
• hepatitis, which can cause yellowing of the skin or eyes,
• changes in the results of certain blood tests, related to liver function (increased activity of AlAT and AspAT) or triglyceride levels in serum,
• allergic reactions, such as itching, flushing, rash. The patient should immediately contact their doctor if they experience 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 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 lesions.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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, it is possible to gather more information on the safety of the medicine.

5. How to store Concor Cor 2.5

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 stated.

• Do not store above 25°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 pack and other information

What Concor Cor 2.5 contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, calcium hydrogen phosphate; tablet coating: dimethicone, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 2.5 looks like and contents of the pack

Concor Cor 2.5 is a white, film-coated, heart-shaped tablet with a score line on both sides of the tablet.
The pack contains 30 or 100 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:

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
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
MEDICOFARMA S.A., ul. Sokołowska nr 9, lok. 19, 01-142 Warsaw
Authorization number in Romania, the country of export:6094/2014/02
6094/2014/01
6094/2014/03
6094/2014/04
Parallel import authorization number:362/19
Date of leaflet approval: 27.06.2022
[Information about the trademark]