Concor Cor 1,25

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Concor COR 1,25

1.25 mg, 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 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 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. Contents of the packaging 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-adrenergic 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 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

Concor COR 1,25 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 circulatory disorders in the limbs (such as Raynaud's syndrome) that may 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 it is necessary to administer intravenously drugs 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 discuss them with their doctor before starting to take Concor COR 1,25; 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 obstructive pulmonary disease,
• psoriatic skin lesions, also in the medical history,
• pheochromocytoma of the adrenal gland,
• thyroid dysfunction.

In addition, the patient should tell their doctor if:

• desensitization treatment is planned (e.g., to avoid hay fever), as Concor COR 1,25 may increase the likelihood of an allergic reaction or increase its severity;
• a surgical procedure under general anesthesia is planned, as Concor COR 1,25 may change the body's response to the administered medicines.

Children and adolescents

Concor COR 1,25 is not recommended for use in children and adolescents.

Concor COR 1,25 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 1,25 must not be taken with the following medicines 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 together with Concor COR 1,25, 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 (calcium antagonists of the dihydropyridine type, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class III anti-arrhythmic medicines, such as amiodarone);
• locally used beta-adrenergic blockers (such as eye drops for glaucoma treatment);
• certain medicines used to treat, for example, 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;
• agents used in general anesthesia (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 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, 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 1,25 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 1,25 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.

Driving and using machines

The medicine may impair the ability to drive or operate 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 1,25

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Concor COR 1,25, Concor COR 2,5, Concor COR 3,75, and Concor COR 7,5 are available on the market.
Regular medical check-ups are necessary during treatment with Concor COR 1,25. 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

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 is increased at intervals of two weeks or more 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, 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 lower maintenance dose 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 1,25.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor COR 1,25 is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Concor COR 1,25 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.

Taking a higher dose of Concor COR 1,25 than recommended

In case of taking a higher dose of Concor COR 1,25 than recommended, the patient should immediately inform their doctor. The doctor will decide what actions to take.
Symptoms of overdose include: slowed heart rate, difficulty breathing, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missing a dose of Concor COR 1,25

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

Stopping treatment with Concor COR 1,25

The patient should never stop taking Concor COR 1,25 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 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 frequently than in 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 in 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 in 1 in 1,000 patients):

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (should be considered 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 activity of AlAT and AspAT) or triglyceride levels in serum,
• allergic reactions, such as itching, flushing, rash, The patient should immediately contact their doctor in case of more severe allergic reactions, which may include: facial swelling, neck, tongue, mouth, or throat swelling, or difficulty breathing
• impotence,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (irritation or redness of the eyes),
• hair loss,
• occurrence or worsening 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 1,25

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 specified month.
Translation of the inscriptions on the blister pack:
Ch.-B./Verwendbar bis - Batch number/Expiry date
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 packaging and other information

What Concor COR 1,25 contains

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, pregelatinized starch, corn starch, microcrystalline cellulose, calcium hydrogen phosphate;
tablet coating: dimethicone, talc, macrogol 400, titanium dioxide, hypromellose.

What Concor COR 1,25 looks like and what the pack contains

Concor COR 1,25 is a white, round, coated tablet.
The packaging contains 20 or 60 coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

Merck Healthcare Germany GmbH
Waldstraße 3
64331 Weiterstadt
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
Apartado 47
08100 Mollet del Vallès (Barcelona)
Spain

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 46660.00.00
Parallel import authorization number: 96/21
Date of leaflet approval: 24.11.2022
[Information about the trademark]