CONCOR COR 2,5

Package leaflet: Information for the patient

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 and Concor Cor 2.5 mg are different brand names of the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Concor Cor 2.5 is and what it is 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 Concor Cor 2.5 is and what it is used for

The active substance in 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,
particularly in the heart. As a result, bisoprolol slows down heart activity and thereby improves
the heart's efficiency in pumping blood throughout the body.
Heart failure occurs when the heart muscle is weakened and unable to pump sufficient
blood to meet the body's needs.
Concor Cor 2.5 is used in the treatment of stable, chronic heart failure.

2. Important information before using Concor Cor 2.5

When not to use Concor Cor 2.5
Do not use Concor Cor 2.5 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), which may cause tingling, paleness, or blueness of the fingers of the hands or feet,
• if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland,
• if the patient has metabolic acidosis, i.e. a condition in which the blood pH is abnormal,
• if the patient has acute heart failure,
• if heart failure worsens and intravenous administration of drugs that increase heart contractility becomes necessary,
• if the patient has symptoms of a slow heart rate,
• if the patient has symptoms of low blood pressure,
• if the patient has certain heart diseases causing a very slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) in the absence of a pacemaker,
• if the patient has cardiogenic shock, i.e. an acute, life-threatening impairment of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions are present, the patient should consult a doctor before starting treatment with Concor Cor 2.5; the doctor may decide that special caution is required (e.g. administration of additional medicines or more frequent monitoring):

• diabetes,
• strict fasting,
• certain heart diseases (such as heart rhythm disorders or severe chest pain at rest—Prinzmetal's angina),
• kidney or liver disorders,
• circulatory disorders in the limbs,
• mild bronchial asthma or chronic lung disease,
• presence of scaly skin lesions (psoriasis), even in medical history,
• phaeochromocytoma of the adrenal medulla,
• thyroid dysfunction.

Additionally, the patient should inform the doctor if any of the following are planned:

• allergen immunotherapy (e.g. to prevent hay fever), because Concor Cor 2.5 may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgery under general anaesthesia, because Concor Cor 2.5 may alter the body's response to administered drugs.

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 inform the doctor about all medicines currently used or recently used, as well as any medicines planned for future use.

The following medicines should not be used together with Concor Cor 2.5 without specific medical advice:

• certain medicines used to treat heart rhythm disorders (antiarrhythmics of class I, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat high blood pressure, coronary artery disease, or heart rhythm disorders (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 a doctor.

Before using any of the following medicines together with Concor Cor 2.5, the patient should consult a doctor; the doctor may recommend more frequent medical checks:

• 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 heart rhythm disorders (antiarrhythmics of class III, such as amiodarone);
• locally applied beta-blockers (e.g. eye drops used to treat glaucoma);
• 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 antidiabetic medicines;
• agents used in general anaesthesia (e.g. during surgery);
• cardiac glycosides (e.g. digoxin) used to treat heart failure;
• non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, 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 adverse effect, such as antihypertensives, certain tricyclic antidepressants, certain antiepileptics, barbiturates used in general anaesthesia, and certain medicines used in psychiatric disorders characterised by loss of contact with reality (phenothiazine derivatives);
• mefloquine, used for prevention and treatment of malaria;
• medicines used to treat depression called monoamine oxidase inhibitors (MAOIs), 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 2.5 during pregnancy may harm the unborn child.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using 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; therefore, breastfeeding is not recommended during treatment with Concor Cor 2.5.

Driving and operating machinery
Depending on how it is tolerated, this medicine may impair the ability to drive or operate machinery. Particular caution is advised at the beginning of treatment, after dose increases, after changing medications, and when this medicine is used together with alcohol.

3. How to use Concor Cor 2.5

This medicine should always be used as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
Concor Cor is available in the following doses: 1.25 mg, 2.5 mg, 3.75 mg, 7.5 mg.
Regular medical check-ups are necessary during treatment with Concor Cor 2.5. This is particularly
important at the beginning of treatment, when increasing the dose, and when discontinuing treatment.
The tablet should be taken in the morning with food or independently of meals, with water. The tablet
must not be chewed. Tablets with a score line may 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 longer 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, the doctor may decide to extend the interval before the
next dose increase. If the condition worsens or if 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.
Liver or kidney function disorders
Particular caution is required when increasing the dose of the medicine.
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 discontinuation of treatment is necessary, the doctor will usually recommend gradually reducing the
dose. Otherwise, the condition may worsen.
Use of a higher than recommended dose of Concor Cor 2.5
If you take more Concor Cor 2.5 than recommended, inform your doctor immediately. The doctor will
decide what actions should be taken.
Symptoms of overdose include: slowed heart rate, breathing difficulties, a significant drop in blood
pressure, dizziness, or seizures (caused by decreased blood sugar levels).
Missed dose of Concor Cor 2.5
Do not take a double dose to make up for a missed dose. On the following morning, take the
recommended dose as usual.
Stopping treatment with Concor Cor 2.5
Never stop taking Concor Cor 2.5 unless instructed by your doctor. Otherwise, your condition may
worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very common (occurring in at least 1 out of 10 patients):

• bradycardia (slow heart rate).

Common (occurring in less than 1 out of 10 patients):

• worsening of existing heart failure,
• fatigue, asthenia (weakness), dizziness, headache,
• sensation of coldness or numbness in hands or feet,
• low blood pressure,
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

Uncommon (occurring in less than 1 out of 100 patients):

• atrioventricular conduction disturbances,
• sleep disorders,
• depression,
• bronchospasm (difficulty breathing) in patients with bronchial asthma or chronic obstructive pulmonary disease,
• muscle weakness or muscle cramps.

Rare (occurring in less than 1 out of 1,000 patients):

• hearing disturbances,
• 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 certain blood tests related to liver function (increased AlAT and AspAT activity) or serum triglyceride levels, 5
• allergic reactions such as itching, facial flushing, rash. If more severe allergic reactions occur, contact a doctor immediately. These may include: swelling of the face, neck, tongue, mouth or throat, or difficulty breathing,
• disturbances of potency,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (eye irritation or redness),
• alopecia (hair loss),
• occurrence or worsening of scaly skin lesions (psoriasis), psoriasiform eruptions.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Concor Cor 2.5

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Concor Cor 2.5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg of bisoprolol fumarate.
• Other components are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate; tablet coating: dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

What Concor Cor 2.5 looks like and contents of the pack
Concor Cor 2.5 is in the form of white, film-coated heart-shaped tablets with a break line on both sides of the tablet.
Each pack contains 30 or 60 film-coated tablets.
For further information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Merck Serono SIA
Duntes iela 23A
LV-1005 Riga
Latvia
Manufacturer:
Merck S.L.
Polígono Merck
08100 Mollet del Vallés
Barcelona
Spain
Merck Healthcare KGaA
Frankfurter Strasse 250
D-64293 Darmstadt
Germany
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation number in Latvia, country of export: 02-0168
Parallel import licence number: 52/25