Concor cor 1.25

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Concor Cor 1.25
1.25 mg, coated tablets
Bisoprolol fumarate
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Concor Cor 1.25 is and what it is 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 pack and other information

1. What Concor Cor 1.25 is and what it is used for

The active substance in Concor Cor 1.25 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 weak and unable to pump sufficient blood to meet the body's needs.
Concor Cor 1.25 is used in the treatment of stable chronic heart failure.

2. Important information before using Concor Cor 1.25

When not to use Concor Cor 1.25
Do not use Concor Cor 1.25 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 serious circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness or blueness of the fingers or toes,
• if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal gland,
• if the patient has been diagnosed with 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 intravenous administration of drugs that increase heart contractility becomes necessary,
• if the patient has symptoms of bradycardia (slow heart rate),
• if the patient has symptoms of low blood pressure,

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• if the patient has certain heart diseases causing 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 disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, the patient should talk to a doctor before starting treatment with Concor Cor 1.25; the doctor may decide that special precautions are necessary (e.g. additional medication 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, inform the doctor if any of the following is planned:

• allergen immunotherapy (e.g. to prevent hay fever), as Concor Cor 1.25 may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgical procedure under general anaesthesia, as Concor Cor 1.25 may alter the body's response to administered drugs.

Children and adolescents
Concor Cor 1.25 is not recommended for use in children and adolescents.

Concor Cor 1.25 and other medicines
Tell the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not use the following medicines together with Concor Cor 1.25 without specific medical advice:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmics 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 1.25, 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 (class III antiarrhythmics such as amiodarone);
• locally applied beta-blockers (such as 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);

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• 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 antiepileptic medicines or barbiturates used during 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, known as monoamine oxidase inhibitors (excluding 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 1.25 during pregnancy may harm the unborn child.
If the patient is pregnant or 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 1.25 can be used during pregnancy.
It is not known whether bisoprolol passes into human breast milk; therefore, breastfeeding is not recommended during treatment with Concor Cor 1.25.

Driving and operating machinery
Depending on individual tolerance, this medicine may impair the ability to drive or operate machinery. Particular caution is advised at the beginning of treatment, after dose increases, or when changing medications, as well as when combining the medicine with alcohol.

3. How to use Concor Cor 1.25

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The following products are available on the market: Concor Cor 1.25 (1.25 mg), Concor Cor 2.5 (2.5 mg), Concor Cor 3.75 (3.75 mg), Concor Cor 7.5 (7.5 mg).
Regular medical check-ups are necessary during treatment with Concor Cor 1.25. 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, swallowed with water. Do not chew the tablets.

Adults
Your doctor will start treatment with a low dose of bisoprolol and gradually increase it – your doctor will decide how to adjust the dose. The recommended initial dose is 1.25 mg once daily.
The dose should be increased at intervals of two weeks or longer, up 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;

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• 10 mg bisoprolol once daily as maintenance (chronic) therapy.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before the next dose increase. If the condition worsens or if the medicine is not well 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.
Your doctor will determine the appropriate course of action.

Liver or kidney function disorders
Exercise particular caution when increasing the dose of the medicine.

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 discontinuation of treatment becomes necessary, your doctor will usually recommend gradually reducing the dose. Otherwise, the condition may worsen.

Taking more than the recommended dose of Concor Cor 1.25
If you take more Concor Cor 1.25 than prescribed, inform your doctor immediately. Your doctor will decide what actions should be taken.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missed dose of Concor Cor 1.25
Do not take a double dose to make up for a missed dose. On the following morning, take the next dose as prescribed.

Stopping Concor Cor 1.25
Never stop taking Concor Cor 1.25 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 everyone will experience them.

Very common (occurring in at least 1 out of 10 patients):

• bradycardia (slow heart rate).

Common (occurring in fewer 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.

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

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

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

• hearing disturbances,
• allergic rhinitis,
• reduced tear production (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,
• 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,
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

Very rare (occurring in fewer 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, pharmacist or nurse. 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

Reporting adverse reactions allows additional information on the safety of the medicine to be collected.

5. How to store Concor Cor 1.25

Keep this medicine out of the sight and reach of children.
Al/PVC blisters: Do not store above 25°C.
Al/Al blisters: No special storage precautions.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Translation of some information on the blister:
Ch.-B.:/Verw. bis: siehe Prägung – Batch number/Expiry date: see imprint.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
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6. Contents of the pack and other information

What Concor Cor 1.25 contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg of bisoprolol fumarate.
• Other ingredients are: colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized starch, maize starch, microcrystalline cellulose, calcium hydrogen phosphate.
  Tablet coating: dimethicon, talc, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 1.25 looks like and contents of the pack
Concor Cor 1.25 is a white, round film-coated tablet.
Each pack contains 20, 40, 60 or 100 film-coated tablets.
For further information, please contact the responsible party or the parallel importer.
Responsible entity in Austria, country of export:
Merck GmbH, Zimbagasse 5, 1147 Vienna, Austria
Manufacturer:
Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany
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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Austrian licence number, country of export: 1-23302
Parallel import licence number: 131/20
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