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 (Concor COR 1.25 mg)
1.25 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 1.25 and Concor COR 1.25 mg are different trade names of the same medicinal product.
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you may read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, 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 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, especially 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 serious circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness or blueness of fingers or toes,
• if the patient has untreated phaeochromocytoma, a rare tumour 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 intravenous administration of drugs that increase heart contractility is required,
• if the patient has symptoms of bradycardia (slow heart rate),
• if the patient has symptoms of low blood pressure,
• 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, 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, speak to your doctor before starting treatment with Concor Cor 1.25; your doctor may decide that special caution is necessary (e.g. additional medication or more frequent monitoring):

• 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 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 your doctor if you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), as Concor Cor 1.25 may increase the likelihood or severity of allergic reactions;
• surgery under general anaesthesia, as Concor Cor 1.25 may alter the body's response to anaesthetic drugs.

Children and adolescents
Use of Concor Cor 1.25 is not recommended in children and adolescents.

Concor Cor 1.25 and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take the following medicines together with Concor Cor 1.25 without specific instruction from your doctor:

• 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 heart 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 your doctor.

Before taking any of the following medicines together with Concor Cor 1.25, consult your doctor; your doctor may recommend more frequent medical checks:

• certain medicines used to treat high blood pressure or coronary heart 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 (e.g. eye drops used to treat glaucoma);
• certain medicines used to treat conditions such as 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 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, 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 or 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, known as 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 1.25 during pregnancy may harm the unborn child.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Concor Cor 1.25 can be taken 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 using machines
This medicine may, depending on individual tolerance, impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increases, or when changing medications, as well as when combining this medicine with alcohol.

3. How to use Concor Cor 1.25

This medicine should always be taken exactly as prescribed 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 bisoprolol at a low dose and gradually increase it – your doctor
will decide how the dose should be increased. The recommended starting dose is 1.25 mg once daily.
The dose is increased at two-week intervals 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;
• 10 mg bisoprolol once daily for maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before
increasing the dose further. If the condition worsens or 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.
Impaired liver or kidney function
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 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).
Missing a dose of Concor Cor 1.25
Do not take a double dose to make up for a missed dose. Take the next dose as prescribed the
following morning.
Stopping treatment with Concor Cor 1.25
Never stop taking Concor Cor 1.25 unless your doctor advises you to do so. 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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.

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 results of certain blood tests assessing liver function (increased AlAT and AspAT activity) or serum triglyceride levels,
• allergic reactions such as itching, facial flushing, rash. Immediate medical advice should be sought if more severe allergic reactions occur, which may include swelling of the face, neck, tongue, mouth or throat, or difficulty breathing,
• disturbances of potency,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (eye irritation or redness),
• alopecia (hair loss),
• onset or exacerbation of scaly skin lesions (psoriasis), psoriasiform skin changes.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store Concor Cor 1,25

Keep this medicine 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 stated month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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.
• Other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized starch, corn starch, microcrystalline cellulose, calcium hydrogen phosphate; tablet coating: dimethicone, talc, polyethylene glycol 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 30, 60 or 100 film-coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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
Merck S.L.
Polígono Merck
08100 Mollet del Vallès (Barcelona)
Spain
Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Germany, the country of export: 46660.00.00
Parallel Import Authorisation Number: 226/23