Concor cor 1.25

PACKAGE LEAFLET: 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, film-coated tablets
Bisoprolol fumarate
Please read the following leaflet carefully before using 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 pass it on to others. This medicine may harm others, 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 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 the heart rate 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 enough 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 circulation problems 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 becomes necessary,
• if the patient has symptoms of slow heart function,
• 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) without 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, talk to your doctor before starting treatment with Concor COR 1.25; your doctor may decide that special caution is required (for example, 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,
• circulation disorders in the limbs,
• mild 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), because Concor COR 1.25 may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgery under general anaesthesia, because 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 your doctor about all medicines you are currently taking, have recently taken, or plan 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 your doctor.

Before using 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 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 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 (such as 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 or barbiturates used in general anaesthesia, and certain medicines used in psychiatric disorders involving 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 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 milk; therefore, breastfeeding is not recommended during treatment with Concor COR.

Driving and operating machinery
This medicine may impair the ability to drive or operate machinery, depending on individual response. Exercise particular caution at the beginning of treatment, after dose increases, or when switching medications, as well as when combining this medicine with alcohol.

3. How to use Concor COR 1.25

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The following medicines are available on the market: Concor COR 1.25, Concor COR 2.5, Concor COR
3.75, Concor COR 7.5.
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 stopping
treatment.
The tablet should be taken in the morning with food or independently of meals, with water. Do not
chew the tablet. Tablets with a score line may be divided into two equal doses.
Adults
Your doctor will start treatment with bisoprolol at a low dose and gradually increase it – your doctor
will decide how to adjust the dose. The recommended starting dose is 1.25 mg once daily.
The dose is increased every 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 of bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before
increasing the dose. 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.
Liver or kidney function impairment
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 treatment needs to be discontinued, 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, contact your doctor immediately. Your doctor
will decide what actions are necessary.
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. Take the next dose as prescribed the
following morning.
Stopping treatment with Concor COR 1.25
Never stop taking Concor COR 1.25 unless instructed by your doctor.
Otherwise, the 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 will experience them.
Very common (affects at least 1 in 10 patients):

• bradycardia (slow heart rate).

Common (affects less than 1 in 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 (affects less than 1 in 100 patients):

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

Rare (affects less than 1 in 1000 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,
• allergic reactions such as itching, facial flushing, rash. If more severe allergic reactions occur, including swelling of the face, neck, tongue, mouth or throat, or breathing difficulties, contact a doctor immediately,
• disturbances of potency,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (eye irritation or redness),
• alopecia (hair loss),
• occurrence or worsening 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 this 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.
Translation of the labels on the blister:
Ch.-B./Verwendbar bis - Batch number/Expiry date
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. Following this advice helps 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.
The other components are:
Tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized starch, maize starch, microcrystalline cellulose, calcium hydrogen phosphate;
Tablet coating: dimethicone, talc, macrogol 400, titanium dioxide, hypromellose.

What Concor COR 1,25 looks like and contents of the pack
Concor COR 1,25 is a white, round, film-coated tablet.
The pack contains 20 or 60 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder 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
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
Poland

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Poland
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
Poland
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
Poland
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Poland
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Number of the marketing authorisation in Germany, the country of export: 46660.00.00
Number of the parallel import authorisation: 96/21