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 (Emconcor Cor)
2.5 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 2.5 and Emconcor Cor are different brand names of the same medicine.
Please read carefully the information in this leaflet before taking 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, please 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, tell 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 weak and unable to pump enough 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, 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 a 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) 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, speak with your doctor before starting treatment with Concor Cor 2.5; the doctor may decide that special caution is needed (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 your 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
Use of Concor Cor 2.5 is not recommended in children and adolescents.

Concor Cor 2.5 with other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines you plan to take.
Do not take the following medicines together with Concor Cor 2.5 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 channel blockers 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 2.5, consult your doctor; more frequent medical checks may be required:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine-type calcium channel blockers 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);
• digitalis 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, 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 drugs 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 (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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her 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 breast milk; therefore, breastfeeding is not recommended during treatment with Concor Cor 2.5.

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

3. How to use Concor Cor 2.5

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Regular medical check-ups are necessary while taking 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 a glass of water. Do not chew the tablets. Tablets with a score line may be divided into two equal doses.
Concor Cor is available in the following strengths: 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg.
Adults
Your doctor will start bisoprolol treatment with 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 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 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 as 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 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 of 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 usually 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 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 2.5
If you take more Concor Cor 2.5 than prescribed, contact your doctor immediately. Your doctor will decide what actions should be taken.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, a significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar levels).
Missed dose of Concor Cor 2.5
Do not take a double dose to make up for a missed dose. Take the next dose as prescribed the following morning.
Stopping 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 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 disorders,
• sleep disturbances,
• 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 1 000 patients):

• hearing disturbances,
• allergic rhinitis,
• decreased tear production (should be considered if the patient uses 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 breathing difficulties.
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 helps to provide more information on the safety of the medicine.

5. How to store Concor Cor 2.5

Keep this medicine out of the 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. Such measures will help protect the environment.

6. Contents of the package and other information

What Concor Cor 2.5 contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg of bisoprolol fumarate.
• The other ingredients are: colloidal anhydrous silica, magnesium stearate, crospovidone, maize starch, microcrystalline cellulose, calcium hydrogen phosphate; Coating: dimethicone, polyethylene glycol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 2.5 looks like and contents of the pack
Concor Cor 2.5 is a white, film-coated tablet, heart-shaped, with a score line on both sides of the tablet.
Each pack contains 28 or 56 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, the country of export:
Merck, S.L.
María de Molina, 40
28006 Madrid
Spain
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
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
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
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Spanish marketing authorisation number (country of export): 869735.9
Parallel import licence number: 218/18