Concor cor 5

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Concor Cor 5 (Emconcor Cor)
5 mg, film-coated tablets
Bisoprololi fumaras
Concor Cor 5 and Emconcor Cor are different trade names of the same medicinal product.
Please read the following information carefully before using the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• 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 5 is and what it is used for
2. Important information before taking Concor Cor 5
3. How to take Concor Cor 5
4. Possible side effects
5. How to store Concor Cor 5
6. Contents of the pack and other information

1. What Concor Cor 5 is and what it is used for

The active substance in Concor Cor 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. Bisoprolol at doses of 5 mg and 10 mg lowers high blood pressure.
Heart failure occurs when the heart muscle is weakened and unable to pump sufficient blood to meet the body's needs.
Concor Cor 5 is used in the treatment of stable, chronic heart failure.
Concor Cor 5 and Concor Cor 10 are used in the treatment of hypertension or angina pectoris (chest pain caused by insufficient oxygen supply to the heart).

2. Important information before using Concor Cor 5

When not to use Concor Cor 5
Do not use Concor Cor 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 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) 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 5; 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;
• thyroid dysfunction;
• phaeochromocytoma of the adrenal medulla.

Additionally, inform your doctor if you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), because Concor Cor 5 may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgery under general anaesthesia, because Concor Cor 5 may alter the body's response to administered drugs.

Children and adolescents
Concor Cor 5 is not recommended for use in children and adolescents.

Concor Cor 5 and other medicines
Tell 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 5 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 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 taking any of the following medicines together with Concor Cor 5, talk to your doctor; your doctor may recommend more frequent medical checks:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine-type 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);
• 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 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 5 during pregnancy may harm the unborn child.
If you are pregnant or breastfeeding, suspect 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 you can take Concor Cor 5 during pregnancy.
It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor Cor 5.

Driving and operating machinery
This medicine may impair the ability to drive or operate machinery, depending on how it is tolerated. Exercise particular caution at the beginning of treatment, after increasing the dose, or when switching medicines, as well as when combining the medicine with alcohol.

3. How to use Concor Cor 5

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Available on the market are: Concor Cor 5 (5 mg) and Concor Cor 10 (10 mg).
Regular medical check-ups are necessary during treatment with Concor Cor 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, swallowed with water. Do not chew the tablets. Tablets with a score line may be divided into two equal doses.

Adults
Treatment of stable chronic heart failure
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 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 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 for long-term (chronic) treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how well the medicine is tolerated, your doctor may decide to extend the interval before increasing the dose. 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.

Treatment of hypertension and angina pectoris
For both indications, the usual dose is one tablet of Concor Cor 5 or 1/2 tablet of Concor Cor 10 (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to one tablet of Concor Cor 10 or two tablets of Concor Cor 5 (equivalent to 10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.

Impaired liver or kidney function
Treatment of hypertension and angina pectoris
In patients with mild to moderate liver or kidney impairment, dosage adjustment is usually not required. In patients with severe renal impairment or severe hepatic impairment, doses higher than 10 mg of bisoprolol per day should not be used.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence indicating the need for dosage adjustment.

Treatment of stable chronic heart failure
Extreme caution should be exercised when increasing the dose of the medicine.

Elderly patients
Dosage adjustment is not necessary.

Use in children and adolescents
Concor Cor 5 is not recommended for use in children and adolescents.

Duration of treatment
Treatment with Concor Cor 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.

Use of a higher than recommended dose of Concor Cor 5
If you take more Concor Cor 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, significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar).

Missed dose of Concor Cor 5
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time the following morning.

Stopping Concor Cor 5
Never stop taking Concor Cor 5 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 may cause adverse effects, although not everybody gets them.
Very common (affects at least 1 in 10 patients):

• bradycardia (slow heart rate) (in patients with stable, chronic heart failure).

Common (affects less than 1 in 10 patients):

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

Applies only to patients with hypertension or angina pectoris:
* These symptoms occur mainly at the beginning of treatment. They are usually mild and resolve within 1-2 weeks.
Uncommon (affects less than 1 in 100 patients):

• atrioventricular conduction disturbances, worsening of existing heart failure (in patients with hypertension or angina pectoris); bradycardia (slow heart rate) (in patients with hypertension or angina pectoris),
• sleep disorders,
• depression,
• asthenia (weakness) (in patients with hypertension or angina pectoris),
• bronchospasm (difficulty breathing) 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,
• reduced tear production (should be considered if the patient uses contact lenses),
• hepatitis, which may cause yellowing of the skin or eyes,
• changes in the 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, including: swelling of the face, neck, tongue, mouth or throat, or difficulty breathing,
• 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 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 the medicine Concor Cor 5

Keep the 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 30°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 5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
• The other components are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate; tablet coating: yellow iron oxide (E 172), dimethicone, polyethylene glycol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 5 looks like and contents of the pack
Concor Cor 5 is a yellowish-white, coated, heart-shaped tablet with a score line on both sides.
The pack contains 28 or 56 coated tablets.
For further information, please contact the responsible party 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 Healthcare KGaA
Frankfurter Strasse, 250
D-64293 Darmstadt
Germany
Merck, S.L.
Polígono Merck
08100 Mollet del Vallés (Barcelona)
Spain
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Poland
Marketing Authorisation number in Spain, the country of export: 869750.2
Parallel Import Licence number: 103/21