Concor cor 5

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in foreign languages
Concor Cor 5
5 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before using 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, 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, 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
arterial pressure.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the
body's needs.
Concor Cor 5 is used in the treatment of stable chronic heart failure.
Concor Cor 5 is 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 circulation 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 adrenal gland tumour,
• if the patient has metabolic acidosis, a condition in which blood pH is abnormal,
• if the patient has acute heart failure,
• if the patient's heart failure worsens and intravenous administration of drugs increasing 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 disturbance 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; your doctor may decide that special precautions are necessary (for example, additional medications 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 problems;
• circulation disorders in the limbs;
• mild asthma or chronic lung disease;
• presence or history of psoriasis (scaly skin lesions);
• thyroid dysfunction;
• phaeochromocytoma of the adrenal medulla.

Additionally, inform your doctor if you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), as Concor COR 5 may increase the likelihood or severity of allergic reactions;
• a surgical procedure under general anaesthesia, as Concor COR 5 may alter the body's response to anaesthetic drugs.

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

Concor COR 5 with other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Do not take the following medicines together with Concor COR 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 antagonists such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, rilmenidine. Do not stop taking these medicines without consulting your doctor.

Before taking any of the following medicines together with Concor COR 5, 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, 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);
• 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, 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 with loss of contact with reality (phenothiazine derivatives);
• mefloquine, used for prevention and treatment of malaria;
• antidepressants 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 5 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 5 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 5.

Driving and operating machinery
This medicine may impair the ability to drive or operate machinery, depending on individual tolerance. 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 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 during treatment with Concor COR 5. 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, swallowed with water.
Do not chew the tablets. Tablets with a score line may be divided into two equal doses.
The following are available in commerce: Concor Cor 1.25 (1.25 mg), Concor Cor 2.5 (2.5 mg), Concor Cor 3.75
(3.75 mg), Concor Cor 5 (5 mg), Concor Cor 7.5 (7.5 mg), Concor Cor 10 (10 mg).
Adults
Treatment of stable chronic heart failure
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 should be 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 bisoprol0l 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.
If your 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 of bisoprolol may be sufficient. Your doctor will determine the appropriate approach.
Treatment of hypertension and angina pectoris
In both indications, the usual dose is one tablet of Concor COR 5 (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to 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 impairment of liver or kidney function, dose adjustment is usually not required.
In patients with severe renal impairment or severe hepatic impairment, doses greater 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 to suggest that dose adjustment is necessary.
Treatment of stable chronic heart failure
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 5 is not recommended for use in children and adolescents.
Duration of treatment
Treatment with Concor COR 5 is usually long-term.
If treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose. Otherwise, your condition may worsen.
Taking more than the 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 to take.
Symptoms of overdose may include: slowed heart rate, difficulty breathing, 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 as scheduled the following morning.
Stopping Concor COR 5
Never stop taking Concor COR 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 experiences them.

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

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

Common (occurring in fewer than 1 out of 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 (occurring in fewer than 1 out of 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 (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 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 difficulty breathing, contact a doctor immediately,
• 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 exacerbation 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 your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 5

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after "EXP" and on the cardboard package after "EXP:". The expiry date refers to the last day of the stated month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Concor COR 5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
• Other components are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate;

coating: iron oxide yellow (E 172), dimethicone 100, 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 tablet, heart-shaped, with a break line on both sides of the tablet.
The pack contains 30, 50 or 100 coated tablets.
For further information, please contact the responsible entity or the parallel importer.
Responsible entity in Bulgaria, country of export:
Merck Bulgaria EAD
48, Sitnyakovo Blvd.
Serdika Offices, 6th Floor
1505 Sofia
Bulgaria
Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
Merck S.L.
Poligono Merck
Mollet del Vallès
08100 Barcelona
Spain
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
Bulgaria, country of export, marketing authorization number: 20060182
Parallel import authorization number: 290/24