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 (Concor Cor 2.5 mg)
2.5 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 2.5 and Concor Cor 2.5 mg are different brand names for the same medicine.
Please read the entire leaflet carefully before taking this 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 questions, 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, inform 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 sufficient 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 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 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 conditions 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 with a doctor before starting treatment with Concor Cor 2.5; the doctor may decide special caution is needed (e.g. additional medication or more frequent monitoring):

• diabetes,
• strict fasting,
• certain heart conditions (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 the 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 allergic reactions or intensify their severity;
• surgery under general anaesthesia, because Concor Cor 2.5 may alter the body's response to anaesthetic drugs.

Children and adolescents
Concor Cor 2.5 is not recommended for use in children and adolescents.

Concor Cor 2.5 and other medicines
Inform the doctor about all medicines currently used, recently used, or planned for use.
Do not use 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 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 a doctor.

Before using any of the following medicines together with Concor Cor 2.5, consult a doctor; the 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 administered 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 agents;
• 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, 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;
• 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 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 become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Concor Cor 2.5 can be used 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 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 changing medications, as well as when combining this medicine with alcohol.

3. How to use Concor Cor 2.5

This medicine should always be used exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Concor Cor is available in the following doses: 1.25 mg, 2.5 mg, 3.75 mg, 7.5 mg.
Regular medical check-ups are necessary during treatment with Concor Cor 2.5. 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 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 at
two-week intervals 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 the next
dose increase. 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 bisoprolol
may be sufficient. Your doctor will determine the appropriate course of action.
Liver or kidney function disorders
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 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 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 2.5
If you take more Concor Cor 2.5 than recommended, inform your doctor immediately. Your doctor will
decide what actions should be taken.
Symptoms of overdose 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 2.5
Do not take a double dose to make up for a missed dose. The next morning, take the recommended dose as
usual.
Stopping treatment with 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 (occurring in at least 1 in 10 patients):

• bradycardia (slow heart rate).

Common (occurring in fewer 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 (occurring in fewer than 1 in 100 patients):

• atrioventricular conduction disturbances,
• sleep disorders,
• 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 in 1 000 patients):

• hearing disturbances,
• allergic rhinitis,
• reduced tear secretion (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 related to 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,
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (eye irritation or redness),
• alopecia (hair loss),
• occurrence or worsening 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 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 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 specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Concor Cor 2.5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 2.5 mg of bisoprolol fumarate.
• Other ingredients are:
  Core of the tablet: anhydrous colloidal silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate;
  Tablet coating: dimethicone 100, 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, coated, heart-shaped tablet with a break line on both sides of the tablet.
The pack contains 30, 60, or 90 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.

Responsible party in Bulgaria, the 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.
Polígono Merck
08100 Mollet del Vallès (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 marketing authorization number (country of export): 20060181
Parallel import authorization number: 20/25