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, 2.5 mg, coated tablets
Bisoprolol fumarate
Please read the entire 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 appear identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. 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 weakened 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. 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, pallor or cyanosis of the 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 heart failure worsens and intravenous administration of drugs that increase heart contractility is required,
• 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, speak to your doctor before starting treatment with Concor Cor 2.5; your 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,
• phaeochromocytoma of the adrenal medulla,
• thyroid dysfunction.

Additionally, inform your doctor if you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), as Concor Cor 2.5 may increase the likelihood of an allergic reaction or intensify such a reaction;
• a surgical procedure under general anaesthesia, as 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 and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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 your doctor.

Before using any of the following medicines together with Concor Cor 2.5, 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);
• cardiac 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 undesired effect, such as antihypertensives, certain tricyclic antidepressants, certain antiepileptics 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 (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 use of Concor Cor 2.5 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 Concor Cor 2.5 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 2.5.

Driving and operating machinery
Depending on how it is tolerated, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increases, or when changing 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 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 tablets. Tablets with a score line may be divided into two equal doses.
The following strengths are available on the market: 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), and Concor Cor 10 (10 mg).
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 initial dose is 1.25 mg once daily.
The dose should be increased every 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 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 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 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
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 prescribed, contact your doctor immediately. The 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).
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 scheduled 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 any medicine, this medicine can cause adverse reactions, although not everyone experiences 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 (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 wears 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 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 worsening of scaly skin lesions (psoriasis), psoriasiform eruptions.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. 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 stated month.
Store below 25°C.
Translation of some information on the immediate packaging:
Lot/EXP viz vyraženo – batch number/expiry date see imprint
Medicines should 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 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:
  Tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate.
  Tablet coating: dimethicon 100, macrogol 400, titanium dioxide (E 171), hypromellose 2910/15.

What Concor Cor 2.5 looks like and contents of the pack
Concor Cor 2.5 mg is a white, film-coated tablet, heart-shaped, with a break 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 the Czech Republic, country of export:
Merck spol. s r.o.
Na Hřebenech II 1718/10, 140 00 Prague 4, Czech Republic

Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250, 64293 Darmstadt, Germany
P&G Health Austria GmbH & Co. OG
Hoesslgasse 20, 9800 Spittal/Drau, Austria
Merck S.L.
Poligono Merck, Mollet del Vallès, (Barcelona), Spain

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Marketing authorisation number in the Czech Republic, country of export: 77/026/01-C
Parallel import authorisation number: 159/21