CONCOR COR 2.5

WARNING: Keep the package leaflet. The information on the immediate packaging is 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 trade names for the same medicinal product.
Please read this leaflet carefully 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, 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 any adverse reactions occur, 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 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 taking Concor Cor 2.5

When not to take Concor Cor 2.5
Do not take Concor Cor 2.5 if:

• you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6),
• you have severe asthma,
• you have serious circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness or blueness of fingers or toes,
• you have untreated phaeochromocytoma, a rare tumour of the adrenal gland,
• you have metabolic acidosis, a condition in which blood pH is abnormal,
• you have acute heart failure,
• your heart failure worsens and intravenous administration of drugs that increase heart contractility becomes necessary,
• you have symptoms of a slow heartbeat,
• you have symptoms of low blood pressure,
• you have 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,
• you have cardiogenic shock, an acute, life-threatening disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If you have any of the following conditions, speak to your doctor before starting Concor Cor 2.5; your doctor may decide that special caution is required (e.g. additional medicines or more frequent monitoring):

• diabetes,
• prolonged fasting,
• certain heart conditions (such as arrhythmias 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 or history of psoriasis (scaly skin lesions),
• 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 increase its severity;
• surgery under general anaesthesia, as Concor Cor 2.5 may alter the body’s response to anaesthetic medicines.

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

Concor Cor 2.5 and other medicines
Tell 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 2.5 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 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, as more frequent medical monitoring may be required:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine 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, for example, Alzheimer’s disease or glaucoma (parasympathomimetics);
• medicines used to treat acute heart conditions (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, pain and inflammation (e.g. ibuprofen and diclofenac);
• adrenaline (epinephrine), 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;
• 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 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 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 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 medicines, as well as when combining this 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.
Available in the market are: Concor Cor 1.25 mg, Concor Cor 2.5 mg, Concor Cor 3.75 mg, Concor Cor 5 mg, Concor Cor 7.5 mg, and Concor Cor 10 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 discontinuing therapy.
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
Your doctor will start treatment with bisoprolol at a low dose and gradually increase it—your doctor will decide how to adjust the dosage. The recommended initial dose is 1.25 mg once daily.
The dose is increased at intervals of 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 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 bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before the next dose increase. If symptoms worsen 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 impairment
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 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, inform your doctor immediately. Your doctor will decide what actions are needed.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, a 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. Take the next dose as scheduled the following morning.

Stopping Concor Cor 2.5
Never stop taking Concor Cor 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 medicinal product may 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 disturbances,
• sleep disorders,
• 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 1000 patients):

• hearing disturbances,
• allergic rhinitis,
• reduced tear secretion (should be considered if the patient wears 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. If more severe allergic reactions occur, including swelling of the face, neck, tongue, oral cavity or throat, or difficulty breathing, medical advice should be sought immediately.
• 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 eruptions.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 4921301
Fax: +48 22 4921309
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.

• 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 you no longer use. This will help protect the environment.

6. Contents of the pack 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 components are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate; tablet coating: dimethicon, 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 in the form of white, film-coated heart-shaped tablets, with a score line on both sides of the tablet.
Pack contains 30 or 100 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Romania, country of export:
Merck Romania SRL, Str. Gara Herăstrău Nr. 4D, Clădirea C, Etaj 6, Sector 2, 020334 Bucharest,
Romania
Manufacturer:
MERCK Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany,
P&G Health Austria GmbH & Co. OG Hösslgasse 20, 9800 Spittal/Drau, Austria,
FAMAR LYON, 29 avenue Charles de Gaulle, 69230 Saint-Genis-Laval, France,
Merck, S.L., Polígono Merck, 08100 Mollet del Vallès, Barcelona, Spain
Parallel importer:
PharmaVitae Sp. z o.o. sp. k., ul. E. Orzeszkowej 3/35, 59-820 Leśna
Repackaged in:
Pharma Innovations Sp. z o.o., ul. Jagiellońska 76, 03-301 Warsaw
Synoptis Industrial Sp. z o.o., ul. Szosa Bydgoska 58, 87-100 Toruń
Prespack Jacek Karoński, ul. Św. Wawrzyńca 34, 60-541 Poznań
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
MEDICOFARMA S.A., ul. Sokołowska nr 9, lok. 19, 01-142 Warsaw
Marketing authorisation numbers in Romania, country of export: 6094/2014/02
6094/2014/01
6094/2014/03
6094/2014/04
Parallel import authorisation number: 362/19