Patient Information Leaflet

Warning! Keep this leaflet! 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 brand names for the same medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

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. It may harm other people, even if their symptoms are identical.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

What Concor Cor 2.5 is and what it is used for
What you need to know before taking Concor Cor 2.5
How to take Concor Cor 2.5
Possible side effects
How to store Concor Cor 2.5
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. 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 blood circulation disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, pallor, or blueness of the fingers or toes,
if the patient has untreated phaeochromocytoma, a rare tumour of the adrenal glands,
if the patient has metabolic acidosis, a condition in which the blood pH is abnormally low,
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) in the absence of a pacemaker,
if the patient has cardiogenic shock, an acute, life-threatening heart disorder 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 caution is needed (e.g. additional medications 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;
blood circulation 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 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 such reactions;
a surgical procedure under general anaesthesia, because Concor Cor 2.5 may alter the body's response to administered 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 your doctor about all medicines currently used or 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 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 2.5, consult your doctor, as more frequent medical checks may be required:

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 (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 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, pain, and swelling (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 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 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 after changing medications, 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 directed 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 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.
The following strengths of Concor Cor 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 dosage. The recommended initial 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 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 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 bisoprolol may be sufficient.
Your doctor will determine the appropriate course of action.
Impaired liver or kidney function
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, contact your doctor immediately. Your doctor will decide what actions are required.
Symptoms of overdose may include: slowing of the heartbeat, breathing difficulties, a marked 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 2.5 unless your doctor tells 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Very common (occurring in at least 1 out of 10 patients):

bradycardia (slow heart rate).

Common (occurring in less than 1 out of 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 less than 1 out of 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 less than 1 out of 1,000 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 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 less than 1 out of 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 or pharmacist. Adverse reactions can also be reported directly to the Department of Monitoring of 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 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 no longer in 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 ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, maize starch, microcrystalline cellulose, calcium hydrogen phosphate; tablet coating: dimethicone, macrogol 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, film-coated heart-shaped tablet with a break line on both sides of the tablet.
Each pack contains 30, 60 or 100 film-coated tablets.
For further 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
Merck, S.L., Polígono Merck, 08100 Mollet del Vallès (Barcelona), Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw, Poland
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorisation number in Romania, country of export: 6094/2014/01
6094/2014/02
6094/2014/03
6094/2014/04
Parallel import authorisation number: 231/19