Concor cor 2,5

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the 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 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, 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 reactions, including any adverse reactions 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, especially 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 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 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, paleness or blueness of fingers or toes, 1
• if the patient has untreated pheochromocytoma, a rare tumour of the adrenal gland,
• if the patient has metabolic acidosis, i.e. a condition in which the 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 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, i.e. acute, life-threatening impairment of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, consult a doctor before starting treatment with Concor Cor 2.5; the doctor may consider special precautions 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,
• disorders of blood circulation in the limbs,
• mild bronchial asthma or chronic lung disease,
• presence of scaly skin lesions (psoriasis), even in medical history,
• pheochromocytoma of the adrenal medulla,
• thyroid dysfunction.

In addition, 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 such reactions;
• surgery under general anaesthesia, because 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 the doctor about all medicines currently used or recently used, as well as any medicines the patient plans 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); 2
• 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 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, 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 (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, 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 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 (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 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 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 increase, or after switching 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 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.

Adults
Your doctor will start treatment with a low dose of bisoprolol 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 bisoprolol 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 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 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
of 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 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, inform your doctor immediately. Your doctor will decide
what actions are necessary.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, significant drop in blood
pressure, dizziness, or seizures (caused by low 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 prescribed 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 will experience them.

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

• bradycardia (slow heart rate).

Common (occurring in fewer 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 fewer than 1 out of 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 (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. Immediate medical advice should be sought if more severe allergic reactions occur, including: swelling of the face, neck, tongue, oral cavity or throat, or difficulty breathing,
• 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 skin changes.

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 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 required. Such measures help protect the environment.

6. Contents of the package 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.
• The other ingredients 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 2910/15.

What Concor Cor 2.5 looks like and contents of the pack
Concor Cor 2.5 is a white, coated tablet in the shape of a heart, with a score line on both sides of the tablet.
The pack contains 30, 60 or 100 coated tablets.
For more detailed information, please contact the responsible party 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.
Polígon 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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź

Marketing Authorisation Numbers in Romania, country of export:
6094/2014/01
6094/2014/02
6094/2014/03
6094/2014/04

Parallel Import Licence Number: 341/22