Concor cor 1.25

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging is in a foreign language!
Concor Cor 1.25
1.25 mg, film-coated tablets
Bisoprolol fumarate
Please read all of this leaflet carefully before taking this medicine, because 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. This medicine may harm other people, 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.

Contents of the leaflet

1. What Concor Cor 1.25 is and what it is used for
2. Important information before taking Concor Cor 1.25
3. How to take Concor Cor 1.25
4. Possible side effects
5. How to store Concor Cor 1.25
6. Contents of the pack and other information

1. What Concor Cor 1.25 is and what it is used for

The active substance in Concor Cor 1.25 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 1.25 is used in the treatment of stable chronic heart failure.

2. Important information before using Concor Cor 1.25

When not to use Concor Cor 1.25
Do not use Concor Cor 1.25 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 circulation disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness or blueness 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 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 heart dysfunction 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 1.25; 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,
• 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 you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), because Concor Cor 1.25 may increase the likelihood of allergic reactions or intensify their severity;
• surgery under general anaesthesia, because Concor Cor 1.25 may alter the body's response to administered drugs.

Children and adolescents
Concor Cor 1.25 is not recommended for use in children and adolescents.

Concor Cor 1.25 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 take the following medicines together with Concor Cor 1.25 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 using any of the following medicines together with Concor Cor 1.25, consult your doctor; your 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 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 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 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 called 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 1.25 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 1.25 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.

Driving and operating machinery
This medicine may impair the ability to drive or operate machinery, depending on how it is tolerated. Exercise particular caution at the beginning of treatment, after dose increase, or when switching medications, as well as when combining the medicine with alcohol.

3. How to use Concor Cor 1.25

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 1.25. 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, with water. Do not
chew the tablet. Tablets with a score line may be divided into two equal doses.
Concor Cor 1.25, Concor Cor 2.5, Concor Cor 3.75, Concor Cor 5, and Concor Cor 7.5 are available on
the market.
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
should be increased every two weeks or longer until reaching doses of 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 the condition worsens or 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.
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 1.25 is not recommended for use in children and adolescents.
Duration of treatment
Treatment with Concor Cor 1.25 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 1.25
If you take more Concor Cor 1.25 than recommended, contact your doctor immediately. Your doctor
will decide what actions are necessary.
Symptoms of overdose 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 1.25
Do not take a double dose to make up for a missed dose. On the following morning, take the
recommended dose as usual.
Stopping Concor Cor 1.25
Never stop taking Concor Cor 1.25 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 effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Very common (affects at least 1 in 10 people):

• bradycardia (slow heart rate).

Common (affects less than 1 in 10 people):

• 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 people):

• atrioventricular conduction disorders,
• sleep disturbances,
• depression,
• bronchospasm (breathing difficulties) in patients with bronchial asthma or chronic obstructive pulmonary disease,
• muscle weakness or muscle cramps.

Rare (affects less than 1 in 1 000 people):

• hearing disturbances,
• allergic rhinitis,
• decreased 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 regarding 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 breathing difficulties,
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

Very rare (affects less than 1 in 10 000 people):

• 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 effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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 1.25

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard package. The expiry date refers to the last day of the stated month.
Translation of some information on the immediate packaging:
Ch.-B./Verw. bis: siehe Prägung – batch number/expiry date: see embossing.
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. These measures help protect the environment.

6. Contents of the package and other information

What Concor Cor 1,25 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 1.25 mg of bisoprolol fumarate.
• Other components are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized corn starch, corn starch, microcrystalline cellulose, calcium hydrogen phosphate; tablet coating: dimethicone, talc, polyethylene glycol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 1,25 looks like and contents of the pack
Concor Cor 1,25 is a white, round, film-coated tablet.
The pack contains 20 or 60 film-coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Austria, country of export:
Merck Gesellschaft mbH
Zimbagasse 5
1147 Vienna
Austria
Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
Merck, S.L.
Polígono Merck
08100 Mollet del Vallés (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
Austrian marketing authorization number (country of export): 1-23302
Parallel import authorization number: 8/24