Concor cor 3.75

Package leaflet: Information for the patient

Concor COR 1.25, 1.25 mg, film-coated tablets
Concor COR 2.5, 2.5 mg, film-coated tablets
Concor COR 3.75, 3.75 mg, film-coated tablets
Concor COR 7.5, 7.5 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• 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 the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Concor COR is and what it is used for

The active substance in Concor COR 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 cannot pump enough blood to meet the body's needs.
Concor COR is used in the treatment of stable chronic heart failure.

2. Important information before using Concor COR

When not to use Concor COR
Do not use Concor COR 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,

• 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 becomes necessary,

• if the patient has symptoms of a 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 disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, talk to your doctor before starting treatment with Concor COR; your doctor may decide that special caution is required (for example, additional medications 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 problems,
• 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 you are planning:

• allergen immunotherapy (e.g. to prevent hay fever), as Concor COR may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgery under general anaesthesia, as Concor COR may alter the body's response to administered drugs.

Children and adolescents
Use of Concor COR is not recommended in children and adolescents.
Concor COR and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Do not use the following medicines together with Concor COR 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, 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 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, 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 unwanted effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants), certain antiepileptic drugs or those used during general anaesthesia (barbiturates), 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 (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 during pregnancy may harm the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Concor COR 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.
Driving and operating machinery
Depending on how it is tolerated, this medicine may impair the ability to drive or operate machinery. Particular caution is advised at the beginning of treatment, after dose increase, or after changing medications, as well as when combining the medicine with alcohol.

3. How to use Concor COR

This medicine should always be used 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. 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 tablet. Tablets with a score line may be divided into two equal doses.
Adults
Your doctor will start treatment with bisoprolol at a low dose, which will be gradually increased – your
doctor will decide how to increase the dose. The recommended starting dose is 1.25 mg once daily. The
dose should be 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 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 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
Exercise particular caution when increasing the dose of the medicine.
Elderly patients
Dose adjustment is not necessary.
Use in children and adolescents
Concor COR is not recommended for use in children and adolescents.
Duration of treatment
Treatment with Concor COR is usually long-term.
If treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose.
Otherwise, the condition may worsen.
Use of a higher than recommended dose of Concor COR
If you take more Concor COR than prescribed, inform 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
Do not take a double dose to make up for a missed dose. The next morning, take the prescribed dose as
usual.
Stopping Concor COR treatment
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 effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
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 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 the 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. In case of severe allergic reactions, including swelling of the face, neck, tongue, mouth or throat, or difficulty breathing, contact a doctor immediately,
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (eye irritation or redness),
• alopecia⁵,
• occurrence or worsening of scaly skin lesions (psoriasis), psoriasiform skin lesions.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Concor COR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after the abbreviation EXP and on the cardboard package after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Concor Cor 3,75 / Concor Cor 1,25 / Concor Cor 2,5 / Concor Cor 3,75

• Store below 25°C.

Concor Cor 7,5

• Store below 30°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 will help protect the environment.

6. Contents of the pack and other information

What Concor COR contains
Concor COR 1.25 film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 1.25 mg of bisoprolol fumarate.
• Other ingredients are:
  Tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, pregelatinized starch, maize starch, microcrystalline cellulose, anhydrous calcium hydrogen phosphate;
  Tablet coating: simethicone 100, talc, polyethylene glycol 400, titanium dioxide (E171), hypromellose.

Concor COR 2.5 film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 2.5 mg of bisoprolol fumarate.
• Other ingredients are:
  Tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, anhydrous calcium hydrogen phosphate;
  Tablet coating: simethicone 100, polyethylene glycol 400, titanium dioxide (E171), hypromellose.

Concor COR 3.75 film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 3.75 mg of bisoprolol fumarate.
• Other ingredients are:
  Tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, anhydrous calcium hydrogen phosphate;
  Tablet coating: yellow iron oxide (E172), simethicone 100, polyethylene glycol 400, titanium dioxide (E171), hypromellose.

Concor COR 7.5 film-coated tablets

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 7.5 mg of bisoprolol fumarate.
• Other ingredients are:
  Tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, anhydrous calcium hydrogen phosphate;
  Tablet coating: yellow iron oxide (E172), simethicone 100, polyethylene glycol 400, titanium dioxide (E171), hypromellose.

What Concor COR looks like and contents of the pack
Concor COR 1.25 are white, round film-coated tablets.
Concor COR 2.5 are white, heart-shaped film-coated tablets with a score line on both sides of the tablet.
Concor COR 3.75 are off-white, heart-shaped film-coated tablets with a score line on both sides of the tablet.
Concor COR 7.5 are light yellow, heart-shaped film-coated tablets with a score line on both sides of the tablet.
The pack contains 28, 56 or 100 film-coated tablets.

Marketing Authorization Holder
Merck Sp. z o.o.
Al. Jerozolimskie 142B
02-305 Warsaw, Poland
Company logo

Manufacturer
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany
Merck S.L.
Poligono Merck
08100 Mollet del Vallès (Barcelona), Spain