Concor 5

Package Leaflet: Information for the Patient

Concor 5, 5 mg, film-coated tablets

Concor 10, 10 mg, film-coated tablets

Bisoprolol fumarate

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for the patient. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform the doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Concor and what is it used for

The active substance of Concor 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 the heart rate and increases the heart's efficiency in pumping blood throughout the body. Bisoprolol at doses of 5 mg and 10 mg lowers high blood pressure.

Concor is used to treat high blood pressure or coronary heart disease (chest pain caused by insufficient blood supply to the heart).

2. Important information before taking Concor

When not to take Concor

Concor should not be taken in the following cases:

• if the patient is allergic to bisoprolol or any other ingredient of this medicine (listed in section 6),
• if the patient has severe asthma,
• if the patient has severe circulatory problems in the limbs (such as Raynaud's syndrome), which can cause tingling, pallor, or cyanosis of the fingers or toes,
• if the patient has an untreated pheochromocytoma, a rare tumor 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 requires intravenous administration of medicines that increase heart contractility,
• if the patient has symptoms of slow heart rate,
• if the patient has symptoms of low blood pressure,
• if the patient has certain heart diseases that cause very slow or irregular heartbeats (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) without a pacemaker,
• if the patient has cardiogenic shock, a severe and life-threatening heart condition that leads to low blood pressure and circulatory failure.

Warnings and precautions

If any of the following conditions occur, the patient should discuss them with their doctor before starting Concor; the doctor may decide that special caution is necessary (e.g., additional medication or more frequent medical check-ups):

• diabetes;
• strict fasting;
• certain heart diseases (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina);
• mild circulatory disorders in the limbs;
• mild bronchial asthma or chronic obstructive pulmonary disease;
• psoriasis (including a history of psoriasis);
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, the patient should inform their doctor if:

• desensitization treatment is planned (e.g., to avoid hay fever), as Concor may increase the risk of an allergic reaction or worsen its severity;
• a surgical procedure under general anesthesia is planned, as Concor may alter the body's response to anesthetics.

Children and adolescents

Concor is not recommended for children and adolescents.

Concor and other medicines

The patient should inform their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

The following medicines should not be taken with Concor without special recommendation by the doctor:

• certain medicines used to treat high blood pressure, coronary heart disease, or arrhythmias (calcium antagonists, such as verapamil and diltiazem);
• certain medicines used to treat high blood pressure, such as clonidine, methyldopa, moxonidine, and rilmenidine. However, the patient should not stop taking these medicines without consulting their doctor.

Before taking the following medicines with Concor, the patient should discuss them with their doctor, as the doctor may recommend more frequent medical check-ups:

• certain medicines used to treat high blood pressure or coronary heart disease (calcium antagonists of the dihydropyridine type, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class I antiarrhythmic medicines, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, and propafenone);
• certain medicines used to treat arrhythmias (class III antiarrhythmic medicines, such as amiodarone);
• locally applied beta-blockers (such as eye drops for 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;
• general anesthetics (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• nonsteroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, relieve pain, and reduce inflammation (e.g., ibuprofen and diclofenac);
• adrenaline, a medicine used to treat severe, life-threatening allergic reactions and cardiac arrest;
• any medicines that may lower blood pressure, either as a desired or undesired effect, such as antihypertensive medicines, certain antidepressants (tricyclic antidepressants), certain antiepileptic medicines, or medicines used during general anesthesia (barbiturates) and certain medicines used for psychiatric disorders characterized by a loss of contact with reality (phenothiazine derivatives);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, known as monoamine oxidase inhibitors (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 taking Concor during pregnancy may harm the baby.

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. The doctor will decide whether Concor can be taken during pregnancy.

It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor.

Driving and using machines

The medicine may affect the ability to drive or use machines, depending on how it is tolerated. The patient should be particularly careful at the beginning of treatment, after increasing the dose, or when changing medicines, as well as when combining the medicine with alcohol.

3. How to take Concor

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.

Regular medical check-ups are necessary during treatment with Concor. This is especially 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 food, washed down with water. The tablets should not be crushed or chewed.

Adults

In both indications, the usual dose is one Concor 5 tablet or half a Concor 10 tablet (equivalent to 5 mg of bisoprolol fumarate) once daily.

If necessary, the doctor may increase the dose to one Concor 10 mg tablet or two Concor 5 mg tablets (equivalent to 10 mg of bisoprolol fumarate) once daily.

The maximum recommended dose is 20 mg once daily.

Impaired liver or kidney function

In patients with mild to moderate liver or kidney impairment, there is usually no need to adjust the dosage. In patients with severe kidney or liver impairment, the dose should not exceed 10 mg of bisoprolol per day.

Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence that the dosage needs to be adjusted.

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor is not recommended for children and adolescents.

Duration of treatment

Treatment with Concor is usually long-term.

If treatment needs to be stopped, the doctor will usually recommend gradual reduction of the dose, otherwise, the disease may worsen.

Overdose of Concor

In case of overdose, the patient should immediately inform their doctor. The doctor will decide what actions to take.

Symptoms of overdose include: slow heart rate, difficulty breathing, significant decrease in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missing a dose of Concor

The patient should not take a double dose to make up for a missed dose. The next morning, they should take the prescribed dose.

Stopping treatment with Concor

The patient should never stop taking Concor without consulting their doctor, otherwise, the disease may worsen.

If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor can cause side effects, although not everybody gets them.

Frequent(occurring in less than 1 in 10 patients)

• fatigue*, dizziness*, headache*,
• feeling of coldness or numbness in the hands or feet,
• low blood pressure,
• gastrointestinal disorders, such as nausea, vomiting, diarrhea, or constipation.

* These symptoms occur mainly at the beginning of treatment. They are usually mild and disappear within 1-2 weeks.

Uncommon(occurring in less than 1 in 100 patients)

• conduction disorders, worsening of existing heart failure, bradycardia (slow heart rate),
• sleep disorders,
• depression,
• asthenia (weakness),
• bronchospasm (difficulty breathing) in patients with asthma or chronic obstructive pulmonary disease,
• muscle weakness or cramps.

Rare(occurring in less than 1 in 1000 patients)

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (should be considered if the patient wears contact lenses),
• hepatitis, which can cause yellowing of the skin or eyes,
• changes in the results of some blood tests, related to liver function (increased activity of ALT and AST) or triglyceride levels in the blood,
• allergic reactions, such as itching, flushing, rash. The patient should immediately consult their doctor if they experience severe allergic reactions, which may include: swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing,
• impotence,
• nightmares, hallucinations,
• fainting.

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

• conjunctivitis (irritation or redness of the eyes),
• hair loss,
• psoriasis (including a history of psoriasis) or psoriasis-like skin changes.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Concor

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Concor contains

• The active substance is bisoprolol fumarate. Each film-coated tablet contains 5 mg or 10 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, anhydrous calcium hydrogen phosphate; tablet coating: yellow iron oxide (E 172), dimethicone 100, macrogol 400, titanium dioxide (E 171), hypromellose, red iron oxide (E 172) [only Concor 10].

What Concor looks like and contents of the pack

Concor 5 film-coated tablets are yellowish-white, heart-shaped, with a score line.

Concor 10 film-coated tablets are pale orange/light orange, heart-shaped, with a score line.

Blister packs with aluminum/PVC foil in a cardboard box.

The pack contains 30, 50, or 100 film-coated tablets.

Marketing authorization holder

Merck Sp. z o.o.

Al. Jerozolimskie 142B

02-305 Warsaw, Poland

Manufacturer

Merck Healthcare KGaA

Frankfurter Strasse 250

64293 Darmstadt, Germany

Merck S.L.

Poligono Merck

08100 Mollet del Vallès (Barcelona), Spain

Date of last revision of the leaflet: March 2022