Concor 10

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Concor 10

10 mg, coated tablets

Bisoprolol fumarate

Please read carefully the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

• The leaflet should be kept in order to be able to read it again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for this person. 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 any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Concor 10 and what is it used for
• 2. Important information before taking Concor 10
• 3. How to take Concor 10
• 4. Possible side effects
• 5. How to store Concor 10
• 6. Contents of the packaging and other information

1. What is Concor 10 and what is it used for

The active substance of Concor 10 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 10 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 10

When not to take Concor 10

Concor 10 should not be taken 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 been diagnosed with severe circulatory disorders in the limbs (such as Raynaud's syndrome), which can cause tingling, paleness, or bluish discoloration 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 has worsened 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 disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If any of the following conditions occur, the doctor should be consulted before starting Concor 10; the doctor may consider it necessary to take special precautions (e.g., administer additional medicines or perform 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 asthma or chronic obstructive pulmonary disease;
• the occurrence of scaly skin lesions (psoriasis), including in the medical history;
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, the doctor should be informed if:

• desensitization treatment is planned (e.g., to avoid hay fever), as Concor 10 may increase the likelihood of an allergic reaction or worsen its severity;
• a surgical procedure under general anesthesia is planned, as Concor 10 may alter the body's response to administered medicines.

Children and adolescents

Concor 10 is not recommended for use in children and adolescents.

Concor 10 and other medicines

The doctor should be informed about all medicines currently being taken by the patient or recently taken, as well as any medicines planned to be taken.

The following medicines should not be taken with Concor 10 without special doctor's recommendation:

• 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, these medicines should not be stopped without consulting a doctor.

Before taking the following medicines together with Concor 10, the doctor should be consulted; 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 derivative, 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 used beta-blockers (such as eye drops for glaucoma treatment);
• certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
• medicines used to treat acute heart disorders (adrenergic medicines, such as isoprenaline and dobutamine);
• insulin and oral antidiabetic medicines;
• agents used in general anesthesia (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory medicines (NSAIDs) used to treat arthritis, relieve pain, and 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), as well as certain medicines used in psychiatric disorders characterized by loss of contact with reality (phenothiazine derivatives);
• mefloquine, used to prevent and treat malaria;
• medicines used to treat depression, called monoamine oxidase inhibitors (except MAO-B);
• 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 10 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 10 can be taken during pregnancy.

It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor 10.

Driving and using machines

The medicine may affect the ability to drive or operate machines, depending on how it is tolerated. Special caution should be exercised 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 10

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

Regular medical check-ups are necessary during treatment with Concor 10. This is especially important at the beginning of treatment, during dose increase, 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 tablet or two Concor 5 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 modify the dosage. In patients with severe kidney or liver impairment, a dose greater than 10 mg of bisoprolol per day should not be taken.

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

Elderly patients

Dose adjustment is not necessary.

Use in children and adolescents

Concor 10 is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Concor 10 is usually long-term.

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

Taking a higher dose of Concor 10 than recommended

In case of taking a higher dose of Concor 10 than recommended, the doctor should be informed immediately. The doctor will decide what actions to take.

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

Missing a dose of Concor 10

A double dose should not be taken to make up for a missed dose. The next morning, the prescribed dose should be taken.

Stopping treatment with Concor 10

Treatment with Concor 10 should never be stopped without consulting a doctor; otherwise, the disease may worsen.

In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Concor 10 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 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 AlAT and AspAT) or triglyceride levels in serum,
• allergic reactions, such as itching, flushing, rash. The doctor should be contacted immediately in case of more 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,
• the occurrence or worsening of scaly skin lesions (psoriasis), psoriasis-like changes.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects helps to gather more information on the safety of the medicine.

5. How to store Concor 10

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

This medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.

Store in a temperature below 30°C.

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

6. Contents of the packaging and other information

What Concor 10 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 10 mg.
• The other ingredients are: tablet core: colloidal silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, calcium hydrogen phosphate; tablet coating: yellow iron oxide (E 172), red iron oxide (E 172), dimethicone, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor 10 looks like and contents of the pack

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

PVC-PVDC/Aluminum blisters in a cardboard box.

The pack contains 30, 60, or 90 coated tablets.

For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Greece, the country of export:

Merck A.E., Ave. Kifisias 41-45, building B, 15123 Marousi, Athens, Greece

Manufacturer:

Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Marketing authorization number in Greece, the country of export: 78137/9-11-2011

Parallel import authorization number: 3/22

Date of leaflet approval:04.01.2022

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