Concor 10

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.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What Concor is and what it is 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 Concor is and what it is 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 efficiency of the heart 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

Do not take Concor in the following cases:

• if you are allergic to bisoprolol or any of the other ingredients of this medicine (listed in section 6),
• if you have severe asthma,
• if you have severe circulation problems in your limbs (such as Raynaud's syndrome) that may cause tingling, pallor, or cyanosis of the fingers or toes,
• if you have an untreated pheochromocytoma, a rare tumor of the adrenal gland,
• if you have metabolic acidosis, a condition in which the blood pH is abnormal,
• if you have acute heart failure,
• if you have worsening heart failure and need to be treated with intravenous medications that increase heart contractility,
• if you have symptoms of slow heart rate,
• if you have symptoms of low blood pressure,
• if you have certain heart conditions that cause very slow or irregular heartbeats (second or third degree atrioventricular block, sinoatrial block, sick sinus syndrome) without a pacemaker,
• if you have cardiogenic shock, a severe and life-threatening heart condition that leads to low blood pressure and poor circulation.

Warnings and precautions

If you have any of the following conditions, you should discuss them with your doctor before taking Concor; your doctor may decide that special caution is needed (e.g., additional medications or more frequent medical check-ups):

• diabetes;
• strict fasting;
• certain heart conditions (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina);
• mild circulation problems in the limbs;
• mild asthma or chronic lung disease;
• psoriasis (a skin condition) or a history of psoriasis;
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, you should tell your doctor if you are planning:

• desensitization treatment (e.g., to avoid hay fever), as Concor may increase the risk of an allergic reaction or worsen such a reaction;
• undergoing surgery under general anesthesia, as Concor may affect the body's response to anesthetics.

Children and adolescents

Concor is not recommended for children and adolescents.

Concor and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Do not take the following medicines with Concor without special advice from your 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, rilmenidine. However, do not stop taking these medicines without consulting your doctor.

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

• certain medicines used to treat high blood pressure or coronary heart disease (dihydropyridine calcium antagonists, such as felodipine and amlodipine);
• certain medicines used to treat arrhythmias (class I antiarrhythmic agents, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain medicines used to treat arrhythmias (class III antiarrhythmic agents, 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;
• non-steroidal anti-inflammatory drugs (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 agents, certain antidepressants (tricyclic antidepressants), certain antiepileptic drugs, or medicines used during general anesthesia (barbiturates) and certain medicines used for psychiatric disorders characterized by 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether you can take Concor during pregnancy.

It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Concor.

Driving and using machines

The medicine may affect your ability to drive or use machines, depending on how well you tolerate it. Be particularly careful at the beginning of treatment, when increasing the dose, or when changing medicines, as well as when combining Concor with alcohol.

3. How to take Concor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Regular medical check-ups are necessary while taking Concor. This is especially important at the beginning of treatment, when increasing the dose, and when stopping treatment.

Take the tablet in the morning with or without food, with a glass of water. Do not crush or chew the tablets.

Adults

For 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, your 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 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, your doctor will usually recommend gradual reduction of the dose, otherwise, the disease may worsen.

Overdose of Concor

If you have taken more Concor than prescribed, inform your doctor immediately. Your 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 low blood sugar).

Missed dose of Concor

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

Stopping Concor treatment

Never stop taking Concor without consulting your doctor, otherwise, the disease may worsen.

If you have any further questions about the use of this medicine, ask your 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 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 (consider if you wear contact lenses),
• hepatitis, which may cause yellowing of the skin or eyes,
• changes in the results of some blood tests, related to liver function (increased ALT and AST activity) or triglyceride levels in the blood,
• allergic reactions, such as itching, flushing, rash. You should immediately contact your doctor if you 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,
• onset or exacerbation of psoriatic skin lesions, psoriasis-like skin lesions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Concor

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and carton after EXP.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, maize starch, calcium hydrogen phosphate anhydrous; tablet coating: yellow iron oxide (E 172), dimeticone 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.

Aluminum/PVC blisters 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 package leaflet: March 2022