Concor 5

Leaflet attached to the packaging: patient information

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

Concor 5 (Concor 5 mg)

5 mg, coated tablets

Bisoprolol fumarate
Concor 5 and Concor 5 mg are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before taking the medicine, as it contains

important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific 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 5 and what is it used for
• 2. Important information before taking Concor 5
• 3. How to take Concor 5
• 4. Possible side effects
• 5. How to store Concor 5
• 6. Contents of the packaging and other information

1. What is Concor 5 and what is it used for

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

When not to take Concor 5

Concor 5 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 contractions,
• 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, an acute, life-threatening heart disorder 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 5; the doctor may decide that special caution is necessary (e.g., additional medications 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 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 patient should tell their doctor if:

• desensitization treatment is planned (e.g., to avoid hay fever), as Concor 5 may increase the likelihood of an allergic reaction or worsen such a reaction;
• a surgical procedure under general anesthesia is planned, as Concor 5 may alter the body's response to administered medications.

Children and adolescents

Concor 5 is not recommended for children and adolescents.

Concor 5 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concor 5 should not be taken with the following medicines 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, these medicines should not be stopped without consulting a doctor.

Before taking the following medicines together with Concor 5, the patient should discuss them with their doctor; 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 agents, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, and propafenone);
• certain medicines used to treat arrhythmias (class III antiarrhythmic agents, 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 agents, such as isoprenaline and dobutamine);
• insulin and oral antidiabetic agents;
• agents used in general anesthesia (e.g., during surgery);
• digitalis glycosides used to treat heart failure;
• non-steroidal anti-inflammatory agents (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 agents, or agents 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, known as 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 5 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 5 can be taken during pregnancy.
It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor 5.

Driving and operating machinery

The medicine may impair the ability to drive or operate machinery, 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 5

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 5.
This is especially important at the beginning of treatment, during dose increases, 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.
Concor 5 (5 mg) and Concor 10 (10 mg) are available on the market.

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 5 is not recommended for children and adolescents.

Duration of treatment

Treatment with Concor 5 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 5 than recommended

In case of taking a higher dose of Concor 5 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 decrease in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

Missing a dose of Concor 5

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 5

Treatment with Concor 5 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 5 can cause side effects, although not everybody gets them.
Common(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 and are usually mild and resolve 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 1,000 patients)

• hearing disorders,
• allergic rhinitis,
• decreased 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 doctor should be contacted immediately in case of 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,
• 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 the 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:
Jerozolimskie Avenue 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 can help gather more information on the safety of the medicine.

5. How to store Concor 5

The medicine should be stored out of sight and reach of children.
Concor 5 should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store at 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 unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Concor 5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, calcium hydrogen phosphate; tablet coating: yellow iron oxide (E 172), dimethicone 100, macrogol 400, titanium dioxide (E 171), hypromellose.

What Concor 5 looks like and contents of the pack

Concor 5 coated tablets are yellowish-white, heart-shaped with a dividing line.
PVC/Al blisters in a cardboard box. The pack contains 30, 50, or 100 coated tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Romania, the country of export:

Merck Romania SRL
Gara Herăstrău Street, No. 4D, Building C, 6th floor
Sector 2, 020334 Bucharest, Romania

Manufacturer:

Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany
P&G Health Austria GmbH & Co. OG
Hösslgasse 20, 9800 Spittal/Drau
Austria
Famar Lyon
29 avenue Charles de Gaulle
69230 Saint-Genis-Laval, France

Parallel importer:

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

Repackaged by:

Delfarma Sp. z o.o.
Św. Teresy od Dzieciątka Jezus Street 111
91-222 Łódź
Marketing authorization number in Romania, the country of export:
6251/2014/01
6251/2014/02

Parallel import authorization number: 347/22 Date of approval of the leaflet: 23.09.2022

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