Concor 5

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Concor 5 (Concor 5 mg), 5 mg, film-coated tablets

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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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 heart's efficiency in pumping blood throughout the body. Bisoprolol at 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

Do not take Concor 5 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 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 you have been diagnosed with an untreated pheochromocytoma, a rare tumor of the adrenal gland,
• if you have been diagnosed with metabolic acidosis, a condition in which the blood pH is abnormal,
• if you have been diagnosed with acute heart failure,
• if you have worsening heart failure and need intravenous administration of medicines that increase heart contractility,
• if you have been diagnosed with symptoms of slow heart rate,
• if you have been diagnosed with symptoms of low blood pressure,
• if you have 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 you have been diagnosed with cardiogenic shock, a severe, life-threatening heart disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If any of the following conditions occur, you should discuss them with your doctor before starting Concor 5; your doctor may decide that special caution is necessary (e.g., additional medication or more frequent 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 lung disease;
• the occurrence of scaly skin lesions (psoriasis), including in the medical history;
• thyroid dysfunction;
• pheochromocytoma of the adrenal medulla.

In addition, you should tell your 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 it;
• a surgical procedure under general anesthesia is planned, as Concor 5 may change the body's response to the administered medicines.

Children and adolescents

Concor 5 is not recommended for children and adolescents.

Concor 5 and other medicines

You should tell your doctor about all 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 5 without special recommendation by 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 5, you should discuss them with your doctor; your 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, 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 joint inflammation, pain relief, 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 5 during pregnancy may harm the baby.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor or pharmacist before taking this medicine. Your doctor will decide whether you can take Concor 5 during pregnancy.
It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Concor 5.

Driving and using machines

The medicine, depending on how it is tolerated, may impair the ability to drive or operate machines. You 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 5

This medicine should always be taken according to your doctor's instructions. If you have any doubts, you should consult your doctor or pharmacist.
During treatment with Concor 5, regular medical check-ups are necessary. This is especially important at the beginning of treatment, during dose increase, and in case of treatment discontinuation.
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 1/2 Concor 10 tablet (equivalent to 5 mg of bisoprolol fumarate) once a day.
If necessary, your 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 a day.
The maximum recommended dose is 20 mg once a day.

Liver or kidney impairment

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

Taking a higher dose of Concor 5 than recommended

If you have taken a higher dose of Concor 5 than recommended, you should immediately inform your doctor. 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 decreased blood sugar levels).

Missing a dose of Concor 5

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

Stopping treatment with Concor 5

You should never stop taking Concor 5 unless your doctor recommends it. Otherwise, the disease may worsen.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor 5 can cause side effects, although not everybody gets them.
Frequently(occurring in less than 1 in 10 patients)

• fatigue*, dizziness*, headache*,
• feeling of cold 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.
Less frequently(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.

Rarely(occurring in less than 1 in 1000 patients)

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (should be considered if you wear 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 serum,
• allergic reactions, such as itching, flushing, rash. You should immediately contact your doctor if you experience more severe allergic reactions, which may include: swelling of the face, neck, tongue, mouth, or throat, or difficulty breathing,
• potency disorders,
• nightmares, hallucinations,
• fainting.

Very rarely(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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. 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.
By reporting side effects, you 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.
Do not use this medicine 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 film-coated tablet contains 5 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: silicon dioxide, anhydrous, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, 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 film-coated tablets are yellowish-white, heart-shaped, with a dividing line.
PVC/Al blisters in a cardboard box.
The pack contains 30, 60, or 90 film-coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, the country of export:

Merck Serono SIA
Duntes iela 23A
LV-1005, Riga
Latvia

Manufacturer:

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

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:99-0010

Parallel import authorization number: 98/23

Date of leaflet approval: 01.06.2023

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