Concor 5

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Concor 5

5 mg, coated tablets

Bisoprolol fumarate

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

important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, 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 pack 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 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 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 serious blood circulation disorders in the limbs (such as Raynaud's syndrome) that may cause tingling, paleness, or bluish discoloration 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 your heart failure has worsened and you need to be given medicines that increase the heart's contractility intravenously,
• if you have symptoms of slow heart rate,
• if you have 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 cardiogenic shock, a severe and life-threatening heart disorder that leads to low blood pressure and circulatory failure.

Warnings and precautions

If you have any of the following conditions, you should discuss them with your doctor before taking Concor 5; your doctor may decide that special caution is necessary (e.g., taking additional medicines 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 blood circulation disorders in the limbs;
• mild asthma or chronic lung disease;
• psoriasis (a skin condition) or a history of psoriasis;
• thyroid dysfunction;
• pheochromocytoma of the adrenal gland.

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

• desensitization treatment (e.g., to avoid hay fever), as Concor 5 may increase the risk of an allergic reaction or worsen such a reaction;
• a surgical procedure under general anesthesia, as Concor 5 may change the body's response to the medicines given.

Children and adolescents

Concor 5 is not recommended for children and adolescents.

Concor 5 and other medicines

Tell your doctor about all the medicines you are 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 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, and rilmenidine. However, do not stop taking these medicines without consulting your doctor.

Before taking the following medicines with Concor 5, consult your doctor, as they may require 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 (antiarrhythmic drugs of class I, such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, and propafenone);
• certain medicines used to treat arrhythmias (antiarrhythmic drugs of class III, such as amiodarone);
• locally used 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 disorders (adrenergic agents, 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 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, 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 you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, 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 human milk, so breastfeeding is not recommended during treatment with Concor 5.

Driving and using machines

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

3. How to take Concor 5

Concor 5 (5 mg) and Concor 10 (10 mg) are available.

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

Regular medical check-ups are necessary while taking Concor 5. This is especially important at the beginning of treatment, when increasing the dose, and when stopping treatment.

Take the tablet in the morning with food or on an empty stomach, with a glass of water. Do not crush or chew the tablets.

Adults

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

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

The maximum recommended dose is 20 mg once daily.

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, do not take more than 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 stopped, your doctor will usually recommend gradually reducing the dose of Concor 5; otherwise, the disease may worsen.

Overdose of Concor 5

If you have taken more Concor 5 than prescribed, contact your doctor immediately. Your doctor will decide what actions to take.

Overdose symptoms include: slow heart rate, difficulty breathing, significant drop in blood pressure, dizziness, or seizures (caused by low blood sugar levels).

Missing a dose of Concor 5

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

Stopping treatment with Concor 5

Never stop taking Concor 5 unless your doctor tells you to. Otherwise, the disease may worsen.

If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor 5 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 usually occur at the beginning of treatment and are generally 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 activity of AlAT and AspAT) or triglyceride levels in the blood,
• 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,
• 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 worsening of psoriatic skin lesions (psoriasis), psoriasis-like changes.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, 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 provide more information on the safety of this medicine.

5. How to store Concor 5

Keep the 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.

The expiry date refers to the last day of the month.

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 5 contains

• The active substance is bisoprolol fumarate. Each 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 coated tablets are yellowish-white, heart-shaped, with a dividing line.

PVC/Al blisters in a carton box. The pack contains 30, 50, or 100 coated tablets.

For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Merck Romania SRL

Str. Gara Herăstrău Nr. 4D, Clădirea C, Etaj 6

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

Merck, S.L.

Polígono Merck

8100 Mollet del Vallès (Barcelona)

Spain

Parallel importer:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.

ul. Zbąszyńska 3

91-342 Łódź

Marketing authorization number in Romania, the country of export: 6251/2014/01

6251/2014/02

Parallel import authorization number: 277/23

Date of approval of the leaflet: 29.11.2023

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