Concor 10

Leaflet accompanying the packaging: patient information

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

Concor 10

10 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.
• If you have 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 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 in 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

Do not take Concor 10 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 circulatory problems in your limbs (such as Raynaud's syndrome), which can cause tingling, paleness, or bluish discoloration of your 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 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 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 condition that affects the heart's ability to pump blood, leading to low blood pressure and poor circulation.

Warnings and precautions

If you have any of the following conditions, you should talk to your doctor before taking Concor 10; your doctor may decide that you need to be particularly careful (for example, by taking additional medicines or having more frequent check-ups):

• diabetes;
• strict fasting;
• certain heart conditions (such as arrhythmias or severe chest pain at rest - Prinzmetal's angina);
• mild circulatory problems in your limbs;
• mild asthma or chronic obstructive pulmonary 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 10 may increase the risk of an allergic reaction or make it worse;
• undergoing surgery under general anesthesia, as Concor 10 may affect your body's response to the medicines given.

Children and adolescents

Concor 10 is not recommended for children and adolescents.

Concor 10 and other medicines

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

Do not take the following medicines with Concor 10 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 10, talk to your doctor; your doctor may recommend more frequent check-ups:

• certain medicines used to treat high blood pressure or coronary heart disease (dihydropyridine derivatives, 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);
• 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;
• nonsteroidal 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 10 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 10 during pregnancy.

It is not known whether bisoprolol passes into breast milk, so breastfeeding is not recommended during treatment with Concor 10.

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 the medicine with alcohol.

3. How to take Concor 10

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Regular check-ups are necessary while taking Concor 10. 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.

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

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 a day.

If necessary, your doctor may increase the dose to one Concor 10 tablet (10 mg) or two Concor 5 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 adjust the dose. 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 to suggest that the dose needs to be adjusted.

Elderly patients

No dose adjustment is necessary.

Use in children and adolescents

Concor 10 is not recommended for children and adolescents.

Duration of treatment

Treatment with Concor 10 is usually long-term.

If treatment needs to be stopped, your doctor will usually recommend gradually reducing the dose of Concor 10; otherwise, the condition may worsen.

Taking more than the recommended dose of Concor 10

If you have taken more than the recommended dose of Concor 10, contact 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).

Missing a dose of Concor 10

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

Stopping treatment with Concor 10

Never stop taking Concor 10 unless your doctor tells you to. Otherwise, your condition 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 10 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 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 1,000 patients)

• hearing disorders,
• allergic rhinitis,
• reduced tear secretion (consider 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 AlAT and AspAT) or triglyceride levels in the blood,
• allergic reactions, such as itching, flushing, rash. If you experience severe allergic reactions, which may include: facial swelling, neck, tongue, mouth, or throat swelling, or difficulty breathing, contact your doctor immediately,
• impotence,
• nightmares, hallucinations,
• fainting.

Very rare(occurring in less than 1 in 10,000 patients)

• conjunctivitis (irritation or redness of the eyes),
• hair loss,
• psoriasis (a skin condition) or psoriasis-like skin conditions.

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 Drug Safety Monitoring, 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 10

Keep the medicine out of the 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. 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 10 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 10 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: silica, colloidal, 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, red iron oxide (E 172).

What Concor 10 looks like and contents of the pack

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

PVC/Al blisters in a cardboard box.

The pack contains 30 coated tablets.

For more detailed information, 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

P&G Health Austria GmbH & Co. OG

Hoesslgasse 20

9800 Spittal/Drau, Austria

Famar Lyon

29 Avenue Charles de Gaule

F-69230 Saint Genis Laval, France

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

Pharma Innovations Sp. z o.o.

ul. Jagiellońska 76

03-301 Warsaw

Marketing authorization number in Latvia, the country of export:99-0011

Parallel import authorization number:420/19

Date of approval of the leaflet: 08.10.2024

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