Concor 10

Leaflet accompanying the packaging: patient information

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

Concor 10 (Concor 10 mg)

10 mg, coated tablets

Bisoprolol fumarate
Concor 10 and Concor 10 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 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 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 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 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 been diagnosed with serious 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 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 take medicines that increase the contractility of the heart 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, 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, you should discuss them with your doctor before starting to take Concor 10; 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);
• milder circulatory disorders in the limbs;
• mild asthma or chronic obstructive pulmonary disease;
• the occurrence of scaly skin lesions (psoriasis), also in the past;
• 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 10 may increase the likelihood of an allergic reaction or increase its severity;
• a surgical procedure under general anesthesia, as Concor 10 may change the body's response to the medicines administered.

Children and adolescents

Concor 10 is not recommended for use in children and adolescents.

Concor 10 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 10 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, and rilmenidine. However, do not stop taking these medicines without consulting your doctor.

Before taking the following medicines together with Concor 10, 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, 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 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, 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 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 10 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 10 during pregnancy.

It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor 10.

Driving and using machines

The medicine, depending on how it is tolerated, may impair the ability to drive vehicles 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 10

This medicine should always be taken according to your doctor's recommendations. In case of doubts, you should consult your doctor or pharmacist.

During treatment with Concor 10, regular medical check-ups are necessary. This is especially important at the beginning of treatment, during dose increase, 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.

Adults

In both indications, the usual dose is one Concor 5 tablet or half a Concor 10 tablet (i.e., 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 (which corresponds 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 failure, 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 10 is not recommended for use in children and adolescents.

Duration of treatment

Treatment with Concor 10 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 10 than recommended

If you have taken a higher dose of Concor 10 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 10

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 10

You should never stop taking Concor 10 unless your doctor recommends it. Otherwise, the disease may worsen.

In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Concor 10 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 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,
• 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 AlAT and AspAT) or triglyceride levels in serum,
• allergic reactions, such as itching, flushing, rash. You should immediately contact your doctor in case of 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 rare(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, pharmacist, or nurse. 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 this medicine.

5. How to store Concor 10

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 10 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 10 mg of bisoprolol fumarate.
• The other ingredients are: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, cornstarch, calcium hydrogen phosphate;

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 what the packaging contains

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

Al/PVC blisters in a cardboard box.

The packaging contains 28 coated tablets.