Patient Information Leaflet

Warning! Keep this leaflet. 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 medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Concor 10 is and what it is used for
Important information before taking Concor 10
How to take Concor 10
Possible side effects
How to store Concor 10
Contents of the pack and other information

1. What Concor 10 is and what it is used for

The active substance in 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, particularly in the heart. As a result, bisoprolol slows down heart activity and thereby improves the heart's efficiency in pumping blood throughout the body. Bisoprolol at doses of 5 mg and 10 mg lowers high blood pressure.
Concor 10 is used in the treatment of hypertension or ischemic heart disease (chest pain caused by insufficient oxygen supply to the heart).

2. Important information before using Concor 10

When not to use Concor 10
Do not use Concor 10 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 serious blood circulation disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness or blueness of fingers or toes,
if the patient has untreated phaeochromocytoma, a rare tumour 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 worsens and intravenous administration of drugs that increase heart contractility is required,
if the patient has symptoms of bradycardia (slow heart rate),
if the patient has symptoms of low blood pressure,
if the patient has certain heart diseases causing very slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) in the absence of a pacemaker,
if the patient has cardiogenic shock, an acute, life-threatening impairment of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, speak to a doctor before starting treatment with Concor 10; the doctor may decide that special caution is required (e.g. additional medication or more frequent monitoring):

diabetes;
strict fasting;
certain heart conditions (such as heart rhythm disorders or severe chest pain at rest – Prinzmetal's angina);
milder circulation disorders in the limbs;
mild bronchial asthma or chronic lung disease;
presence of scaly skin lesions (psoriasis), even in medical history;
thyroid dysfunction;
phaeochromocytoma of the adrenal medulla.

Additionally, inform the doctor if any of the following are planned:

allergen immunotherapy (e.g. to prevent hay fever), because Concor 10 may increase the likelihood of an allergic reaction or intensify such a reaction;
surgery under general anaesthesia, because Concor 10 may alter the body's response to administered drugs.

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

Concor 10 with other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Do not take the following medicines together with Concor 10 without specific medical advice:

certain medicines used to treat high blood pressure, coronary heart disease or heart rhythm disorders (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 a doctor.

Before taking any of the following medicines together with Concor 10, consult a doctor; the doctor may recommend more frequent medical checks:

certain medicines used to treat high blood pressure or coronary heart disease (dihydropyridine calcium antagonists such as felodipine and amlodipine);
certain medicines used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone);
locally applied beta-blockers (such as eye drops used to treat glaucoma);
certain medicines used to treat, for example, Alzheimer's disease or glaucoma (parasympathomimetics);
medicines used to treat acute heart disorders (adrenergic agonists such as isoprenaline and dobutamine);
insulin and oral antidiabetic medicines;
agents used in general anaesthesia (e.g. during surgery);
digitalis glycosides used to treat heart failure;
non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, 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 as a desired or undesired effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants), certain antiepileptic drugs or those used in general anaesthesia (barbiturates), and certain medicines used in psychiatric disorders characterised by loss of contact with reality (phenothiazine derivatives);
mefloquine, used for prevention and treatment of 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 using Concor 10 during pregnancy may harm the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Concor 10 can be taken during pregnancy.
It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor 10.

Driving and operating machinery
This medicine may impair the ability to drive or operate machinery, depending on how it is tolerated. Exercise particular caution at the beginning of treatment, after dose increases, or when changing medications, as well as when combining the medicine with alcohol.

3. How to use Concor 10

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Regular medical check-ups are necessary during treatment with Concor 10. This is particularly
important at the beginning of treatment, when increasing the dose, and when stopping treatment.
The tablet should be taken in the morning with food or independently of meals, with water. Tablets
must not be crushed or chewed.
Adults
For both indications, the usual dose is one Concor 5 tablet or 1/2 tablet of Concor 10 (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 (i.e.
10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.
Liver or kidney function impairment
In patients with mild to moderate liver or kidney function impairment, dose adjustment is usually
not required. In patients with severe renal or hepatic insufficiency, doses exceeding 10 mg of
bisoprolol per day should not be used.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence
requiring dose adjustment.
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, the doctor will usually recommend gradually reducing the
dose. Otherwise, the condition may worsen.
Taking more Concor 10 than prescribed
If you take more Concor 10 than prescribed, inform your doctor immediately. The doctor will decide
what actions should be taken.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, significant drop in
blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).
Missed dose of Concor 10
Do not take a double dose to make up for a missed dose. The next morning, take the prescribed
dose as usual.
Stopping Concor 10 treatment
Never stop taking Concor 10 unless instructed by your doctor. Otherwise, your condition may
worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common (occurring in fewer than 1 in 10 patients)

fatigue*, dizziness*, headache*,
sensation of coldness or numbness in hands or feet,
low blood pressure,
gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation. * These symptoms occur mainly at the beginning of treatment. They are usually mild and resolve within 1–2 weeks.

Uncommon (occurring in fewer than 1 in 100 patients)

atrioventricular conduction disturbances, worsening of existing heart failure, bradycardia (slow heart rate),
sleep disorders,
depression,
asthenia (weakness),
bronchospasm (difficulty breathing) in patients with bronchial asthma or chronic obstructive pulmonary disease,
muscle weakness or muscle cramps.

Rare (occurring in fewer than 1 in 1,000 patients)

hearing disturbances,
allergic rhinitis,
reduced tear secretion (should be considered if the patient wears contact lenses),
hepatitis, which may cause yellowing of the skin or eyes,
changes in the results of certain blood tests assessing liver function (increased AlAT and AspAT activity) or serum triglyceride levels,
allergic reactions such as itching, facial flushing, rash. Immediate medical advice should be sought if more severe allergic reactions occur, which may include swelling of the face, neck, tongue, mouth or throat, or difficulty breathing,
erectile dysfunction,
nightmares, hallucinations,
fainting.

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

conjunctivitis (eye irritation or redness),
hair loss,
occurrence or worsening of scaly skin lesions (psoriasis), psoriasiform eruptions.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Concor 10

Keep this 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 stated month.
Store below 30°C.
Medicines must 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 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, maize starch, calcium hydrogen phosphate;

coating: iron oxide yellow (E 172), dimethicone 100, polyethylene glycol 400, titanium dioxide (E 171),
hypromellose, iron oxide red (E 172).
What Concor 10 looks like and contents of the pack
Concor 10 coated tablets are pale orange/light orange, heart-shaped, with a division line.
Al/PVC foil blisters in a cardboard box.
The pack contains 28 coated tablets.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Bulgaria, the country of export:
Merck Bulgaria EAD
48 “Sitnyakovo” Str.
Serdika Office, 6th floor, Sofia 1505, Bulgaria
Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany
Merck S.L.
Poligono Merck
Mollet del Vallès
08100 Barcelona
Spain
Parallel importer:
Delfarma Sp. z o.o.
Sw. Teresy od Dzieciatka Jezus 111
91-222 Lodz
Repackaged in:
Delfarma Sp. z o.o.
Sw. Teresy od Dzieciatka Jezus 111
91-222 Lodz
Marketing authorisation number in Bulgaria, the country of export: 20030464
Parallel import authorisation number: 94/22