Package leaflet: Information for the patient

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

Keep this leaflet so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Concor 5 is and what it is used for
What you need to know before taking Concor 5
How to take Concor 5
Possible side effects
How to store Concor 5
Contents of the pack and other information

1. What Concor 5 is and what it is used for

The active substance in 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 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 5 is used in the treatment of hypertension or ischemic heart disease (chest pain caused by inadequate oxygen supply to the heart).

2. Important information before using Concor 5

When not to use Concor 5
Do not use Concor 5 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 circulation problems 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 abnormally low,
if the patient has acute heart failure,
if heart failure worsens and intravenous administration of drugs that increase heart contractility becomes necessary,
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 condition involving impaired heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, talk to your doctor before starting Concor 5; your doctor may decide that special caution is needed (for example, additional medication or more frequent monitoring):

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

Additionally, inform your doctor if you are planning:

allergen immunotherapy (e.g. to prevent hay fever), because Concor 5 may increase the likelihood or severity of allergic reactions;
surgery under general anaesthesia, because Concor 5 may alter the body's response to anaesthetic drugs.

Children and adolescents
Concor 5 is not recommended for use in children and adolescents.

Concor 5 and other medicines
Inform your doctor about all medicines you are currently taking, have recently taken, or plan to take.
Do not use the following medicines together with Concor 5 without specific medical advice:

certain medicines used to treat high blood pressure, coronary artery 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 your doctor.

Before using any of the following medicines together with Concor 5, consult your doctor, who may recommend more frequent medical checks:

certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine-type 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 conditions such as 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;
agents used in general anaesthesia (e.g. during surgery);
cardiac glycosides (e.g. digoxin) used to treat heart failure;
non-steroidal anti-inflammatory drugs (NSAIDs) used to treat joint inflammation, relieve pain and reduce inflammation (e.g. ibuprofen and diclofenac);
adrenaline (epinephrine), used to treat severe, life-threatening allergic reactions and cardiac arrest;
any medicines that may lower blood pressure, either as a desired or adverse effect, such as antihypertensives, certain tricyclic antidepressants, certain antiepileptic drugs, barbiturates used during general anaesthesia, and certain medicines used for psychiatric disorders involving loss of contact with reality (phenothiazine derivatives);
mefloquine, used for prevention and treatment of malaria;
antidepressants known as monoamine oxidase inhibitors (MAO 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 5 during pregnancy may harm the unborn child.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Concor 5 can be taken during pregnancy.
It is not known whether bisoprolol passes into human breast milk; therefore, breastfeeding is not recommended during treatment with Concor 5.

Driving and operating machinery
Depending on individual response, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increases, or when switching medications, as well as when combining the medicine with alcohol.

3. How to use Concor 5

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Concor 5 (5 mg) and Concor 10 (10 mg) are available on the market.
Regular medical check-ups are necessary during treatment with Concor 5. This is particularly
important at the beginning of treatment, when increasing the dose, and when discontinuing therapy.
The tablet should be taken in the morning with food or independently of meals, swallowed with water. Tablets must not be crushed or chewed.
Adults
For both indications, the usual dose is one tablet of Concor 5 or 1/2 tablet of Concor 10 (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to one tablet of Concor 10 or two tablets of Concor 5 (corresponding to 10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.
Impaired liver or kidney function
Dosage adjustment is usually not required in patients with mild to moderate liver or kidney impairment. 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 to suggest that dosage adjustment is necessary.
Elderly patients
Dose adjustment is not necessary.
Use in children and adolescents
The use of Concor 5 is not recommended in children and adolescents.
Duration of treatment
Treatment with Concor 5 is usually long-term.
If discontinuation of treatment becomes necessary, your doctor will usually recommend gradually reducing the dose. Otherwise, the condition may worsen.
Taking more Concor 5 than prescribed
If you take more Concor 5 than prescribed, inform your doctor immediately. Your doctor will decide what actions should be taken.
Symptoms of overdose include: slowed heart rate, breathing difficulties, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).
Missed dose of Concor 5
Do not take a double dose to make up for a missed dose. On the following day, take the prescribed dose in the morning as usual.
Stopping Concor 5
Never stop taking Concor 5 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 subside within 1–2 weeks.

Uncommon (occurring in fewer than 1 in 100 patients)

atrioventricular conduction disorders, worsening of existing heart failure, bradycardia (slow heart rate),
sleep disturbances,
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 production (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 regarding liver function (increased AlAT and AspAT activity) or serum triglyceride levels,
allergic reactions such as itching, facial flushing, rash. Immediate contact with a physician is required
in case of more severe allergic reactions, which may include: swelling of the face, neck, tongue, mouth or throat, or difficulty breathing,
disturbances in potency,
nightmares, hallucinations,
fainting.

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

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

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

5. How to store Concor 5

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
pack. The expiry date refers to the last day of the stated month.
Do not store above 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. Package contents and other information

What Concor 5 contains

The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
Other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate; tablet coating: yellow iron oxide (E 172), dimethicone 100, polyethylene glycol 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 division line.
PVC/Al blisters in a cardboard box.
The pack contains 30 coated tablets.
For further information, please contact the responsible party or parallel importer.
Responsible party in Croatia, country of export:
Merck d.o.o.
Oreškovićeva ulica 6H/1
10010 Zagreb
Croatia
Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
Merck S.L.
Polígono Merck
Mollet del Vallès
08100 Barcelona
Spain
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorisation number in Croatia, country of export: HR-H-148909302-01
HR-H-148909302-03
HR-H-148909302-04
Parallel import authorisation number: 28/25