CONCOR 5

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 for the same medicine.
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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Concor 5 is and what it is 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 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 the heart rate 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 high blood pressure or ischemic heart disease (chest pain caused by
inadequate oxygen 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 severe circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness or blueness of the fingers or toes,
• if you have untreated phaeochromocytoma, a rare adrenal gland tumour,
• if you have metabolic acidosis, a condition in which blood pH is abnormal,
• if you have acute heart failure,
• if you have worsening heart failure requiring intravenous administration of medicines that increase heart contractility,
• if you have symptoms of slow heart rate,
• if you have symptoms of low blood pressure,
• if you have certain heart conditions causing very slow or irregular heartbeat (second- or third-degree atrioventricular block, sinoatrial block, sick sinus syndrome) without a pacemaker,
• if you have cardiogenic shock, an acute, life-threatening disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If you have any of the following conditions, talk to your doctor before starting Concor 5; your doctor may decide that special precautions are necessary (e.g. additional medicines 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 circulatory 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.

In addition, tell your doctor if you are planning:

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

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

Concor 5 and other medicines
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 together with Concor 5 without specific instruction from your doctor:

• 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 your doctor.

Before taking the following medicines together with Concor 5, talk to your doctor; your 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);
• cardiac 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, either as a desired or adverse effect, such as antihypertensive medicines, certain tricyclic antidepressants, certain antiepileptic medicines or barbiturates used in general anaesthesia, and certain medicines used in psychiatric disorders characterized 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 (MAOIs), 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 or breastfeeding, suspect you may be pregnant, or are planning to have a baby, you should 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 using machines
Depending on how it is tolerated, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increases, after switching medicines, and when combining this medicine with alcohol.

3. How to use Concor 5

This medicine should always be taken exactly as prescribed 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 (i.e. equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, the doctor may increase the dose to one tablet of Concor 10 mg or two tablets of Concor 5 mg (corresponding to 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 dysfunction, dosage adjustment is usually not required. In patients with severe renal or hepatic impairment, the dose should not exceed 10 mg of bisoprolol per day.
Experience with bisoprolol use in patients undergoing dialysis is limited; however, there is no evidence indicating the need for dosage adjustment.
Elderly patients
Dosage adjustment is not necessary.
Use in children and adolescents
Concor 5 is not recommended for use 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 than the recommended dose of Concor 5
If you take more Concor 5 than prescribed, inform your doctor immediately. The 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. Take the next dose as scheduled the following morning.
Stopping Concor 5 treatment
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 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 results of certain blood tests related to 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, including 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),
• alopecia (hair loss),
• occurrence or worsening of scaly skin lesions (psoriasis), psoriasiform eruptions.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of 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
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Concor 5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
• Other components: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate; tablet coating: iron oxide yellow (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 score line.
PVC/Al blisters in a cardboard box.
Pack contains 30, 60, or 90 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Latvia, country of export:
Merck Serono SIA
Duntes iela 23A
LV-1005 Riga
Latvia
Manufacturer
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
Merck S.L.
Polígono Merck
08100 Mollet del Vallès (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 Latvia, country of export: 99-0010
Parallel import licence number: 11/25