CONCOR COR 5

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet; the information on the immediate packaging is in a foreign language!
Concor Cor 5
5 mg, film-coated tablets
Bisoprolol fumarate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
• If you experience any adverse effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Concor Cor 5 is and what it is used for
2. Important information before taking Concor Cor 5
3. How to take Concor Cor 5
4. Possible side effects
5. How to store Concor Cor 5
6. Contents of the pack and other information

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

The active substance in Concor Cor 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, 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 a dose of 5 mg lowers high blood pressure.
Heart failure occurs when the heart muscle is weak and unable to pump enough blood to meet the body's needs. Concor Cor 5 is used in the treatment of stable, chronic heart failure.
Concor Cor 5 is used in the treatment of hypertension or angina pectoris (chest pain caused by insufficient oxygen supply to the heart).

2. Information before using Concor Cor 5

When not to use Concor Cor 5
Do not use Concor Cor 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 circulatory 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 a 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 heart disorder leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, talk to your doctor before starting treatment with Concor Cor 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);
• kidney or liver disorders;
• circulatory disorders in the limbs;
• mild asthma or chronic lung disease;
• presence of scaly skin lesions (psoriasis), 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 Cor 5 may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgery under general anaesthesia, because Concor Cor 5 may alter the body's response to administered drugs.

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

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

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• 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 Cor 5, talk to your doctor; your doctor may recommend more frequent medical checks:

• certain medicines used to treat high blood pressure or coronary artery disease (dihydropyridine calcium antagonists such as felodipine and amlodipine);
• certain medicines used to treat heart rhythm disorders (class III antiarrhythmics such as amiodarone);
• locally administered 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;
• all medicines that may lower blood pressure, either as a desired or an adverse effect, such as antihypertensive medicines, certain tricyclic antidepressants, certain antiepileptic medicines or barbiturates used during general anaesthesia, 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, known as 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 Cor 5 during pregnancy may harm the unborn child. If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether you may take Concor Cor 5 during pregnancy.
It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor Cor 5.

Driving and operating machinery
Concor Cor 5 may impair the ability to drive or operate machinery, depending on individual response. Exercise particular caution at the beginning of treatment, after dose increases, or when switching medicines, as well as when combining this medicine with alcohol.

3. How to use Concor Cor 5

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Concor Cor 5 (5 mg) and Concor Cor 10 (10 mg) are available on the market.
Regular medical check-ups are necessary during treatment with Concor Cor 5. 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, swallowed with water. Do not chew the tablets. Tablets with a score line may be divided into two equal doses.

Adults
Treatment of stable chronic heart failure
Your doctor will start treatment with a low dose of bisoprolol and gradually increase it – your doctor will decide how to increase the dose. The recommended starting dose is 1.25 mg once daily.
The dose should be increased at intervals of two weeks or longer to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg, and 10 mg once daily. This is usually done as follows:

• 1.25 mg bisoprolol once daily for 2 weeks;
• 2.5 mg bisoprolol once daily for 2 weeks;
• 3.75 mg bisoprolol once daily for 2 weeks;
• 5 mg bisoprolol once daily for 2 weeks;
• 7.5 mg bisoprolol once daily for 2 weeks;
• 10 mg bisoprolol once daily as maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before increasing the dose further. If your condition worsens or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue treatment. In some patients, a maintenance dose lower than 10 mg bisoprolol may be sufficient. Your doctor will determine the appropriate course of action.

Treatment of hypertension and angina pectoris
For both indications, the usual dose is one tablet of Concor Cor 5 (equivalent to 5 mg bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to two tablets of Concor Cor 5 (equivalent to 10 mg bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.

Impaired liver or kidney function
Treatment of hypertension and angina pectoris
In patients with mild to moderate impairment of liver or kidney function, dosage adjustment is usually not required. In patients with severe renal impairment or severe hepatic impairment, doses exceeding 10 mg bisoprolol per day should not be used.
Experience with the use of bisoprolol in patients undergoing dialysis is limited; however, there is no evidence to suggest that dosage adjustment is necessary.

Treatment of stable chronic heart failure
Particular caution is required when increasing the dose of the medicine.

Elderly patients
Dosage adjustment is not necessary.

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

Duration of treatment
Treatment with Concor Cor 5 is usually long-term.
If treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose. Otherwise, your condition may worsen.

Taking more Concor Cor 5 than prescribed
If you take more Concor Cor 5 than prescribed, contact your doctor immediately. Your doctor will decide what actions should be taken.
Symptoms of overdose may include: slowed heart rate, breathing difficulties, a significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).

If you miss a dose of Concor Cor 5
Do not take a double dose to make up for a missed dose. Take the next dose as prescribed the following morning.

Stopping Concor Cor 5
Never stop taking Concor Cor 5 unless your doctor tells you to. 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 everybody gets them.
Very common (occurring in at least 1 out of 10 patients):

• bradycardia (slow heart rate) (in patients with stable, chronic heart failure).

Common (occurring in fewer than 1 out of 10 patients):

• worsening of existing heart failure (in patients with stable, chronic heart failure),
• fatigue*, asthenia (weakness) (in patients with stable, chronic heart failure), dizziness*, headache*,
• sensation of coldness or numbness in hands or feet,
• low blood pressure (especially in patients with heart failure),
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

Applies only to patients with hypertension or angina pectoris:
* 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 out of 100 patients):

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

Rare (occurring in fewer than 1 out of 1,000 patients):

• hearing disturbances,
• allergic rhinitis,
• decreased tear production (should be considered if the patient wears contact lenses),
• hepatitis, which may cause yellowing of the skin or eyes,
• changes in laboratory 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 out of 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, inform your 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 Cor 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
package following the abbreviation EXP. The expiry date refers to the last day of the
specified 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. Such measures will help protect the
environment.

6. Contents of the pack and other information

What Concor Cor 5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
• The other ingredients are: tablet core: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, calcium hydrogen phosphate;

coating: iron oxide yellow (E 172), dimethicone, macrogol 400, titanium dioxide (E 171),
hypromellose.

What Concor Cor 5 looks like and contents of the pack

Concor Cor 5 is a yellowish-white, coated tablet, heart-shaped, with a division line on both sides of the tablet.

The pack contains 30 or 60 coated tablets.

For further information, please contact the responsible party or the parallel importer.

Responsible party in Romania, the country of export:
Merck Romania SRL
Str. Gara Herăstrău Nr. 4D, Clădirea C, Etaj 6
Sector 2, 020334 Bucharest
Romania

Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
P&G Health Austria GmbH & Co. OG
Hösslgasse 20
9800 Spittal/Drau
Austria
Famar Lyon
29 Avenue Charles de Gaulle
69230 Saint-Genis-Laval
France
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
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Romania, country of export, marketing authorization numbers: 6095/2014/02
6095/2014/01
6095/2014/03
6095/2014/04

Parallel import authorization number: 225/23