Concor cor 5

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Concor Cor 5 (Concor Cor 5 mg), 5 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 5 and Concor Cor 5 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 you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Leaflet contents

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 doses of 5 mg and 10 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 also used to treat hypertension or angina pectoris (chest pain caused by insufficient oxygen supply to the heart).

2. Important 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 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 disorder of heart function leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, consult a doctor before starting treatment with Concor Cor 5; the doctor may decide that special caution is required (e.g. administration of additional medicines 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 bronchial asthma or chronic lung disease;
• presence of psoriatic skin lesions, even in medical history;
• thyroid dysfunction;
• phaeochromocytoma of the adrenal medulla.

In addition, inform the doctor if any of the following are planned:

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

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

Concor Cor 5 and other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines planned for use.
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 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 using any of the following medicines together with Concor Cor 5, 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 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;
• all medicines that may lower blood pressure, either as a desired or an adverse effect, such as antihypertensive medicines, certain tricyclic antidepressants, certain antiepileptic drugs 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 called monoamine oxidase inhibitors (excluding 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 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 Cor 5 can be used 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
This medicine may impair the ability to drive or operate machinery, depending on individual tolerance. Exercise particular caution at the beginning of treatment, after dose increase, or after switching medicines, as well as when combining the medicine with alcohol.

3. How to use Concor Cor 5

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 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, with water. Do not chew the tablets. Tablets with a score line may be divided into two equal doses.
The following are available on the market: Concor Cor 1.25 (1.25 mg), Concor Cor 2.5 (2.5 mg), Concor Cor 3.75 (3.75 mg), Concor Cor 5 (5 mg), Concor Cor 7.5 (7.5 mg), Concor Cor 10 (10 mg).
Adults
Treatment of stable chronic heart failure
Your doctor will start bisoprolol treatment at a low dose and gradually increase it – your doctor will decide how to adjust the dose. The recommended starting dose is 1.25 mg once daily. The dose should be increased every 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 between dose increases. If the 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 (corresponding to 5 mg bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to two tablets of Concor Cor 5 (corresponding 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 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
Dose 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, the condition may worsen.
Taking more than the recommended dose of Concor Cor 5
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 include: slowed heart rate, difficulty breathing, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).
Missing a dose of Concor Cor 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 Cor 5
Never stop taking Concor Cor 5 unless your doctor tells you to do so. 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.

Very common (affects at least 1 in 10 patients):

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

Common (affects less than 1 in 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 cold or numbness in hands or feet,
• low blood pressure (especially in patients with heart failure),
• gastrointestinal disturbances such as nausea, vomiting, diarrhoea or constipation.

For patients with hypertension or angina pectoris only:
* These symptoms occur mainly at the beginning of treatment. They are usually mild and resolve within 1–2 weeks.

Uncommon (affects less than 1 in 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 (affects less than 1 in 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 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, including: swelling of the face, neck, tongue, mouth or throat, or difficulty breathing.
• erectile dysfunction,
• nightmares, hallucinations,
• fainting.

Very rare (affects less than 1 in 10,000 patients):

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

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

5. How to store the medicine 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 packaging. 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. 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, maize starch, microcrystalline cellulose, calcium hydrogen phosphate; tablet coating: iron oxide yellow (E 172), dimethicone, polyethylene glycol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 5 looks like and contents of the pack
Concor Cor 5 is a yellowish-white, film-coated heart-shaped tablet, with a division line on both sides of the tablet.
Each pack contains 30, 60 or 100 film-coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Romania, 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
Merck, S.L., Polígono Merck, 08100 Mollet del Vallès (Barcelona), Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Romania, country of export: 6095/2014/01
6095/2014/02
6095/2014/03
6095/2014/04
Parallel import authorisation number: 232/19