Concor cor 10

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Concor Cor 10 (Cardicor)
10 mg, film-coated tablets
Bisoprolol fumarate
Concor Cor 10 and Cardicor are different trade names for the same medicine.
Please read this leaflet carefully before using 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 for a specific individual. Do not pass it on to others. This medicine may harm other people, 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 of the leaflet

1. What Concor Cor 10 is and what it is used for
2. Important information before taking Concor Cor 10
3. How to take Concor Cor 10
4. Possible side effects
5. How to store Concor Cor 10
6. Contents of the pack and other information

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

The active substance in Concor Cor 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 reduces 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 10 is used in the treatment of stable chronic heart failure.
Concor Cor 5 and Concor Cor 10 are used in the treatment of hypertension or angina pectoris (chest pain caused by insufficient oxygen supply to the heart).

2. Important information before using Concor Cor 10

When not to use Concor Cor 10
Do not use Concor Cor 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 been diagnosed with 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 been diagnosed with metabolic acidosis, a condition in which 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) without 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 your doctor before starting treatment with Concor Cor 10; your doctor may decide that special precautions are necessary (e.g. 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 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 your doctor if you are planning:

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

Children and adolescents
Concor Cor 10 is not recommended for use in children and adolescents.
Concor Cor 10 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 10 without specific instruction from your doctor:

• 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 your doctor.

Before taking any of the following medicines together with Concor Cor 10, consult 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 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;
• all 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 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 (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 Cor 10 during pregnancy may harm the unborn child.
If you are pregnant or 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 you can take Concor Cor 10 during pregnancy.
It is not known whether bisoprolol passes into human milk; therefore, breastfeeding is not recommended during treatment with Concor Cor 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, when changing medicines, and if the medicine is taken together with alcohol.

3. How to use Concor Cor 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 Cor 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, swallowed 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 treatment with a low dose of bisoprolol 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 of bisoprolol once daily for 2 weeks;
• 2.5 mg of bisoprolol once daily for 2 weeks;
• 3.75 mg of bisoprolol once daily for 2 weeks;
• 5 mg of bisoprolol once daily for 2 weeks;
• 7.5 mg of bisoprolol once daily for 2 weeks;
• 10 mg of bisoprolol once daily as maintenance (chronic) treatment.

The maximum recommended daily dose is 10 mg of bisoprolol.
Depending on how the medicine is tolerated, your doctor may decide to extend the interval before increasing the dose. If your condition worsens or if the medicine is not well tolerated, it may be necessary to reduce the dose again or discontinue treatment. For some patients, a maintenance dose lower than 10 mg of 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 or 1/2 tablet of Concor Cor 10 (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to one tablet of Concor Cor 10 or two tablets of Concor Cor 5 (equivalent to 10 mg of 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, dose adjustment is usually not required. In patients with severe renal impairment or severe hepatic impairment, doses greater than 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 dose 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 10 is not recommended for use in children and adolescents.
Duration of treatment
Treatment with Concor Cor 10 is usually long-term.
If it becomes necessary to discontinue treatment, your doctor will usually recommend gradually reducing the dose. Otherwise, your condition may worsen.
Taking more than the recommended dose of Concor Cor 10
If you take more Concor Cor 10 than prescribed, contact your doctor immediately. Your doctor will decide what actions are necessary.
Symptoms of overdose may include: slowed heart rate, difficulty breathing, a significant drop in blood pressure, dizziness, or seizures (caused by reduced blood sugar levels).
Missing a dose of Concor Cor 10
Do not take a double dose to make up for a missed dose. Take the next dose as prescribed the following morning.
Stopping treatment with Concor Cor 10
Never stop taking Concor Cor 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 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*,
• feeling 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.

In patients with arterial 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 (occurring in fewer than 1 out of 100 patients):

• atrioventricular conduction disturbances, worsening of existing heart failure (in patients with arterial hypertension or angina pectoris); bradycardia (slow heart rate) (in patients with arterial hypertension or angina pectoris),
• sleep disorders,
• depression,
• asthenia (weakness) (in patients with arterial 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 in patients wearing contact lenses),

• hepatitis, which may cause yellowing of the skin or eyes,

• changes in the results of certain blood tests related to liver function (increased activity of AlAT and AspAT) 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 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, pharmacist or nurse. 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 provide more information on the safety of the medicine.

5. How to store Concor Cor 10

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 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. This will help protect the environment.

6. Contents of the pack and other information

What Concor Cor 10 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 10 mg of bisoprolol fumarate.
• The other ingredients are:
  Tablet core: anhydrous colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose, corn starch, calcium hydrogen phosphate.
  Tablet coating: iron oxide red (E 172), iron oxide yellow (E 172), dimethicone, polyethylene glycol 400, titanium dioxide (E 171), hypromellose.

What Concor Cor 10 looks like and contents of the pack
Concor Cor 10 mg is a pale orange/light orange, film-coated tablet, heart-shaped, with a division line on both sides of the tablet.
The pack contains 28 or 56 film-coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Ireland, the country of export:
Merck Serono (Ireland) Limited
4045 Kingswood Road, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:
Merck S.L.
Polígono Merck, Mollet del Vallès, 08100 Barcelona, Spain
Merck Healthcare KGaA
Frankfurter Strasse 250, 64293 Darmstadt, Germany

Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland

Irish Marketing Authorisation Number (country of export): PA2286/004/006
Parallel Import Licence Number: 242/24

Translation of the weekday symbols printed next to each tablet on the immediate packaging:
Mon - Monday
Tue - Tuesday
Wed - Wednesday
Thu - Thursday
Fri - Friday
Sat - Saturday
Sun - Sunday