Concor cor 5

Package leaflet: Information for the patient

Warning! Keep this leaflet. 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 questions, please 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 another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, 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 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 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, pallor or cyanosis of the 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, speak to your doctor before starting treatment with Concor Cor 5; your doctor may decide that special caution is needed (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 5 may increase the likelihood or severity of allergic reactions;
• surgery under general anaesthesia, as 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 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 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 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, consult 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 applied beta-blockers (e.g. 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 disorders (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 inflammation (e.g. ibuprofen and diclofenac);
• adrenaline (epinephrine), 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 drugs, barbiturates used during general anaesthesia, and certain medicines used in psychiatric disorders involving loss of contact with reality (phenothiazine derivatives);
• mefloquine, used for prevention and treatment of malaria;
• antidepressant medicines 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 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 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 response. Exercise particular caution at the beginning of treatment, after dose increases, when switching medicines, and when combining this medicine with alcohol.

3. How to use Concor Cor 5

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Available on the market are: 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), and Concor Cor 10 (10 mg).
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 discontinuing 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.

Adults
Treatment of stable chronic heart failure
Your doctor will start treatment with bisoprolol at a low dose, which will be gradually increased – your doctor will decide how to increase the dose. The recommended starting dose is 1.25 mg once daily.
The dose is 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 for long-term (chronic) maintenance 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 further. If symptoms worsen 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 of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to two tablets of Concor Cor 5 (corresponding 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, dosage adjustment is usually not necessary. In patients with severe renal insufficiency or severe hepatic insufficiency, doses higher 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 dosage adjustment is required.

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

Missed dose of Concor Cor 5
Do not take a double dose to make up for a missed dose. On the following morning, take the next dose as prescribed.

Stopping Concor Cor 5
Never stop taking Concor Cor 5 unless your doctor specifically advises 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 they do not occur in everyone.
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 the 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. Contact a doctor immediately 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 exacerbation of scaly skin lesions (psoriasis), psoriasiform skin changes.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Concor Cor 5

Keep the medicine out of the 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 packaging 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, maize starch, calcium hydrogen phosphate; tablet coating: yellow iron oxide (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 mg is a yellowish-white, coated, heart-shaped tablet with a break line on both sides of the tablet.
The pack contains 30 coated tablets.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Marketing Authorisation Number in Romania, the country of export: 6095/2014/02
Parallel Import Licence Number: 350/18