Concor 5

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Concor 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 so that you can read it again if necessary.
• 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 not listed in this leaflet, inform 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. What you need to know 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,
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.
Concor 5 is used in the treatment of hypertension or ischaemic heart disease
(chest pain caused by inadequate oxygen supply to the heart).

2. Important information before using Concor 5

When not to use Concor 5
Do not use Concor 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 blood circulation 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 (very 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 heart disorder 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 5; the 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);
• mild disorders of blood circulation 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 the doctor if any of the following are planned:

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

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

Concor 5 with other medicines
Inform the doctor about all medicines currently used or recently taken, as well as any medicines planned for future use.
The following medicines should not be used together with Concor 5 without specific medical advice:

• certain medicines used to treat high blood pressure, coronary heart disease or heart rhythm disorders (calcium channel blockers 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 5, consult a doctor, as more frequent medical monitoring may be required:

• certain medicines used to treat high blood pressure or coronary heart disease (dihydropyridine calcium channel blockers 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 administered 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), 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 antihypertensives, 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;
• antidepressants 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 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 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 5.

Driving and using machines
Depending on individual tolerance, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after increasing the dose, or when switching medications, as well as when combining the 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.
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 stopping treatment.
The tablet should be taken in the morning, with or without food, and swallowed with water. Do not crush or chew the tablets.
Concor 5 (5 mg) and Concor 10 (10 mg) tablets are available.
Adults
For both indications, the usual dose is 1 tablet of Concor 5 or ½ tablet of Concor 10 (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to 1 tablet of Concor 10 mg or 2 tablets of Concor 5 mg (equivalent 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 impairment, dosage adjustment is usually not required. In patients with severe renal or 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 dosage adjustment is necessary.
Elderly patients
Dosage adjustment is not required.
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 treatment needs to be discontinued, your doctor will usually recommend gradually reducing the dose. Otherwise, the condition may worsen.
Taking more Concor 5 than prescribed
If you take more Concor 5 than prescribed, contact your doctor immediately. Your doctor will decide what actions are necessary.
Symptoms of overdose include: slowed heart rate, breathing difficulties, significant drop in blood pressure, dizziness, or seizures (caused by decreased blood sugar levels).
If you miss a dose of Concor 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 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 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 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 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, patients should inform their 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 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Concor 5 contains

• The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
• The other ingredients are: colloidal anhydrous silica, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate; tablet coating: yellow iron oxide (E 172), dimethicone 100, polyethylene glycol 400, titanium dioxide (E 171), hypromellose 2910/15.

What Concor 5 looks like and contents of the pack
The medicine is in the form of yellowish-white, heart-shaped coated tablets with a break line.
Al/PVC foil blisters in a cardboard box.
The pack contains 28 or 56 coated tablets.
For further information, please contact the responsible or parallel importer.

Marketing Authorisation Holder in Bulgaria, country of export:
Merck Bulgaria EAD
48, Sitnyakovo Blvd.
Serdika Offices, 6 Floor
1505 Sofia, Bulgaria

Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
Famar Lyon
29, Avenue Charles de Gaulle
F-69230 Saint Genis Laval
France
Merck S.L.
Polígono Merck
Mollet del Vallés
08100 Barcelona
Spain

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Relabeled in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in Bulgaria, country of export: 20030463
Parallel Import Licence Number: 183/20