CONCOR 5

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Concor 5 (Concor 5 mg), 5 mg, film-coated tablets
Bisoprolol fumarate
Concor 5 and Concor 5 mg are different trade names of the same medicinal product.
Please read this leaflet carefully before taking 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 effects, 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. Important information 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 essential hypertension or ischemic 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 glands,
• 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 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 precautions are necessary (e.g. additional medications 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 of allergic reactions or intensify their severity;
• surgery under general anaesthesia, because Concor 5 may alter the body's response to administered drugs.

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

Concor 5 and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines planned for future use.

Do not use the following medicines together with Concor 5 without specific medical advice:

• 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 a doctor.

Before taking any of the following medicines together with Concor 5, consult a doctor; the 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 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 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 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;
• any medicines that may lower blood pressure, either as a desired or adverse effect, such as antihypertensives, certain antidepressants (tricyclic antidepressants), certain antiepileptic drugs or barbiturates used in 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;
• 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 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 operating machinery
Depending on individual tolerance, this medicine may impair the ability to drive or operate machinery. Extreme caution is advised at the beginning of treatment, after dose increases, or after switching medications, as well as when combining the medicine with alcohol.

3. How to use Concor 5

This medicine should always be used exactly as your doctor has instructed. If you are unsure, 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 food or independently of meals, with a glass of water. Do not crush or chew the tablets.
Concor 5 (5 mg) and Concor 10 (10 mg) are available on the market.
Adults
For both indications, the usual dose is one tablet of Concor 5 or 1/2 tablet of Concor 10 (equivalent to 5 mg of bisoprolol fumarate) once daily.
If necessary, your doctor may increase the dose to one tablet of Concor 10 mg or two tablets of Concor 5 mg (corresponding to 10 mg of bisoprolol fumarate) once daily.
The maximum recommended dose is 20 mg once daily.
Impaired liver or kidney function
In patients with mild to moderate impairment of liver or kidney function, dosage adjustment is usually not required. In patients with severe renal or hepatic impairment, doses exceeding 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 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 discontinuation of treatment becomes necessary, 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, inform 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 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 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 effects

Like all medicines, this medicine can cause adverse effects, 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 disorders, worsening of existing heart failure, bradycardia (slow heart rate),
• sleep disturbances,
• 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 secretion (should be considered if the patient wears contact lenses),
• hepatitis, which may cause yellowing of the skin or eyes,
• changes in blood test results 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, 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 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 effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects 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 effects 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.
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. These measures 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: tablet core: 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.

What Concor 5 looks like and contents of the pack
Concor 5 coated tablets are yellowish-white, heart-shaped, with a breakline.
PVC/Al blisters in a cardboard box.
The pack contains 30, 50 or 100 coated tablets.
For more detailed information, please contact the responsible party or 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
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, 8100 Mollet del Vallès (Barcelona), Spain
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Romania, country of export: 6251/2014/01
Parallel import authorization number: 23/23