CONCOR 10

Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging is in a foreign language!
Concor 10
10 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 doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm other people, 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 10 is and what it is used for
2. Important information before taking Concor 10
3. How to take Concor 10
4. Possible side effects
5. How to store Concor 10
6. Contents of the pack and other information

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

The active substance in Concor 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 lowers high blood pressure.
Concor 10 is used in the treatment of hypertension or ischemic heart disease (chest pain caused by insufficient oxygen supply to the heart).

2. Important information before using Concor 10

When not to use Concor 10
Do not use Concor 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 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 increasing 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 heart disorder leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, speak to a doctor before starting treatment with Concor 10; the doctor may consider special precautions necessary (for example, 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);
• milder blood circulation disorders in the limbs;
• milder 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), as Concor 10 may increase the likelihood of an allergic reaction or intensify such a reaction;
• surgery under general anaesthesia, as Concor 10 may alter the body's response to administered drugs.

Children and adolescents
Concor 10 is not recommended for use in children and adolescents.

Concor 10 with other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient intends to take.
Do not use the following medicines together with Concor 10 without specific medical advice:

• certain medicines used to treat hypertension, coronary heart disease or heart rhythm disorders (calcium antagonists such as verapamil and diltiazem);
• certain medicines used to treat hypertension 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 10, consult a doctor, who may recommend more frequent medical checks:

• certain medicines used to treat hypertension or coronary heart 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 (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 (such as 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, 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 antiepileptics 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 (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 10 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 10 can be taken during pregnancy.
It is not known whether bisoprolol passes into human breast milk; therefore, breastfeeding is not recommended during treatment with Concor 10.

Driving and using machines
Depending on how it is tolerated, 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 changing medications, as well as when combining the medicine with alcohol.

3. How to use Concor 10

This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The following medicines are available: Concor 5 (5 mg) and Concor 10 (10 mg).
Regular medical check-ups are necessary during treatment with Concor 10. 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, swallowed with water.
Do not crush or chew the tablets.
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 (10 mg bisoprolol fumarate) or two tablets of Concor 5 (equivalent to 10 mg 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 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 requiring dosage adjustment.
Elderly patients
Dosage adjustment is not necessary.
Use in children and adolescents
Concor 10 is not recommended for use in children and adolescents.
Duration of treatment
Treatment with Concor 10 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 10 than prescribed
If you take more Concor 10 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 10
Do not take a double dose to make up for a missed dose. On the following morning, take the prescribed dose as usual.
Stopping Concor 10
Never stop taking Concor 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 effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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,
• 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 related to liver function (increased AlAT and AspAT activity) or serum triglyceride levels,
• allergic reactions such as itching, facial flushing, rash. You should immediately
• contact your doctor if more severe allergic reactions occur, which may include: swelling of the face, neck, tongue, mouth or throat, or difficulty breathing,
• disturbances in potency,
• 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 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
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Concor 10

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton.
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. These measures will help protect the environment.

6. Contents of the pack and other information

What Concor 10 contains

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

What Concor 10 looks like and contents of the pack
Concor 10 film-coated tablets are pale orange/light orange heart-shaped tablets with a division line.
Blister packs made of PVC-PVDC/Aluminum in cardboard packaging.
Pack contains 30, 60 or 90 film-coated tablets.

For further information about this medicinal product, please contact the Marketing Authorisation Holder:
Marketing Authorisation Holder in Greece, country of export:
Merck A.E.
Ave. Kifisias 41-45 (Building B)
15123 Marousi, Athens
Greece
Manufacturer
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt
Germany
Famar Lyon
29 Avenue Charles de Gaulle
69230 Saint Genis Laval
France
Merck S.L.
Mollet Del Valles
8100 Barcelona
Spain
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing Authorisation number in Greece, country of export: 78137/9-11-2011
Parallel Import Licence number: 190/25