Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Concor 5 (Concor 5 mg)
5 mg, film-coated tablets
Bisoprolol fumarate
Concor 5 and Concor 5 mg are different brand names for the same medicine.
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 doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are identical.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

What Concor 5 is and what it is used for
What you need to know before taking Concor 5
How to take Concor 5
Possible side effects
How to store Concor 5
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 reduces high
blood pressure.
Concor 5 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 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 circulation problems 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 (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 condition leading to low blood pressure and circulatory failure.

Warnings and precautions
If any of the following conditions apply, speak to your doctor before starting Concor 5; your doctor may decide that special precautions are necessary (such as additional medication or more frequent monitoring):

diabetes;
strict fasting;
certain heart conditions (such as heart rhythm disorders or severe chest pain at rest – Prinzmetal's angina);
milder circulation problems in the limbs;
milder 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), because Concor 5 may increase the likelihood of an allergic reaction or intensify such a reaction;
surgery under general anaesthesia, because Concor 5 may alter the body's response to administered drugs.

Children and adolescents
Use of Concor 5 is not recommended in children and adolescents.
Concor 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 take 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 your doctor.

Before taking any of the following medicines together with Concor 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 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 conditions (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;
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 5 during pregnancy may harm the unborn child.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. The doctor will decide whether Concor 5 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 5.

Driving and operating machinery
Depending on how it is tolerated, this medicine may impair the ability to drive or operate machinery. Exercise particular caution at the beginning of treatment, after dose increases, when changing medications, and when combining the medicine with alcohol.

3. How to take Concor 5

This medicine should always be taken exactly as directed 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 food or independently of meals, with a glass of water. Tablets must not be crushed or chewed.
The medicine Concor 5 (5 mg) and Concor 10 (10 mg) are available.
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 or two tablets of Concor 5 (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 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 dosage adjustment is necessary.
Elderly patients
Dosage adjustment is not necessary.
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 have taken more Concor 5 than prescribed, inform your doctor immediately. Your doctor will decide what actions should be taken.
Symptoms of overdose include: slowed heart rate, difficulty breathing, 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 scheduled 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 everybody will experience them.
Common (occurring less frequently than in 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 less frequently than in 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 less frequently than in 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 more 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 less frequently than in 1 in 10,000 patients):

conjunctivitis (eye irritation or redness),
alopecia (hair loss),
occurrence or exacerbation of scaly skin lesions (psoriasis), psoriasiform eruptions.

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 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 reactions, additional information on the safety of this medicine can be collected.

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. This will help protect the environment.

6. Contents of the packaging and other information

What Concor 5 contains

The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
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 division line.
Al/PVC foil blisters in cardboard packaging. The pack contains 30 or 60 coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Croatia, country of export:
Merck d.o.o.
Oreškovićeva ulica 6H/1
10010 Zagreb, Croatia
Manufacturer:
Merck Healthcare KGaA
Frankfurter Strasse 250
64293 Darmstadt, Germany
Merck S.L.
Poligono Merck
Mollet del Valles 08100 Barcelona, Spain
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
Marketing Authorisation Number in Croatia, country of export: HR-H-148909302-01
HR-H-148909302-03
Parallel import licence number: 32/24