Concor 5

Package leaflet: Information for the patient

Warning! Keep this leaflet. The 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 trade names for the same medicine.
Please read the entire 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 pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, 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 doses of 5 mg and 10 mg lowers 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 circulatory disorders in the limbs (such as Raynaud's syndrome), which may cause tingling, paleness, or blueness 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 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, talk to your doctor before starting treatment with Concor 5; your 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);
• milder circulatory disorders 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), as Concor 5 may increase the likelihood of allergic reactions or intensify their severity;
• surgery under general anaesthesia, as Concor 5 may alter the body's response to anaesthetic 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 use the following medicines together with Concor 5 without specific medical advice:

• certain drugs used to treat hypertension, coronary heart disease, or heart rhythm disorders (calcium channel blockers such as verapamil and diltiazem);
• certain drugs used to treat hypertension, 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 5, consult your doctor; your doctor may recommend more frequent medical checks:

• certain drugs used to treat hypertension or coronary heart disease (dihydropyridine calcium channel blockers such as felodipine and amlodipine);
• certain drugs used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone);
• certain drugs 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 drugs used to treat conditions such as Alzheimer's disease or glaucoma (parasympathomimetics);
• drugs used to treat acute heart disorders (adrenergic agonists such as isoprenaline and dobutamine);
• insulin and oral antidiabetic drugs;
• 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 drug used to treat severe, life-threatening allergic reactions and cardiac arrest;
• any drugs that may lower blood pressure, either as a desired or adverse effect, such as antihypertensives, certain tricyclic antidepressants, certain antiepileptic drugs or barbiturates used during general anaesthesia, and certain drugs used in psychiatric disorders characterised by loss of contact with reality (phenothiazine derivatives);
• mefloquine, used for prevention and treatment of malaria;
• drugs used to treat depression known as monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors);
• rifampicin, an antibiotic used to treat infections;
• ergotamine derivatives, drugs 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
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, 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 as directed by the physician. 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 discontinuing treatment.
The tablet should be taken in the morning, with food or independently of meals, accompanied by water. Tablets must not be crushed or chewed.
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, the 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 insufficiency, the daily dose should not exceed 10 mg of bisoprolol.
Experience with bisoprolol in patients undergoing dialysis is limited; however, there is no evidence indicating the need for dosage adjustment.
Elderly patients
Dosage adjustment is not necessary.
Use in children and adolescents
The use of Concor 5 is not recommended in children and adolescents.
Duration of treatment
Treatment with Concor 5 is usually long-term.
If discontinuation of treatment is necessary, the doctor will usually recommend gradually reducing the dose. Otherwise, the condition may worsen.
Taking more Concor 5 than recommended
If you take more Concor 5 than recommended, inform your doctor immediately. The doctor will decide on the necessary actions.
Symptoms of overdose 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 instructed by your doctor. Otherwise, the 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 they do not occur in everyone.

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 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. 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 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 changes.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 gather further information on the safety of the medicine.

5. How to store Concor 5

Keep this 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.
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. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Concor 5 contains

• The active substance is bisoprolol fumarate. Each film-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), simethicone 100, polyethylene glycol 400, titanium dioxide (E 171), hypromellose.

What Concor 5 looks like and contents of the pack
Concor 5 film-coated tablets are yellowish-white, heart-shaped, with a score line.
Blister packs made of PVC/Aluminum foil in cardboard boxes. The pack contains 30, 50 or 100 film-coated tablets.
For further information, please contact the responsible party or the 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
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
Authorization number in Romania, country of export: 6251/2014/01
6251/2014/02
Parallel import authorization number: 347/22