Concor 5

Package leaflet: Information for the patient

Warning! Keep the leaflet – the information on the outer packaging is in a foreign language!
Concor 5
5 mg, film-coated tablets
Bisoprolol fumarate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so 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. This medicine may harm someone else, 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.

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 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 circulatory 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 a slow heart rate,
• if the patient has symptoms of low blood pressure,
• if the patient has certain heart diseases causing a 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, speak to your doctor before starting Concor 5; your doctor may decide that special caution is needed (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 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 an allergic reaction or intensify such a reaction;
• a surgical procedure under general anaesthesia, as 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 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 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 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);
• 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 for 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 (except MAO-B);
• 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 you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether Concor 5 can be used 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
This medicine may impair the ability to drive or operate machinery, depending on individual response. 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

Available on the market are: Concor 5 (5 mg) and Concor 10 (10 mg).
This medicine should always be used as directed by your doctor. If you have any doubts, 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, with water. Tablets
must not be crushed or chewed.
Adults
For both indications, the usual dose is one tablet of Concor 5 (equivalent to 5 mg of bisoprolol fumarate)
once daily.
If necessary, your doctor may increase the dose to two tablets of Concor 5 mg (corresponding 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 function impairment, dosage adjustment is usually
not required. In patients with severe renal or hepatic insufficiency, doses exceeding 10 mg of bisoprolol
per day should not be used.
Experience with the use of 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 than the recommended dose of Concor 5
If you take more Concor 5 than prescribed, contact your doctor immediately. The doctor will decide
what actions should be taken.
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. The next morning, take the prescribed dose as
usual.
Stopping use of Concor 5
Never stop taking Concor 5 unless instructed by your doctor. Otherwise, your condition may worsen.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody 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 (breathing difficulties) in patients with bronchial asthma or chronic obstructive pulmonary disease,
• muscle weakness or muscle cramps.

Rare (occurring in fewer than 1 in 1000 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 laboratory blood tests related to liver function (increased AlAT and AspAT activity) or serum triglyceride levels,
• allergic reactions such as itching, facial flushing, rash. Contact your doctor immediately if severe allergic reactions occur, which may include: swelling of the face, neck, tongue, mouth or throat, or breathing difficulties,
• disturbances of 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 changes.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side
effects can also 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 side 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 blister and carton.
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 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 score line.
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 the parallel importer.
Marketing Authorisation Holder in Romania, the 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing Authorisation numbers in Romania, the country of export: 6251/2014/01
6251/2014/02
Parallel import authorisation number: 277/23