Bisoprolol Vitabalans

PATIENT INFORMATION LEAFLET: USER INFORMATION

Bisoprolol Vitabalans 5 mg tablets

Bisoprolol Vitabalans 10 mg tablets

Bisoprolol hemifumarate

Read the leaflet carefully before taking the medicine.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or pharmacist if you need advice or more information.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of contents of the leaflet:

• 1. What is Bisoprolol Vitabalans and what is it used for
• 2. Important information before taking Bisoprolol Vitabalans
• 3. How to take Bisoprolol Vitabalans
• 4. Possible side effects
• 5. How to store Bisoprolol Vitabalans
• 6. Other information

1.

WHAT IS BISOPROLOL VITABALANS AND WHAT IS IT USED FOR

Bisoprolol Vitabalans contains bisoprolol, a selective beta-adrenergic receptor blocker. Bisoprolol Vitabalans is used to treat high blood pressure and chest pain caused by a lack of oxygen to the heart muscle (angina pectoris).

2. IMPORTANT INFORMATION BEFORE TAKING BISOPROLOL VITABALANS

When not to take Bisoprolol Vitabalans

• in case of allergy (hypersensitivity) to the active substance (bisoprolol) or to any of the excipients of the medicine (see section 6 of the leaflet),
• in case of untreated heart failure (leading to shortness of breath or swelling),
• in case of very low blood pressure (systolic blood pressure below 100 mm/Hg), which may cause dizziness or fainting,
• in case of very slow heart rate (below 45-50 beats per minute),
• in case of conduction disorders in the heart (such as sick sinus syndrome or atrioventricular block) if a pacemaker has not been implanted,
• in case of severe asthma or chronic obstructive pulmonary disease,
• in case of severe circulatory disorders in the limbs, such as intermittent claudication (pain or cramps in the legs during exercise or walking due to insufficient blood circulation) or Raynaud's syndrome (pallor, cyanosis, and redness of the fingers with accompanying pain),
• in case of metabolic acidosis (occurring, for example, in patients with diabetes, when blood glucose levels are too high),
• in case of untreated pheochromocytoma (a tumor of the adrenal gland) or
• in case of taking floctafenine (a non-steroidal anti-inflammatory drug (NSAID) used to treat pain) or sultopride (a drug used to treat psychiatric disorders such as psychoses).

When to be cautious when taking Bisoprolol Vitabalans

• in case of heart failure (the heart's inability to pump enough blood to meet the body's needs),
• in case of first-degree atrioventricular block in the heart,
• in case of chest pain caused by coronary artery spasm (Prinzmetal's angina or vasospastic angina),
• in case of asthma or chronic obstructive pulmonary disease (when bronchodilators are used, it may be necessary to increase their dose),
• in case of diabetes (Bisoprolol Vitabalans may mask symptoms and may require a change in the dose of antidiabetic drugs),
• in case of hyperthyroidism (Bisoprolol Vitabalans may mask symptoms),
• in case of desensitization therapy, e.g. against insect stings (allergic reactions may be stronger and may require more medication to resolve),
• in case of planned radiological examination with iodine contrast agent,
• in case of psoriasis (Bisoprolol Vitabalans may exacerbate symptoms),
• in case of fasting or
• in case of planned doping test (Bisoprolol Vitabalans may cause a positive result in such a test).

In case of planned surgery under general, spinal, or epidural anesthesia, inform the anesthesiologist about taking Bisoprolol Vitabalans. Consult your doctor before taking Bisoprolol Vitabalans if you have any of the above-mentioned diseases or situations. If Bisoprolol Vitabalans needs to be discontinued, it should be done gradually. Do not stop treatment or change the dose of Bisoprolol Vitabalans without consulting your doctor.

Taking Bisoprolol Vitabalans with other medicines

Inform your doctor about all medicines taken recently, including those available without a prescription, herbal preparations, or natural products. Especially, inform your doctor about taking the following medicines:

• floctafenine (pain reliever) or sultopride (antipsychotic) - Bisoprolol Vitabalans should not be administered in combination with these medicines,
• calcium channel blockers used in hypertension and heart diseases, such as bepridil, diltiazem, verapamil, amlodipine, felodipine, nifedipine, or lercanidipine,
• clonidine, methyldopa, moxonidine, guanfacine, or rilmenidine (used in hypertension),
• antiarrhythmic drugs (such as amiodarone, disopyramide, or quinidine),
• digoxin or other digitalis glycosides (used to treat heart failure),
• other antihypertensive or nitrate medications used to treat angina - increased blood pressure-lowering effect,
• other beta-adrenergic blockers (even eye drops containing timolol or betaxolol),
• medicines used to treat diabetes (insulin and oral preparations),
• ergotamine derivatives (used to treat migraine or low blood pressure),
• acetylcholinesterase inhibitors, such as donepezil, galantamine, rivastigmine, or tacrine (used to treat dementia), pyridostigmine or neostigmine (used to treat myasthenia gravis), or physostigmine (used to treat increased intraocular pressure, glaucoma),
• MAO inhibitors, such as moclobemide or phenelzine (used to treat depression),
• tricyclic antidepressants (used to treat depression), phenothiazine derivatives (used to treat psychoses), or barbiturates (used to treat epilepsy) - these medicines may also lower blood pressure,
• amifostine (protective agent used during chemotherapy or radiotherapy),
• baclofen (muscle relaxant),
• mefloquine (antimalarial agent),
• oral corticosteroids (cortisone in tablets) or
• anti-inflammatory and pain relievers (non-steroidal anti-inflammatory drugs - NSAIDs) used to treat pain and inflammation, such as acetylsalicylic acid, ibuprofen, or ketoprofen, used regularly and long-term - small daily doses of acetylsalicylic acid with antiplatelet effect (e.g. 50 or 100 mg) can be safely used with Bisoprolol Vitabalans.

Pregnancy and breastfeeding

Before taking any medicine, consult your doctor or pharmacist. Bisoprolol Vitabalans may affect the fetus. Therefore, Bisoprolol Vitabalans should not be taken during pregnancy unless it is clearly necessary. Consult your doctor before taking this medicine during pregnancy. It is not known whether Bisoprolol Vitabalans passes into breast milk. Therefore, breastfeeding is not recommended during treatment with Bisoprolol Vitabalans. Always consult your doctor.

Driving and using machines

The ability to drive vehicles or operate machinery may be impaired. Bisoprolol Vitabalans may cause side effects related to low blood pressure, such as dizziness or fatigue (see section 4 of the leaflet). The occurrence of side effects is more likely at the beginning of treatment, after increasing the dose, or after concurrent consumption of alcohol. If side effects occur, do not drive or perform other activities that require attention.

3. HOW TO TAKE BISOPROLOL VITABALANS

Your doctor will recommend individual dosing for each patient. Bisoprolol Vitabalans should always be taken according to the doctor's recommendations. In case of doubts, consult your doctor or pharmacist again. The tablets should be swallowed with a sufficient amount of liquid (e.g. one glass of water) during breakfast. The tablets should not be chewed. The tablet can be divided into equal doses. The usual initial dose for adults is 5 mg once daily. The doctor may increase the dose to 10 mg once daily if necessary. In exceptional cases, the daily dose may be increased to 20 mg. In cases of mild hypertension, the doctor may start treatment with a dose of half a 5 mg tablet (2.5 mg). In patients with severe renal or hepatic impairment, the maximum daily dose is 10 mg of bisoprolol. Since there is insufficient experience with the use of Bisoprolol Vitabalans in children and adolescents under 18 years of age, its use is not recommended in this age group.

Taking a higher dose of Bisoprolol Vitabalans than recommended

In case of overdose and poisoning, contact your doctor or go to the emergency department of a hospital immediately. To prevent bisoprolol absorption, take activated charcoal. In case of doubts about the use of the medicine, consult your doctor or pharmacist.

Missing a dose of Bisoprolol Vitabalans

The next tablet should be taken at the usual time. Do not take a double dose or a larger dose to make up for the missed dose.

Stopping treatment with Bisoprolol Vitabalans

In case of sudden discontinuation of Bisoprolol Vitabalans, a dangerous exacerbation of symptoms may occur. This applies especially to patients with angina pectoris. Therefore, do not stop treatment with Bisoprolol Vitabalans abruptly. The dose should be reduced gradually. If you want to stop treatment, consult your doctor. In case of doubts about the use of the medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bisoprolol Vitabalans can cause side effects, although not everybody gets them. The following side effects have been reported:

• fatigue, dizziness, and headaches (especially at the beginning of treatment; they are usually mild and resolve within 1-2 weeks),
• feeling of coldness or numbness in the limbs, exacerbation of Raynaud's syndrome (pallor, cyanosis, and redness of the fingers with accompanying pain) or exacerbation of intermittent claudication (pain or cramps in the legs during exercise or walking),
• nausea, vomiting, abdominal pain, diarrhea, or constipation.

Uncommon(may occur in less than 1 in 100 patients but more than 1 in 1,000 patients):

• depression or sleep disorders,
• too slow heart rate, conduction disorders in the heart, or exacerbation of heart failure (shortness of breath and swelling),
• dizziness or fainting when changing position to standing (orthostatic hypotension),
• bronchospasm (with difficulty breathing) in patients with asthma or chronic obstructive pulmonary disease,
• muscle weakness, muscle cramps, or joint pain,
• asthenia (weakness, loss of strength).

Rare(may occur in less than 1 in 1,000 patients but more than 1 in 10,000 patients):

• allergic rhinitis,
• Lupus-like syndrome (appearance of antinuclear antibodies in the blood, fever, muscle or joint pain, vasculitis, and skin changes),
• nightmares or hallucinations,
• fainting,
• reduced tear secretion, which may cause dryness of the conjunctiva (people wearing contact lenses should take this into account),
• hearing disorders,
• increased triglyceride levels in the blood or decreased glucose levels in the blood,
• increased activity of liver enzymes (ALT, AST) in the blood,
• hepatitis (usually causing abdominal pain),
• allergic skin reactions (itching, redness, rash),
• impotence.

Very rare(may occur in less than 1 in 10,000 patients):

• conjunctivitis (redness and irritation of the eyes),
• induction or exacerbation of psoriasis,
• hair loss.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to: Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE BISOPROLOL VITABALANS

Do not store above 30 °C. Store in a place inaccessible and invisible to children. Do not use Bisoprolol Vitabalans after the expiry date stated on the packaging. The expiry date refers to the last day of the given month. Medicines should 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. OTHER INFORMATION

What Bisoprolol Vitabalans contains

The active substance is bisoprolol hemifumarate. Bisoprolol Vitabalans, 5 mg: Each tablet contains 5 mg of bisoprolol hemifumarate, which is equivalent to 4.2 mg of bisoprolol. Bisoprolol Vitabalans, 10 mg: Each tablet contains 10 mg of bisoprolol hemifumarate, which is equivalent to 8.5 mg of bisoprolol. The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, magnesium stearate. Bisoprolol Vitabalans, 10 mg, also contains yellow iron oxide (E172).

What Bisoprolol Vitabalans looks like and what the pack contains

Bisoprolol Vitabalans, 5 mg: White, round, convex tablets with a dividing line. The diameter is 8 mm. Bisoprolol Vitabalans, 10 mg: Beige, speckled, round, convex tablets with a dividing line. The diameter is 8 mm. The tablet can be divided into equal doses. Pack sizes: 10, 20, 28, 30, 50, 56, 60, 90, and 100 tablets (PVC/PVDC/Aluminum or PVC/Aluminum blister pack in a cardboard box). Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Vitabalans Oy, Varastokatu 8, 13500 Hämeenlinna, Finland, Tel.: +358 (3) 615600, Telefax: +358 (3) 6183130

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Bisoprolol Vitabalans (CZ, DE, DK, EE, FI, HU, LT, LV, NO, PL, SE, SK)
Date of revision of the leaflet:01.09.2022