Bisoprolol Vp

Package Leaflet: Information for the Patient

Bisoprolol VP, 5 mg, tablets
Bisoprolol VP, 10 mg, tablets
Bisoprolol Fumarate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Bisoprolol VP and what is it used for
• 2. Important information before taking Bisoprolol VP
• 3. How to take Bisoprolol VP
• 4. Possible side effects
• 5. How to store Bisoprolol VP
• 6. Contents of the pack and other information

1. What is Bisoprolol VP and what is it used for

Bisoprolol VP belongs to a group of medicines called beta-blockers, which are highly selective for beta-receptors located in the heart. It blocks the activity of these receptors, slowing down the heart rate, which reduces the heart's output and oxygen consumption.
It is used to treat:

• high blood pressure;
• chronic, stable angina pectoris.

2. Important information before taking Bisoprolol VP

When not to take Bisoprolol VP

Do not take the medicine if you have:

• allergy to the active substance of the medicine (bisoprolol fumarate) or to any of the other ingredients of this medicine (listed in section 6);
• acute or untreated heart failure or episodes of decompensated heart failure requiring intravenous administration of drugs that increase the strength of heart contractions;
• cardiogenic shock;
• second- or third-degree atrioventricular block (without a pacemaker);
• sick sinus syndrome;
• atrioventricular block;
• bradycardia with a heart rate below 60 beats per minute before starting treatment;
• low blood pressure;
• severe asthma or severe chronic obstructive pulmonary disease with difficulty breathing, wheezing;
• advanced stage of peripheral arterial occlusive disease and Raynaud's syndrome (associated with circulatory disorders);
• metabolic acidosis;
• untreated pheochromocytoma of the adrenal gland. Bisoprolol VP should not be taken by patients who are also taking floctafenine or sultopride.

Warnings and precautions:

Before starting treatment with Bisoprolol VP, discuss it with your doctor, pharmacist, or nurse and exercise caution:

• in patients with circulatory failure, treatment with bisoprolol should be initiated with caution, under close medical supervision. Treatment starts with small doses, which are then gradually increased to the optimal dose for the patient;
• in patients with asthma or chronic obstructive pulmonary disease. The doctor may recommend regular check-ups, lung function tests, increased doses of beta-receptor stimulants, and the use of additional medications. In some cases, the doctor may decide to discontinue treatment;
• in case of planned use of general anesthetic inhalation agents. Inform the anesthesiologist about taking Bisoprolol VP;
• in patients with diabetes with large fluctuations in blood glucose levels, as the symptoms of low blood sugar may be masked;
• in patients with hyperthyroidism, as the symptoms of hyperthyroidism may be masked;
• in case of fasting;
• during desensitization treatment with Bisoprolol VP, as with other beta-blockers, it may increase sensitivity to allergens and exacerbate anaphylactic reactions. Treatment with adrenaline may not always be effective;
• in patients with first-degree atrioventricular block;
• in patients with Prinzmetal's angina (vasospastic angina pectoris), as bisoprolol may increase the frequency and duration of attacks of this angina;
• in patients with severe renal or hepatic impairment. The doctor may recommend using smaller doses of the medicine;
• in patients with peripheral circulatory disorders, as they may worsen, especially during the initiation of treatment;
• in patients with pheochromocytoma of the adrenal gland. In these patients, the doctor may allow the use of Bisoprolol VP only after additional treatment has been initiated to block alpha-receptors;
• in patients with a history of or existing psoriasis, due to the possibility of exacerbation of psoriasis or psoriasis-like rashes. In these patients, the doctor will weigh the benefits and risks of using Bisoprolol VP.

In cases where it is not justified, Bisoprolol VP should not be stopped abruptly, as this may lead to severe side effects, including myocardial infarction, and even death, especially in patients with coronary artery disease. The decision to discontinue the medicine is made exclusively by the doctor.

The doctor.

The medicine should be discontinued gradually, reducing the dose by half each week.

Bisoprolol VP and other medicines

Tell your doctor about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Taking certain other medicines at the same time as Bisoprolol VP may affect the strength and safety of this medicine. Bisoprolol VP may also affect other medicines if taken at the same time.

Concomitant use with bisoprolol is contraindicated:

• floctafenine:beta-blockers may inhibit mechanisms that compensate for hypotension or shock caused by taking floctafenine;
• sultopride:increased risk of ventricular arrhythmias.

Concomitant use with bisoprolol is not recommended:

• calcium channel antagonists (verapamil, diltiazem, bepridil): negative effect on contractility, atrioventricular conduction, and blood pressure;
• clonidine: increased risk of significant blood pressure increase (so-called "rebound hypertension") and excessive slowing of heart rate and decreased cardiac conduction;
• monoamine oxidase inhibitors (except for monoamine oxidase-B inhibitors): possible enhancement of the hypotensive effect of bisoprolol, risk of hypertensive crisis.

Caution should be exercised when taking bisoprolol concomitantly with:

• class I antiarrhythmic drugs (e.g., disopyramide, quinidine): may prolong atrial conduction time and increase negative inotropic effect;
• class III antiarrhythmic drugs (e.g., amiodarone): may prolong atrial conduction time;
• calcium channel antagonists - dihydropyridine derivatives (e.g., nifedipine): increased risk of hypotension. In patients with latent circulatory failure, concomitant treatment with a calcium channel antagonist and Bisoprolol VP may cause circulatory failure;
• cholinomimetic drugs, including tacrine: may prolong atrioventricular conduction time;
• other beta-blockers, including those used in eye drops: additive effect of bisoprolol and these drugs;
• insulin and oral hypoglycemic agents: enhancement of the hypoglycemic effect of these agents and possible masking of symptoms of low blood sugar;
• general anesthetics used for surgical procedures. Inform the anesthesiologist about taking Bisoprolol VP;
• digitalis glycosides: slowing of heart rate and prolongation of atrioventricular conduction time;
• prostaglandin synthesis inhibitors: reduction of the antihypertensive effect of Bisoprolol VP;
• ergotamine derivatives: exacerbation of peripheral circulatory disorders;
• sympathomimetic agents: mutual weakening of the effect of each of these drugs;
• tricyclic antidepressants, barbiturates, phenothiazine derivatives: enhanced hypotensive effect;
• rifampicin: possible shortening of the duration of action of Bisoprolol VP;
• baclofen: possible enhancement of the effect of Bisoprolol VP;
• iodinated contrast agents: beta-blockers may inhibit compensatory mechanisms related to hypotension or shock caused by the administration of iodinated contrast agents.

Bisoprolol should be used with caution with:

• mefloquine: increased risk of bradycardia;
• corticosteroids: possible weakening of the antihypertensive effect of bisoprolol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.
The doctor may allow the use of Bisoprolol VP in pregnant women only if absolutely necessary.
If you become pregnant during treatment with bisoprolol, inform your doctor immediately.
It is not known whether bisoprolol passes into breast milk. Therefore, breastfeeding is not recommended during treatment with bisoprolol.

Driving and using machines

Bisoprolol VP may cause dizziness, fatigue, drowsiness, and thus impair the ability to drive vehicles and operate machinery. These symptoms occur especially at the beginning of treatment, during dose increases, and when consuming alcohol.
In case of doubts about the ability to perform these activities while taking Bisoprolol VP, consult your doctor.

Bisoprolol VP contains:

• the active substance bisoprolol, which gives a positive result in doping tests;
• the excipient lactose monohydrate (Bisoprolol VP, 5 mg - 135 mg lactose, Bisoprolol VP, 10 mg - 130 mg lactose). If you have been diagnosed with intolerance to some sugars, consult your doctor before taking Bisoprolol VP.

3. How to take Bisoprolol VP

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Usual dosage in both indications

The dosage is adjusted individually by the doctor for each patient. Treatment starts with a small dose of the medicine, which is then gradually increased if necessary to the optimal maintenance dose. This is usually 10 mg per day, although some patients may require a dose of 5 mg per day. The maximum daily dose is 20 mg per day.
Take the medicine once a day, on an empty stomach or during breakfast, without chewing, with a small amount of water. Treatment is long-term and requires periodic medical check-ups.
In patients with diastolic blood pressure up to 105 mmHg, treatment can be started with a dose of 2.5 mg per day.

Dosage in patients with renal or hepatic impairment

In patients with mild or moderate renal or hepatic impairment, the usual recommended dose of the medicine is used.
In patients with severe renal impairment (creatinine clearance less than 20 ml/min) or hepatic impairment (e.g., hepatitis or liver cirrhosis), a dose of 2.5 mg per day is recommended at the start of treatment and no more than 10 mg per day in further therapy, in one or two divided doses.

Dosage in elderly patients

In elderly patients, the usual recommended dose of the medicine is used, unless they have severe renal or hepatic impairment.

Use in children

Bisoprolol should not be used in children due to the lack of data on safety and efficacy in this age group.
If you feel that the effect of Bisoprolol VP is too strong or too weak, talk to your doctor or pharmacist.
If any change in the use of Bisoprolol VP is necessary, you must consult your doctor.

Taking a higher dose of Bisoprolol VP than recommended

Taking too much of the medicine or an additional dose may cause bradycardia, hypotension, bronchospasm, acute heart failure, or decreased blood sugar levels. In this case, consult your doctor immediately. In case of significant overdose, immediate hospital treatment is necessary.

Missing a dose of Bisoprolol VP

Do not take a double dose to make up for a missed dose. If you miss a dose at the scheduled time, do not double the next dose to make up for the missed dose, but take the recommended dose at the usual time.

Stopping treatment with Bisoprolol VP

Do not stop taking Bisoprolol VP abruptly unless your doctor decides it is absolutely necessary.
In case of sudden discontinuation of the medicine, be aware that severe side effects may occur.
The medicine should be discontinued gradually, reducing the dose by half each week.
If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Bisoprolol VP can cause side effects, although not everybody gets them.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Frequency of side effects.

Common(occurring in 1 to 10 people in 100)
Vascular disorders:feeling of coldness or numbness in the limbs.
Nervous system disorders:feeling of tiredness, exhaustion, dizziness, headaches. These symptoms usually occur at the beginning of treatment and are generally mild and transient, lasting 1 to 2 weeks.
Gastrointestinal disorders:nausea, vomiting, diarrhea, constipation.

Uncommon(occurring in 1 to 10 people in 1,000)
General disorders and administration site conditions:weakness and muscle cramps.
Cardiac disorders:bradycardia, atrioventricular conduction disorders, worsening of heart failure, orthostatic hypotension.
Nervous system disorders:sleep disorders, depression.
Respiratory, thoracic, and mediastinal disorders:bronchospasm in patients with asthma or chronic obstructive pulmonary disease in their medical history.

Rare(occurring in 1 to 10 people in 10,000)
Psychiatric disorders:nightmares, hallucinations.
Skin and subcutaneous tissue disorders:hypersensitivity reactions (itching, flushing, rash).
Hepatobiliary disorders:increased activity of liver enzymes (ALT, AST), hepatitis.
Metabolism and nutrition disorders:increased triglyceride levels.
Reproductive system and breast disorders:potency disorders.
Ear and labyrinth disorders:hearing disorders.
Immune system disorders:allergic rhinitis.
Eye disorders:decreased tear secretion (important if the patient uses contact lenses).

Very rare(occurring in less than 1 person in 10,000)
Eye disorders:conjunctivitis.
Skin and subcutaneous tissue disorders:psoriasis, exacerbation of psoriasis or psoriasis-like rash, alopecia.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Bisoprolol VP

Store in a temperature below 25°C, store in the original package to protect from moisture.
Keep the 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 given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Bisoprolol VP contains

• The active substance of the medicine is bisoprolol fumarate. Bisoprolol VP 5 mg: one tablet contains 5 mg of bisoprolol fumarate. Bisoprolol VP 10 mg: one tablet contains 10 mg of bisoprolol fumarate.
• Other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, and a dye (in Bisoprolol VP 5 mg: yellow dye PB 22 812 composed of lactose monohydrate and yellow iron oxide (E 172), and in Bisoprolol VP 10 mg: beige dye PB 27 215 composed of lactose monohydrate, yellow iron oxide (E 172), and red iron oxide (E 172)).

What Bisoprolol VP looks like and what the pack contains

Bisoprolol VP5 mg tablet: yellow, film-coated, round, biconvex tablet with "BI" embossed, score line, and "5" on one side. The other side is smooth. The tablet can be divided into equal doses.
Bisoprolol VP10 mg tablet: beige, film-coated, round, biconvex tablet with "BI" embossed, score line, and "10" on one side. The other side is smooth. The tablet can be divided into equal doses.
Pack size:
30 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

ICN Polfa Rzeszów S.A.
Przemysłowa 2
35-959 Rzeszów
To obtain more detailed information, contact the representative of the marketing authorization holder:
Valeant Pharma Poland sp. z o.o.
Przemysłowa 2, 35-959 Rzeszów
tel. (+48) 17 865 51 00
fax: (+48) 17 862 46 18
Date of last revision of the leaflet:August 2021