Package leaflet: Information for the patient

Bisoprolol VP, 5 mg, tablets
Bisoprolol VP, 10 mg, tablets
Bisoprololi fumaras
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, 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 the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Bisoprolol VP is and what it is used for
Important information before taking Bisoprolol VP
How to take Bisoprolol VP
Possible side effects
How to store Bisoprolol VP
Contents of the pack and other information

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

Bisoprolol VP belongs to a group of medicines known as β-adrenolytics, highly selective for β₁-receptors located in the heart. It inhibits the activity of these receptors, slows down heart rate, thereby reducing cardiac output and oxygen consumption.
It is used in the treatment of:

arterial hypertension;
chronic, stable angina pectoris.

2. Important information before using Bisoprolol VP

When not to use Bisoprolol VP
Do not use this medicine if the patient:

is allergic to the active substance (bisoprolol fumarate) or to any of the other ingredients of this medicine (listed in section 6);
has acute, untreated heart failure or episodes of decompensated heart failure requiring intravenous administration of drugs that increase myocardial contractility;
has cardiogenic shock;
has second- or third-degree atrioventricular block (without a pacemaker);
has sick sinus syndrome;
has sinoatrial block;
has bradycardia with a heart rate below 60 beats per minute before starting treatment;
has low blood pressure;
has severe bronchial asthma or severe obstructive lung disease, manifesting as difficulty breathing or wheezing;
has advanced peripheral arterial occlusive disease or Raynaud's syndrome (related to circulatory disorders);
has metabolic acidosis;
has untreated phaeochromocytoma. Do not use Bisoprolol VP in patients concurrently taking floctafine or sultopride.

Warnings and precautions:
Before starting treatment with Bisoprolol VP, discuss this with your doctor, pharmacist, or nurse and exercise appropriate caution:

in patients with circulatory failure, treatment with bisoprolol should be initiated very carefully and under strict medical supervision. Treatment should begin with low doses, which are then gradually increased to the optimal dose for the patient;
in patients with bronchial asthma or obstructive lung disease. The doctor may recommend regular visits, respiratory function tests, increased doses of bronchodilators, or additional medications. In some cases, the doctor may decide to discontinue treatment;
if inhalational general anaesthetics are planned. Inform the anaesthesiologist that Bisoprolol VP is being used;
in patients with diabetes and large fluctuations in blood glucose levels, as symptoms of hypoglycaemia may be masked;
in patients with hyperthyroidism, as symptoms of hyperthyroidism may be masked;
during fasting;
during allergen immunotherapy: Bisoprolol VP, like other beta-receptor blocking agents, may increase sensitivity to allergens and exacerbate anaphylactic reactions. Treatment with adrenaline may not always produce the expected effect;
in patients with first-degree atrioventricular block;
in patients with Prinzmetal's angina (vasospastic angina), as bisoprolol may increase the frequency and duration of angina attacks;
in patients with severe renal or hepatic impairment. The doctor may recommend lower doses;
in patients with peripheral circulatory disorders, as these may worsen, especially at the beginning of treatment;
in patients with phaeochromocytoma. The doctor may allow use of Bisoprolol VP only after initiating additional treatment aimed at blocking α-receptors;
in patients with current or past psoriasis, due to the possibility of onset or worsening of psoriasis or psoriasiform rashes. In such patients, the doctor will weigh the benefits and risks of using Bisoprolol VP.

Bisoprolol VP must not be discontinued abruptly without medical justification, as this may lead,
especially in patients with coronary artery disease, to severe adverse effects,
including myocardial infarction and even death. The decision to discontinue the medicine must be made exclusively by the doctor.
The medicine should be discontinued gradually, reducing the dose by half each week.

Bisoprolol VP and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines planned for future use.
Taking certain other medicines together with Bisoprolol VP may affect its efficacy and safety. Likewise, Bisoprolol VP may affect other medicines when taken concomitantly.

Concomitant use with bisoprolol is contraindicated:

floctafine: beta-adrenolytic agents may inhibit compensatory mechanisms related to hypotension or shock induced by floctafine;
sultopride: increased risk of ventricular arrhythmias.

Concomitant use with bisoprolol is not recommended:

calcium channel blockers (verapamil, diltiazem, bepridil): negative effects on contractility, atrioventricular conduction, and blood pressure;
clonidine: increased risk of significant rebound hypertension, excessive slowing of heart rate, and reduced cardiac conduction;
monoamine oxidase inhibitors (except monoamine oxidase-B inhibitors): possible enhancement of bisoprolol's hypotensive (antihypertensive) effect and risk of hypertensive crisis.

Exercise caution when using simultaneously with bisoprolol:

Class I antiarrhythmics (e.g. disopyramide, quinidine): may prolong atrial conduction time and increase negative inotropic effects;
Class III antiarrhythmics (e.g. amiodarone): may prolong atrial conduction time;
calcium channel blockers – dihydropyridine derivatives (e.g. nifedipine): increased risk of arterial hypotension. In patients with latent heart failure, combined treatment with a calcium channel blocker and Bisoprolol VP may lead to heart failure;
cholinomimetic agents, including tacrine: may prolong atrioventricular conduction time;
other beta-adrenolytics, including those used as eye drops: additive effects with bisoprolol;
insulin and oral antidiabetic agents: enhanced hypoglycaemic (antidiabetic) effect and possible masking of hypoglycaemia symptoms;
general anaesthetics used during surgical procedures. Inform the anaesthesiologist that Bisoprolol VP is being used;
cardiac glycosides: slowed heart rate and prolonged atrioventricular conduction;
drugs inhibiting prostaglandin synthase: reduced antihypertensive effect of Bisoprolol VP;
ergotamine derivatives: worsening of peripheral circulatory disorders;
sympathomimetics: mutual attenuation of each drug's effect;
tricyclic antidepressants, barbiturates, phenothiazine derivatives: enhanced hypotensive effect;
rifampicin: possible reduction in the duration of action of Bisoprolol VP;
baclofen: possible enhancement of Bisoprolol VP's effect;
iodinated contrast agents: beta-adrenolytic agents may inhibit compensatory mechanisms related to hypotension or shock caused by iodine-containing contrast media.

Use with bisoprolol requires careful consideration:

mefloquine: increased risk of bradycardia;
corticosteroids: possible weakening of bisoprolol's antihypertensive effect.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine. The doctor may allow use of Bisoprolol VP during pregnancy only if clearly necessary.
If the patient becomes pregnant while being treated with bisoprolol, she should inform her doctor immediately.
It is not known whether bisoprolol passes into human breast milk. Therefore, breastfeeding is not recommended during bisoprolol treatment.

Driving and operating machinery
Bisoprolol VP may cause dizziness, fatigue, and drowsiness in some patients, thereby impairing the ability to drive or operate machinery. These symptoms occur especially at the beginning of treatment, during dose escalation, and when consuming alcohol concurrently.
If in doubt about the ability to perform such activities while taking Bisoprolol VP, consult a doctor.

Bisoprolol VP contains:

the active substance bisoprolol, which may result in a positive anti-doping test;
the excipient lactose monohydrate (Bisoprolol VP 5 mg – 135 mg lactose, Bisoprolol VP 10 mg – 130 mg lactose). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking Bisoprolol VP.

3. How to use Bisoprolol VP

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Dosage usually recommended for both indications
The dosage is individually adjusted by the physician for each patient. Treatment is initiated with
a low dose of the medicine, which is then gradually increased, if necessary, to the optimal
maintenance dose. This is usually 10 mg once daily, although some patients may require only
5 mg once daily. The maximum daily dose is 20 mg.
The medicine should be taken once daily, on an empty stomach or with breakfast, without chewing,
and with a small amount of water. Treatment is long-term and requires periodic medical monitoring.
In patients with diastolic blood pressure up to 105 mmHg, treatment may be initiated with a dose of 2.5 mg
once daily.
Dosage in patients with impaired renal or hepatic function
In patients with mild or moderate renal or hepatic impairment, the usual recommended dosage
is generally used.
In patients with severe renal impairment (creatinine clearance less than 20 ml/min) or hepatic
impairment (e.g. hepatitis or cirrhosis of the liver), a starting dose of 2.5 mg once daily is recommended,
and during further therapy, no more than 10 mg daily should be administered, in one or two divided doses.
Dosage in elderly patients
In elderly patients, the usual recommended dosage is generally used, unless severe renal or hepatic
impairment is present.
Use in children
Bisoprolol should not be used in children due to lack of data on safety and efficacy in this age group.
If a patient feels that Bisoprolol VP is working too strongly or too weakly, they should discuss this
with their physician or pharmacist.
If any change in the use of Bisoprolol VP is necessary, it is essential to contact the treating physician.
Taking more than the recommended dose of Bisoprolol VP
Taking an excessive dose or an additional dose of Bisoprolol VP may cause bradycardia, hypotension,
bronchospasm, acute heart failure, or decreased blood glucose levels. In such a case, contact a doctor
immediately. In the case of significant overdose, immediate hospital treatment is required.
Missed dose of Bisoprolol VP
Do not take a double dose to make up for a missed dose. If a dose is missed at the scheduled time,
do not double the next dose to compensate. Instead, take the recommended dose at the usual time
of administration.
Stopping Bisoprolol VP
Do not abruptly stop taking Bisoprolol VP, unless absolutely necessary in the opinion of the physician.
In case of sudden discontinuation, patients should be aware that serious adverse effects may occur.
The medicine should be discontinued gradually by reducing the dose by half each week.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If any adverse symptoms occur, including any possible adverse effects not listed in this leaflet,
consult a doctor or pharmacist.

Frequency of adverse effects:
Common (occur in 1 to 10 out of 100 people):
Vascular disorders: feeling of coldness or numbness in the extremities.
Nervous system disorders: feeling of fatigue, exhaustion, dizziness, headache. These symptoms usually occur at the beginning of treatment, are generally mild, and resolve within 1 to 2 weeks.
Gastrointestinal disorders: nausea, vomiting, diarrhoea, constipation.

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

Rare (occur in 1 to 10 out of 10,000 people):
Psychiatric disorders: nightmares, hallucinations.
Skin and subcutaneous tissue disorders: hypersensitivity reactions (itching, sudden reddening of the face, rash).
Hepatobiliary disorders: increased liver enzyme activity (AlAT, AspAT), hepatitis.
Metabolism and nutrition disorders: increased triglyceride levels.
Reproductive system and breast disorders: erectile dysfunction.
Ear and labyrinth disorders: hearing disturbances.
Immune system disorders: allergic rhinitis.
Eye disorders: reduced tear production (important if the patient wears contact lenses).

Very rare (occur in less than 1 out of 10,000 people):
Eye disorders: conjunctivitis.
Skin and subcutaneous tissue disorders: onset of psoriasis, worsening of psoriasis symptoms, or occurrence of psoriasiform rash, alopecia.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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 181 C, 02-222 Warsaw, Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Bisoprolol VP

Store below 25°C and keep in the original packaging 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 stated month.
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 pack and other information

What Bisoprolol VP contains

The active substance 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 are: lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, and a colouring agent (in Bisoprolol VP 5 mg: yellow colouring PB 22 812 composed of lactose monohydrate and yellow iron oxide (E 172); in Bisoprolol VP 10 mg: beige colouring PB 27 215 composed of lactose monohydrate, yellow iron oxide (E 172) and red iron oxide (E 172)).

What Bisoprolol VP looks like and contents of the pack
Bisoprolol VP 5 mg tablet: a light yellow, speckled, round, biconvex tablet, with “BI” and “5” engraved on one side, and a dividing line. The other side is smooth. The tablet can be divided into equal doses.
Bisoprolol VP 10 mg tablet: a beige, speckled, round, biconvex tablet, with “BI” and “10” engraved on one side, and a dividing line. The other side is smooth. The tablet can be divided into equal doses.
Pack size:
30 tablets

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer
ICN Polfa Rzeszów S.A.
Przemysłowa 2 Street
35-105 Rzeszów
Poland