Ebivol

Patient Information Leaflet

Ebivol, 5 mg, tablets
Nebivololum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents

1. What Ebivol is and what it is used for
2. What you need to know before taking Ebivol
3. How to take Ebivol
4. Possible side effects
5. How to store Ebivol
6. Contents of the pack and other information

1. What Ebivol is and what it is used for

Ebivol mainly affects heart function (beta-adrenergic blocker). It reduces blood pressure and improves heart performance.
Ebivol is used:

• for the treatment of high blood pressure (hypertension)
• as an addition to standard therapy (e.g. with diuretics, digoxin, ACE inhibitors, angiotensin II antagonists) in the treatment of stable, mild to moderate chronic heart failure in patients aged 70 years or older
• for the treatment of symptomatic, stable angina pectoris.

2. Important information before using Ebivol

When not to use Ebivol

• if the patient has a known allergy (hypersensitivity) to nebivolol or any of the other ingredients of this medicine (listed in section 6)
• if liver function disorders (liver failure) are present
• during pregnancy or breastfeeding
• in cases of acute heart failure, cardiogenic shock, or episodes of worsening heart failure (decompensation) requiring intravenous administration of positively inotropic drugs
• if sick sinus syndrome (a certain type of heart rhythm disorder) has been diagnosed, including sinoatrial block
• if certain conduction disorders of the heart are present (second- or third-degree atrioventricular block (without a pacemaker))
• in patients with bronchospasm or a history of bronchial asthma
• if untreated pheochromocytoma is present
• in cases of excessive blood acidity (metabolic acidosis)
• if heart rate (pulse) at rest, before starting treatment, is less than 60 beats per minute (bradycardia)
• if significantly low blood pressure is present (systolic blood pressure <90 mmHg)
• in cases of severe peripheral circulatory disorders.

If in doubt, consult a physician.
Warnings and precautions
Before starting treatment with Ebivol, discuss it with your doctor or pharmacist.

• if, during treatment with nebivolol, a significant slowing of the heart rate occurs (less than 50–55 beats per minute at rest and/or symptoms such as dizziness, weakness, or unsteady gait);
• in cases of heart disease (e.g. angina pectoris, ischemic heart disease, heart rhythm disorders); in patients with ischemic heart disease, treatment should be discontinued gradually over more than 1–2 weeks, and other treatments may be needed simultaneously;
• if the patient has circulatory disorders in the upper or lower limbs;
• if chronic respiratory disorders are present, especially chronic obstructive pulmonary disease (COPD);
• if diabetes is present. Ebivol does not affect blood glucose levels, but it may mask symptoms of low blood sugar (such as nervousness, tremor, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic drugs called sulfonylureas (e.g. glipizide, glyburide, gliclazide, glimepiride, tolbutamide, or gliquidone). However, Ebivol does not mask the symptom of excessive sweating.
• if hyperthyroidism is present: Ebivol may mask the symptom of increased heart rate (tachycardia) associated with the disease; abrupt discontinuation of Ebivol may cause an increase in heart rate.
• in cases of allergies. Ebivol may intensify the reaction to allergens such as pollen.
• in cases of psoriasis: patients with active psoriasis or a history of psoriasis should use Ebivol only after careful assessment of benefit versus risk.
• Ebivol may reduce tear secretion (important information for contact lens wearers).

Children and adolescents
Studies in children and adolescents have not been conducted. Therefore, use in children and adolescents under 18 years of age is not recommended.
Elderly patients
In patients over 65 years of age, a lower starting dose is recommended (see section "How to use Ebivol").
In patients over 75 years of age, particular caution is required, and treatment should be closely supervised by a physician.
Ebivol with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to take.
This especially includes:

• certain medicines used to treat heart rhythm disorders (antiarrhythmics of class I, such as quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, mexiletine, propafenone, and lidocaine, as well as amiodarone), which may enhance the negative effect of Ebivol on heart function when used concomitantly.
• certain medicines used to treat high blood pressure and coronary artery spasm (calcium channel blockers), which may enhance the effect of Ebivol (e.g. verapamil and diltiazem, or amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, and nitrendipine).
• other antihypertensive medicines with central action (clonidine, guanfacine, moxonidine, methyldopa, rilmenidine), as they may increase the risk of significant rebound hypertension—especially in case of abrupt discontinuation after prolonged use. These medicines should be discontinued only after beta-blockers (e.g. Ebivol) have been stopped several days earlier.
• concomitant use of beta-blockers and cardiac glycosides, which may cause certain disturbances in heart conduction. However, clinical studies have not shown such interaction. Nebivolol does not affect digoxin blood levels.
• certain medicines used to treat asthma, nasal congestion, and certain eye diseases (sympathomimetics), as they may reduce the effectiveness of Ebivol (e.g. dopamine, ephedrine).
• antidiabetic medicines such as insulin or oral antidiabetic agents. See also section "When to exercise special caution with Ebivol".
• baclofen (a muscle relaxant) and amifostine (a medicine used during chemotherapy): may enhance the blood pressure-lowering effect. The doctor may adjust the dose of Ebivol accordingly.
• anesthetics: always inform the anesthesiologist about Ebivol use before anesthesia.
• certain antipsychotics, as they may enhance the effect of Ebivol. Concomitant use of antidepressants (tricyclic antidepressants, paroxetine), barbiturates (e.g. used in epilepsy treatment), sedatives (phenothiazine derivatives, e.g. thioridazine), organic nitrates (used in angina pectoris and heart failure), and other antihypertensives may lead to a significant drop in blood pressure.
• concomitant use of serotonin reuptake inhibitors (certain antidepressants, e.g. paroxetine, fluoxetine) and Ebivol, as dose adjustment may be necessary.
• certain medicines that are metabolized similarly to nebivolol, as they may increase nebivolol blood levels, increasing the risk of adverse effects. These include, for example: bupropion (an antidepressant), chloroquine (used for malaria prophylaxis and treatment of autoimmune diseases such as rheumatoid arthritis), levomepromazine (a neuroleptic), and terbinafine (an antifungal agent).

If antacids are used concomitantly with Ebivol, Ebivol should be taken with food, and antacids should be taken between meals.
Ebivol with food and drink
Ebivol may be taken with food and drink.
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.
Pregnancy
There is a risk of harmful effects on the fetus. Therefore, Ebivol should not be used during pregnancy.
Breastfeeding
It is not known whether Ebivol passes into breast milk. Therefore, Ebivol should not be used during breastfeeding.
Driving and operating machinery
No studies have been conducted on the effect of Ebivol on the ability to drive or operate machinery.
During treatment with Ebivol, dizziness or fatigue may occasionally occur. This should be taken into account when driving or operating machinery (see section 4 "Possible side effects").
Ebivol contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Ebivol contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ebivol

This medicine should always be taken exactly as prescribed by your doctor. In case of doubt, consult your doctor or pharmacist.

Arterial hypertension
Adults:
The usual dose is 1 tablet daily (5 mg nebisolol). The maximum effect of Ebivol is usually achieved after 1–2 weeks of treatment.

Concomitant use with other antihypertensive medicines:
Beta-blockers may be used as monotherapy or in combination with other antihypertensive medicines. To date, additional antihypertensive effect has been observed only when Ebivol 5 mg was administered concomitantly with hydrochlorothiazide 12.5–25 mg.

Patients with renal function impairment (renal failure):
In patients with renal failure, the recommended initial dose is ½ tablet daily (2.5 mg nebisolol). If necessary, the daily dose may be increased to 1 tablet (5 mg nebisolol).

Patients with hepatic function impairment (liver failure):
There is insufficient experience regarding the use of Ebivol in patients with impaired liver function or liver disease. Therefore, Ebivol must not be used in these patients (see section "When not to use Ebivol").

Elderly patients:
In patients aged 65 years or older, the recommended initial dose is ½ tablet daily (2.5 mg nebisolol). If necessary, the daily dose may be increased to 1 tablet (5 mg nebisolol). Particular caution should be exercised in all cases, and treatment must be conducted under strict medical supervision due to limited experience with use in patients over 75 years of age.

Use in children and adolescents:
Studies in children and adolescents have not been conducted. Therefore, use in children and adolescents under 18 years of age is not recommended.

Chronic heart failure
Treatment of chronic heart failure should begin with a gradual dose escalation until reaching the individually determined optimal maintenance dose.

In patients receiving other medicines used for cardiovascular diseases, such as diuretics, digoxin, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin II antagonists, the dosing of these medicines must be stabilized before initiating Ebivol treatment.

Initial dose escalation should follow the scheme below, with intervals of 1 to 2 weeks depending on patient tolerance:

• ¼ tablet (1.25 mg nebisolol) once daily,
• increased to ½ tablet (2.5 mg nebisolol) once daily,
• then 1 tablet (5 mg nebisolol) once daily,
• and subsequently 2 tablets (10 mg nebisolol) once daily. The maximum recommended dose is 2 tablets (10 mg nebisolol) once daily.

The patient should remain under medical supervision for 2 hours after taking the first dose and for 2 hours after each dose increase to ensure that the patient's condition remains stable.

Patients with renal function impairment (renal failure):
In patients with mild to moderate renal failure, dose adjustment is not necessary, as the dose is individually increased up to the maximum tolerated dose.

Patients with hepatic function impairment (liver failure):
There is insufficient experience in patients with impaired liver function. Therefore, Ebivol must not be used in these patients (see section "When not to use Ebivol").

Elderly patients:
Dose adjustment is not required, as the dose is individually increased up to the maximum tolerated dose.

Use in children and adolescents:
Studies in children and adolescents have not been conducted. Therefore, use in children and adolescents under 18 years of age is not recommended.

Treatment of symptomatic stable coronary artery disease
Adults:

• The patient's treatment will be initiated and monitored by an experienced physician.
• Treatment starts with an initial dose of ¼ tablet (1.25 mg nebisolol) daily. This dose may be increased after 1–2 weeks to ½ tablet (2.5 mg nebisolol) daily, then to 1 tablet (5 mg nebisolol) daily, and subsequently to 2 tablets (10 mg nebisolol) daily, until reaching the dose appropriate for the individual patient.
• The maximum recommended dose is 2 tablets (10 mg nebisolol) daily.

Patients with renal function impairment (renal failure):
In patients with mild to moderate renal failure, dose adjustment is not necessary, as the dose is individually increased up to the maximum tolerated dose. There is no experience in patients with severe renal failure; therefore, nebisolol is not recommended in these patients.

Patients with hepatic function impairment (liver failure):
There is insufficient experience in patients with impaired liver function. Therefore, Ebivol must not be used in these patients (see section "When not to use Ebivol").

Elderly patients:
Dose adjustment is not required, as the dose is individually increased up to the maximum tolerated dose.

Use in children and adolescents:
Studies in children and adolescents have not been conducted. Therefore, use in children and adolescents under 18 years of age is not recommended.

Method of administration:
The recommended daily dose should preferably be taken at the same time each day.
Tablets should be swallowed whole with sufficient liquid (e.g. a glass of water), with or without food.

If you feel that the effect of Ebivol is too strong or too weak, consult your doctor.

Overdose of Ebivol
Symptoms of overdose include: slow heart rate, low blood pressure, breathing difficulties, or sudden (acute) heart-related disturbances.
If you have taken more than the recommended dose of Ebivol, contact your doctor immediately.
Lie down with your legs elevated above the level of your heart.

Missed dose of Ebivol
If you miss a dose of Ebivol, take the next dose the following day at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping Ebivol treatment
Do not stop treatment until you have consulted your doctor, even if you feel better.
Do not stop taking Ebivol suddenly. Sudden discontinuation of the medicine may cause dangerous worsening of symptoms, particularly in patients with angina pectoris.

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 not everyone will experience them.
The observed adverse effects are listed below, classified according to their frequency of occurrence.
The following adverse effects may occur:

Patients with high blood pressure
Common adverse effects (occur in 1 to 10 out of 100 people):
Headache, dizziness, skin tingling, difficulty breathing, constipation, nausea, diarrhoea, fatigue, oedema related to fluid retention.

Uncommon adverse effects (occur in 1 to 10 out of 1,000 people):
Nightmares, depression, visual disturbances, slower than normal heart rate (bradycardia), weakened heart function, disturbances in heart conduction, abnormally low blood pressure (hypotension), onset or worsening of pain during walking due to arterial narrowing and insufficient blood circulation (intermittent claudication), wheezing or shortness of breath (bronchospasm), indigestion, bloating with flatulence, vomiting, itching, skin rash, impotence.

Very rare adverse effects (occur in less than 1 out of 10,000 people):
Fainting, worsening of psoriasis.

Frequency not known (cannot be estimated from the available data):
Swelling of the face, lips, throat or tongue (angioedema), allergy (hypersensitivity), itchy skin rash (urticaria).

In addition, the following adverse effects have been reported with similar medicines:
hallucinations, psychotic reactions (psychoses), confusion, coldness or bluish discolouration of upper and lower limbs, pain in fingers of hands and feet which first turn blue, then pale, and finally red (Raynaud’s phenomenon), dry eyes, and formation of new connective tissue in the eyes and diaphragm (practolol-type oculomucocutaneous syndrome).

Patients with chronic heart failure
Very common adverse effects (occur in more than 1 out of 10 people):
Dizziness, slower than normal heart rate (bradycardia).

Common adverse effects (occur in 1 to 10 out of 100 people):
Headache, worsening of heart failure, heart rhythm disturbances (known as first-degree atrioventricular block), drop in blood pressure upon standing (orthostatic hypotension), fatigue/weakness, intolerance to the medicine, fluid retention (oedema) in the lower limbs, slower heart rate, low blood pressure.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. 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, 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 authorisation holder. Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Ebivol

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the stated month.
Ebivol does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the packaging and other information

What the medicine Ebivol contains

• The active substance is nebivolol. Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
• Other ingredients are: colloidal anhydrous silica, magnesium stearate, sodium croscarmellose, macrogol 6000 and lactose monohydrate.

What Ebivol looks like and contents of the pack
White, round, convex tablets with cross-scored dividing lines, 9 mm in diameter,
marked with "N5" on one side.
The tablet can be divided into halves and quarters.
Pack sizes: 30, 56 and 60 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd.
BLB015-016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
For more detailed information about the medicine and its names in the European Economic Area member states,
please contact the representative of the marketing authorisation holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of the latest revision of the leaflet: March 2025