EBIVOL 5 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Ebivol, 5 mg, tablets
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ebivol and what is it used for
4. Important information before taking Ebivol
   1. When not to take Ebivol
   2. Warnings and precautions
   3. Ebivol and other medicines
   4. Ebivol with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Ebivol contains lactose monohydrate
   8. Ebivol contains sodium
5. How to take Ebivol
   1. Hypertension Adults:
   2. Chronic heart failure
   3. Treatment of symptomatic stable coronary artery disease Adults:
   4. Overdose of Ebivol
   5. Missing a dose of Ebivol
   6. Discontinuation of Ebivol
6. Possible side effects
   1. Patients with high blood pressure
   2. Patients with chronic heart failure
   3. Reporting side effects
7. How to store Ebivol
8. Contents of the packaging and other information
   1. What Ebivol contains
   2. What Ebivol looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, you should contact the representative of the marketing authorization holder:

Leaflet attached to the packaging: information for the user

Ebivol, 5 mg, tablets

Nebivolol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• The 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ebivol and what is it used for

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

• to treat high blood pressure (hypertension)
• as a supplement to standard treatment (e.g., diuretics, digoxin, ACE inhibitors, angiotensin II antagonists) for stable, mild or moderate, chronic heart failure in patients aged 70 or older
• to treat symptomatic, stable coronary artery disease.

2. Important information before taking Ebivol

When not to take Ebivol

• if you have been diagnosed with an allergy (hypersensitivity) to nebivolol or any of the other ingredients of this medicine (listed in section 6)
• if you have liver function disorders (liver failure)
• during pregnancy or breastfeeding
• in case of acute heart failure, cardiogenic shock or episodes of decompensation that require intravenous administration of positive inotropic drugs
• if you have been diagnosed with sick sinus syndrome (a type of heart rhythm disorder) including sinoatrial block
• if you have certain conduction disorders in the heart (second and third degree atrioventricular block - atrioventricular block without a pacemaker)
• in patients with a history of bronchial asthma or bronchial asthma,
• if you have an untreated pheochromocytoma (adrenal gland tumor)
• in case of excessive blood acidity (metabolic acidosis)
• if your heart rate (pulse) at rest, before starting treatment, was less than 60 beats per minute (bradycardia)
• if you have significantly low blood pressure (systolic blood pressure <90 mmhg)< li>
• in case of severe circulatory disorders in the limbs.

In case of doubts, you should contact your doctor.

Warnings and precautions

Before starting to take Ebivol, you should discuss it with your doctor or pharmacist.

• if during treatment with nebivolol, you experience a significantly slowed heart rate (less than 50-55 beats per minute at rest and/or symptoms such as dizziness, weakness, and unsteady gait);
• in case of heart disease (e.g., angina pectoris, coronary heart disease, heart rhythm disorders); in patients with coronary heart disease, treatment should be discontinued gradually, over more than 1-2 weeks, and, if necessary, other treatment should be applied at the same time;
• if you have circulatory disorders in the upper or lower limbs;
• if you have chronic respiratory disorders, especially chronic obstructive pulmonary disease;
• if you have diabetes. Ebivol does not affect blood sugar levels, but it may mask the symptoms of low blood sugar (nervousness, tremors, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain types of oral antidiabetic drugs called sulfonylureas (such as gliclazide, glipizide, glibenclamide, glimepiride, or tolbutamide). However, Ebivol does not mask the symptom of excessive sweating.
• if you have hyperthyroidism: the possibility of masking rapid heart rate (tachycardia) as a symptom of the disease; sudden discontinuation of Ebivol may cause rapid heart rate.
• in case of allergies. Taking Ebivol may exacerbate the reaction to pollen and other allergens.
• in case of psoriasis: patients with active psoriasis or a history of psoriasis should only take Ebivol after careful assessment of the benefit-risk ratio.
• Ebivol may reduce tear secretion (information for contact lens wearers).

Children and adolescents
No studies have been conducted in children and adolescents. Therefore, the use of Ebivol in children and adolescents under the age of 18 is not recommended.
Elderly patients
In patients over 65 years of age, a lower initial dose is recommended (see "How to take Ebivol").
In patients over 75 years of age, special caution is recommended, and treatment should be carried out under close medical supervision due to limited experience with the use of Ebivol in this age group.

Ebivol and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as the medicines you plan to take.
This applies in particular to:

• certain medicines used to treat heart rhythm disorders (class I antiarrhythmic drugs, such as quinidine, hydroquinidine, cybenzoline, flecainide, disopyramide, mexiletine, propafenone, and lidocaine, as well as amiodarone), which may enhance the depressant effect of Ebivol on heart function if taken at the same time.
• certain medicines used to treat high blood pressure and coronary artery spasm (drugs called calcium antagonists), which may enhance the effect of Ebivol (e.g., verapamil and diltiazem, or amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, and nitrendipine).
• other centrally acting antihypertensive drugs (clonidine, guanfacine, moxonidine, methyldopa, rilmenidine), as they may increase the risk of a significant increase in blood pressure (so-called "rebound hypertension") - especially

in case of sudden discontinuation of a drug taken for a long time. These drugs can only be discontinued if beta-blockers (e.g., Ebivol) have been discontinued a few days earlier.

• concomitant use of beta-blockers and cardiac glycosides, which may cause certain heart function disorders (prolonged conduction time). However, clinical trials have not revealed the occurrence of this interaction. Nebivolol does not affect the level of digoxin in the blood.
• certain medicines used to treat asthma, nasal congestion, and certain eye diseases (so-called sympathomimetics), as they may weaken the effect of Ebivol (e.g., dopamine, ephedrine).
• diabetes medicines, such as insulin or oral antidiabetic drugs. See also "Special warnings and precautions for use".
• baclofen (a muscle relaxant) and amifostine (a drug used during chemotherapy): may enhance the decrease in blood pressure. The doctor may adjust the dose of Ebivol accordingly.
• anesthetics: you should always inform the anesthesiologist about taking Ebivol before undergoing anesthesia.
• certain antipsychotic drugs, as they may enhance the effect of Ebivol. Concomitant use of antidepressant drugs (tricyclic antidepressants, paroxetine), barbiturates (e.g., used to treat epilepsy), sedatives (phenothiazine derivatives, e.g., thioridazine), organic nitrates (used to treat angina pectoris and heart failure), and other antihypertensive drugs may lead to a significant decrease in blood pressure.
• concomitant use of serotonin reuptake inhibitors (certain antidepressant drugs, e.g., paroxetine, fluoxetine) and Ebivol, as the dose may need to be adjusted.
• certain drugs that are metabolized in a similar way to nebivolol, as they may increase the level of nebivolol in the blood, which is associated with an increased frequency of side effects. These drugs include, for example, bupropion (an antidepressant), chloroquine (used to prevent malaria and treat autoimmune diseases, such as rheumatoid arthritis), levomepromazine (a neuroleptic), and terbinafine (an antifungal drug).

If you are taking antacids with Ebivol, you should take Ebivol with food, and the antacid between meals.

Ebivol with food and drink

Ebivol can be taken with or without food and drink.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
There is a risk of harm to the fetus. Therefore, you should not take Ebivol during pregnancy.
Breastfeeding
It is not known whether Ebivol passes into breast milk. Therefore, you should not take Ebivol during breastfeeding.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.
During treatment with Ebivol, dizziness or fatigue may occasionally occur.
You should take this into account when driving or operating machines (see section 4 "Possible side effects").

Ebivol contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Ebivol contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is essentially "sodium-free".

3. How to take Ebivol

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should ask your doctor or pharmacist.

Hypertension Adults:

The usual dose is 1 tablet per day (5 mg of nebivolol). The maximum effect of Ebivol is usually achieved after 1-2 weeks of treatment.
Concomitant use with other antihypertensive drugs:
Beta-blockers can be used as monotherapy or in combination with other antihypertensive drugs. So far, additional antihypertensive effects have only been observed when Ebivol at a dose of 5 mg was used concomitantly with hydrochlorothiazide at a dose of 12.5-25 mg.
Patients with renal impairment (renal failure):
The recommended initial dose is ½ tablet per day (2.5 mg of nebivolol). If necessary, the daily dose may be increased to 1 tablet (5 mg of nebivolol).
Patients with liver function disorders (liver failure):
There is insufficient experience with the use of Ebivol in patients with liver function disorders or liver diseases. Therefore, Ebivol should not be used in these patients (see "When not to take Ebivol").
Elderly patients:
In patients aged 65 or older, the recommended initial dose is ½ tablet (2.5 mg of nebivolol) per day. If necessary, the daily dose may be increased to 1 tablet (5 mg of nebivolol). In all cases, special caution is recommended, and treatment should be carried out under close medical supervision due to limited experience with the use of Ebivol in patients over 75 years of age.
Use in children and adolescents:
No studies have been conducted in children and adolescents. Therefore, the use of Ebivol in children and adolescents under the age of 18 is not recommended.

Chronic heart failure

Treatment of chronic heart failure should be started with a gradual increase in dose until the optimal maintenance dose is reached, determined individually.
In patients receiving other drugs used in cardiovascular diseases, such as diuretics, digoxin, ACE inhibitors, or angiotensin II antagonists, the dosing of these drugs must be stabilized before starting Ebivol.
The initial dose increase should be done according to the following scheme at intervals of 1 to 2 weeks, depending on the patient's tolerance:

• ¼ tablet (1.25 mg of nebivolol) once a day,
• increased to ½ tablet (2.5 mg of nebivolol) once a day,
• then 1 tablet (5 mg of nebivolol) once a day,
• and then 2 tablets (10 mg of nebivolol) once a day. The maximum recommended dose is 2 tablets (10 mg of nebivolol) once a day.

The patient should be under medical supervision for 2 hours after taking the first dose of Ebivol and for 2 hours after each dose increase, to ensure that the patient's condition remains stable.
Patients with renal impairment (renal failure):
In patients with mild to moderate renal impairment, dose adjustment is not necessary, as the dose is increased individually up to the maximum tolerated dose.
Patients with liver function disorders (liver failure):
There is insufficient experience in patients with liver function disorders. Therefore, Ebivol should not be used in these patients (see "When not to take Ebivol").
Elderly patients:
Dose adjustment is not required, as the dose is increased individually up to the maximum tolerated dose.
Use in children and adolescents:
No studies have been conducted in children and adolescents. Therefore, the use of Ebivol in children and adolescents under the age of 18 is not recommended.

Treatment of symptomatic stable coronary artery disease Adults:

• -The patient's treatment will be started and monitored by an experienced doctor.
• Treatment starts with an initial dose of ¼ tablet (1.25 mg of nebivolol) per day. This dose may be increased after 1-2 weeks to a dose of ½ tablet (2.5 mg of nebivolol) per day, then to a dose of 1 tablet (5 mg of nebivolol) per day, and then to a dose of 2 tablets (10 mg of nebivolol) per day, until the dose suitable for the patient is reached.
• The maximum recommended dose is 2 tablets (10 mg of nebivolol) per day.

Patients with renal impairment (renal failure):
In patients with mild to moderate renal impairment, dose adjustment is not necessary, as the dose is increased individually up to the maximum tolerated dose. There is limited experience in patients with severe renal impairment, so nebivolol is not recommended for these patients.
Patients with liver function disorders (liver failure):
There is insufficient experience in patients with liver function disorders. Therefore, Ebivol should not be used in these patients (see "When not to take Ebivol").
Elderly patients:
Dose adjustment is not required, as the dose is increased individually up to the maximum tolerated dose.
Use in children and adolescents:
No studies have been conducted in children and adolescents. Therefore, the use of Ebivol in children and adolescents under the age of 18 is not recommended.
Method of administration:
The recommended daily dose should be taken at the same time every day.
Tablets should be swallowed with a sufficient amount of 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, you should consult your doctor.

Overdose of Ebivol

Symptoms of overdose are: slow heart rate, low blood pressure, difficulty breathing, or sudden (acute) heart disorders.
If you have taken more than the recommended dose of Ebivol, you should immediately contact your doctor.
You should lie down with your legs elevated above the level of your heart.

Missing a dose of Ebivol

If you miss a dose of Ebivol, you should take the next dose the next day at the right time.
You should not take a double dose to make up for the missed dose.

Discontinuation of Ebivol

You should not stop treatment until you have consulted your doctor, even if you feel better.
You should not stop taking Ebivol suddenly. Sudden discontinuation of Ebivol may cause dangerous worsening of symptoms in the patient. This applies in particular to patients with angina pectoris.
If you have any further doubts about taking Ebivol, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ebivol can cause side effects, although not everybody gets them.
The observed side effects are listed below, according to their frequency of occurrence.
The following side effects may occur:

Patients with high blood pressure

Common side effects (occurring in 1 to 10 out of 100 people):
Headache, dizziness, tingling of the skin, difficulty breathing, constipation, nausea, diarrhea, fatigue, water retention.

Uncommon side effects (occurring in 1 to 10 out of 1,000 people):
Bad dreams, depression, vision disorders, slower than normal heart rate (bradycardia), decreased heart function, heart conduction disorders, excessively low blood pressure (hypotension), worsening of angina pectoris symptoms during walking due to coronary artery narrowing and insufficient blood flow (intermittent claudication), wheezing or shortness of breath (bronchospasm), indigestion, bloating with gas, vomiting, itching, skin rash, impotence.

Rare side effects (occurring in less than 1 out of 10,000 people):
Fainting, worsening of psoriasis.
Frequency not known (cannot be estimated from available data):
Swelling of the face, lips, throat, or tongue (angioedema), allergy (hypersensitivity), itchy skin rash (hives).
Additionally, the following side effects have been reported with the use of similar drugs:
hallucinations, psychotic reactions (psychosis), confusion, cooling/cyanosis of the upper and lower limbs, finger pain, which first turns blue, then pale, and finally red (Raynaud's phenomenon), dry eyes, and the formation of new connective tissue in the eyes and diaphragm (a syndrome typical of practolol).

Patients with chronic heart failure

Very common side effects (occurring in more than 1 out of 10 people):
Dizziness, slower than normal heart rate (bradycardia).
Common side effects (occurring in 1 to 10 out of 100 people):
Headache, worsening of heart failure, heart rhythm disorders (so-called atrioventricular block grade I), decrease in blood pressure when standing up (orthostatic hypotension), fatigue/weakness, intolerance to the drug, water retention (edema) in the lower limbs, slow heart rate, decrease in blood pressure.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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 181C, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ebivol

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

6. Contents of the packaging and other information

What Ebivol contains

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

What Ebivol looks like and contents of the packaging

White, round, convex tablets with cross-shaped notches, 9 mm in diameter, with the marking "N5" on one side.
The tablet can be divided into halves and quarters.
Pack sizes: 30, 56, and 60 tablets.

Marketing authorization 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

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, you should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:March 2025.