Nebilinin

Package leaflet: Information for the patient

Nebilenin, 5 mg, tablets
Nebivolol
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm others, even if their symptoms appear identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Nebilenin is and what it is used for

Nebilenin contains nebiwolol, which is a selective beta-adrenolytic agent with vasodilating properties. This medicine is used to treat high blood pressure (arterial hypertension).
Nebilenin is also used in the treatment of chronic heart failure in patients aged 70 years or older.
Nebilenin may also be used in the treatment of symptomatic, stable coronary artery disease.

2. Important information before using Nebilenin

When not to use Nebilenin

• if the patient has a known allergy (hypersensitivity) to nebivolol or any of the other ingredients of Nebilenin (listed in section 6),
• in case of low blood pressure (systolic or "upper" blood pressure less than 90 mmHg),
• in case of poor blood circulation in the limbs,
• in case of very slow heart rate (less than 60 beats per minute before starting this medicine),
• if the patient has been diagnosed with conduction disorders in the heart (such as sick sinus syndrome or atrioventricular block) and does not have a pacemaker implanted,
• in case of acute heart failure or intravenous treatment (via intravenous infusion) to support heart function,
• in case of breathing difficulties or wheezing,
• if the patient has a tumour of the adrenal gland called phaeochromocytoma,
• if the patient has severe liver disease or impaired liver function,
• in case of metabolic acidosis (such as in patients with diabetes, when blood sugar levels become too high and blood pH becomes too acidic).

Warnings and precautions
Before starting treatment with Nebilenin, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or develops any of the following conditions:

• heart failure (inability of the heart to pump sufficient blood to meet the body's needs),
• mild atrioventricular block in the heart (first-degree),
• chest pain caused by coronary artery spasm (so-called Prinzmetal's angina or nocturnal angina),
• poor circulation in the limbs, e.g. Raynaud's disease or Raynaud's phenomenon, muscle cramp-like pain during walking,
• long-term breathing problems,
• diabetes: Nebilenin does not affect blood sugar levels, but may mask symptoms of low blood sugar (e.g. tremor, rapid heartbeat) and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic drugs called sulfonylureas (such as gliclazide, glimepiride, glipizide, glyburide, tolbutamide or glibenclamide),
• hyperthyroidism, as Nebilenin may mask abnormally rapid heart rate associated with this condition,
• allergies, as allergic reactions may be more severe and a larger dose of medication may be required for treatment,
• skin changes known as psoriasis, as Nebilenin may worsen symptoms,
• wearing contact lenses, as Nebilenin may cause dry eyes.

In such cases, the doctor may adjust the treatment or monitor the patient more frequently.
If surgery is planned and anaesthesia is required, it is important that the patient informs the surgeon or dentist about taking this medicine.
In case of impaired kidney function, this medicine should not be used to treat heart failure. Inform your doctor about this.

Children and adolescents
There is no data available on the use of this product in children and adolescents. Therefore, use of this product is not recommended in these age groups.

Nebilenin with other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Always inform your doctor or pharmacist if the patient is taking any of the following medicines together with Nebilenin:

• diltiazem or verapamil (used to treat high blood pressure or other heart conditions); verapamil should not be administered intravenously during treatment with Nebilenin,
• other calcium antagonists used to treat high blood pressure or other heart conditions, such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine,
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure,
• medicines used to treat heart rhythm disorders (irregular heartbeat), such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone,
• tricyclic antidepressants (used to treat depression), phenothiazines (used to treat psychosis), or barbiturates (used to treat epilepsy),
• medicines used to treat diabetes, such as insulin or oral antidiabetic drugs,
• digoxin or drugs known as cardiac glycosides (used to treat heart failure),
• non-steroidal anti-inflammatory drugs (NSAIDs) used for pain and inflammation,
• medicines used to treat asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation,
• anaesthetics: always inform the anaesthesiologist that the patient is taking Nebilenin before undergoing anaesthesia,
• cimetidine (used to treat stomach acidity) – Nebilenin should be taken with food, while antacids should be taken between meals,
• drugs affecting nebivolol metabolism, i.e. paroxetine, fluoxetine, thioridazine (used to treat depression),
• amifostine (a protective agent used during chemotherapy or radiotherapy),
• baclofen (a muscle relaxant).

Nebilenin with food and drink
Nebilenin can be taken before, during, or after meals, or without food. The tablet or its parts should be swallowed with water or another liquid.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not use Nebilenin during pregnancy unless otherwise directed by a doctor.
Breastfeeding
Breastfeeding is not recommended while taking Nebilenin.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
No studies have been conducted on the effect on the ability to drive vehicles or operate machinery.
When driving motor vehicles or operating mechanical equipment, patients should consider the possibility of occasional dizziness and fatigue.

Nebilenin contains lactose.
If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

3. How to take Nebilenin

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (1 tablet) once daily.
• For elderly patients and patients with impaired kidney function, the initial dose is usually 1/2 tablet once daily.
• It may take up to 4 weeks before the medicine starts to work fully.

Treatment of chronic heart failure

• Treatment must be initiated and monitored by an experienced physician.
• Treatment starts with an initial dose of 1/4 tablet once daily. This dose may be increased after 1–2 weeks to 1/2 tablet once daily, then to 1 tablet once daily, and subsequently to 2 tablets once daily, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets once daily).
• The patient must be monitored by an experienced physician for 2 hours after starting treatment and each time the dose is increased.
• If necessary, the doctor may reduce the dose. Do not stop treatment suddenly, as this may worsen heart failure. Patients with severe kidney function impairment should not take this medicine.

Treatment of symptomatic stable coronary artery disease

• Treatment must be initiated and monitored by an experienced physician.
• Treatment starts with an initial dose of 1/4 tablet once daily (1.25 mg). Depending on the patient's tolerance, this dose may be increased after 1–2 weeks to 1/2 tablet (2.5 mg) once daily, then to 1 tablet (5 mg) once daily, and subsequently to 2 tablets (10 mg) once daily, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets once daily).

The medicine should be taken once daily, preferably at the same time each day.
Your doctor may decide to use this medicine together with another medicine appropriate for the patient.

Use in children and adolescents
Nebilenin is not recommended for use in children and adolescents.

If you take more Nebilenin than you should
If too many tablets are accidentally taken (overdose), symptoms may include slow heart rate, low blood pressure, other heart-related problems, breathing difficulties, or wheezing. Seek immediate medical attention at the nearest hospital or contact your doctor or pharmacist without delay.

If you forget to take Nebilenin
If you forget to take a dose but remember shortly afterwards, take the next tablet as close as possible to the usual time. However, if a significant delay has occurred (e.g. a full day), skip the missed dose and take the next dose at the usual time the following day. Do not take a double dose to make up for a missed dose. Avoid repeated missed doses.

Stopping Nebilenin treatment
Do not stop taking Nebilenin without first consulting your doctor. Suddenly stopping the medicine may cause a 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

When Nebilenin is used for hypertension, the following adverse reactions have been observed:

Common adverse reactions (may affect fewer than 1 in 10 people):

• Headache
• Dizziness
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Shortness of breath
• Swelling of the hands or feet

Uncommon adverse reactions (may affect fewer than 1 in 100 people):

• Slow heart rate or other heart-related disorders
• Low blood pressure
• Cramping leg pain during walking
• Blurred vision
• Impotence (difficulty achieving erection)
• Depressive feelings
• Indigestion, stomach or intestinal gas, vomiting
• Skin rash
• Chest tightness, breathing difficulties, or wheezing
• Nightmares

Very rare adverse reactions (may affect fewer than 1 in 10,000 patients):

• Fainting/Fainting spells
• Worsening of psoriasis

Frequency not known (cannot be estimated from available data):
Swelling of the face or limbs, lips, tongue, mucous membranes of the throat and respiratory tract, causing shortness of breath or difficulty swallowing.
Allergic reactions with skin rash (hypersensitivity reactions),
a type of skin rash characterized by pale red, raised, itchy wheals, resulting from allergy or non-allergic causes (urticaria).

In a clinical trial concerning chronic heart failure, the following adverse reactions were observed:

Very common adverse reactions (may affect more than 1 in 10 people):
slow heart rate,
dizziness.

Common adverse reactions (may affect fewer than 1 in 10 people):
worsening of heart failure,
low blood pressure (e.g. feeling faint upon sudden standing),
drug intolerance,
irregular heart rate,
swelling (e.g. swelling around the ankles).

If any of the adverse reactions worsen, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

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

5. How to store Nebilenin

Keep Nebilenin out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the outer packaging and
immediate packaging. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicinal products must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the packaging and other information

What Nebilenin contains
The active substance is nebivolol.
Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
Other ingredients are:
Monohydrate lactose
Crospovidone type A
Poloxamer 188
Povidone K-30
Microcrystalline cellulose
Magnesium stearate

What Nebilenin looks like and contents of the pack
Nebilenin tablets are white, round, biconvex, with crossed, double-scored lines dividing one side, and approximately 9 mm in diameter.
Nebilenin tablets can be divided into four equal parts.
Tablets are packed in PVC/PVDC/Aluminium blisters (containing 7, 10 or 14 tablets).
Pack sizes: 28, 30, 56, 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer:
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
{Poland} {Nebilenin}
{Denmark} {Nebilenin}

12.2025