Nebinad

Package Leaflet: Information for the User

Nebinad, 5 mg, tablets

Nebivolol

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, 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 of the Leaflet

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

1. What is Nebinad and what is it used for

Nebinad contains nebivolol, a medicine that acts on the heart and blood vessels, belonging to a group of selective beta-blockers (i.e., they selectively affect the heart and blood vessels).
The medicine prevents the acceleration of heart rate and controls the strength of heart contractions, has a dilating effect on blood vessels, which leads to a decrease in blood pressure.
Nebinad is used to treat high blood pressure (hypertension).
Nebinad is also used to treat mild and moderate chronic heart failure in patients aged 70 or older, as a supplement to other treatments.
Nebinad is also used to treat symptomatic stable angina.

2. Important information before taking Nebinad

When not to take Nebinad:

• If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• If you have one or more of the following conditions:
• low blood pressure (systolic or "upper" pressure is less than 90 mmHg),
• severe circulatory disorders in the limbs,
• very slow heart rate (less than 60 beats per minute before starting to take this medicine),
• conduction disorders in the heart (such as sick sinus syndrome, including sinoatrial block, or second- or third-degree atrioventricular block in a patient without a pacemaker), or if you have acute heart failure, cardiogenic shock, or are receiving intravenous treatment (through a drip) to support heart function,
• breathing difficulties or wheezing (currently or in the past),
• severe asthma or chronic obstructive pulmonary disease (COPD),
• untreated pheochromocytoma (a tumor located on the top of the kidneys, in the adrenal glands),
• liver function disorders,
• metabolic disorders (metabolic acidosis), such as diabetic ketoacidosis (when blood sugar levels become too high and the blood reaction is too acidic).
• If you are taking medicines containing floctafenine or sultopride.

Warnings and precautions

Before starting to take Nebinad, discuss it with your doctor or pharmacist.
Tell your doctor if you have or develop any of the following conditions:

• abnormally slow heart rate,
• chest pain caused by coronary artery spasm (so-called Prinzmetal's angina),
• untreated chronic heart failure (the heart's inability to pump blood in sufficient quantities for the body's needs),
• first-degree atrioventricular block (a type of conduction disorder that affects heart rhythm),
• poor circulation in the limbs, such as Raynaud's disease or muscle cramps while walking,
• long-term breathing problems,
• diabetes: this medicine does not affect blood sugar levels, but may mask the symptoms of low blood sugar levels (e.g., palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (such as gliclazide, glibenclamide, glipizide, gliburide, or tolbutamide),
• hyperthyroidism, as this medicine may mask the symptoms of abnormally rapid heart rate associated with this condition,
• allergy, as allergic reactions may be more severe and may require more medication to treat them,
• psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past, as this medicine may exacerbate symptoms.

In the event of planned surgery or the need for anesthesia, you should always inform the anesthesiologist or dentist that you are taking this medicine.
In the event of severe kidney function disorders, you should not take this medicine for the treatment of heart failure. You should inform your doctor about this.
At the beginning of the treatment of chronic heart failure, the patient will be regularly monitored by an experienced doctor (see section 3).
You should not suddenly stop taking the medicine without clear advice and assessment by your doctor (see also section 4).

• 3).

Nebinad may reduce tear production, so if you wear contact lenses, you should inform your doctor.

Children and adolescents

Due to the lack of data on the use of Nebinad in children and adolescents, it is not recommendedto use Nebinad in this group of patients.

Nebinad and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Always inform your doctor or pharmacist if you are taking any of the following medicines at the same time as Nebinad, as it may affect how nebivolol or other medicines work:

• medicines used to treat heart diseases or high blood pressure (such as amiodarone, amlodipine, cybenzoline, clonidine, digoxin, or other digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, meksiletine, moksonidine, nifedipine, nicardipine, nimodipine, nitrendipine, organic nitrates, propafenone, quinidine, rilmenidine, verapamil - verapamil should not be administered intravenously),
• medicines used to treat depression or psychosis, such as fluoxetine, paroxetine, tricyclic antidepressants, thioridazine, phenothiazines such as levomepromazine,
• sedatives that may be used to treat epilepsy (barbiturates),
• pain-relieving and anti-inflammatory medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs) used to treat rheumatic diseases,
• medicines for diabetes, such as insulin or oral antidiabetic medicines,
• medicines for acid reflux (cimetidine) - Nebinad should be taken during meals, and antacids between meals,
• anesthetics - you should always inform the anesthesiologist about taking Nebinad before being anesthetized,
• muscle relaxants (baclofen),
• protective agents used during chemotherapy or radiotherapy (amifostine),
• medicines used to treat fungal or yeast infections (terbinafine),
• medicines used to help quit smoking (bupropion),
• antimalarial medicines (mefloquine, chloroquine - also used to treat rheumatism),
• medicines used to treat asthma and stuffy nose,
• medicines used to treat certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils.

Nebinad with food and drink

Nebinad can be taken before, during, or after a meal, and can also be taken without food.
The tablet or its parts should be swallowed with water or another liquid.

Pregnancy and breastfeeding

Nebinad should not be used during pregnancy, unless your doctor has decided otherwise.
Breastfeeding is not recommended while taking Nebinad.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive or use machines.
The medicine may cause dizziness or fainting, due to low blood pressure. If such symptoms occur, DO NOTdrive or operate machines. The occurrence of these symptoms is more likely at the beginning of treatment or when the dose is increased (see also section 4).

Nebinad contains lactose monohydrate

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

3. How to take Nebinad

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

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet (5 mg) per day. The medicine should be taken once a day, preferably at the same time every day.
• For elderly patients and patients with kidney function disorders, the initial dose is usually ½ tablet (2.5 mg) per day.
• It may take up to 4 weeks for the medicine to start working fully.
• In patients over 75 years of age, the doctor will monitor the patient's condition more closely.

Treatment of chronic heart failure

• The patient's treatment will be initiated and monitored by an experienced doctor.
• Treatment starts with a dose of ¼ tablet per day (1.25 mg). This dose may be increased after 1-2 weeks to a dose of ½ tablet (2.5 mg) per day, then to a dose of 1 tablet (5 mg) per day, and then to a dose of 2 tablets (10 mg) per day, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets per day).
• The patient will require observation by an experienced doctor for 2 hours after starting treatment and each time the dose of the medicine is increased.
• Depending on the need, the doctor may reduce the dose of the medicine. You should not suddenly stop taking the medicine without clear advice and assessment by your doctor (see also section 4).
• Patients with severe kidney function disorders should not take this medicine.

Treatment of symptomatic stable angina

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

Patients with liver failure should not take this medicine.
The medicine should be taken once a day, preferably at the same time every day.
The doctor may recommend taking another medicine at the same time, depending on the patient's condition.

Use in children and adolescents

Nebinad is not recommended for use in children and adolescents.

Overdose of Nebinad

In case of accidental ingestion of too many tablets (overdose), the patient may experience:
slow heart rate, low blood pressure, and other heart disorders, breathing difficulties or wheezing. You should immediately go to the nearest hospital or consult a doctor or pharmacist.

Missing a dose of Nebinad

If you forget to take the medicine, but remember soon after, you should take the next tablet at a time close to the usual time of administration. If, however, a long time has passed (e.g., a whole day), you should skip the missed dose and take the next dose at the usual time the next day. You should not take a double dose to make up for the missed dose. You should avoid repeatedly missing doses.

Stopping treatment with Nebinad

You should not stop taking Nebinad without prior consultation with your doctor. Suddenly stopping the medicine may cause a dangerous worsening of symptoms in the patient. This applies especially to patients with heart failure.
If you have any doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebinad can cause side effects, although not everybody gets them.
Side effects that may occur when taking Nebinad for high blood pressure:

• Frequently(occurring in more than 1 in 100 people but less than 1 in 10):
• headache,
• dizziness,
• fatigue,
• paresthesia, unusual itching or tingling sensation,
• diarrhea,
• constipation,
• nausea,
• shortness of breath,
• swelling of hands or feet.

Less frequently(occurring in more than 1 in 1,000 people but less than 1 in 100):

• slow heart rate, heart failure, or other heart disorders,
• low blood pressure,
• cramping leg pain while walking,
• abnormal vision,
• impotence (difficulty achieving an erection),
• depressive disorders,
• indigestion, digestive disorders, gas accumulation in the stomach or intestines,
• vomiting,
• skin rash, itching,
• chest tightness, breathing difficulties, or wheezing,
• nightmares.

Very rarely(occurring in more than 1 in 10,000 people):

• fainting,
• worsening of psoriasis (a skin disease characterized by scaly, pink patches).

Unknown(frequency cannot be estimated from available data):

• angioedema: swelling of the skin of the face or limbs, lips, tongue, mucous membranes of the throat and airways, causing shortness of breath or difficulty swallowing - you should immediately contact your doctor!,
• hypersensitivity,
• hives.

In clinical trials for chronic heart failure, the following side effects were observed:
Very frequently(occurring in more than 1 in 10 people):

• slow heart rate,
• dizziness.

Frequently(occurring in more than 1 in 100 people but less than 1 in 10):

• worsening of heart failure,
• low blood pressure (manifested, for example, as a feeling of fainting when standing up suddenly),
• intolerance to the medicine,
• conduction disorders in the heart affecting heart rhythm (first-degree atrioventricular block),
• swelling of the lower limbs (swollen ankles).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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.
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 Nebinad

Do not store above 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of the month.
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 pack and other information

What Nebinad contains

• The active substance of the medicine is nebivolol in the form of nebivolol hydrochloride.
• The other ingredients are: lactose monohydrate, crospovidone type A, poloxamer 188, povidone K-30, microcrystalline cellulose, magnesium stearate.

What Nebinad looks like and contents of the pack

Nebinad is a white, round, biconvex tablet with a cross-shaped groove on one side, 9 mm in diameter.
The Nebinad tablet can be divided into four equal parts.
The tablets are packaged in PVC/PE/PVDC/Aluminum blisters, in a cardboard box. One pack contains 28 tablets or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw

Manufacturer

PharmaPath S.A.
1, 28 Octovriou str.
Ag, Varvara
12351 Athens,
Greece
Date of last revision of the leaflet:03/2025