Nebivolol Genoptim

Package Leaflet: Information for the Patient

Nebivolol Genoptim, 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.
In case of any doubts, consult a doctor or pharmacist.

• This medicine has been prescribed specifically 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Nebivolol Genoptim and what is it used for

Nebivolol Genoptim contains nebulol, which acts on the cardiovascular system. Nebulol belongs to a group of selective beta-adrenergic blocking agents (i.e., with a selective effect on the cardiovascular system). It prevents the acceleration of heart activity and controls the strength of heart contractions. It also dilates blood vessels, which helps to lower blood pressure.
It is used to treat high blood pressure (hypertension).
Nebivolol Genoptim is also used to treat mild and moderate chronic heart failure, as an addition to standard therapy in patients over 70 years of age.

2. Important information before taking Nebivolol Genoptim

When not to take Nebivolol Genoptim:

• if you are allergic to nebulol or any of the other ingredients of this medicine (listed in section 6),
• if you have been diagnosed with one or more of the following disorders: low blood pressure, severe circulatory disorders in the upper or lower limbs, very slow heart rate (less than 60 beats per minute), certain other severe heart rhythm disorders (e.g., atrioventricular block of the second and third degree, conduction disorders in the heart), heart failure that has recently occurred or worsened, or if you are receiving intravenous medications to support heart function due to cardiogenic shock in acute heart failure, asthma or wheezing (currently or in the past), untreated pheochromocytoma - a tumor located in the upper part of the kidney (in the adrenal gland), liver function disorders,

metabolic disorders (metabolic acidosis), e.g., diabetic ketoacidosis.

Warnings and precautions

Before starting to take Nebivolol Genoptim, 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 spontaneous contraction of the coronary arteries (Prinzmetal's angina),
untreated chronic heart failure,
first-degree atrioventricular block (mild conduction disorder in the heart that affects the heart rhythm),
circulatory disorders in the hands or feet, e.g., Raynaud's disease or syndrome, intermittent claudication,
persistent breathing difficulties,
diabetes - Nebivolol Genoptim does not affect blood sugar levels, but may mask the warning signs of low blood sugar (e.g., palpitations, rapid heart rate),
and may increase the risk of severe hypoglycemia when used with certain types of anti-diabetic medications called sulfonylureas (such as glibenclamide, glipizide, or tolbutamide),
hyperthyroidism - Nebivolol Genoptim may mask the symptoms of abnormally rapid heart rate in this disease,
allergy - Nebivolol Genoptim may exacerbate the reaction to pollen or other allergens,
psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past,
planned surgical procedure - before anesthesia, inform the anesthesiologist about taking Nebivolol Genoptim,
in case of severe kidney function disorders, do not take Nebivolol Genoptim for the treatment of heart failure and discuss it with your doctor.
The patient's condition with chronic heart failure at the beginning of treatment will be monitored by an experienced doctor (see section 3).
Do not suddenly stop treatment unless clearly advised to do so by your doctor (see section 3).

Children and adolescents

Nebivolol Genoptim is not recommended for children and adolescents due to the lack of data on its use in this age group.

Nebivolol Genoptim 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.
Tell your doctor about taking any of the following medicines at the same time as Nebivolol Genoptim:
medicines used to treat high blood pressure or heart disease (such as amiodarone, amlodipine, cybenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, meksiletine, moksonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil),
sedatives and antipsychotics (used in mental disorders), e.g., barbiturates (also used in epilepsy), phenothiazine (also used in case of vomiting and nausea) and thioridazine,
antidepressants, e.g., amitriptyline, paroxetine, fluoxetine,
medicines used for anesthesia during surgery,
medicines used for asthma, stuffy nose, or certain eye diseases, such as glaucoma (increased pressure in the eye), or to dilate the pupils,
baclofen (a muscle relaxant),
amifostine (a protective agent used during cancer treatment),
medicines for diabetes, such as insulin or oral anti-diabetic medications.
All of the above medicines, as well as nebulol, may affect blood pressure and/or heart rate.
Medicines used for stomach acid or stomach ulcers (medicines that reduce stomach acid production), Nebivolol Genoptim should be taken during meals, and antacids between meals.

Nebivolol Genoptim with food and drink

Nebivolol Genoptim can be taken before, during, or after meals, as well as independently of meals. The tablet should be swallowed, washed down with a sufficient amount of water.

Pregnancy, breastfeeding, and fertility

Nebivolol Genoptim should not be used during pregnancy, unless its use is necessary.
It is not recommended to use this medicine during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

This medicine may cause dizziness and fatigue. If such symptoms occur, do not drive or operate machines.

Nebivolol Genoptim contains lactose

This medicine contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Nebivolol Genoptim

This medicine should always be taken as directed by your doctor. In case of doubts, consult your doctor or pharmacist.
The recommended dose is:

Treatment of high blood pressure (hypertension)

The usual dose is 1 tablet per day. Try to take the dose at the same time every day.
In elderly patients and patients with kidney function disorders, treatment usually starts with ½ (half) a tablet per day.
The effect on blood pressure is visible after 1-2 weeks of treatment. In rare cases, optimal effect is achieved after 4 weeks.

Treatment of chronic heart failure

Treatment will be started and monitored by an experienced doctor.
The doctor will start treatment with ¼ (quarter) of a tablet per day. After 1-2 weeks of treatment, the dose may be increased to ½ (half) a tablet per day, then to 1 tablet per day, and subsequently to 2 tablets per day, until the optimal dose for the patient is achieved. The doctor will determine the appropriate dose at each stage of treatment. Follow the doctor's instructions carefully.
The maximum recommended dose is 2 tablets per day (10 mg of nebulol).
The patient will require observation by an experienced doctor for 2 hours after starting treatment and each time the dose is increased.
If necessary, the doctor may reduce the dose of the medicine.
Do not suddenly stop treatment, as it may worsen heart failure.
Patients with severe kidney 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 Nebivolol Genoptim in combination with other medicines suitable for the treatment of the patient's disease.

Use in children and adolescents

Nebivolol Genoptim is not recommended for children and adolescents due to the lack of data on its use.

Use of a higher than recommended dose of Nebivolol Genoptim

In case of accidental overdose, consult a doctor or pharmacist immediately. The most common objective and subjective symptoms of overdose of Nebivolol Genoptim are: very slow heart rate (bradycardia), low blood pressure that can cause fainting (hypotension), shortness of breath similar to that in asthma (bronchospasm), and acute heart failure.
The patient can take activated charcoal (available at pharmacies) while waiting for the doctor to arrive.

Missing a dose of Nebivolol Genoptim

If a dose of Nebivolol Genoptim is missed, but remembered soon after, take the missed dose for that day. However, if it is significantly delayed (e.g., several hours) and the next dose is approaching, skip the missed dose and take the next dose at the usual time. Do not take a double dose of the medicine to make up for the missed dose. Avoid missing doses of the medicine frequently.

Stopping treatment with Nebivolol Genoptim

Do not stop taking Nebivolol Genoptim without consulting your doctor first, regardless of whether it is being taken to treat high blood pressure or chronic heart failure.
Sudden discontinuation of treatment may lead to a temporary worsening of heart failure symptoms. If it is necessary to stop taking Nebivolol Genoptim for the treatment of chronic heart failure, the dose should be gradually reduced, by half, at weekly intervals.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebivolol Genoptim can cause side effects, although not everybody gets them.

Use of Nebivolol Genoptim in the treatment of high blood pressure may cause the following side effects:

Common(may affect up to 1 in 10 people):
headache,
dizziness,
fatigue,
unusual sensation of tingling or numbness,
diarrhea,
constipation,
nausea,
shortness of breath,
swelling of hands or feet.
Uncommon(may affect up to 1 in 100 people):
slow heart rate or other heart disorders,
low blood pressure,
cramping leg pain when walking,
vision disorders,
impotence,
symptoms of depression,
digestive disorders (indigestion), bloating, vomiting,
skin rash, itching,
shortness of breath similar to that in asthma, caused by sudden contraction of the airway muscles (bronchospasm),
nightmares.
Rare(may affect up to 1 in 10,000 people):
fainting,
worsening of psoriasis (a skin disease with scaly, pink patches).
The following side effects have been reported in individual cases during treatment with nebulol:
allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions),
sudden onset of swelling, particularly of the lips, eyes, or tongue, with possible sudden breathing difficulties (angioedema),
a type of skin rash characterized by pale red, raised, itchy bumps, resulting from an allergy or without an allergic background (hives).

In a clinical study on chronic heart failure, the following side effects were observed:

Very common(may affect more than 1 in 10 people):
slow heart rate,
dizziness.
Common(may affect up to 1 in 10 people):
worsening of heart failure,
low blood pressure (e.g., feeling of fainting when standing up quickly),
intolerance to the medicine,
mild conduction disorder in the heart that affects the heart rhythm (first-degree atrioventricular block),
swelling of the lower limbs (e.g., swelling around the ankles).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Nebivolol Genoptim

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" and on the blister after "EXP". The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should 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.
Consult your pharmacist in case of changes in the color or any other signs of deterioration of the medicine.

6. Contents of the pack and other information

What Nebivolol Genoptim contains

The active substance is nebulol. Each tablet contains 5 mg of nebulol (in the form of nebulol hydrochloride).
The other ingredients are: lactose monohydrate, cornstarch, sodium croscarmellose, hypromellose, polysorbate 80, microcrystalline cellulose, silicon dioxide, magnesium stearate.

What Nebivolol Genoptim looks like and contents of the pack

White or almost white, round, biconvex, uncoated tablets with the inscription "T56" on one side and cross-scored on the other side. The tablet can be divided into equal doses.
The tablets are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters.
Package sizes: 28, 30, 50, and 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer/Importer

Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Mawdsley-Brooks & Company Limited
Unit 22, Quest Park, Wheatley Hall Road
Doncaster, DN2 4LT
United Kingdom

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

United Kingdom
Nebivolol 5mg Tablets
Germany
Nebivolol Macleods 5mg Tabletten
Spain
Nebivolol Combix 5 mg comprimidos EFG
Poland
Nebivolol Genoptim

Date of last revision of the leaflet: March 2025