Nebivolol genoptim

Package leaflet: Information for the user

Nebivolol Genoptim, 5 mg, tablets
Nebivololum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
Keep this leaflet as 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 a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same. If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Nebivolol Genoptim is and what it is used for
2. What you need to know 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 Nebivolol Genoptim is and what it is used for

Nebivolol Genoptim contains nebvivolol, which acts on the cardiovascular system. Nebivolol belongs to a group of medicines called selective beta-adrenolytics (i.e. with selective action on the cardiovascular system). It prevents the heart from beating too fast and controls the force of the heart's contractions. It also dilates blood vessels, which helps lower blood pressure.
It is used in the treatment of high blood pressure (hypertension).
Nebivolol Genoptim is also used in the treatment of mild to moderate chronic heart failure, as an addition to standard therapy in patients aged 70 years and older.

2. Important information before using Nebivolol Genoptim

When not to use Nebivolol Genoptim:

• if the patient is allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has been diagnosed with one or more of the following conditions: low blood pressure, severe circulatory disorders in the upper or lower limbs, very slow heart rate (less than 60 beats per minute), certain other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders), heart failure which has recently developed or worsened, or if the patient is receiving intravenous drugs to support heart function due to cardiogenic shock in acute heart failure, asthma or wheezing (currently or in the past), untreated phaeochromocytoma – a tumour 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 treatment with Nebivolol Genoptim, discuss this with your doctor or pharmacist.

Inform your doctor if the patient has or develops any of the following conditions:

• abnormally slow heart rate,
• chest pain caused by spontaneous coronary artery spasm (Prinzmetal's angina),
• untreated chronic heart failure,
• first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm),
• circulatory disorders in hands or feet, e.g. Raynaud's disease or syndrome, cramping pain during walking,
• persistent breathing difficulties,
• diabetes – Nebivolol Genoptim does not affect blood sugar levels, but it may mask warning symptoms of low blood sugar (e.g. palpitations, rapid heartbeat), and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulfonylureas (such as gliclazide, glipizide, glimepiride, tolbutamide, glibenclamide, or glyquidone),
• hyperthyroidism – Nebivolol Genoptim may mask symptoms of abnormally rapid heartbeat associated with this condition,
• allergies – Nebivolol Genoptim may intensify the reaction to pollen or other allergens,
• psoriasis (a skin disease characterized by scaly, red patches) or history of psoriasis,
• planned surgical procedure – inform the anaesthesiologist about taking Nebivolol Genoptim before anaesthesia,
• in case of severe kidney function impairment, Nebivolol Genoptim should not be used for the treatment of heart failure and this should be discussed with the doctor.

The patient's condition with chronic heart failure will be monitored by an experienced physician at the beginning of treatment (see section 3).

Do not abruptly stop treatment unless specifically instructed by the doctor (see section 3).

Children and adolescents

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

Nebivolol Genoptim and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Inform your doctor if the patient is taking any of the following medicines together with Nebivolol Genoptim:

• medicines used to treat high blood pressure or heart conditions (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil),
• sedatives and antipsychotic medicines (used in psychiatric disorders), e.g. barbiturates (also used in epilepsy), phenothiazines (also used for nausea and vomiting) and thioridazine,
• antidepressants, e.g. amitriptyline, paroxetine, fluoxetine,
• medicines used for anaesthesia during surgery,
• medicines used for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased eye pressure), or to dilate the pupils,
• baclofen (a medicine that reduces muscle tension),
• amifostine (a protective agent used during cancer treatment),
• medicines for diabetes, such as insulin or oral antidiabetic medicines.

All of the above medicines, as well as nebivolol, may affect blood pressure and/or heart rate.

• medicines used for acid reflux or peptic ulcer disease (medicines that reduce stomach acid secretion) – Nebivolol Genoptim should be taken with food, and the acid-neutralizing medicine should be taken between meals.

Nebivolol Genoptim with food and drink

Nebivolol Genoptim may be taken before, during, or after a meal, or independently of meals. Swallow the tablet with sufficient liquid.

Pregnancy, breastfeeding, and fertility

Nebivolol Genoptim should not be used during pregnancy unless clearly necessary.

Use of this medicine during breastfeeding is not recommended.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and using machines

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

Nebivolol Genoptim contains lactose

This medicine contains lactose. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Nebivolol Genoptim

This medicine should always be used as directed by the doctor. If in doubt, consult your
doctor or pharmacist.
Recommended dose:
Treatment of high blood pressure (hypertension)
The usual dose is 1 tablet per day. Try to take the dose at the same time each day.
For elderly patients and patients with impaired kidney function, treatment usually starts with ½ (half) a tablet per day.
The effect on blood pressure becomes apparent after 1–2 weeks of treatment. In rare cases, optimal effect is achieved after 4 weeks.
Treatment of chronic heart failure
Treatment will be initiated and monitored by an experienced physician.
The doctor will start treatment with ¼ (one quarter) of a tablet per day. After 1–2 weeks of treatment, this 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 reached. The doctor will determine the appropriate dose at each stage of treatment. You must strictly follow the doctor’s instructions.
The maximum recommended dose is 2 tablets per day (10 mg of nebivolol).
The patient will require monitoring by an experienced physician for 2 hours after initiation of treatment and each time the dose is increased.
If necessary, the doctor may reduce the dose of the medicine.
Do not stop treatment suddenly, as this may worsen heart failure.
Patients with severe renal impairment should not take this medicine.
The medicine should be taken once daily, preferably at the same time each day.
The doctor may recommend using Nebivolol Genoptim in combination with other medicines appropriate for treating the patient’s condition.
Use in children and adolescents
Nebivolol Genoptim is not recommended for use in children and adolescents due to lack of data on its use.
Taking more Nebivolol Genoptim than recommended
If you accidentally take too much medicine, consult a doctor or pharmacist immediately. The most common signs and symptoms of overdose with Nebivolol Genoptim are: very slow heart rate (bradycardia), low blood pressure that may cause fainting (hypotension), breathlessness similar to that occurring in bronchial asthma (bronchospasm), and acute heart failure.
The patient may take activated charcoal (available from pharmacies) while waiting for the doctor to arrive.
If you forget to take Nebivolol Genoptim
If you forget to take a dose of Nebivolol Genoptim but remember shortly afterwards on the same day, take the missed dose as soon as you remember. However, if a significant delay has occurred (e.g. several hours) and it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose. Avoid repeatedly missing doses of this medicine.
Stopping Nebivolol Genoptim
Do not stop taking Nebivolol Genoptim without first consulting your doctor, regardless of whether it is being used to treat high blood pressure or chronic heart failure.
Stopping the medicine suddenly may lead to a temporary worsening of heart failure symptoms. If it is necessary to discontinue Nebivolol Genoptim in the treatment of chronic heart failure, the dose should be gradually reduced by half at weekly intervals.
If you have any further doubts 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 everybody will experience them.
Use of Nebivolol Genoptim in the treatment of hypertension may cause the following
adverse effects:
Common (may affect up to 1 in 10 patients):
headache,
dizziness,
fatigue,
unusual sensations of itching or tingling,
diarrhea,
constipation,
nausea,
dyspnea (shortness of breath),
swelling of hands or feet.
Uncommon (may affect up to 1 in 100 patients):
slow heart rate or other heart disorders,
low blood pressure,
cramping leg pain during walking,
visual disturbances,
impotence,
depression-like symptoms,
digestive disorders (dyspepsia), bloating, vomiting,
skin rash, itching,
asthma-like dyspnea caused by sudden contraction of respiratory muscles (bronchospasm),
nightmares.
Very rare (may affect up to 1 in 10,000 patients):
fainting,
worsening of psoriasis (a skin disease with scaly, pink patches).
The following adverse effects have been reported only in isolated cases during treatment with nebivolol:
systemic allergic reactions with generalized skin lesions (hypersensitivity reactions),
sudden onset of swelling, particularly of the lips, eye area or tongue, possibly accompanied by sudden breathing difficulties (angioedema),
a type of skin rash characterized by pale red, raised, itchy bumps, resulting from allergy or non-allergic causes (urticaria).
In a clinical trial on chronic heart failure, the following adverse effects were observed:
Very common (may affect at least 1 in 10 patients):
slow heart rate,
dizziness.
Common (may affect up to 1 in 10 patients):
worsening of heart failure,
low blood pressure (e.g. feeling faint when standing up quickly),
intolerance to the medicine,
mild disturbance in cardiac conduction affecting heart rhythm (first-degree atrioventricular block),
swelling of lower limbs (e.g. swelling around the ankles).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Nebivolol Genoptim

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date (EXP)" and on the blister after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
Consult your pharmacist if there is any change in colour or other signs indicating deterioration in the quality of the medicine.

6. Contents of the packaging and other information

What Nebivolol Genoptim contains
The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (in the form of
nebivolol hydrochloride).
The other ingredients are: monohydrate lactose, corn starch, sodium croscarmellose,
hypromellose, polysorbate 80, microcrystalline cellulose, colloidal anhydrous silica,
magnesium stearate.

What Nebivolol Genoptim looks like and contents of the pack
White or almost white, round, biconvex, uncoated tablets with the imprint “T56” on one side and
crossed grooves on the other side. The tablet may be divided into equal doses.
The tablets are packed in PVC/PVDC/Aluminium blisters or OPA/Aluminium/PVC/Aluminium blisters.
Pack sizes: 28, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Poland

Manufacturer/Importer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

This medicinal product is authorised in 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