Nebivolok
Poland
Table of Contents
Package leaflet: Information for the patient
NebivoLEK, 5 mg, tablets
Nebivololum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- 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 other people, even if their symptoms are the same.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
- What NebivoLEK is and what it is used for
- Important information before taking NebivoLEK
- How to take NebivoLEK
- Possible side effects
- How to store NebivoLEK
- Contents of the pack and other information
1. What NebivoLEK is and what it is used for
NebivoLEK contains nebivolol, a medicine acting on the cardiovascular system, belonging to the group of selective beta-adrenolytic agents (i.e. with selective action on the circulatory system). The medicine prevents acceleration of heart rate, controls the force of heart contractions, and also exerts vasodilatory effects, resulting in reduction of blood pressure.
The medicine is used in the treatment of high blood pressure (hypertension).
NebivoLEK is also used as an adjunctive treatment in mild to moderate chronic heart failure in patients aged 70 years or older.
2. Important information before using NebivoLEK
When not to use NebivoLEK
if the patient is allergic (hypersensitive) to nebivolol or to any of the other
ingredients of this medicine (listed in section 6);
if the patient has one or more of the following conditions:
- low blood pressure;
- severe circulation disorders in the limbs;
- very slow heart rate (less than 60 beats per minute);
- other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders);
- heart failure that has just occurred or has recently worsened, or the patient is receiving intravenous drugs supporting heart function due to cardiogenic shock caused by acute heart failure;
- bronchial asthma or wheezing (currently or in the past);
- untreated pheochromocytoma – a tumour located in the glands above the upper part of the kidneys (adrenal glands);
- liver function disorders;
- metabolic disorder (metabolic acidosis), e.g. diabetic ketoacidosis.
Warnings and precautions
Before starting treatment with NebivoLEK, discuss with a doctor or pharmacist if
the patient has or develops any of the following conditions:
abnormally slow heart rate;
chest pain caused by spontaneous constriction of the heart's blood vessels
(so-called Prinzmetal's angina);
untreated chronic heart failure;
first-degree heart block (a type of mild cardiac conduction disorder affecting
heart rhythm);
poor circulation in the limbs, e.g. Raynaud's disease or syndrome, cramping pain during
walking;
long-term breathing disorders;
diabetes: this medicine does not affect blood glucose levels, but it may mask warning
symptoms of low blood glucose (such as palpitations, rapid heartbeat) and may
increase the risk of severe hypoglycaemia when used together with certain types of
antidiabetic medicines called sulphonylureas (e.g. gliclazide, glipizide, glimepiride,
glibenclamide, tolbutamide, or glyquidone);
hyperthyroidism: the medicine may mask abnormally rapid heart rate caused
by this condition;
allergy: this medicine may intensify the reaction to pollen or other substances to which the patient is allergic;
psoriasis (a skin disease – scaly, pink skin lesions) currently present or in the past;
if the patient is scheduled for surgery: before anaesthesia, always
inform the anaesthesiologist about taking NebivoLEK.
If the patient has severe kidney function disorders, NebivoLEK should not be used for the treatment of heart failure. Inform the doctor about this.
At the beginning of treatment for chronic heart failure, the patient will be regularly monitored by an experienced physician (see section 3).
Do not stop treatment suddenly without clear recommendation and evaluation by a doctor (see section 3).
Children and adolescents
NebivoLEK is not recommended for use in children and adolescents due to lack of data on the use of nebivolol in this patient group.
NebivoLEK and other medicines
Tell your doctor or pharmacist about all medicines currently taken or taken recently, including those available without a prescription. Some medicines must not be used at the same time, while others require certain adjustments (e.g. dosage).
Always inform your doctor if you are taking any of the following medicines in addition to NebivoLEK:
medicines controlling blood pressure or used in heart diseases (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);
sympathomimetic drugs (stimulating the sympathetic nervous system and affecting heart function and circulation);
sedatives and antipsychotics (used to treat mental disorders),
e.g. barbiturates (also used in epilepsy treatment), phenothiazines (also used for vomiting and nausea), and thioridazine;
antidiabetic medicines, such as insulin or oral antidiabetic drugs;
antidepressants, such as amitriptyline, paroxetine, fluoxetine;
anaesthetics used during surgery;
medicines used in bronchial asthma, nasal congestion, or certain eye conditions,
such as glaucoma (increased intraocular pressure) or pupil dilation;
amifostine used in cancer treatment;
baclofen used in epilepsy treatment.
All these medicines, like nebivolol, may affect blood pressure and/or heart function.
medicines reducing stomach hydrochloric acid or used in peptic ulcer disease (antacids), i.e. cimetidine. NebivoLEK should be taken with food, while antacids should be taken between meals.
NebivoLEK with food and drink
NebivoLEK can be taken with or without food, but the tablet should be taken with water.
Pregnancy and breastfeeding
NebivoLEK should not be used during pregnancy, unless absolutely necessary.
Use of this medicine is not recommended during breastfeeding.
If a woman 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
This medicine may cause dizziness or fatigue. If these symptoms occur, do not drive or operate machinery.
NebivoLEK contains lactose and sodium
This medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to use NebivoLEK
This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor.
NebivoLEK may be taken before, during, or after a meal, or independently of meals. Swallow the tablet with water.
Treatment of high blood pressure (hypertension)
The usual dose is 1 tablet once daily. It is best to take the tablet at the same time each day.
Elderly patients and patients with impaired kidney function usually start treatment with a dose of ½ (half) tablet per day.
The therapeutic effect on blood pressure becomes noticeable after 1 to 2 weeks of treatment. Sometimes the optimal treatment effect is only achieved after 4 weeks.
Treatment of chronic heart failure
Treatment will be initiated and closely monitored by an experienced physician.
Your doctor will start treatment with a dose of ¼ (one quarter) of a tablet per day. This dose may be increased after 1 to 2 weeks to ½ (half) tablet per day, then to 1 tablet per day, and subsequently to 2 tablets per day, until an appropriate dose for the patient is reached. At each stage, your doctor will prescribe the appropriate dose, and you must strictly follow their instructions.
The maximum recommended dose is 2 tablets (10 mg) per day.
At the beginning of treatment and with each dose increase, the patient must remain under close supervision of an experienced physician for 2 hours.
If necessary, your doctor may reduce the dose of the medicine.
Do not stop treatment abruptly, as this may worsen heart failure.
Patients with severe kidney function impairment must not take this medicine.
The medicine should be taken once daily, preferably at the same time each day.
How to split the tablet
If your doctor has prescribed ¼ or ½ tablet (two quarters), follow these steps:
- Place the tablet on a smooth, hard surface with the four-leaf clover symbol facing upwards and the tablet's break lines aligned with the clock positions at 12, 3, 6, and 9 o'clock (Figure 1).
Figure 1 – Correct positioning of the tablet
- Place your thumb on the tablet, aligned from 3 to 9 o'clock (Figure 2).
Figure 2 – Positioning of the thumb on the tablet
- Press evenly with your finger across the entire surface of the tablet until it breaks apart.
Your doctor may decide to combine NebivoLEK tablets with other medicines.
Do not use this medicine in children and adolescents.
Accidental overdose of NebivoLEK
In case of accidental overdose, immediately inform your doctor or pharmacist. The most common symptoms of NebivoLEK overdose are: very slow heart rate (bradycardia), low blood pressure possibly leading to fainting (hypotension), shortness of breath with bronchospasm (as in bronchial asthma), and acute heart failure.
While waiting for medical help, activated charcoal (available from pharmacies) may be taken.
Missed dose of NebivoLEK
If a patient forgets to take a dose of NebivoLEK but remembers shortly afterwards, they should take their usual daily dose. However, if the delay is significant (e.g. several hours) and the time for the next dose is approaching, the missed dose should not be taken. Instead, take the next scheduled dose at the usual time. Do not take a double dose. Avoid repeatedly missing doses.
Stopping treatment with NebivoLEK
Before stopping treatment with NebivoLEK, you must always consult your doctor, regardless of whether the medicine is being taken for high blood pressure or chronic heart failure.
Do not stop NebivoLEK treatment abruptly, as this may temporarily worsen heart failure. If discontinuation of nebivolol treatment for chronic heart failure is necessary, the daily dose should be gradually reduced by half every week.
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 they do not occur in everyone.
If NebivoLEK is used for the treatment of high blood pressure, the following adverse reactions may occur:
Common adverse reactions (may occur in fewer than 1 in 10 people):
headache
dizziness
fatigue
itching or tingling sensation
diarrhea
constipation
nausea
shortness of breath
swelling of hands or feet
Uncommon adverse reactions (may occur in fewer than 1 in 100 people):
slow heart rate or other heart-related disorders
low blood pressure
cramping leg pain during walking
vision disturbances
impotence
digestive disorders (dyspepsia), stomach or intestinal gas, vomiting
skin rash, itching
shortness of breath (such as in bronchial asthma), caused by sudden contraction of respiratory muscles (bronchospasm)
nightmares
Very rare adverse reactions (may occur in fewer than 1 in 10,000 people):
fainting
worsening of psoriasis (a skin disease with scaly, red patches)
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
hypersensitivity
angioedema (swelling of the face, lips, oral cavity, tongue or throat)
urticaria (itchy rash)
The following adverse reactions have been observed with similar medicines:
hallucinations
psychotic episodes
confusion
cold extremities, cyanosis of limbs (blue or purple skin discoloration)
Raynaud's phenomenon (discoloration of skin on fingers and toes, occasionally also other body parts)
dry eyes
formation of new connective tissue in the eyes and diaphragm (ocular-mucocutaneous toxicity typical for practolol)
In a clinical trial concerning chronic heart failure, the following adverse reactions were observed:
Very common (may occur in more than 1 in 10 people):
slow heart rate
dizziness
Common (may occur in fewer than 1 in 10 people):
worsening of heart failure
low blood pressure (e.g. feeling faint when standing up quickly)
intolerance to the medicine
a type of mild conduction disorder in the heart affecting heart rhythm (first-degree atrioventricular block)
leg swelling (e.g. swelling around the ankles)
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
5. How to store NebivoLEK
Keep this medicine out of the 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 mentioned month.
No special storage conditions required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What NebivoLEK contains
The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (in the form of
nebivolol hydrochloride).
Other ingredients: sodium croscarmellose, monohydrate lactose, maize starch,
microcrystalline cellulose, hypromellose 5 cps, colloidal anhydrous silica, magnesium stearate.
What NebivoLEK looks like and contents of the pack
White or almost white tablets, divisible into four parts, shaped like a four-leaf clover on one side, convex on the other side, with division lines marked on both sides (9 mm in diameter).
The tablets are packed in PVC/Aluminum blisters and placed in a cardboard box.
Pack sizes: 28 or 56 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
Lek Pharmaceuticals d.d.
Trimlini 2d
9220 Lendava, Slovenia
For further information about the medicinal product and its names in other countries of the
European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00