Nebivolol krka

Package leaflet: Information for the user

Nebivolol Krka, 5 mg, tablets
nebivololum
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 personally. 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, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Nebivolol Krka tablets contain the active substance nebivolol, which acts on the cardiovascular system.
Nebivolol belongs to a group of medicines called selective beta-blockers (i.e. selectively affecting the cardiovascular system). It helps prevent the heart from beating too fast and controls the force of the heart's contractions. It also widens blood vessels, which helps lower blood pressure.
This medicine is used to treat high blood pressure (hypertension) in adults.
Nebivolol Krka 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 Krka

When not to use Nebivolol Krka

• if the patient is allergic to nebivolol or 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 arms or legs;
  • 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 recently developed or worsened, or if the patient is receiving intravenous medicines to support heart function due to cardiogenic shock in acute heart failure;
  • asthma or wheezing (currently or in the past);
  • untreated pheochromocytoma – a tumour located in the upper part of the kidney (adrenal gland);
  • liver function disorders;
  • metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis.

Warnings and precautions
Before starting treatment with Nebivolol Krka, 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 known as 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 hands or feet, e.g. Raynaud’s disease or syndrome, cramping pain when walking;
• persistent breathing difficulties;
• diabetes: This medicine does not affect blood sugar levels, but it may mask warning signs of low blood sugar (hypoglycaemia) (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, glimepiride, glipizide, glyburide, tolbutamide or tolazamide);
• hyperthyroidism: This medicine may mask symptoms of abnormally fast heart rate associated with this condition;
• allergies: This medicine may worsen reactions to pollen or other allergens;
• psoriasis (a skin condition characterized by scaly, red patches) or history of psoriasis;
• planned surgery – always inform the anaesthetist that the patient is taking Nebivolol Krka before anaesthesia;
• in case of severe kidney function disorders, Nebivolol Krka should not be used for the treatment of heart failure and this should be discussed with the doctor.

The patient’s condition in chronic heart failure will be regularly monitored at the beginning of treatment by an experienced doctor (see section 3).
Do not stop treatment suddenly unless clearly instructed by the doctor (see section 3).

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

Nebivolol Krka with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Always inform your doctor if any of the following medicines are being taken at the same time as Nebivolol Krka:

• 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 antipsychotics (used in psychiatric disorders), e.g. barbiturates (also used in epilepsy), phenothiazines (also used for nausea and vomiting), 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 pupil;
• antidiabetic medicines such as insulin or oral antidiabetic drugs;
• baclofen (a medicine that reduces muscle stiffness);
• amifostine (a protective agent used during cancer treatment).

The following medicines, as well as Nebivolol Krka, may affect blood pressure and/or heart function:

• medicines used for acidity or peptic ulcer disease (antacids), e.g. cimetidine: Nebivolol Krka should be taken with food, and the antacid should be taken between meals.

Taking Nebivolol Krka with food and drink
Nebivolol Krka may be taken before, during, or after a meal, or independently of meals. The tablet should be swallowed with water.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Nebivolol Krka should not be used during pregnancy unless absolutely necessary.
Use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
This medicine may cause dizziness or fatigue. In such cases, do not drive or operate machinery.

Nebivolol Krka contains lactose and sodium
If the patient has previously been diagnosed with an intolerance to certain sugars, inform the 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 Nebivolol Krka

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (1 tablet) once daily. Try to take the dose at the same time each day.
• In elderly patients and patients with impaired kidney function, treatment is usually started at ½ (half) a tablet once daily.
• 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 closely monitored by an experienced physician.
• The doctor will start treatment at ¼ (one quarter) of a tablet once daily. After 1–2 weeks of treatment, the dose may be increased to ½ (half) a tablet once daily, then to 1 tablet once daily, and subsequently to 2 tablets once daily, until the optimal dose for the patient is reached. The doctor will determine the appropriate dose at each stage of treatment, and the patient should strictly follow the doctor's instructions.
• The maximum recommended dose is 10 mg (2 tablets) once daily.
• The patient will require close monitoring by an experienced physician for 2 hours after initiation of treatment and each time the dose is increased.
• The doctor may reduce the dose as needed.
• Do not stop treatment suddenly, as this may worsen heart failure.
• This medicine should not be used in patients with severe kidney impairment.
• The medicine should be taken once daily, preferably at the same time each day.
• The doctor may decide to use Nebivolol Krka in combination with other medicines appropriate for the patient's condition.

Use in children and adolescents
Nebivolol Krka is not recommended for use in children and adolescents.
Taking more Nebivolol Krka than recommended
If you accidentally take too much Nebivolol Krka, contact a doctor or pharmacist immediately.
The most common symptoms and signs of overdose with Nebivolol Krka are very slow heart rate
(bradycardia), low blood pressure that may cause fainting (hypotension), breathlessness similar
to 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 Krka
If you forget to take a dose of Nebivolol Krka but remember shortly afterwards, take the missed
dose as soon as you remember. However, if a significant delay has occurred (e.g. several hours)
and the time for the next dose is approaching, 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.
Stopping Nebivolol Krka
Do not stop taking Nebivolol Krka without first consulting your doctor, regardless of whether
the medicine is being used to treat high blood pressure or chronic heart failure.
Suddenly stopping Nebivolol Krka may lead to a temporary worsening of heart failure symptoms.
If treatment with Nebivolol Krka for chronic heart failure needs to be discontinued, the daily
dose should be gradually reduced by half at weekly intervals.
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.
The following adverse reactions have been reported only in individual cases during treatment with Nebivolol Krka.
If any of the following symptoms occur in the patient, contact a doctor immediately:

• allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions);
• rapidly developing swelling, particularly around the lips, eyes or tongue, possibly accompanied by sudden breathing difficulties (angioedema).

Adverse reactions that may occur during treatment with Nebivolol Krka for high blood pressure:

Common (may affect up to 1 in 10 people):

• headache
• dizziness
• fatigue
• unusual sensation of itching or tingling
• diarrhoea
• 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 during walking
• visual disturbances
• impotence
• depressive mood
• digestive disturbances (dyspepsia), bloating, vomiting
• skin rash, itching
• asthma-like shortness of breath caused by sudden contraction of the muscles in the airways (bronchospasm)
• nightmares

Very rare (may affect up to 1 in 10,000 people):

• fainting
• worsening of psoriasis (a skin disease with flaky, red patches)

Unknown (frequency cannot be estimated from available data):

• a type of skin rash characterized by raised, pale-red, itchy bumps, resulting from allergy or non-allergic causes (urticaria)

In a clinical trial investigating treatment of chronic heart failure, the following adverse reactions 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 faint when standing up quickly)
• intolerance to the medicine
• mild disturbance in the heart's electrical conduction affecting heart rhythm (first-degree atrioventricular block)
• swelling of the lower limbs (e.g. swelling around the ankles)

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Nebivolol Krka

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 the
abbreviation "EXP". The expiry date refers to the last day of the specified month.
No special storage instructions are required for this medicine.
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 Nebivolol Krka contains

• The active substance is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride, equivalent to 5 mg of nebivolol.
• The other ingredients are: monohydrate lactose, maize starch, sodium croscarmellose, hypromellose, polysorbate 80, microcrystalline cellulose, colloidal anhydrous silica, and magnesium stearate. See section 2, "Nebivolol Krka contains lactose and sodium".

What Nebivolol Krka looks like and contents of the pack
White or almost white, round, biconvex, uncoated tablets with the engraved mark "5" on one side and cross-scored lines on the other side.
Diameter: 9 mm. The tablet can be divided into equal doses.
Nebivolol Krka is available in cardboard boxes containing 30 tablets in blisters.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

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

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
telephone: + 48 22 573 75 00