Nebicard

Package leaflet: Information for the user

Nebicard, 10 mg, tablets
Nebivolol
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 a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Nebicard is and what it is used for

Nebicard contains nebivolol, which is a selective beta-blocker (meaning it acts primarily on the
cardiovascular system). Nebivolol prevents the heart from beating too fast and reduces the force of
the heart muscle contraction. It also has a blood vessel-dilating effect, which contributes to lowering
blood pressure.
This medicine is used to treat high blood pressure (hypertension).
Nebicard is also used in the treatment of mild to moderate chronic heart failure in patients aged 70 years or older, in addition to other medications.
Nebicard may also be used in the treatment of symptomatic stable angina pectoris.

2. Important information before using Nebicard

When not to use Nebicard

• if the patient is allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has low blood pressure (systolic blood pressure < 90 mm Hg),
• if the patient has severe circulatory disorders in the upper or lower limbs,
• if the patient has very slow heart rate (less than 60 beats per minute),
• if the patient has certain other severe heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders) and does not have a pacemaker implanted,
• if the patient has heart failure which has recently developed or worsened, or if the patient is receiving intravenous medications to support heart function due to cardiogenic shock in the course of acute heart failure,
• if the patient has asthma or wheezing (currently or in the past),
• if the patient has untreated pheochromocytoma – a tumour located in the upper part of the kidney (adrenal gland),
• if the patient has liver function disorders,
• if the patient has metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis.

Warnings and precautions
Before starting treatment with Nebicard, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has or develops any of the following conditions:

• untreated heart failure (inability of the heart to pump sufficient blood to meet the body's needs),
• abnormally slow heart rate,
• chest pain caused by spontaneous coronary artery spasm (Prinzmetal's angina),
• untreated chronic heart failure,
• first-degree heart block (mild cardiac conduction disorder affecting heart rhythm),
• poor circulation in the arms or legs, e.g. Raynaud's disease or syndrome, cramping pain while walking,
• persistent breathing disorders,
• diabetes – Nebicard does not affect blood glucose levels, but it may mask warning symptoms of low blood glucose (hypoglycaemia) and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic drugs called sulfonylureas (such as gliclazide, glimepiride, glipizide, glyburide, tolbutamide, or gliquidone),
• hyperthyroidism – Nebicard may mask symptoms of abnormally rapid heart rate associated with this condition,
• allergies – Nebicard may worsen the reaction to pollen or other allergens,
• psoriasis (a skin disease characterised by scaly, red patches) or history of psoriasis,
• planned surgical procedure – before anaesthesia, inform the anaesthesiologist that the patient is taking Nebicard.

In case of severe kidney function disorders, this medicine should not be used for the treatment of heart failure. Consult your doctor.
When starting treatment for chronic heart failure, the doctor will monitor the patient's condition (see section 3).
Do not stop treatment suddenly unless clearly instructed by the doctor (see section 3).

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

Nebicard and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Inform your doctor if the patient is taking any of the following medicines together with Nebicard:

• 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.
• Baclofen (a muscle relaxant), amifostine (a protective agent used during cancer treatment). 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 (antacids), e.g. cimetidine – Nebicard should be taken with food, while antacids should be taken between meals.
• Medicines for diabetes, such as insulin or oral antidiabetic drugs.

Nebicard with food and drink
Nebicard may be taken before, during, or after meals, or independently of meals.
The tablet should be swallowed with sufficient liquid (e.g. a glass of 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.

Pregnancy
Do not use Nebicard during pregnancy unless otherwise directed by a doctor.

Breastfeeding
Nebicard is not recommended during breastfeeding.

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

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

3. How to use Nebicard

This medicine should always be used exactly as prescribed by the doctor. In case of doubt, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The usual dose is half a tablet (5 mg) once daily.
• For elderly patients and patients with kidney function disorders, the initial dose is usually 2.5 mg once daily (this dose cannot be achieved with the 10 mg Nebicard tablet – alternative products or the 5 mg Nebicard tablet, which can be divided into two 2.5 mg doses, should be used).
• The blood pressure-lowering effect appears after 1–2 weeks of treatment, but optimal effect may sometimes be achieved after 4 weeks.
• The dose should be taken daily at the same time.

Treatment of chronic heart failure

• Treatment will be initiated and monitored by an experienced physician.
• Treatment starts with an initial dose of 1.25 mg once daily. This dose may be increased after 1–2 weeks to 2.5 mg once daily (these doses cannot be achieved with the 10 mg Nebicard tablet – alternative products or the 5 mg Nebicard tablet, which can be divided into two 2.5 mg doses or four 1.25 mg doses, should be used), then to 5 mg (half of a 10 mg Nebicard tablet) once daily, and subsequently to 10 mg (1 tablet) once daily, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (1 tablet) once daily.
• After starting treatment and after each dose increase, the patient will remain under medical supervision for 2 hours.
• If necessary, the doctor may recommend reducing the dose.
• Do not stop treatment suddenly, as this may worsen heart failure.
• Patients with severe kidney function disorders must not take this medicine.
• The dose should be taken once daily at the same time.

Treatment of symptomatic stable coronary artery disease

• Treatment will be initiated and monitored by an experienced physician.
• Treatment starts with an initial dose of 1.25 mg once daily. This dose may be increased after 1–2 weeks to 2.5 mg once daily (these doses cannot be achieved with the 10 mg Nebicard tablet – alternative products or the 5 mg Nebicard tablet, which can be divided into two 2.5 mg doses or four 1.25 mg doses, should be used), then to 5 mg (half of a 10 mg Nebicard tablet) once daily, and subsequently to 10 mg (1 tablet) once daily, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (1 tablet) once daily.

The doctor may recommend using Nebicard together with other medicines appropriate for the patient.

Use in children and adolescents
Nebicard is not recommended for use in children and adolescents.

Taking more Nebicard than recommended
If an overdose is taken by accident, contact a doctor immediately or go to the nearest hospital emergency department.
The patient may experience the following symptoms: slow heart rate, low blood pressure with possible fainting (hypotension), breathing difficulty resembling asthma (due to bronchospasm), and acute heart failure.

If a dose of Nebicard is missed
If the patient forgets to take a dose of Nebicard but remembers within 12 hours, they should take the missed dose as usual. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken at the usual time. Do not take a double dose to make up for a missed dose. Avoid repeatedly missing doses.

Stopping Nebicard treatment
Do not stop taking Nebicard without first consulting your doctor, regardless of whether it is being used to treat high blood pressure or chronic heart failure.
Sudden discontinuation may worsen symptoms of heart failure. If discontinuation is necessary in patients with chronic heart failure, the doctor will recommend gradually reducing the dose 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.

The following adverse reactions have been reported during treatment with nebisolol for high blood pressure:

Common adverse reactions (occur in no more than 1 in 10 people):

• headache
• dizziness
• fatigue
• unusual sensations of itching or tingling
• diarrhoea
• constipation
• nausea
• shortness of breath
• swelling (oedema)

Uncommon adverse reactions (occur in no more than 1 in 100 people):

• slow heart rate or other heart disorders
• low blood pressure
• cramping leg pain during walking or worsening of such pain
• visual disturbances
• impotence
• low mood (depression)
• digestive disorders (dyspepsia), bloating, vomiting
• skin rash, itching
• asthma-like shortness of breath caused by sudden contraction of the airway muscles (bronchospasm)
• nightmares
• depression

Very rare adverse reactions (occur in fewer than 1 in 10,000 people):

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

Frequency not known (cannot be estimated from the available data):

• allergic reactions affecting the whole body, with generalized skin lesions (hypersensitivity reactions)
• sudden onset of swelling, particularly around the lips, eyes or tongue, possibly leading to sudden breathing difficulties (angioedema)
• skin rash with pale red, raised, itchy bumps, due to allergy or non-allergic causes (urticaria)

In clinical trials for chronic heart failure, the following adverse reactions have been observed:

Very common adverse reactions (occur in at least 1 in 10 people):

• slow heart rate
• dizziness

Common adverse reactions (occur in fewer than 1 in 10 people, but in at least 1 in 100):

• worsening of heart failure
• low blood pressure (e.g. feeling faint when standing up quickly)
• drug intolerance
• mild disturbances in heart 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 not listed in this leaflet, tell your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nebicard

Keep this medicine out of sight and reach of children.
No special storage conditions are required for this medicinal product.
Do not use this medicine after the expiry date stated on the cardboard box and on the blister pack following the abbreviation "EXP:". The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer used. Such measures help protect the environment.

6. Contents of the packaging and other information

What Nebicard contains

• The active substance is nebivolol. Each tablet contains 10 mg of nebivolol, equivalent to 10.90 mg of nebivolol hydrochloride.
• The other ingredients are: monohydrate lactose, crospovidone type A, poloxamer 188, povidone K 30, microcrystalline cellulose, magnesium stearate.

What Nebicard looks like and contents of the pack
Nebicard tablets are white or almost white, round, biconvex, with a diameter of 11.9 mm – 12.3 mm, and a score line on one side.
Nebicard tablets can be divided into two equal doses.
The tablets are packed in PVC/PVDC/Aluminium blisters, placed in a cardboard box.
Pack sizes:
14, 28, 30, 56, 60, 84 tablets.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]