Nebicard

Leaflet attached to the packaging: information for the user

Nebicard, 10 mg, tablets

Nebivolol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor and is intended for your use only. Do not give it to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Nebicard and what is it used for
• 2. Important information 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 is Nebicard and what is it used for

Nebicard contains nebivolol, which is a selective beta-adrenergic receptor blocker (i.e., it only acts on the cardiovascular system). Nebivolol prevents the acceleration of heart rate and controls the strength of heart muscle contractions. It also has a vasodilating effect, which contributes to lowering blood pressure. This medicine is used to treat high blood pressure (hypertension). Nebicard is also used to treat mild and moderate chronic heart failure in patients aged 70 or older, in addition to other medications. Nebicard may also be used to treat symptomatic stable angina.

2. Important information before taking Nebicard

When not to take Nebicard

• if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6),
• if you have low blood pressure (systolic blood pressure <90 mm hg),< li>
• if you have severe circulatory disorders in the upper or lower limbs,
• if you have a very slow heart rate (less than 60 beats per minute),
• if you have certain other severe heart rhythm disorders (e.g., second- or third-degree atrioventricular block, conduction disorders in the heart) and do not have a pacemaker,
• if you have heart failure that has recently occurred or worsened, or if you are receiving intravenous medications to support heart function due to cardiogenic shock in the course of acute heart failure,

in the case of acute heart failure,

• if you have asthma or wheezing (currently or in the past),
• if you have an untreated pheochromocytoma - a tumor located in the upper part of the kidney (in the adrenal gland),
• if you have liver function disorders,
• if you have metabolic disorders (metabolic acidosis), such as diabetic ketoacidosis.

Warnings and precautions

Before starting treatment with Nebicard, you should discuss it with your doctor or pharmacist. You should inform your doctor if you have or develop any of the following conditions:

• untreated heart failure (the heart's inability to pump blood in sufficient quantities for the body's needs),
• abnormally slow heart rate,
• chest pain caused by spontaneous contraction of the coronary arteries (Prinzmetal's angina),
• untreated chronic heart failure,
• first-degree heart block (a mild conduction disorder in the heart that affects heart rhythm),
• poor circulation in the hands or feet, such as Raynaud's disease or syndrome, leg pain when walking,
• persistent breathing disorders,
• diabetes - Nebicard does not affect blood glucose levels, but may mask the warning signs of low blood glucose levels (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic medications called sulfonylureas (such as gliclazide, glipizide, glibenclamide, glimepiride, or tolbutamide),
• hyperthyroidism - Nebicard may mask the symptoms of abnormally rapid heart rate that occur in this disease,
• allergy - Nebicard may exacerbate the reaction to pollen or other allergens,
• psoriasis (a skin disease characterized by scaly, pink patches) or psoriasis in the past,
• planned surgery - before anesthesia, you should inform the anesthesiologist about taking Nebicard.

In the case of severe kidney function disorders, you should not take this medicine for the treatment of heart failure. You should consult a doctor. At the beginning of treatment for chronic heart failure, your doctor will monitor your condition (see section 3). You should not suddenly stop treatment unless it is clearly recommended by your doctor (see section 3).

Children and adolescents

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

Nebicard and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You should inform your doctor about taking any of the following medicines at the same time as Nebicard:

• 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, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sedatives and antipsychotic medications (used in mental disorders), such as barbiturates (also used in epilepsy), phenothiazine (also used in case of vomiting and nausea), thioridazine.
• Antidepressant medications, such as amitriptyline, paroxetine, fluoxetine.
• Medicines used for anesthesia during surgery.
• Medicines used for asthma, nasal congestion, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils.
• Baclofen (a muscle relaxant), amifostine (a protective medication used during cancer treatment). All of the above medications, as well as nebivolol, may affect blood pressure and/or heart rate.
• Medicines used to treat acidosis or stomach ulcers (medicines that neutralize stomach acid), such as cimetidine - Nebicard should be taken during meals, and the acid-neutralizing medicine between meals.
• Medicines for diabetes, such as insulin or oral antidiabetic medications.

Nebicard with food and drink

Nebicard can be taken before, during, or after meals, as well as independently of meals. The tablet should be swallowed with a sufficient amount of water (e.g., a glass).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before taking this medicine. PregnancyYou should not take Nebicard during pregnancy, unless your doctor has advised you to do so. BreastfeedingYou should not take Nebicard while breastfeeding.

Driving and using machines

This medicine may cause dizziness and fatigue. In this case, you should notdrive vehicles or operate machines.

Nebicard contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.

3. How to take Nebicard

This medicine should always be taken according to your doctor's recommendations. If you have any doubts, you should consult a doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The usual dose is half a tablet (5 mg) per day.
• For elderly patients and patients with kidney function disorders, the initial dose is usually 2.5 mg per day (such a dose cannot be obtained using a 10 mg Nebicard tablet - other products or a 5 mg Nebicard product, whose tablet can be divided into two 2.5 mg doses, should be used).

The blood pressure-lowering effect occurs after 1-2 weeks of treatment, but sometimes the optimal effect is achieved after 4 weeks of treatment. The dose should be taken daily at the same time.

• The blood pressure-lowering effect occurs after 1-2 weeks of treatment, but sometimes the optimal effect is achieved after 4 weeks of treatment.
• The dose should be taken daily at the same time.

Treatment of chronic heart failure

• Treatment will be initiated and monitored by an experienced doctor.
• Treatment starts with an initial dose of 1.25 mg per day. This dose may be increased after 1-2 weeks to 2.5 mg per day (such doses cannot be obtained using a 10 mg Nebicard tablet - other products or a 5 mg Nebicard product, whose tablet can be divided into two 2.5 mg doses or four 1.25 mg doses, should be used), then to 5 mg (half a 10 mg Nebicard tablet) per day, and subsequently to 10 mg (1 tablet) per day, until the appropriate dose for the patient is achieved.
• The maximum recommended dose is 10 mg (1 tablet) per day.
• After starting treatment and each time the dose is increased, the patient will be under the doctor's supervision for 2 hours.
• If necessary, the doctor may recommend reducing the dose of the medicine.
• You should not suddenly stop treatment, as it may worsen heart failure.
• Patients with severe kidney function disorders should not take this medicine.
• The dose should be taken once a day, daily at the same time.

Treatment of symptomatic stable angina

• Treatment will be initiated and monitored by an experienced doctor.
• Treatment starts with an initial dose of 1.25 mg per day. This dose may be increased after 1-2 weeks to 2.5 mg per day (such doses cannot be obtained using a 10 mg Nebicard tablet - other products or a 5 mg Nebicard product, whose tablet can be divided into two 2.5 mg doses or four 1.25 mg doses, should be used), then to 5 mg (half a 10 mg Nebicard tablet) per day, and subsequently to 10 mg (1 tablet) per day, until the appropriate dose for the patient is achieved.
• The maximum recommended dose is 10 mg (1 tablet) per day.

Your doctor may recommend taking Nebicard with other medications suitable for you.

Use in children and adolescents

Nebicard is not recommended for children and adolescents.

Taking a higher dose of Nebicard than recommended

In case of accidental ingestion of too many tablets (overdose), you should immediately consult a doctor or go to the emergency department of the nearest hospital. You may experience the following symptoms: slow heart rate, low blood pressure with possible fainting (hypotension), shortness of breath similar to that in asthma (due to bronchospasm), and acute heart failure.

Missing a dose of Nebicard

If you forget to take a dose of Nebicard, but remember within 12 hours, you should take the missed daily dose as usual. If it is almost time for the next dose, you should skip the missed dose and take the next dose at the usual time. You should not take a double dose to make up for the missed dose. You should avoid repeatedly missing doses.

Stopping treatment with Nebicard

You should not stop taking Nebicard without consulting your doctor first, regardless of whether you are taking it to treat high blood pressure or chronic heart failure. Suddenly stopping the medicine may worsen heart failure. If it is necessary to stop the medicine in patients with chronic heart failure, your doctor will recommend gradually reducing the dose, by half every week. If you have any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebicard can cause side effects, although not everybody gets them. During treatment with nebivolol for high blood pressure, the following side effects have been reported: Common side effects (occurring in no more than 1 in 10 people ):

• headache
• dizziness
• fatigue
• abnormal sensation of tingling or prickling
• diarrhea
• constipation
• nausea
• shortness of breath
• edema

Uncommon side effects (occurring in no more than 1 in 100 people ):

• slow heart rate or other heart disorders
• low blood pressure
• leg pain when walking or worsening of it
• vision disorders
• impotence
• depression
• digestive disorders (indigestion), bloating, vomiting
• skin rash, itching,
• shortness of breath similar to that in asthma, caused by sudden bronchospasm
• nightmares
• depression

Rare side effects (occurring in less than 1 in 10,000 people ):

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

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

• allergic reactions affecting the whole body, with generalized skin changes (hypersensitivity reactions);
• rapidly developing swelling, especially around the lips, eyes, or tongue, with possible sudden breathing difficulties (angioedema);
• skin rash with pale red, raised, itchy bumps, resulting from an allergy or without an allergic cause (urticaria).

In clinical trials for chronic heart failure, the following side effects have been observed: Very common side effects (occurring in at least 1 in 10 people ):

• slow heart rate
• dizziness

Common side effects (occurring in less than 1 in 10 people, but at least 1 in 100 ):

• worsening of heart failure
• low blood pressure (e.g., feeling faint when standing up quickly)
• intolerance to the medicine
• mild conduction disorders in the heart that affect heart rhythm (first-degree atrioventricular block)
• edema 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, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebicard

The medicine should be stored out of sight and reach of children.

There are no special recommendations for storing the medicinal product. You should not use this medicine after the expiry date stated on the carton and blister pack after "EXP:". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nebicard contains

• The active substance of the medicine is nebivolol. Each tablet contains 10 mg of nebivolol, equivalent to 10.90 mg of nebivolol hydrochloride.
• The other ingredients are: lactose monohydrate, 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 11.9-12.3 mm, with a dividing line on one side. The Nebicard tablet can be divided into two equal doses. The tablets are packaged in PVC/PVDC/Aluminum blisters, placed in a cardboard box. Pack sizes: 14, 28, 30, 56, 60, 84 tablets.

Marketing authorization 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]

Date of last revision of the leaflet: