Nebilet

Leaflet accompanying the packaging: information for the user

NEBILET, 5 mg, tablets

Nebivolol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Nebilet and what is it used for

Nebilet contains nebivolol, which acts on the cardiovascular system. Nebivolol belongs to a group of selective beta-adrenergic blocking agents (i.e., they selectively affect the cardiovascular system). It prevents the acceleration of heart rate and controls the strength of heart contractions. It also dilates blood vessels, which helps to lower blood pressure. Nebilet is used to treat high blood pressure (hypertension). It is also used to treat mild and moderate, chronic heart failure as an adjunct to standard therapy in patients over 70 years old.

2. Important information before taking Nebilet

When not to take Nebilet

• 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 disorders:
• low blood pressure,
• severe circulatory disorders in the upper or lower limbs,
• very slow heart rate (less than 60 beats per minute),
• certain other severe heart rhythm disorders (e.g., second- and third-degree atrioventricular block, conduction disorders in the heart),
• heart failure that has recently occurred or worsened, or if the patient is receiving intravenous medications to support heart function due to cardiogenic shock in acute heart failure,
• asthma or wheezing (currently or in the past),
• untreated pheochromocytoma - a tumor 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 to take Nebilet, discuss it with your doctor or pharmacist. Inform your doctor if you have or develop 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 atrioventricular block (mild conduction disorder in the heart that affects heart rhythm),
• circulatory disorders in the hands or feet, e.g., Raynaud's disease or syndrome, cramping pains when walking,
• persistent breathing difficulties,
• diabetes - Nebilet does not affect blood sugar levels, but it may mask the warning signs of low blood sugar (e.g., palpitations, rapid heart rate),
• hyperthyroidism - Nebilet may mask the symptoms of abnormally rapid heart rate in this disease,
• allergy - Nebilet may increase the reaction to pollen or other allergens,
• psoriasis (a skin disease characterized by scaly, pink patches) or a history of psoriasis, planned surgery - before anesthesia, inform the anesthesiologist about taking Nebilet. In case of severe kidney function disorders, do not take Nebilet for heart failure treatment and discuss it with your doctor.

The patient's condition with chronic heart failure at the beginning of treatment will be monitored by an experienced doctor (see section 3). Do not suddenly stop treatment unless explicitly advised by your doctor (see section 3).

Children and adolescents

Do notrecommend Nebilet for children and adolescents due to the lack of data on its use in this age group.

Nebilet and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. Inform your doctor about taking any of the following medicines at the same time as Nebilet:

• 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 medicines (used in mental disorders), e.g., barbiturates (also used in epilepsy), phenothiazine (also used in case of vomiting and nausea), thioridazine.
• Antidepressant medicines, e.g., amitriptyline, paroxetine, fluoxetine.
• Medicines used for anesthesia during surgery.
• Medicines used for asthma, stuffy nose, or certain eye diseases, such as glaucoma (increased eye pressure) or to dilate the pupils.
• Baclofen (a medicine that reduces muscle tension), amifostine (a medicine with a protective effect, used during cancer treatment). All of the above medicines, as well as nebivolol, may affect blood pressure and/or heart rate.
• Medicines used for stomach acid or stomach ulcers (medicines that reduce stomach acid secretion) - take Nebilet during meals, and antacids between meals.

Nebilet with food and drink

See section 3.

Pregnancy and breastfeeding

Nebilet should not be used during pregnancy unless necessary. Women taking nebivolol should not breastfeed. If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Nebilet contains lactose

If you have previously been diagnosed with intolerance to some sugars, you should contactyour doctor before takingthe medicine. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Nebilet

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Nebilet can be taken before, during, or after meals, as well as independently of meals. Take the tablet with a sufficient amount of water. Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet per day. Try to take the dose at the same time every day.
• In elderly patients and patients with kidney function disorders, treatment usually starts with ½ (half) a tablet once a day.
• The effect on blood pressure is visible after 1-2 weeks of treatment. In rare cases, optimal efficacy is achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment will be started and monitored by an experienced doctor.
• The doctor will start treatment with ¼ (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 achieved. 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 2 tablets per day (10 mg of nebivolol).
• The patient will require close observation by an experienced doctor for 2 hours after starting treatment and each time the dose of the medicine is increased.
• Depending on the need, the doctor may reduce the dose of the medicine.
• Do not suddenly stop treatment, as it may worsen heart failure.
• Patient with severe kidney failure should not take this medicine.
• Use in patients with liver function disorders is contraindicated.
• Take the medicine once a day, preferably at the same time every day.

If your doctor has prescribed ¼ (quarter) or ½ (half) a tablet per day, read the instructions for breaking the Nebilet tablets below.

• Place the tablet on a flat, hard surface (e.g., a table or countertop), with the scored lines facing up.
• Break the tablet along the vertical line, pressing it against the surface with your index fingers, as shown in figures 1 and 2.
• Quarter-tablets can be obtained by breaking the halves in the same way, as shown in figures 3 and 4.

Figures 1 and 2: Dividing the Nebilet tablet into 2 halves.
Figures 3 and 4: Dividing a half-tablet of Nebilet into 2 halves (obtaining ¼ of a tablet).

• Your doctor may recommend taking Nebilet in combination with other medicines suitable for the treatment of your disease.
• Do not take Nebilet in children and adolescents.

Taking a higher dose of Nebilet than recommended

In case of accidental overdose, immediatelyconsult a doctor or pharmacist. The most common subjective and objective symptoms of Nebilet overdose are: very slow heart rate (bradycardia), low blood pressure that can cause fainting (hypotension), shortness of breath similar to that in bronchial asthma, and acute heart failure. The patient can take activated charcoal (available at pharmacies) while waiting for the doctor to arrive.

Missing a dose of Nebilet

If you miss a dose of Nebilet but remember soon after, take the missed dose for that day. However, if it is significantly delayed (e.g., several hours) and the time for the next dose is approaching, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose of the medicine. Avoid missing multiple doses of the medicine.

Stopping treatment with Nebilet

Always consult your doctor before stopping treatment with Nebilet, whether it is for high blood pressure, chronic heart failure, or stable coronary artery disease. Do not suddenly stop taking the medicine, as it may lead to a temporary worsening of heart failure symptoms. If it is necessary to stop treatment for chronic heart failure with Nebilet, the dose should be gradually reduced by half over a period of weeks. In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebilet 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 (may affect up to 1 in 10 people):

• headache,
• dizziness,
• fatigue,
• unusual sensation of tingling or prickling,
• diarrhea,
• constipation,
• nausea,
• shortness of breath,
• swelling, e.g., of hands or feet.

Uncommon (may affect up to 1 in 100 people):

• slow heart rate or other heart disorders,
• low blood pressure,
• cramping pains in the legs when walking,
• vision disorders,
• impotence,
• depressive mood,
• digestive disorders (indigestion), bloating, vomiting,
• skin rash, itching,
• shortness of breath similar to that in bronchial asthma, caused by sudden constriction of airway muscles (bronchospasm),
• nightmares.

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

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

The following side effects have been reported in individual cases during treatment with Nebilet:

• 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);
• a type of skin rash characterized by pale red, raised, itchy bumps, resulting from an allergy or without an allergic background (urticaria).

In a clinical trial where Nebilet was used in chronic heart failure, the following side effects 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 of fainting when standing up quickly),
• intolerance to the medicine,
• mild conduction disorder in the heart that affects heart rhythm (first-degree atrioventricular block),
• swelling of the lower limbs (e.g., swelling around the ankles).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
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 Nebilet

Keep the medicine out of sight and reach of children. The medicine does not require special storage precautions. Do not use this medicine after the expiry date stated on the blisters and carton after the abbreviation "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. 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 Nebilet contains

The active substance of the medicine is nebivolol. Each tablet contains 5 mg of nebivolol (in the form of nebivolol hydrochloride): 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol. The other ingredients are: lactose monohydrate, cornstarch, croscarmellose sodium (E468), hypromellose (E464), polysorbate 80 (E433), microcrystalline cellulose (E460), colloidal silicon dioxide (E551), magnesium stearate (E572), purified water.

What Nebilet looks like and contents of the pack

White, round tablets with cross-scored lines. The tablets can be divided into four equal parts. Packs of 7 or 28 tablets. Blisters of PVC/Aluminum in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin, Germany

Manufacturer

Berlin-Chemie AG
(Menarini Group)
Glienicker Weg 125
12489 Berlin, Germany
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13

• 01097 – Dresden Germany

For more detailed information, please contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.

Date of last revision of the leaflet: