Nebinad

Patient Information Leaflet

Nebinad, 5 mg, tablets
Nebivolol
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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 Nebinad is and what it is used for
2. Important information before taking Nebinad
3. How to take Nebinad
4. Possible side effects
5. How to store Nebinad
6. Contents of the pack and other information

1. What Nebinad is and what it is used for

Nebinad contains nebivolol, a medicine acting on the cardiovascular system, belonging to the group of selective beta-blockers (i.e. selectively affecting the cardiovascular system).
The medicine prevents the heart rate from increasing and controls the force of heart contractions. It also causes blood vessels to dilate, resulting in a reduction of blood pressure.
Nebinad is used to treat high blood pressure (hypertension).
Nebinad is also used in the treatment of mild to moderate chronic heart failure in patients aged 70 years or older, as an add-on to other therapies.
Nebinad is also used in the treatment of symptomatic stable coronary artery disease.

2. Important information before using Nebinad

When not to use Nebinad:

• 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 (systolic or "upper" pressure less than 90 mmHg),
  • severe circulatory disorders in the limbs,
  • very slow heart rate (less than 60 beats per minute before starting this medicine),
  • conduction disorders in the heart (such as sick sinus syndrome, including sinoatrial block, or second- or third-degree atrioventricular block in a patient without an implanted pacemaker), or if the patient has acute heart failure, cardiogenic shock, or is receiving intravenous treatment (via intravenous infusion) to support heart function,
  • breathing difficulties or wheezing (currently or in the past),
• severe asthma or chronic obstructive pulmonary disease (COPD),
• untreated phaeochromocytoma: a tumor located on top of the kidneys (in the adrenal glands),
• liver function disorders,
• metabolic disorders (metabolic acidosis), e.g. diabetic ketoacidosis (when blood sugar levels become too high and blood pH becomes too acidic).
  • If the patient is taking medicines containing floctafene or sultopride.

Warnings and precautions
Before starting treatment with Nebinad, discuss it 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 coronary artery spasm (so-called Prinzmetal's angina),
• untreated chronic heart failure (inability of the heart to pump sufficient blood to meet the body's needs),
• first-degree atrioventricular block (a type of conduction disorder affecting heart rhythm),
• poor circulation in the limbs, e.g. Raynaud's disease or symptoms, muscle cramp-like pain during walking,
• long-term breathing problems,
• diabetes: this medicine does not affect blood sugar levels, but it may mask symptoms of low blood sugar (e.g. palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (such as gliclazide, glipizide, glimepiride, tolbutamide, glyquidone, or glyburide),
• hyperthyroidism, because this medicine may mask symptoms of abnormally rapid heartbeat associated with this condition,
• allergies, because allergic reactions may be more severe and a higher dose of medication may be needed to treat them,
• psoriasis (a skin condition characterized by scaly, pink patches) or a history of psoriasis, as this medicine may worsen symptoms.

If surgery is planned or anesthesia is required, always inform the anesthesiologist or dentist about taking this medicine.
This medicine should not be used to treat heart failure in patients with severe kidney function impairment. Inform your 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 instructions and evaluation by a doctor (see section 3).
Nebinad may reduce tear secretion; therefore, if the patient wears contact lenses, they should inform their doctor.

Children and adolescents
Due to lack of data on use in children and adolescents, Nebinad is not recommended in this patient group.

Nebinad 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 or pharmacist if the patient is taking any of the following medicines together with Nebinad, as this may affect how nebivolol or other medicines work:

• medicines used to treat heart diseases or high blood pressure (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin or other products called cardiac glycosides, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nifedipine, nicardipine, nimodipine, nitrendipine, organic nitrates, propafenone, quinidine, rilmenidine, verapamil – verapamil should not be administered intravenously),
• medicines used to treat depression or psychosis, e.g. fluoxetine, paroxetine, tricyclic antidepressants, thioridazine, phenothiazines such as levomepromazine,
• sedatives, which may be used to treat epilepsy (barbiturates),
• pain-relieving and anti-inflammatory medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs) used, for example, in the treatment of rheumatic diseases,
• medicines for diabetes, such as insulin or oral antidiabetic medicines,
• medicines used for acidity (cimetidine) – Nebinad should be taken with food, and antacids should be taken between meals,
• medicines used for anesthesia – always inform the anesthesiologist that Nebinad is being taken before undergoing anesthesia,
• muscle relaxants (baclofen),
• protective agents used during chemotherapy or radiotherapy (amifostine),
• medicines used to treat fungal or yeast infections (terbinafine),
• medicines to help stop smoking (bupropion),
• antimalarial medicines (mefloquine, chloroquine – also used to treat rheumatism),
• medicines used for asthma and nasal congestion,
• medicines used for certain eye conditions, such as glaucoma (increased pressure in the eye) or to dilate the pupil.

Nebinad with food and drink
Nebinad can be taken before, during, or after a meal, or on an empty stomach.
The tablet or its parts should be swallowed with water or another liquid.

Pregnancy and breastfeeding
Do not use Nebinad during pregnancy unless your doctor decides otherwise.
Breastfeeding is not recommended while taking Nebinad.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
No studies have been conducted on the effect on the ability to drive vehicles or operate machinery.
This medicine may cause dizziness or fainting due to lowering of blood pressure. If such symptoms occur, DO NOT drive or operate machinery. These symptoms are more likely at the beginning of treatment or after a dose increase (see also section 4).

Nebinad contains monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use Nebinad

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

• The usual dose is 1 tablet (5 mg) once daily. The medicine should be taken once a day, preferably at the same time each day.
• For elderly patients and patients with impaired renal function, the initial dose is usually ½ tablet (2.5 mg) once daily.
• It may take up to 4 weeks before the medicine starts to work fully.
• For patients over 75 years of age, the doctor will additionally monitor the patient's condition.

Treatment of chronic heart failure

• Treatment must be initiated and monitored by an experienced physician.
• Treatment starts at an initial dose of ¼ tablet daily (1.25 mg). This dose may be increased after 1–2 weeks to ½ tablet (2.5 mg) daily, then to 1 tablet (5 mg) daily, and subsequently to 2 tablets (10 mg) daily, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets daily).
• The patient must be observed by an experienced physician for 2 hours after starting treatment and each time the dose is increased.
• If necessary, the doctor may reduce the dose. Do not stop treatment suddenly, as this may worsen heart failure.
• Patients with severe renal impairment should not take this medicine.

Treatment of symptomatic stable coronary artery disease

• Treatment must be initiated and monitored by an experienced physician.
• Treatment starts at an initial dose of ¼ tablet daily (1.25 mg). This dose may be increased according to the patient's tolerance after 1–2 weeks to ½ tablet (2.5 mg) daily, then to 1 tablet (5 mg) daily, and subsequently to 2 tablets (10 mg) daily, until the appropriate dose for the patient is reached.
• The maximum recommended dose is 10 mg (2 tablets daily).

Patients with hepatic impairment should not use this medicine.
The medicine should be taken once daily, preferably at the same time each day.
The doctor may recommend concomitant use of another medicine, depending on the patient's condition.
Use in children and adolescents
Nebinad is not recommended for use in children and adolescents.
Taking more Nebinad than prescribed
If too many tablets are accidentally taken (overdose), the patient may experience:
slow heart rate, low blood pressure, other cardiac disturbances, breathing difficulties or wheezing. Seek immediate medical attention at the nearest hospital or contact your doctor or pharmacist.
Missing a dose of Nebinad
If the patient forgets to take the medicine but remembers shortly afterwards, they should take the next tablet at the usual time. However, if a significant delay has occurred (e.g. a full day), the missed dose should be skipped and the next dose taken at the usual time the following day. Do not take a double dose to make up for a missed dose. Avoid repeatedly missing doses.
Stopping Nebinad treatment
Do not stop taking Nebinad without first consulting your doctor. Abrupt discontinuation of the medicine may cause dangerous worsening of symptoms, particularly in patients with heart failure.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions that may occur during treatment with Nebinad for high blood pressure:

Common (occurring in more than 1 in 100 people but less than 1 in 10):

• headache,
• dizziness,
• fatigue,
• paraesthesia, unusual itching or tingling sensation,
• diarrhoea,
• constipation,
• nausea,
• shortness of breath,
• swelling of hands or feet.

Uncommon (occurring in more than 1 in 1,000 people but less than 1 in 100):

• slow heart rate, heart failure or other heart-related disorders,
• low blood pressure,
• cramping leg pain during walking,
• visual disturbances,
• impotence (difficulty achieving erection),
• depressive disorders,
• indigestion, digestive disturbances, bloating,
• vomiting,
• skin rash, itching,
• chest tightness, breathing difficulties or wheezing,
• nightmares.

Rare (occurring in more than 1 in 10,000 people):

• fainting,
• exacerbation of psoriasis (a skin disease characterized by scaly, pink patches).

Unknown frequency (frequency cannot be estimated from available data):

• angioedema: swelling of the facial skin or limbs, lips, tongue, mucous membranes of the throat and airways, causing breathing difficulties or swallowing problems – seek immediate medical attention!,
• hypersensitivity,
• urticaria.

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

Very common (occurring in more than 1 in 10 people):

• slow heart rate,
• dizziness.

Common (occurring in more than 1 in 100 people but less than 1 in 10):

• worsening of heart failure,
• low blood pressure (manifesting, for example, as a feeling of faintness upon sudden standing),
• drug intolerance,
• cardiac conduction disorders affecting heart rhythm (first-degree atrioventricular block),
• lower limb oedema (swollen ankles).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, 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 Nebinad

Do not store above 30°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and blister after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nebinad contains

• The active substance is nebisolol in the form of nebisolol hydrochloride.
• The other ingredients are: monohydrate lactose, crospovidone type A, poloxamer 188, povidone K-30, microcrystalline cellulose, magnesium stearate.

What Nebinad looks like and contents of the pack
Nebinad is a white, round, biconvex tablet with crossed grooves dividing it on one side, 9 mm in diameter.
The Nebinad tablet can be divided into four equal parts.
The tablets are packed in PVC/PE/PVDC/Aluminium blisters, in a cardboard box. One pack contains 28 tablets or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
Poland

Manufacturer
PharmaPath S.A.
1, 28 Octovriou str.
Ag. Varvara
12351 Athens,
Greece