Nebivolol Zentiva

PATIENT INFORMATION LEAFLET

Nebivololo Zentiva 5 mg tablets

Generic medicine
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT IS NEBIVOLOL ZENTIVA AND WHAT IS IT USED FOR

Nebivolol Zentiva contains nebivolol, a cardiovascular medicine belonging to the group of selective beta-blocking agents (i.e. with selective action on the cardiovascular system). Nebivolol Zentiva prevents the increase in heart rate and controls the force with which the heart pumps. It also has a dilating effect on blood vessels, which contributes to lowering blood pressure. It is used to treat high blood pressure (hypertension).
Nebivolol Zentiva is also used to treat mild to moderate chronic heart failure, in addition to other therapies, in patients aged 70 years and older.

2. WHAT YOU SHOULD KNOW BEFORE TAKING NEBIVOLOL ZENTIVA

Do not take Nebivolol Zentiva if:

• You are allergic to nebivolol or to any of the other ingredients of this medicine (listed in section 6).
• You have one or more of the following conditions:
  • Low blood pressure
  • Severe circulation problems 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 just developed or recently worsened, or if you are receiving intravenous treatment for circulatory shock caused by acute heart failure to help the heart function
  • Asthma or shortness of breath (current or previous)
  • Untreated phaeochromocytoma, a tumour located in the upper part of the kidney (in the adrenal gland)
  • Liver function disorders
  • Metabolic disorder (metabolic acidosis, e.g. diabetic ketoacidosis)

Warnings and precautions

Talk to your doctor or pharmacist before taking Nebivolol Zentiva.

It is important to inform your doctor if you have or develop any of the following conditions:

• Unusually slow heartbeat
• A type of chest pain caused by spontaneous spasm in the heart (called Prinzmetal's angina)
• Untreated chronic heart failure
• First-degree heart block (a mild type of cardiac conduction disorder affecting heart rhythm)
• Poor circulation in the arms and legs, e.g. Raynaud’s disease or syndrome, cramp-like pain when walking
• Prolonged breathing problems
• Diabetes: this medicine does not affect blood sugar levels, but it may mask warning signs of low blood sugar (e.g. palpitations, rapid heartbeat)
• Overactive thyroid gland: this medicine may mask signs of abnormally fast heart rate due to this condition
• Allergies: this medicine may intensify your reaction to pollen or other substances you are allergic to
• Psoriasis (a skin disease causing scaly pink patches), or if you have had psoriasis in the past
• If you are undergoing surgery, always inform the anaesthetist that you are taking Nebivolol Zentiva before being anaesthetized

If you have severe kidney problems, do not take Nebivolol Zentiva for heart failure and consult your doctor.

You will be regularly monitored by an experienced doctor at the beginning of treatment for chronic heart failure (see section 3).

This treatment must not be stopped abruptly unless clearly indicated and evaluated by your doctor (refer to section 3).

Children and adolescents

Due to lack of data on the use of this medicine in children and adolescents, Nebivolol Zentiva is not recommended for children and adolescents under 18 years of age.

Other medicines and Nebivolol Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines should not be used at the same time, while others may require specific adjustments (e.g. dose changes).

Always inform your doctor or pharmacist if you are using or taking any of the following medicines in addition to Nebivolol Zentiva:

• Medicines for blood pressure control or heart problems (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 treatments for psychosis (a mental illness), such as barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting), and thioridazine
• Medicines for depression, such as amitriptyline, paroxetine, fluoxetine
• Medicines used for anaesthesia during surgery
• Medicines for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased eye pressure) or pupil dilation (enlargement)
• Baclofen (a muscle relaxant used for spasticity)
• Amifostine (a protective agent used during cancer treatment)

All these medicines, like nebivolol, can affect blood pressure and/or heart function.

• Medicines used to treat excessive stomach acidity or ulcers (antacids) such as cimetidine: you should take Nebivolol Zentiva with meals, and the antacid between meals.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Nebivolol Zentiva must not be taken during pregnancy unless prescribed by a doctor.

Breastfeeding

Breastfeeding is not recommended during treatment with Nebivolol Zentiva.

Driving and using machines

This medicine may cause dizziness or weakness. If this occurs, do not drive or operate machinery.

For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Nebivolol Zentiva contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE NEBIVOLOL ZENTIVA

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Nebivolol Zentiva may be taken before, during, or after meals, or alternatively, it can be taken
independently of meals. It is preferable to swallow the tablet or its parts with water.

Treatment of high blood pressure (hypertension)
The usual dose is 1 tablet per day. The dose should preferably be taken at the
same time each day.
Elderly patients and patients with kidney disease will generally start with ½
tablet per day.
The therapeutic effect on blood pressure becomes evident after 1–2 weeks of
treatment. Sometimes the optimal effect is only achieved after 4 weeks.

Treatment of chronic heart failure
Treatment must be initiated and closely monitored by an experienced physician.
Your doctor will start treatment with ¼ (one quarter) of a tablet per day. This dose may be
increased after 1–2 weeks to ½ tablet per day, then to 1 tablet per day, and subsequently to 2
tablets per day until the appropriate dose for you is reached.
Your doctor will prescribe the dose considered suitable for you at each stage, and you must
strictly follow your doctor’s instructions. The maximum recommended dose is 2 tablets (10 mg)
per day.
You will need to be closely monitored by an experienced physician for 2 hours when starting
treatment and each time the dose is increased.
Your doctor may reduce the dose if necessary.
Do not stop treatment abruptly, as this may worsen heart failure.
Patients with severe kidney problems must not take this medicine.
Take the medicine once daily, preferably at the same time each day.
Your doctor may decide to combine Nebivolol Zentiva tablets with another medicine for the
treatment of your condition.

Use in children and adolescents
Nebivolol Zentiva is not recommended for children and adolescents.

If you take more Nebivolol Zentiva than you should
If you accidentally take an excessive dose of this medicine, speak to your doctor or pharmacist
immediately. The most common signs and symptoms of an overdose of Nebivolol Zentiva are
very slow heartbeat (bradycardia), low blood pressure possibly with fatigue (hypotension),
breathing difficulty as in asthma (bronchospasm), and acute heart failure.
You may take activated charcoal (available from pharmacies) while waiting for medical help.

If you forget to take Nebivolol Zentiva
If you forget to take a dose of Nebivolol Zentiva but remember shortly afterwards, take your
daily dose as usual. However, if a long delay has occurred (e.g., several hours) and the next
dose is approaching, skip the missed dose and take the next regular dose at the scheduled
time. Do not take a double dose to make up for the missed dose. Nevertheless, avoid repeatedly
missing doses of the medicine.

If you stop taking Nebivolol Zentiva
You must always consult your doctor before stopping treatment with Nebivolol Zentiva, whether
you are taking it for high blood pressure or for chronic heart failure.
Do not stop treatment with Nebivolol Zentiva abruptly, as this may temporarily worsen heart
failure. If it is necessary to discontinue treatment with Nebivolol Zentiva for chronic heart
failure, the daily dose should be gradually reduced by halving the dose at weekly intervals.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
When Nebivololo Zentiva is used to treat high blood pressure, the possible adverse effects are:

Common adverse effects (may affect up to 1 in 10 people)

• Headache
• Dizziness
• Tiredness
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Shortness of breath
• Swollen hands or feet

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

• Slow heartbeat or other heart problems
• Low blood pressure
• Cramp-like leg pain while walking
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Feeling of depression
• Difficulty digesting (dyspepsia), gas in the stomach and intestines
• Vomiting
• Skin rash, itching
• Breathlessness as in asthma, caused by sudden cramps in the muscles around the airways (bronchospasm)
• Nightmares

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

• Fainting
• Worsening of psoriasis (a skin disease – scaly pink patches)

Not known (frequency cannot be estimated from the available data)

• Allergic reactions affecting the whole body with widespread skin rashes (hypersensitivity reaction)
• Rapid onset of swelling, particularly around the lips, eyes, or tongue, possibly leading to sudden breathing difficulties (angioedema)
• Hives (urticaria)

In a clinical study on chronic heart failure, the following adverse effects were observed:

Very common adverse effects (may affect more than 1 in 10 people)

• Slowed heartbeat
• Dizziness

Common adverse effects (may affect up to 1 in 10 people)

• Worsening of heart failure
• Low blood pressure (feeling faint when standing up quickly)
• Inability to tolerate this medicine
• A mild heart conduction disorder affecting heart rhythm (first-degree A-V block)
• Swelling of the lower limbs (such as swollen ankles)

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili".
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NEBIVOLOLO ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use Nebivololo Zentiva after the expiry date stated on the label after EXP.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Nebivololo Zentiva contains
The active substance is nebivolol.
Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
The other components are:
Monohydrate lactose
Crospovidone Type A
Poloxamer 188
Povidone K 30
Microcrystalline cellulose
Magnesium stearate

Description of the appearance of Nebivololo Zentiva and pack contents
Nebivololo Zentiva tablets are white, round, biconvex tablets, marked with a cross on one side, with a diameter of approximately 9 mm.
Nebivololo Zentiva tablets can be divided into equal doses.
The tablets are available in PVC/PE/PVDC/Al blisters of 7 and 10.
Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100, 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio 37/b
20158 Milano
Manufacturer
Specifar S.A.
1, 28 Octovriou str., Ag
Varvara – 1251 Athens (Greece)

This medicinal product is authorized in the European Economic Area countries under the following names:
IT: Nebivololo Zentiva 5 mg tablets
PT: Nebivolol Zentiva 5 mg tablets
ES: Nebivolol Zentiva 5 mg tablets EFG
UK: Nebivolol 5 mg tablets