Nebivololo Mylan Italia

Package leaflet: Information for the user

NEBIVOLOL MYLAN ITALIA 5 mg tablets

Generic Medicine
Please read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nebivololo Mylan Italia 5 mg is and what it is used for

Nebivololo Mylan Italia 5 mg is a medicine that primarily affects the function of your heart
(beta-blocker). It reduces blood pressure and improves the heart's pumping ability.
Nebivololo Mylan Italia 5 mg is used

• For the treatment of high blood pressure (essential hypertension).
• As an addition to standard therapy (e.g. with diuretics, digoxin, ACE inhibitors, angiotensin II antagonists) for the treatment of stable chronic heart failure, mild to moderate, in patients aged 70 years and over.

2. What you need to know before taking Nebivololo Mylan Italia 5 mg

Do not take Nebivololo Mylan Italia 5 mg

• If you are allergic to the active substance nebivolol hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have liver function disorders or impaired liver function (hepatic insufficiency).
• If you are pregnant or breastfeeding.
• If you suffer from acute heart failure, cardiogenic shock, or episodes of worsened heart failure (decompensation) requiring intravenous treatment with an inotropic agent.
• If you have sinus node dysfunction (a specific type of heart rhythm disorder), including sinoatrial block (SA block).
• If you have certain cardiac conduction disorders (second- or third-degree heart block – AV block [without a pacemaker]).
• If you have previously experienced bronchospasm or bronchial asthma.
• If you have an untreated tumour of the adrenal gland (pheochromocytoma).
• If you suffer from excessive acidity of the blood (metabolic acidosis).
• If your resting heart rate (pulse) before treatment is less than 60 beats per minute while lying down (bradycardia).
• If you have pathologically low blood pressure (systolic blood pressure <90 mmHg).
• If you have severely impaired circulation in the limbs.
• If you are taking any other medicine containing floctafenic acid (for pain and inflammation) or sultopride (an antipsychotic).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo Mylan Italia.
Exercise particular caution with Nebivololo Mylan Italia 5 mg:

• If your pulse becomes unusually low (less than 50–55 beats per minute at rest and/or symptoms such as dizziness, weakness, and unsteady gait) during treatment with nebivolol.
• If you have a heart condition (e.g. angina pectoris, ischemic heart disease, heart rhythm disorders); in patients with ischemic heart disease, treatment should be discontinued gradually, for example over 1–2 weeks, and if necessary, alternative therapy should be initiated simultaneously.
• If you have circulatory problems in the arms or legs.
• If you suffer from chronic respiratory disorders, particularly chronic obstructive pulmonary disease (COPD).
• If you have diabetes. Nebivololo Mylan Italia 5 mg does not affect blood sugar levels, but it may mask symptoms of low blood sugar (such as irritability, tremor, rapid heartbeat). However, sweating as a symptom is not masked by Nebivololo Mylan Italia 5 mg.
• If you have an overactive thyroid gland: possible masking of increased heart rate (tachycardia) as a sign of disease; sudden discontinuation of treatment with Nebivololo Mylan Italia 5 mg may cause an increase in heart rate.
• If you have allergies. Nebivololo Mylan Italia 5 mg may intensify allergic reactions to pollen or other allergens.
• If you suffer from psoriasis: patients with persistent psoriasis or a known history of the disorder should take Nebivololo Mylan Italia 5 mg only after careful assessment of risks and benefits.
• Nebivololo Mylan Italia 5 mg may reduce tear production (inform your doctor if you wear contact lenses).

Children and adolescents
Nebivololo Mylan Italia 5 mg is not recommended for children and adolescents under 18 years of age due to insufficient data on safety and efficacy.
Elderly
In patients over 65 years of age, a lower initial dose is recommended (see section “How to take Nebivololo Mylan Italia 5 mg”).
In patients over 75 years of age, particular caution is required and treatment must be closely monitored by the physician.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Nebivololo Mylan Italia 5 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important for:

• Certain medicines used to treat heart rhythm disorders (class I antiarrhythmics such as quinidine, lidocaine, and also amiodarone), which may enhance the sedative effects of nebivolol on heart activity when taken concurrently with nebivolol.
• Certain medicines for high blood pressure and coronary vasospasm (so-called calcium antagonists) that may increase the effect of Nebivololo Mylan Italia 5 mg (e.g. verapamil and diltiazem).
• Other medicines acting centrally to lower blood pressure (clonidine, guanfacine, moxonidine, methyldopa, rilmenidine), which may increase the risk of severe blood pressure elevation (“rebound hypertension”), especially after sudden discontinuation following long-term use. These medicines should only be discontinued if the beta-blocker (e.g. nebivolol) has been stopped a few days earlier.
• If beta-blockers and digitalis glycosides are used together, disturbances in cardiac conduction (prolonged conduction time) may occur. However, clinical studies with nebivolol have not shown evidence of this interaction. Nebivolol does not affect digoxin blood levels.
• Certain medicines for asthma, nasal congestion, or certain eye conditions (so-called sympathomimetics), which may reduce the effect of Nebivololo Mylan Italia 5 mg (e.g. dopamine, ephedrine).
• Baclofen (a muscle relaxant); Amifostine (a protective agent used during anti-tumour therapy).
• Medicines for diabetes (insulin and oral antidiabetic agents). See also “Exercise particular caution with Nebivololo Mylan Italia 5 mg”.
• Anaesthetics: always inform your anaesthetist that you are taking Nebivololo Mylan Italia 5 mg before undergoing anaesthesia.
• Certain antipsychotics may enhance the effect of Nebivololo Mylan Italia 5 mg. Concurrent treatment with agents used to treat depression (tricyclic antidepressants, paroxetine), barbiturates (e.g. for epilepsy treatment), sedatives (phenothiazines, e.g. thioridazine), organic nitrates (for angina and renal failure), and other antihypertensive medicines may cause a sudden drop in blood pressure.
• If selective serotonin reuptake inhibitors (SSRIs – certain antidepressants) are taken concurrently with Nebivololo Mylan Italia 5 mg, your doctor may consider dose adjustment necessary.
• Certain medicines metabolized similarly to nebivolol may increase nebivolol blood levels, leading to an increased risk of adverse effects. Examples include: bupropion (antidepressant), chloroquine (used for malaria prevention and treatment of autoimmune disorders such as rheumatoid arthritis), levomepromazine (neuroleptic agent), and terbinafine (antifungal).

If you are also taking an antacid for excess stomach acid in addition to Nebivololo Mylan Italia 5 mg, take Nebivololo Mylan Italia 5 mg with food and the antacid between meals.

Nebivololo Mylan Italia 5 mg with food and drinks
You may take Nebivololo Mylan Italia 5 mg with food and drinks.

Pregnancy and breastfeeding
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
There is a risk of effects on the foetus. Therefore, do not use Nebivololo Mylan Italia 5 mg during pregnancy.

Breastfeeding
It is not known whether Nebivololo Mylan Italia 5 mg is excreted in breast milk. Therefore, do not use Nebivololo Mylan Italia 5 mg while breastfeeding.

Driving and using machines
No studies have been conducted on the effects on the ability to drive and use machines.
Dizziness and fatigue may occasionally occur as side effects of Nebivololo Mylan Italia 5 mg. Keep this in mind when driving or operating machinery (see section 4 “Possible side effects”).

Nebivololo Mylan Italia 5 mg contains lactose monohydrate and sodium.
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take Nebivololo Mylan Italia 5 mg

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Hypertension
Adults
The usual dose is 1 tablet daily (5 mg of nebivolol). It usually takes 1–2 weeks
before Nebivololo Mylan Italia 5 mg reaches its maximum effect.
Combination with other antihypertensive medicines
Beta-blockers can be used alone or in combination with other antihypertensive
medicines. To date, an additional antihypertensive effect has been observed only with the combination
of 5 mg of nebivolol and 12.5–25 mg of the active ingredient hydrochlorothiazide.
Patients with impaired kidney function (renal insufficiency)
In patients with renal insufficiency, the recommended initial dose is ½ tablet (2.5 mg of
nebivolol) daily. If necessary, the daily dose may be increased to 1 tablet (5 mg of
nebivolol).
Patients with impaired liver function (hepatic insufficiency)
Sufficient experience has not been obtained with the use of Nebivololo Mylan Italia 5 mg in patients with
impaired liver function or liver dysfunction. For this reason, Nebivololo Mylan
Italia 5 mg must not be used in these patients (see “Do not take Nebivololo Mylan Italia 5 mg
if”).
Elderly patients:
In patients aged 65 years or older, the recommended initial dose is ½ tablet (2.5 mg of nebivolol) daily. If necessary, the daily dose may be increased to 1 tablet (5 mg of nebivolol).
In any case, particular caution is required and treatment must be closely monitored due to limited experience in patients over 75 years of age.
Use in children and adolescents
Nebivololo Mylan Italia 5 mg is not recommended for children and adolescents under 18 years of age
because there is insufficient data on safety and efficacy.
Chronic heart failure
Treatment of stable chronic heart failure must be initiated with a slow dose increase, until the individual optimal maintenance dose is reached.
In patients taking other cardiovascular medicines such as diuretics, digoxin, ACE inhibitors or
angiotensin II antagonists, the doses of these medicines must be stabilized before starting
treatment with Nebivololo Mylan Italia 5 mg.
Initial dose adjustment should be performed as follows, with adjustments every one or two weeks, depending on how well the dose is tolerated by the patient:

• ¼ tablet (1.25 mg of nebivolol) once daily,
• increased to ½ tablet (2.5 mg of nebivolol) once daily,
• then 1 tablet (5 mg of nebivolol) once daily, and
• then 2 tablets (10 mg of nebivolol) once daily. The maximum recommended dose is 2 tablets (10 mg of nebivolol) once daily.

The patient must be monitored for the first 2 hours after taking the first dose and
for the first 2 hours after each dose increase, to ensure that clinical conditions
remain stable.
Patients with impaired kidney function (renal insufficiency):
Since the dose is individually increased up to the maximum tolerated dose, no dose adjustment is required in patients with mild to moderate renal insufficiency. There is no experience in patients with severe renal insufficiency; therefore, the use of nebivolol is not recommended in these patients.
Patients with impaired liver function (hepatic insufficiency):
Sufficient experience has not been obtained in patients with impaired liver function. Nebivololo
Mylan Italia 5 mg must not be used in these patients (see “Do not take Nebivololo Mylan
Italia 5 mg if”).
Elderly patients
Since the dose is individually increased up to the maximum tolerated dose, no dose adjustment is required.
Use in children and adolescents
Nebivololo Mylan Italia 5 mg is not recommended for children and adolescents under 18 years of age
because there is insufficient data on safety and efficacy.
Method of administration:
The prescribed daily dose should preferably be taken at the same time each day.
The tablets must be swallowed with a sufficient amount of liquid (e.g. a glass
of water), with or without food.
If you feel that the effect of Nebivololo Mylan Italia 5 mg is too strong or too weak, contact your doctor or pharmacist.
If you take more Nebivololo Mylan Italia 5 mg than you should
Symptoms of overdose include: slow heartbeat, low blood pressure, difficulty breathing, and sudden (acute) heart problems. Contact your doctor if you have taken more Nebivololo
Mylan Italia 5 mg than you should.
You should lie down with your legs higher than your heart.
If you forget to take Nebivololo Mylan Italia 5 mg
If you forget to take your medicine one day, continue your treatment the next day at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Nebivololo Mylan Italia 5 mg
Do not stop taking the tablets even if you feel better, unless your doctor tells you to.
When treatment is stopped or discontinued prematurely, blood pressure may rise or heart problems may worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
The observed side effects are listed below, classified by system organ class and frequency.
In patients with high blood pressure

The following adverse reactions have also been reported: hallucinations, psychiatric disturbances (psychosis),
confusion, bluish-red cold-induced discoloration of the arms and legs, pain in the fingers and toes which first turn bluish, then white, and finally red (Raynaud's syndrome), dry eyes, and formation of new connective tissue in the eyes and diaphragm
(oculo-muco-cutaneous toxicity similar to practolol).
In patients with chronic heart failure

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
You may also report adverse reactions directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Nebivololo Mylan Italia 5 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP.
The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Nebivololo Mylan Italia 5 mg 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 anhydrous colloidal silica, magnesium stearate, sodium croscarmellose, macrogol 6000, and lactose monohydrate.

Description of the appearance of Nebivololo Mylan Italia 5 mg and package contents
White, round, biconvex tablets, 9 mm in diameter, with a cross scored on one side and "N5" engraved on the other.
The tablets can be divided into equal halves and quarters.
Blister packs made of PVDC/Aluminum (containing 7, 10 or 15 tablets) and HDPE containers with sealed caps in LDPE.

Pack sizes:
Blister packs: 7, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 tablets and hospital pack containing 500 (10 x 50) tablets.
HDPE tablet containers: 7, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 tablets and hospital pack containing 500 (10 x 50) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturers responsible for batch release
Actavis Ltd.
BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000
Malta

Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria