Nebivolol Alter

PACKAGE LEAFLET: INFORMATION FOR THE USER

NEBIVOLOL ALTER 5 mg tablets

Equivalent medicine
Read this leaflet carefully before taking this medicine.

• 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 personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What NEBIVOLOL ALTER 5 mg is and what it is used for
2. Before taking NEBIVOLOL ALTER 5 mg
3. How to take NEBIVOLOL ALTER 5 mg
4. Possible side effects
5. How to store NEBIVOLOL ALTER 5 mg
6. Further information

1. WHAT NEBIVOLOL ALTER 5 mg IS AND WHAT IT IS USED FOR

NEBIVOLOL ALTER 5 mg is a medicine that primarily affects the function of your heart
(beta-blocker). It reduces blood pressure and improves heart function.
NEBIVOLOL ALTER 5 mg is used

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

2. BEFORE TAKING NEBIVOLOLO ALTER 5 mg

Do not take NEBIVOLOLO ALTER 5 mg

• if you are allergic (hypersensitive) to the active substance nebivolol hydrochloride or to any of the excipients of NEBIVOLOLO ALTER 5 mg,
• 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 worsening heart failure (decompensation) requiring intravenous treatment with inotropic agents,
• if you have sinus syndrome (a specific type of heart rate disorder), including sinoatrial block (SA block),
• if you suffer from certain cardiac conduction disorders (second- or third-degree heart block – AV block [without pacemaker]),
• if you have previously experienced bronchospasm or bronchial asthma,
• if you have an untreated tumor of the adrenal gland (pheochromocytoma),
• if you suffer from excess acidity in 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 pressure <90 mmHg),
• if you have severely reduced circulation in the limbs,
• if you are taking any other medicine containing floctafénine (for pain and inflammation) or sultopride (an antipsychotic).

If you have any doubts, consult your doctor.
Take special care with NEBIVOLOLO ALTER 5 mg

• if your pulse is unusually low (less than 50–55 beats per minute at rest and/or symptoms such as dizziness, weakness, or unsteady gait) during treatment with nebivolol,
• if you have a heart condition (e.g. angina pectoris, ischemic heart disease, cardiac arrhythmias); in patients with ischemic heart disease, treatment should be gradually discontinued, 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 problems, particularly chronic obstructive pulmonary disease (COPD),
• if you have diabetes. NEBIVOLOLO ALTER 5 mg has no effect on blood sugar levels, but it may mask symptoms of low blood sugar (such as irritability, tremor, rapid heartbeat). Sweating as a symptom, however, is not masked by NEBIVOLOLO ALTER 5 mg,
• if you have an overactive thyroid gland: possible masking of increased heart rate (tachycardia) as a sign of disease; sudden discontinuation of NEBIVOLOLO ALTER 5 mg treatment may cause an increase in heart rate,
• if you have allergies. NEBIVOLOLO ALTER 5 mg may intensify your reaction to pollen or other allergens,
• if you suffer from psoriasis: patients with persistent psoriasis or a known history of the disorder should take NEBIVOLOLO ALTER 5 mg only after careful assessment of risks and benefits,
• NEBIVOLOLO ALTER 5 mg may reduce tear production (inform your doctor if you wear contact lenses).

Children and adolescents
NEBIVOLOLO ALTER 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 ALTER 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 medication without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Taking with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those not requiring a prescription.
This is particularly important for:

• certain medicines used to treat heart rhythm disorders (antiarrhythmics of class I such as quinidine, lidocaine, as well as amiodarone), which may enhance the sedative effects of nebivolol on heart activity when taken concurrently with nebivolol.
• certain medicines for high blood pressure and heart vessel spasms (so-called calcium antagonists), which may increase the effect of NEBIVOLOLO ALTER 5 mg (e.g. verapamil and diltiazem).
• other medicines acting centrally on high blood pressure (clonidine, guanfacine, moxonidine, methyldopa, rilmenidine), which may increase the risk of a sharp rise in blood pressure (“rebound hypertension”)—especially after sudden discontinuation following long-term use. These medicines should only be stopped if the beta-blocker (e.g. nebivolol) has been discontinued 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 influence blood digoxin concentrations.
• certain medicines for asthma, nasal congestion, or certain eye diseases (so-called sympathomimetics), which may reduce the effect of NEBIVOLOLO ALTER 5 mg (e.g. dopamine, ephedrine).
• medicines for diabetes (insulin and oral antidiabetic agents). See also “Take special care with NEBIVOLOLO ALTER 5 mg”
• anaesthetics: before anaesthesia, always inform the anaesthetist that you are taking NEBIVOLOLO ALTER 5 mg.
• certain antipsychotics may enhance the effect of NEBIVOLOLO ALTER 5 mg. Simultaneous 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 heart failure), and other medicines for high blood pressure may cause a sudden drop in blood pressure.
• if serotonin reuptake inhibitors (certain antidepressants) are taken concurrently with NEBIVOLOLO ALTER 5 mg, your doctor may consider dose adjustment necessary.
• certain medicines metabolized similarly to nebivolol may cause increased blood levels of nebivolol, leading to an increased risk of adverse effects. Examples include: bupropion (antidepressant), chloroquine (used for malaria prevention and treatment of autoimmune diseases such as rheumatoid arthritis), levomepromazine (neuroleptic agent), and terbinafine (antifungal). If you are taking an antacid for excess stomach acid in addition to NEBIVOLOLO ALTER 5 mg, take NEBIVOLOLO ALTER 5 mg with food and the antacid between meals.

Taking NEBIVOLOLO ALTER 5 mg with food and drink
You may take NEBIVOLOLO ALTER 5 mg with food and drink.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There is a risk of effects on the fetus. Therefore, do not use NEBIVOLOLO ALTER 5 mg
during pregnancy.
Breastfeeding
It is not known whether NEBIVOLOLO ALTER 5 mg is excreted in breast milk. Therefore, do not use
NEBIVOLOLO ALTER 5 mg during breastfeeding.
Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles or operate machinery.
Dizziness and fatigue may occasionally occur as adverse effects of NEBIVOLOLO ALTER 5 mg. Keep this in mind when driving or operating machinery (see section 4 “Possible adverse effects”).
Important information about some of the excipients of NEBIVOLOLO ALTER 5 mg
NEBIVOLOLO ALTER 5 mg contains lactose monohydrate. 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 NEBIVOLOLO ALTER 5 mg

Always take NEBIVOLOLO ALTER 5 mg exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Hypertension
Adults
The usual dose is 1 tablet daily (5 mg of nebivolol). It generally takes 1–2 weeks before NEBIVOLOLO ALTER 5 mg reaches its maximum effect.
Combination with other antihypertensive medicines
Beta-blockers may be used alone or in combination with other antihypertensive medicines. To date, an additional antihypertensive effect has only been observed with the combination of 5 mg of nebivolol and 12.5–25 mg of the active substance hydrochlorothiazide.
Patients with impaired renal function (renal insufficiency)
In patients with renal insufficiency, the recommended starting 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 ALTER 5 mg in patients with impaired liver function or hepatic disorders. For this reason, NEBIVOLOLO ALTER 5 mg must not be used in these patients (see “Do not take NEBIVOLOLO ALTER 5 mg if”).
Elderly patients
In patients aged 65 years or older, the recommended starting 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.
Children and adolescents
NEBIVOLOLO ALTER 5 mg is not recommended in 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 escalation until the individual optimal maintenance dose is reached.
In patients taking other cardiovascular medications such as diuretics, digoxin, ACE inhibitors, or angiotensin II antagonists, the doses of these medications must be stabilized before starting treatment with NEBIVOLOLO ALTER 5 mg.
Initial dose adjustment should be performed as follows, with adjustments every one or two weeks depending on how well the patient tolerates the dose:

• ¼ tablet (1.25 mg of nebivolol) once daily,
• increased to ½ tablet (2.5 mg of nebivolol) once daily,
• then to 1 tablet (5 mg of nebivolol) once daily, and
• then to 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 renal function (renal insufficiency)
Since the dose is individually increased up to the maximum tolerated dose, no dose adjustment is necessary 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 ALTER 5 mg must not be used in these patients (see “Do not take NEBIVOLOLO ALTER 5 mg if”).
Elderly patients
Since the dose is individually increased up to the maximum tolerated dose, no dose adjustment is required.
Children and adolescents
NEBIVOLOLO ALTER 5 mg is not recommended in 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 should 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 ALTER 5 mg is too strong or too weak, contact your doctor or pharmacist.
If you take more NEBIVOLOLO ALTER 5 mg than you should
Symptoms of overdose include: slow heartbeat, low blood pressure, breathing difficulties, and sudden (acute) heart problems. Contact your doctor if you have taken more NEBIVOLOLO ALTER 5 mg than prescribed.
You should lie down with your legs elevated higher than your heart.
If you forget to take NEBIVOLOLO ALTER 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 ALTER 5 mg
Do not stop taking the tablets even if you feel better, unless your doctor tells you to. If treatment is stopped or discontinued prematurely, blood pressure may rise or heart problems may worsen.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, NEBIVOLOL ALTER 5 mg can cause adverse reactions, although not
all people experience them.
The following adverse reactions may occur:
The adverse reactions observed are listed below according to 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 discolouration of the arms and legs due to cold, 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
(practolol-like oculo-muco-cutaneous toxicity).
In patients with chronic heart failure

If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE NEBIVOLOLO ALTER 5 mg

Keep out of the reach and sight of children.
Do not use NEBIVOLOLO ALTER 5 mg after the expiry date which is stated on the packaging after
EXP.
The expiry date refers to the last day of the month.
This medicine requires no special storage conditions.
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. OTHER INFORMATION

What NEBIVOLOLO ALTER 5 mg contains
The active substance is nebivolol.
Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.
The excipients are anhydrous colloidal silica, magnesium stearate, sodium croscarmellose, macrogol 6000, and monohydrate lactose.

Description of the appearance of NEBIVOLOLO ALTER 5 mg and contents of the pack
White, round, convex tablets, 9 mm in diameter, cross-scored, with 'N 5' engraved on the other side.
The tablets can be divided into equal halves and quarters.
Blister packs in 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 of 500 (10 x 50) tablets.
HDPE tablet containers: 7, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 tablets and hospital pack of 500 (10 x 50) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter s.r.l., via Egadi 7, 20144 Milano, Italy

Responsible manufacturers for batch release
Actavis hf.
Reykjavikurvegur 78
220 Hafnarfjörður
Iceland

Actavis Ltd.
BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000
Malta

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

This leaflet was last approved on: June 2010