NEBIVOLOLO 5 mg Коированные Таблетки

Содержание инструкции

1. NEBIVOLOLO DOC 5 mg tablets
   1. What is NEBIVOLOLO DOC and what is it used for
   2. What you need to know before taking NEBIVOLOLO DOC
2. NEBIVOLOLO DOC is not recommended in children and adolescents under the age of 18 years
   1. How to take NEBIVOLOLO DOC
3. NEBIVOLOLO DOC should not be used in these patients (see “Do not take
   1. Possible side effects
   2. How to store NEBIVOLOLO DOC
   3. Contents of the pack and other information

NEBIVOLOLO DOC 5 mg tablets

Generic medicine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is NEBIVOLOLO DOC and what is it used for

NEBIVOLOLO DOC is a medicine that acts mainly on the function of your heart
(beta-blocker). It reduces blood pressure and improves the strength of the heart.
NEBIVOLOLO DOC 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 receptor antagonists) for the treatment of stable chronic heart failure, from mild to moderate, in patients aged 70 years and over.

2. What you need to know before taking NEBIVOLOLO DOC

Do not take NEBIVOLOLO DOC

• if you are allergic to nebivolol hydrochloride or to any of the other ingredients of this medicine (listed in section 6),
• if you have a severe liver disease (hepatic insufficiency) or impaired liver function,
• if you have acute heart failure, if you have experienced cardiogenic shock or if you are being treated for heart failure with intravenous administration to help the heart function,
• if you have irregular heartbeat (conditions such as sinus node disease, sinoatrial block or 2nd and 3rd degree heart block for which you have not had a “pacemaker” implanted),
• if you have severe breathing problems (bronchospasm) and bronchial asthma (now or in the past),
• if you have a tumor of the adrenal gland called pheochromocytoma, which is not being treated,
• if you suffer from a metabolic disorder called metabolic acidosis,
• if you have a very slow heart rate (less than 60 beats per minute before starting to take this medicine),
• if you have low blood pressure (systolic or “maximum” blood pressure less than 90 mmHg),
• if you have severe circulatory problems in the arms and legs,
• if you are taking medicines containing floctafenine (pain and inflammation medicine) or sultopride (antipsychotic).

If you have any doubts, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking NEBIVOLOLO DOC or if you have or develop
any of the following conditions:

• 1. if you are going to have surgery, always inform the anesthesiologist that you are being treated with NEBIVOLOLO DOC before undergoing anesthesia,
• 2. if you have untreated heart failure (inability of the heart to pump enough blood for the body's needs),
• 3. if you have an abnormally slow heartbeat,
• 4. if you have poor circulation in your arms and legs (Raynaud's disease or syndrome, cramp-like pains while walking),
• 5. if you have a 1st degree heart block (a mild disturbance of cardiac conduction that affects heart rhythm),
• 6. if you have chest pain due to narrowing of the coronary arteries called Prinzmetal's angina,
• 7. if you have diabetes: NEBIVOLOLO DOC has no effect on blood sugar levels, but may mask the signs of low blood sugar (tremor, fast heartbeat),
• 8. if you have an overactive thyroid gland: NEBIVOLOLO DOC may mask the symptoms of a fast heartbeat (tachycardia) due to this condition,
• 9. if you suffer from continuous respiratory problems, in particular chronic obstructive bronchopneumonia: NEBIVOLOLO DOC may worsen breathing difficulties,
• 10. if you have psoriasis (a skin disease that causes scaly pink patches): NEBIVOLOLO DOC may worsen its symptoms,
• 11. if you have an allergy: NEBIVOLOLO DOC may intensify the reaction to substances to which you are allergic,
• 12. if you use contact lenses: NEBIVOLOLO DOC may reduce tear production.

In the initial phase of therapy for chronic heart failure with nebivolol, an experienced doctor
will need to monitor you regularly (see section 3).
Do not abruptly stop treatment with nebivolol unless you are told to do so by your doctor (see section 3).
For those who play sports: the use of the drug without a therapeutic need constitutes
doping and may still result in a positive doping test.

Children and adolescents

NEBIVOLOLO DOC is not recommended in children and adolescents under the age of 18 years

due to the lack of safety and efficacy data.

Elderly
In patients over 65 years of age, a lower initial dose is recommended (see
section “How to take NEBIVOLOLO DOC”).
In patients over 75 years of age, particular caution should be exercised and treatment should
be closely monitored by the doctor.

Other medicines and NEBIVOLOLO DOC
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Do not take NEBIVOLOLO DOC if you are taking other medicines containing floctafenine or
sultopride (see section “Do not take NEBIVOLOLO DOC”).
Always tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines for the treatment of irregular heartbeat (antiarrhythmics of class I: quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone; antiarrhythmics of class III: amiodarone)
• medicines for the treatment of high blood pressure or other heart problems (verapamil, diltiazem; centrally acting antihypertensives: clonidine, guanfacine, moxonidine, methyldopa, rilmenidine; calcium antagonists: amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine)
• anaesthetics: always inform the anaesthetist that you are being treated with NEBIVOLOLO DOC before undergoing anaesthesia (see section “Warnings and precautions”),
• medicines for the treatment of diabetes mellitus (insulin and oral medicines),
• baclofen (a muscle relaxant); amifostine (a protective medicine used during cancer treatment), medicines for the treatment of heart failure known as cardiac glycosides (digoxin),
• medicines for the treatment of mental problems (psychosis) or depression (tricyclic antidepressants, barbiturates, phenothiazines),
• organic nitrates (medicines for the treatment of angina and heart failure) and other medicines for high blood pressure,
• non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of pain and inflammation,
• medicines for the treatment of asthma, nasal congestion (sinusitis) or certain eye disorders such as glaucoma (increased pressure in the eye) or dilation (widening) of the pupil. These medicines are called sympathomimetics,
• medicines that reduce the metabolism of nebivolol, such as: bupropion (a medicine to help you stop smoking), paroxetine, fluoxetine, thioridazine (medicines for the treatment of depression), quinidine (a medicine for the treatment of irregular heartbeat), chloroquine (a medicine for the treatment of malaria and autoimmune diseases such as rheumatoid arthritis), levomepromazine (a medicine for the treatment of psychosis), terbinafine (a medicine for the treatment of fungal and yeast infections),
• medicines for the treatment of excess acid in the stomach or ulcers, known as antacids (e.g. cimetidine): take NEBIVOLOLO DOC during meals and the antacid medicine between meals.

NEBIVOLOLO DOCwith food and drink
You can take NEBIVOLOLO DOC with food and drink.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine.

Pregnancy
There is a risk of effects on the foetus. Therefore, do not use NEBIVOLOLO DOC
during pregnancy unless it is clearly essential.

Breastfeeding
It is not known whether NEBIVOLOLO DOC is excreted in breast milk. Therefore, NEBIVOLOLO DOC is
not recommended during breastfeeding.

Driving and using machines
Studies on the effects on the ability to drive and use machines have not been conducted.
Dizziness and fatigue may occasionally occur as undesirable effects of
NEBIVOLOLO DOC 5. Keep this in mind when driving a vehicle or using
machines (see section 4 “Possible undesirable effects”).

NEBIVOLOLO DOC contains lactose monohydrate
NEBIVOLOLO DOC contains lactose monohydrate. If you have been diagnosed with
lactose intolerance, contact your doctor before taking this medicine.

3. How to take NEBIVOLOLO DOC

Take this medicine following exactly the instructions of your doctor. If you have
any doubts, ask your doctor or pharmacist.

Hypertension
Adults
The recommended dose is 1 tablet a day (5 mg of nebivolol). Generally, 1-2 weeks pass
before NEBIVOLOLO DOC 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 with 12.5-25 mg of the active ingredient
hydrochlorothiazide.

Patients with impaired renal function (renal insufficiency)
In patients with renal insufficiency, the recommended initial dose is ½ tablet (2.5 mg of
nebivolol) per day. If necessary, the daily dose may be increased to 1 tablet
(5 mg of nebivolol).

Patients with impaired hepatic function (hepatic insufficiency)
Sufficient experience has not been gained in the use of NEBIVOLOLO DOC in patients with
impaired hepatic function or liver function disorders. For this reason
NEBIVOLOLO DOC should not be used in these patients (see “Do not take
NEBIVOLOLO DOC”).

Elderly patients
In patients 65 years of age or older, the recommended initial dose is ½ tablet (2.5 mg of
nebivolol) per day. If necessary, the daily dose may be increased to 1
tablet (5 mg of nebivolol). In any case, particular attention must be paid and the
treatment must be strictly monitored in view of the limited experience in
patients over 75 years of age.

Use in children and adolescents
NEBIVOLOLO DOC 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 should be initiated with a slow
increase in dose, until the optimal individual 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 DOC.
The initial dose adjustment should be made as follows, with adjustments
every one or two weeks, depending on how well the dose is tolerated by the patient:

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

The patient should be monitored during the first 2 hours after taking the
first dose and during the first 2 hours after each dose increase, to ensure that the
clinical conditions remain stable.

Patients with impaired renal function (renal insufficiency)
Since the dose is increased individually 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, for which the use of nebivolol is not
recommended in these patients.

Patients with impaired hepatic function (hepatic insufficiency)
Sufficient experience has not been gained in patients with impaired hepatic function.

NEBIVOLOLO DOC should not be used in these patients (see “Do not take

NEBIVOLOLO DOC”).

Elderly patients
Since the dose is increased individually up to the maximum tolerated dose,
no dose adjustment is necessary.

Use in children and adolescents
NEBIVOLOLO DOC is not recommended in children and adolescents under 18 years of age
because there are 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 DOC is too strong or too weak, contact your doctor or
pharmacist.

If you take more NEBIVOLOLO DOC than you should
Symptoms of overdose are: slow heartbeat, low blood pressure, difficulty
breathing and sudden (acute) heart problems. Contact your doctor if you have taken more
NEBIVOLOLO DOC than you should.
You should lie down with your legs raised above your heart.

If you forget to take NEBIVOLOLO DOC
If you have forgotten to take your medicine one day, continue treatment the next
day at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking NEBIVOLOLO DOC
Do not stop taking the tablets even if you feel better, until your
doctor tells you to.
When treatment is stopped or terminated prematurely, blood pressure may
rise or heart problems may increase.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypertension
The observed side effects, which were, in most cases, of mild or moderate intensity,
are listed below, according to classification by system and organ and their
frequencies.

CLASSIFICATION
BYSYSTEMAND
ORGAN
Common
(may affect
Not common
(may affect
Very rare
(may affect
Not known (the
frequency cannot
up to 1 in 10 peopleup to 1 in 100 peopleup to 1 in 10,000)
be defined based on
available data)
Immune system
disorders
Swelling of the
face, lips,
throat or
tongue (angioedema),
widespread
allergic reactions
throughout the body,
including
generalized skin
rashes
(hypersensitivity
reactions)

Psychiatric
disorders
Nightmares,
depression

Nervous system
disorders
Headache,
dizziness,
tingling in the
skin
Transient loss of
consciousness
(syncope)

Eye disorders
Visual disturbances

Cardiac disordersHeart rate
unusually
slow (bradycardia),
heart failure, defects
in cardiac conduction
(slow
AV conduction/AV
block)

Vascular disordersBlood
pressure
excessively
low, increased
pain in the feet
that occurs
every time
you walk,
due to
narrowing of the
arteries and
insufficient
blood circulation
(intermittent
claudication)

Respiratory,
thoracic and
mediastinal
disorders
Difficulty in
breathing
Spasmodic
constriction of the
bronchi

Gastrointestinal
disorders
Constipation,
nausea, diarrhea
Indigestion,
flatulence, vomiting

Skin and
subcutaneous tissue
disorders
Itching, erythematous
rash
Worsening of
psoriasis
Urticaria

Reproductive
system and breast
disorders
Impotence

Systemic disorders
and conditions related
tothe siteof
administration
Fatigue,
swelling with
fluid retention
(edema)
With some beta-adrenergic antagonists, the following side effects have also been reported:
hallucinations, mental disorders (psychosis), confusion, cold discoloration of
the arms and legs with a bluish-red color, pain in the fingers of the hands and feet that
first turn bluish, then whitish and finally reddish (Raynaud's syndrome), dry eyes and
formation of new connective tissue in the eyes and diaphragm (practolol-like oculo-
mucocutaneous toxicity).

Chronic heart failure
In a clinical study on 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 (with a feeling of fainting when getting up quickly)
• Inability to tolerate this medicine,
• Cardiac conduction disturbance affecting heart rhythm (1st degree AV block),
• Swelling of the lower limbs (ankle swelling).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting
system at
http://www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store NEBIVOLOLO DOC

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 SCAD.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NEBIVOLOLO DOC contains

• The active ingredient is nebivolol. Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.
• The other ingredients are anhydrous colloidal silica, magnesium stearate, sodium croscarmellose, macrogol 6000 and lactose monohydrate.

Description of the appearance of NEBIVOLOLO DOC and contents of the pack
Round, white, convex tablets, 9 mm in diameter, with a cross engraved on one side and ‘N 5’ imprinted on the other.
The tablet can be divided into two or four equal doses.
Blisters in PVDC-Aluminum containing 7, 10 or 15 tablets and container in HDPE with a sealed cap
in LDPE.
Packs:
Blisters: 7, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 tablets and hospital pack of 500
(10x50) tablets.
Container for tablets in HDPE: 7, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 tablets and
hospital pack of 500 (10x50) tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
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
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Follereau, 25
24027 Nembro (Bergamo)
Italy