Package leaflet: Information for the user

NEBIVOLOL DOC 5 mg tablets

Equivalent 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 they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What NEBIVOLOL DOC is and what it is used for
What you need to know before taking NEBIVOLOL DOC
How to take NEBIVOLOL DOC
Possible side effects
How to store NEBIVOLOL DOC
Contents of the pack and other information

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

NEBIVOLOLO DOC is a medicine that primarily affects the function of your heart (beta-blocker). It reduces blood pressure and improves the heart's pumping capacity.
NEBIVOLOLO DOC 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 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 severe liver disease (hepatic insufficiency) or impaired liver function,
if you have acute heart failure, cardiogenic shock, or are receiving intravenous treatment for heart failure to support heart function,
if you have irregular heartbeats (conditions such as sinus node disease, sinoatrial block, or second- or third-degree heart block without a pacemaker),
if you have severe respiratory problems (bronchospasm) or bronchial asthma (currently or in the past),
if you have an untreated adrenal gland tumor called phaeochromocytoma,
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 this medicine),
if you have low blood pressure (systolic blood pressure or "top number" below 90 mmHg),
if you have severe circulatory problems in the arms and legs,
if you are taking medicines containing floctafenic acid (a pain and anti-inflammatory medicine) or sultopride (an 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:

if you are undergoing surgery, always inform the anaesthetist that you are being treated with NEBIVOLOLO DOC before receiving anaesthesia,
if you have untreated heart failure (inability of the heart to pump enough blood to meet the body's needs),
if you have abnormally slow heart rate,
if you have poor circulation in the arms and legs (Raynaud's disease or syndrome, cramp-like pain when walking),
if you have first-degree heart block (a mild heart conduction disorder affecting heart rhythm),
if you have chest pain due to narrowing of the coronary arteries, known as Prinzmetal's angina,
if you have diabetes: NEBIVOLOLO DOC has no effect on blood sugar levels, but it may mask signs of low blood sugar (such as tremor, rapid heartbeat),
if you have an overactive thyroid gland: NEBIVOLOLO DOC may mask symptoms of abnormally fast heartbeat (tachycardia) due to this condition,
if you suffer from ongoing respiratory problems, particularly chronic obstructive pulmonary disease (COPD): NEBIVOLOLO DOC may worsen breathing difficulties,
if you have psoriasis (a skin disease causing scaly pink patches): NEBIVOLOLO DOC may worsen its symptoms,
if you have allergies: NEBIVOLOLO DOC may intensify your reaction to substances you are allergic to,
if you wear contact lenses: NEBIVOLOLO DOC may reduce tear production.

During the initial phase of treatment for chronic heart failure with nebivolol, you must be regularly monitored by an experienced doctor (see section 3).
Do not stop treatment with nebivolol suddenly unless instructed by your doctor (see section 3).
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children and adolescents
NEBIVOLOLO DOC 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 starting dose is recommended (see section "How to take NEBIVOLOLO DOC").
In patients over 75 years of age, particular caution is required and treatment must be closely monitored by the doctor.
Other medicines and NEBIVOLOLO DOC
Inform 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 floctafenic acid or sultopride (see section "Do not take NEBIVOLOLO DOC").
Always inform your doctor or pharmacist if you are taking any of the following medicines:

medicines for irregular heartbeat (Class I antiarrhythmics: quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone; Class III antiarrhythmics: amiodarone),
medicines for 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 receiving anaesthesia (see section "Warnings and precautions"),
medicines for diabetes mellitus (insulin and oral antidiabetic medicines),
baclofen (a muscle relaxant); amifostine (a protective agent used during anti-cancer treatment), medicines for heart failure known as digitalis glycosides (digoxin),
medicines for mental disorders (psychosis) or depression (tricyclic antidepressants, barbiturates, phenothiazines),
organic nitrates (medicines for angina and heart failure) and other medicines for high blood pressure,
non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation,
medicines for asthma, nasal congestion (sinusitis), or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation (sympathomimetic agents),
medicines that reduce the metabolism of nebivolol, such as: bupropion (a medicine to help stop smoking), paroxetine, fluoxetine, thioridazine (medicines for depression), quinidine (a medicine for irregular heartbeat), chloroquine (a medicine for malaria and autoimmune diseases such as rheumatoid arthritis), levomepromazine (a medicine for psychosis), terbinafine (a medicine for fungal and yeast infections),
medicines for excess stomach acid or ulcers, known as antacids (e.g. cimetidine): take NEBIVOLOLO DOC with meals and the antacid between meals.

NEBIVOLOLO DOC with food and drink
You may take NEBIVOLOLO DOC with food and drink.
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 fetus. Therefore, do not use NEBIVOLOLO DOC during pregnancy unless clearly necessary.
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
No studies have been conducted on the effects on the ability to drive or use machines.
Dizziness and fatigue may occasionally occur as side effects of NEBIVOLOLO DOC 5. Keep this in mind when driving or operating machinery (see section 4 "Possible side effects").
NEBIVOLOLO DOC contains lactose monohydrate
NEBIVOLOLO DOC contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take NEBIVOLOL DOC

Take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Hypertension
Adults
The recommended dose is 1 tablet daily (5 mg of nebivolol). It usually takes
1-2 weeks before NEBIVOLOL DOC 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 been observed
only with the combination of 5 mg of nebivolol and 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) 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 NEBIVOLOL DOC in patients with
impaired liver function or liver function disorders. For this reason,
NEBIVOLOL DOC must not be used in these patients (see “Do not take
NEBIVOLOL DOC”).
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 should be exercised and the
treatment must be closely monitored due to limited experience in
patients over 75 years of age.
Use in children and adolescents
NEBIVOLOL DOC is not recommended for children and adolescents under 18 years of age
due to insufficient data on safety and efficacy.
Chronic heart failure
Treatment of stable chronic heart failure should be initiated with a gradual
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 should be
stabilized before starting treatment with NEBIVOLOL DOC.
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 nebivolol) once daily,
then to 1 tablet (5 mg nebivolol) once daily, and
then to 2 tablets (10 mg nebivolol) once daily. The maximum recommended dose is 2 tablets (10 mg of nebivolol) once daily.

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
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 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.
NEBIVOLOL DOC must not be used in these patients (see “Do not take
NEBIVOLOL DOC”).
Elderly patients
Since the dose is individually increased up to the maximum tolerated dose,
no dose adjustment is required.
Use in children and adolescents
NEBIVOLOL DOC is not recommended for children and adolescents under 18 years of age
due to 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 NEBIVOLOL DOC is too strong or too weak, contact your doctor or
pharmacist.
If you take more NEBIVOLOL DOC 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
NEBIVOLOL DOC than prescribed.
You should lie down with your legs higher than your heart.
If you forget to take NEBIVOLOL DOC
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 forgotten
dose.
If you stop taking NEBIVOLOL DOC
Do not stop taking the tablets even if you feel better, unless your doctor tells you
to do so.
When treatment is stopped or discontinued prematurely, blood pressure may
rise or heart problems may worsen.
If you have any doubts about how to use 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.
Hypertension
The observed side effects, which in most cases were of mild to moderate intensity, are listed below according to system organ class and frequency.

CLASSIFICATION BY Common Uncommon Very rare Not known (frequency
SYSTEM ORGAN CLASS (may affect up (may affect up (may affect up cannot be estimated
to 1 in 10 people) to 1 in 100 people) to 1 in 10,000 people) from the available data)
Immune system disorders Swelling of the face, lips, throat or tongue (angioedema), widespread allergic reactions including generalized skin rashes (hypersensitivity reactions)
Psychiatric disorders Nightmares, depression
Nervous system disorders Headache, dizziness, tingling of the skin (paraesthesia), transient loss of consciousness (syncope)
Eye disorders Vision disturbances
Cardiac disorders Unusually slow heart rate (bradycardia), heart failure, conduction defects in the heart (slow AV conduction/AV block)
Vascular disorders Excessively low blood pressure, increased foot pain occurring every time you walk, due to narrowing of the arteries and inadequate blood circulation (intermittent claudication)
Respiratory, thoracic and Breathing difficulties, spasmodic constriction of the bronchi
mediastinal disorders
Gastrointestinal disorders Constipation, indigestion, nausea, diarrhoea, flatulence, vomiting
Skin and subcutaneous Itching, erythematous rash, worsening of psoriasis, urticaria
tissue disorders
Reproductive system and Impotence
breast disorders
General disorders and Fatigue, swelling with fluid retention (oedema)
administration site conditions

The following side effects have also been reported with some beta-adrenergic antagonists: hallucinations, psychic disturbances (psychosis), confusion, cold-induced bluish-red discoloration of arms and legs, finger pain turning first bluish, then white, and finally red (Raynaud's syndrome), dry eyes, and formation of new connective tissue in the eyes and diaphragm (practolol-like oculomucocutaneous toxicity).

Chronic heart failure
In a clinical study on chronic heart failure, the following adverse reactions 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 fainting sensation upon standing up quickly),
Inability to tolerate this medicine,
Cardiac conduction disorder affecting heart rhythm (first-degree AV block),
Swelling of the lower limbs (swollen ankles).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website: 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 NEBIVOLOL DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP.
The expiry date refers to the last day of that 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 DOC 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 monohydrate lactose.

Description of the appearance of NEBIVOLOLO DOC and contents of the pack
White, round, biconvex tablets, 9 mm in diameter, cross-scored on one side and engraved with 'N 5' on the other.
The tablet can be divided into two or four equal doses.
Packs: PVDC-aluminum blisters and HDPE containers with sealed LDPE caps.
Blister packs: 7, 14, 20, 28, 30, 50, 56, 60, 90, 100, 500 tablets and hospital pack of 500 (10x50) tablets.
HDPE tablet containers: 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 Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturers
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