Nebivolol Aurobindo Italia

Package leaflet: Information for the patient

Nebivololo Aurobindo 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 others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nebivololo Aurobindo Italia is and what it is used for

Nebivololo Aurobindo Italia contains nebivolol, a cardiovascular medicine belonging to the group of selective beta-blocking agents (i.e. with selective action on the cardiovascular system). It prevents the increase in heart rate and controls the force of cardiac pumping. It also exerts a vasodilating effect on blood vessels, which contributes to lowering blood pressure.
It is used to treat elevated blood pressure (hypertension).
Nebivololo Aurobindo Italia is also used to treat mild to moderate chronic heart failure in patients aged 70 years or older, in addition to other therapies.

2. What you need to know before taking Nebivololo Aurobindo Italia

Do not take Nebivololo Aurobindo Italia

• if you are allergic to nebivolol or to any of the other ingredients of this medicine (listed in section 6).
• if you have one or more of the following conditions:
  • low blood pressure
  • severe circulatory problems in the arms or legs
  • very slow heart rate (less than 60 beats per minute)
  • certain other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders)
  • heart failure that has recently developed or recently worsened, or if you are being treated for circulatory shock due to acute heart failure with intravenous therapy to support heart function
  • asthma or wheezing (current or past history)
  • untreated phaeochromocytoma, a tumour located above the kidneys (in the adrenal gland)
  • impaired liver function
  • metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nebivololo Aurobindo Italia.
Contact your doctor if you have or develop any of the following conditions:

• abnormally slow heart rate
• a type of chest pain caused by spontaneous spasm of the heart muscle known as Prinzmetal's angina
• untreated chronic heart failure
• first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)
• poor circulation in the arms and legs, e.g. Raynaud’s disease or syndrome, cramp-like pain while walking
• prolonged breathing difficulties
• diabetes: this medicine does not affect blood glucose levels, but it may mask warning signs of low blood sugar (e.g. palpitations, rapid heartbeat), and may increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• hyperactive thyroid: this medicine may mask signs of abnormally rapid 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 – scaly pink patches) or if you have ever had psoriasis in the past
• if you are scheduled for surgery, always inform the anaesthetist that you are taking Nebivololo Aurobindo Italia before receiving anaesthesia.

If you have severe kidney problems, do not take Nebivololo Aurobindo Italia for the treatment of heart failure and inform your doctor.
A specialist doctor will monitor you regularly at the start of treatment for chronic heart failure (see section 3).
This treatment must not be stopped abruptly unless specifically requested and evaluated by your doctor (see section 3).

Children and adolescents
The use of Nebivololo Aurobindo Italia is not recommended in children and adolescents due to lack of data on the use of this medicine.

Other medicines and Nebivololo Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor if you are taking or have recently been given any of the following medicines in addition to Nebivololo Aurobindo Italia:

• medicines for controlling blood pressure or medicines used for heart problems (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nifedipine, nicardipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• sedatives and treatments used in the management of psychosis (a mental illness), e.g. barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting), e.g. thioridazine.
• medicines used to treat depression, e.g. amitriptyline, paroxetine, fluoxetine.
• medicines used for anaesthesia during surgery.
• medicines used for asthma, nasal congestion, or certain eye conditions such as glaucoma (increased pressure in the eye) or dilation (enlargement) of the pupil.
• baclofen (a muscle relaxant); amifostine (a protective agent used during anticancer therapy).
• medicines for diabetes such as insulin or oral antidiabetic medicines.

All of these medicines, including nebivolol, may affect blood pressure and/or heart function.

• medicines used to treat excess stomach acid or ulcers (antacids): you should take this medicine with food, and the antacid between meals.

Nebivololo Aurobindo Italia with food and drink
Refer to section 3.

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

Pregnancy
Nebivololo Aurobindo Italia must not be used during pregnancy unless absolutely necessary.

Breastfeeding
Breastfeeding is not recommended during treatment with Nebivololo Aurobindo Italia.

Driving and using machines
This medicine may cause dizziness or fatigue. If you experience these symptoms, do not drive or operate machinery.

Nebivololo Aurobindo Italia contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Nebivololo Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Nebivololo Aurobindo Italia

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Nebivololo Aurobindo Italia may be taken before, during or after a meal. Alternatively, you can
take this medicine regardless of meals. It is preferable to take the tablet with water.

Treatment of high blood pressure (hypertension)

• The recommended dose is 5 mg (one 5 mg tablet or two 2.5 mg tablets) once daily. The dose should preferably be taken at the same time each day.
• Elderly patients and patients with kidney problems usually start with 2.5 mg (half a 5 mg tablet or one 2.5 mg tablet) once daily.
• The therapeutic effect on blood pressure becomes evident after 1–2 weeks of treatment. Occasionally, the optimal effect is only achieved after 4 weeks of treatment.

Treatment of chronic heart failure

• Treatment must be initiated and closely supervised by an experienced physician.
• Your doctor will start treatment with 1.25 mg (half a 2.5 mg tablet) once daily. After 1–2 weeks, this dose may be increased to 2.5 mg (one 2.5 mg tablet or half a 5 mg tablet) once daily, then to 5 mg (two 2.5 mg tablets or one 5 mg tablet), and subsequently to 10 mg (four 2.5 mg tablets or two 5 mg tablets) once daily, until the appropriate dose is reached. Your doctor will prescribe the dose most suitable for each stage of treatment, and you must strictly follow the doctor’s instructions.
• The maximum recommended dose is 10 mg once daily.
• At the beginning of treatment and each time the dose is increased, you must be closely monitored by an experienced physician for at least 2 hours.
• If necessary, your doctor may reduce the dose.
• Do not stop treatment abruptly, as this may worsen your heart failure.
• Patients with severe kidney problems must not take this medicine.
• Take the medicine once daily, preferably always at the same time each day.
• Your doctor may decide to combine the tablets with other medicines to treat your condition.

If your doctor has instructed you to take ¼ (i.e. 1.25 mg – one quarter) or ½ (i.e. 2.5 mg – half) of a tablet
daily, follow the instructions below on how to split the scored tablets of Nebivololo Aurobindo Italia 5 mg.

• Place the tablet on a flat, hard surface (e.g. a table or countertop), with the cross-scored lines facing upwards.
• Break the tablet by applying pressure with the index fingers of both hands along one of the break lines (Figures 1 and 2).
• To obtain quarters, break each half in the same way (Figures 3 and 4).

Figures 1 and 2: How to easily split in half the cross-scored tablet of Nebivololo
Aurobindo Italia 5 mg.

Figures 3 and 4: How to easily divide into quarters a half tablet of the cross-scored
Nebivololo Aurobindo Italia 5 mg.

Use in children and adolescents
Nebivololo Aurobindo Italia is not recommended for use in children and adolescents.

If you take more Nebivololo Aurobindo Italia than you should
If you accidentally take too high a dose of this medicine, contact your doctor or
pharmacist immediately. The most common symptoms and signs of an overdose of Nebivololo Aurobindo Italia are
very slow heartbeat (bradycardia), low blood pressure possibly leading to fainting (hypotension),
breathing difficulties similar to asthma (bronchospasm), and acute heart failure.
While waiting for medical help, you may take activated charcoal (available from pharmacies).

If you forget to take Nebivololo Aurobindo Italia
If you forget to take your dose but remember shortly afterwards, take the dose as usual.
However, if a considerable amount of time has passed (e.g. several hours), to the point where you are almost due for the next dose, skip the missed dose and take the next scheduled dose as planned. Do not take a double dose to make up for the missed dose. However, avoid repeatedly skipping doses.

If you stop taking Nebivololo Aurobindo Italia
Always consult your doctor before stopping treatment with Nebivololo Aurobindo Italia, whether you are taking it for hypertension or chronic heart failure.
Do not stop treatment with Nebivololo Aurobindo Italia abruptly, as this may cause a temporary worsening of heart failure.
If it becomes necessary to discontinue treatment with Nebivololo Aurobindo Italia for chronic heart failure, the dose should be gradually reduced by halving it at weekly intervals.

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.

When Nebivololo Aurobindo Italia is used for the treatment of high blood pressure, possible side effects are:

Common (may affect up to 1 in 10 people):

• headache
• dizziness
• tiredness
• an unusual sensation of itching or tingling
• diarrhoea
• constipation
• nausea
• shortness of breath
• swelling of the hands and feet

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

• slow heartbeat or other heart problems
• low blood pressure
• cramp-like pains in the legs when walking
• abnormal vision
• impotence
• feeling depressed
• digestive difficulties (dyspepsia), wind in the stomach or intestines, vomiting
• skin rash, itching
• breathlessness as in asthma, due to sudden cramps in the muscles around the airways (bronchospasm)
• nightmares

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

• fainting
• worsening of psoriasis (a skin disease – scaly pink patches)

The following side effects have been reported only in isolated cases during treatment with this medicine:

• allergic reactions affecting the whole body, with widespread rash (hypersensitivity reactions)
• rapidly developing swelling, particularly around the lips, eyes or tongue, possibly causing sudden breathing difficulties (angioedema)
• a type of skin rash characterised by raised, itchy, pale red lumps, either allergic or non-allergic in nature (urticaria)

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 heartbeat
• dizziness

Common (may affect up to 1 in 10 people):

• worsening of heart failure
• low blood pressure (such as feeling faint when standing up quickly)
• inability to tolerate the medicine
• a mild type of heart conduction disorder affecting heart rhythm (first-degree AV block)
• swelling of the lower limbs (such as 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 http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nebivololo Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the packaging, or the bottle after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
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. Contents of the Pack and Other Information

What Nebivololo Aurobindo Italia Contains

• The active substance is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride, equivalent to 5 mg of nebivolol.
• The other components are monohydrate lactose, maize starch, croscarmellose sodium, hypromellose 15 cp, polysorbate 80, anhydrous colloidal silica, microcrystalline cellulose (grade-102), magnesium stearate.

Description of the Appearance of Nebivololo Aurobindo Italia and Contents of the Pack
Tablets.
White to almost white, round-shaped (9.1 mm diameter), biconvex, uncoated tablets, with "N L 5" engraved on one side separated by a cross-shaped score line, and smooth on the other side. The tablet can be divided into equal doses (halves and quarters).
Nebivololo Aurobindo Italia tablets are available in blister packs and in HDPE containers with white polypropylene caps.
Pack sizes:
Blister packs: 14, 28, 30, 50, 60, 90 and 100 tablets.
HDPE containers: 250 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium: Nebivolol AB 5 mg tabletten / Nebivolol AB 5 mg comprimés
Germany: Nebivolol Puren 5 mg Tabletten
Italy: Nebivololo Aurobindo Italia
Netherlands: Nebivolol Aurobindo 2.5 mg/5 mg, tabletten
Poland: Nebivolol Aurovitas
Portugal: Nebivolol Generis
Spain: Nebivolol Aurovitas 5 mg comprimidos EFG