Nebivololo Sandoz

Patient Information Leaflet

Nebivolol Sandoz 5 mg tablets

Generic medicine
Read this entire leaflet carefully before 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 give it to others, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nebivololo Sandoz is and what it is used for

Nebivololo Sandoz contains nebivolol, a cardiovascular medicine belonging to the class of selective beta-blocking agents (i.e. agents with selective action on the cardiovascular system). It prevents the increase in heart rate and controls the force of the heart muscle. It also exerts a vasodilating effect on blood vessels, which contributes to reducing blood pressure.
It is used to treat high blood pressure (hypertension).
Nebivololo Sandoz 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 Sandoz

Do not take Nebivololo Sandoz

• if you are allergic (hypersensitive) to nebivolol or to any of the other ingredients of this medicine (listed in section 6)
• if you have any of the following conditions:
  • low blood pressure
  • severe circulatory disorders in the arms or legs
  • very slow heart rate (less than 60 beats per minute)
  • certain other serious heart rhythm problems (for example, second- or third-degree atrioventricular block, cardiac conduction disorders)
  • heart failure that has recently appeared or worsened, or if you are receiving intravenous treatment for circulatory shock due to severe heart failure to support heart function
  • asthma or shortness of breath (currently or in the past)
  • untreated pheochromocytoma, a tumour located above the kidneys (in the adrenal glands)
  • liver function disorders
  • a metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis

Warnings and precautions
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Contact your doctor or pharmacist before taking Nebivololo Sandoz if you have or develop any of the following conditions:

• excessively slow heart rate
• a form of chest pain caused by spontaneous coronary spasms known as "Prinzmetal's angina"
• untreated chronic heart failure
• first-degree heart block (a mild type of cardiac conduction disorder affecting heart rhythm)
• poor circulation in the arms or legs, for example Raynaud’s disease or syndrome, cramp-like pain when walking
• persistent respiratory disorders
• diabetes: this medicine does not affect blood sugar levels, but it may mask the warning signs of low blood sugar (for example palpitations and increased heart rate) and could increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulfonylureas (for example gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide)
• hyperactive thyroid: this medicine may mask the signs of abnormally increased heart rate caused by this condition
• allergies: this medicine may worsen your reaction to pollen or other substances you are allergic to
• psoriasis (a skin disorder characterised by scaly, reddish patches), currently or in the past
• if you are scheduled for surgery, inform the anaesthetist before the operation that you are taking Nebivololo Sandoz

If you have severe kidney problems, do not take Nebivololo Sandoz for heart failure and inform your doctor.
At the beginning of treatment for chronic heart failure, you will be regularly monitored by an experienced doctor (see section 3).
This treatment must not be stopped suddenly unless clearly indicated and evaluated by your doctor (see section 3).
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

Children and adolescents
Due to lack of data on the use of this medicine in children and adolescents, Nebivololo Sandoz is not recommended for these patient groups.

Other medicines and Nebivololo Sandoz
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Some medicines cannot be used together, while others may require specific adjustments (for example in dosage).
Always inform your doctor if, in addition to Nebivololo Sandoz, you are taking or receiving any of the following medicines:

• medicines used to control blood pressure or treat heart disorders (such as amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydroquinidine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil)
• sympathomimetic agents (medicines that mimic the effects of sympathetic activation on the heart and circulation)
• sedatives and medicines used to treat psychosis (a mental disorder), such as barbiturates (also used for epilepsy), phenothiazines (also used to treat nausea and vomiting), and thioridazine
• medicines for diabetes such as insulin or oral antidiabetic medicines
• medicines for depression such as amitriptyline, paroxetine, fluoxetine
• medicines used for anaesthesia during surgery
• medicines used for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation (enlargement)
• amifostine, used during cancer treatment
• baclofen, used to treat epilepsy

All of these medicines, like nebivolol, can affect blood pressure and/or heart function.

• Medicines used to treat excess stomach acid or ulcers (antacids), for example cimetidine; in this case, it is recommended to take Nebivololo Sandoz with meals and the antacid medicine between meals.

Nebivololo Sandoz with food and drink
Nebivololo Sandoz may be taken during meals or on an empty stomach, but it is best to take the tablet with some water.

Pregnancy and breastfeeding
Nebivololo Sandoz must not be used during pregnancy, unless clearly necessary.
Use during breastfeeding is not recommended.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine may cause dizziness or fatigue. In this case, refrain from driving or operating machinery.

Nebivololo Sandoz contains lactose and sodium
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Nebivololo Sandoz

Take Nebivololo Sandoz exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Nebivololo Sandoz may be taken before, during, or after meals, or independently of meals. It is best to take the tablet with a glass of water.

Treatment of hypertension

• The usual dose is 1 tablet daily. The dose should preferably be taken at the same time each day.
• Elderly patients and those with renal impairment usually start with ½ (half) a tablet daily.
• The therapeutic effect on blood pressure becomes evident after 1–2 weeks of treatment. Occasionally, the optimal effect may only be achieved after 4 weeks.

Treatment of chronic heart failure

• Treatment must be initiated and carefully supervised by an experienced physician.
• Your doctor will start treatment with ¼ (one quarter) of a tablet daily. After 1–2 weeks, this dose may be increased to ½ (half) a tablet daily, then to 1 tablet daily, and finally to 2 tablets daily, until the correct dose for you is reached. Your doctor will prescribe the optimal dose for each stage of therapy: follow their instructions carefully.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• Treatment initiation and any dose increases must be performed under the supervision of an experienced physician, who will monitor you for 2 hours.
• If necessary, your doctor may reduce your dose.
• Do not stop treatment suddenly, as this may worsen heart failure.
• Patients with severe renal impairment must not take this medicine.
• Take the medicine once daily, preferably at the same time each day.

Instructions for splitting the tablet
If your doctor has instructed you to take ¼ or ½ (two quarters) of a tablet, proceed as follows:

1. Place a tablet on a flat, hard surface so that the cloverleaf symbol is facing upwards and the tablet’s break lines align with the 12 o’clock, 3 o’clock, 6 o’clock, and 9 o’clock positions (Figure 1).

2. Place your thumb on the surface of the tablet so that it aligns with the direction from 3 o’clock to 9 o’clock (Figure 2).

3. Apply even pressure to the surface of the tablet until it breaks.

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To treat your condition, your doctor may decide to prescribe Nebivololo Sandoz tablets together with other medicines.
Do not use in children and adolescents.

If you take more Nebivololo Sandoz than you should
If you accidentally take too high a dose of this medicine, inform your doctor or pharmacist immediately. The most common signs and symptoms of Nebivololo Sandoz overdose are:
slowing of the heartbeat (bradycardia), low blood pressure possibly with fainting (hypotension), breathing difficulties resembling asthma (bronchospasm), and acute heart failure.
While waiting for the doctor, you may take activated charcoal (available from pharmacies).

If you forget to take Nebivololo Sandoz
If you forget to take a dose of Nebivololo Sandoz and remember shortly afterwards, take your daily dose as usual. However, if the delay is significant (several hours), such that it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose. Nevertheless, avoid repeatedly missing doses.

If you stop taking Nebivololo Sandoz
You must always consult your doctor before stopping treatment with Nebivololo Sandoz, whether you are taking it for hypertension or chronic heart failure.
Do not stop treatment suddenly, as this may cause a temporary worsening of heart failure. If discontinuation of chronic heart failure treatment with Nebivololo Sandoz becomes necessary, the daily dose should be gradually reduced by halving the dose at weekly intervals.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Nebivolol Sandoz may cause side effects, although not everyone experiences them.
When Nebivolol Sandoz is used to treat hypertension, possible side effects are:
Common side effects (may affect up to 1 in 10 people):

• headache
• dizziness
• fatigue
• unusual sensation of itching or tingling
• diarrhoea
• constipation
• nausea
• shortness of breath
• swelling of hands or feet.

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

• slowing of the heartbeat or other heart disturbances
• low blood pressure
• cramp-like pain when walking
• changes in vision
• impotence
• digestive problems (dyspepsia), gas in the stomach or intestines, vomiting
• skin rashes, itching

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• breathing difficulty similar to asthma, due to sudden cramps in the muscles surrounding the airways (bronchospasm)
• nightmares.

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

• fainting
• worsening of psoriasis (a skin disorder characterized by scaly pink patches).

Not known (frequency cannot be estimated from available data):

• hypersensitivity
• angioedema (swelling of the face, lips, mouth, tongue or throat)
• urticaria (itchy skin rash)

The following side effects have also been reported with similar medicines:

• hallucinations
• psychosis
• confusion
• cold extremities, cyanotic extremities (bluish or purplish skin discoloration)
• Raynaud's phenomenon (discoloration of fingers and toes, and occasionally other areas)
• dry eyes
• formation of new connective tissue in the eyes and diaphragm (practolol-type oculomucocutaneous toxicity).

In a clinical study on chronic heart failure, the following side effects were observed:
Very common side effects (may affect more than 1 in 10 people):

• slowing of the heartbeat
• dizziness

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

• worsening of heart failure
• low blood pressure (for example, feeling faint when standing up quickly)
• inability to tolerate this medicine
• a mild disturbance in cardiac conduction affecting heart rhythm (first-degree atrioventricular block)
• swelling in the lower limbs (for example, the 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 Italian Medicines Agency (Agenzia Italiana del Farmaco) website: https://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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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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. Package contents and other information

What Nebivololo Sandoz contains

• The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (as hydrochloride).
• The other components are: croscarmellose sodium, monohydrate lactose, maize starch, microcrystalline cellulose, hypromellose 5 cps, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Nebivololo Sandoz and package contents
White or almost white clover-shaped tablets on one side, convex on the other, with crosswise scoring on both sides and break lines on both sides (diameter 9 mm).
The tablets are packaged in PVC/aluminum blisters or in polyethylene bottles with tamper-evident polyethylene caps, all contained in a cardboard box.
Pack sizes:
Blister packs: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 500 tablets.
Bottles: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturers
Salutas Pharma GmbH – Otto von Guericke Allee 1 – 39179 Barleben - Germany
LEK S.A. – Ul Domaniewska 50C – 02-672 Warszawa - Poland
LEK Pharmaceuticals d.d. – Verovskova 57 – 1526 Ljubljana – Slovenia
Lek S.A. - 16 Podlipie Str. - 95-010 Stryków – Poland
Lek Pharmaceuticals d.d. - Trimlini 2d - 9220 Lendava - Slovenia

This medicinal product has been authorised in EEA Member States under the following names:
Austria: Nebivolol Sandoz 5 mg – Tabletten
Belgium: Nebivolol Sandoz 5 mg tabletten
Bulgaria: NEBIVOLOL SANDOZ 5 mg tablets
Czech Republic: Nebivolol Sandoz 5 mg
Spain: Nebivolol Sandoz 5 mg comprimidos EFG
France: NEBIVOLOL Sandoz 5 mg, comprimé quadrisécable
Italy: NEBIVOLOLO SANDOZ
Netherlands: Nebivolol Sandoz 5 mg
Poland: NebivoLEK, 5mg, tabletki
Portugal: Nebivolol Sandoz
Romania: NEBIVOLOL SANDOZ 5 mg comprimate
United Kingdom: Nebivolol 5mg Tablets
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