NEBIVOLOL SANDOZ 5 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Nebivolol Sandoz 5 mg tablets EFG

Nebivolol

Read the entire leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, because it could harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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 Nebivolol Sandoz is and what it is used for

Nebivolol Sandoz contains nebivolol, a cardiovascular medicine that belongs 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 heart's pumping strength. It also exerts a dilating effect on blood vessels, which further contributes to lowering blood pressure.

It is used in the treatment of high blood pressure (hypertension).

Nebivolol is also used to treat mild to moderate chronic heart failure in patients aged 70 years and older, in combination with other therapies.

2. What you need to know before starting to take Nebivolol Sandoz

Do not take Nebivolol 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 one or more of the following conditions:

• low blood pressure,

• severe circulation problems in arms or legs,

• very slow heart rate (less than 60 beats per minute),

• other serious heart rhythm disorders (e.g., second- or third-degree atrioventricular block, heart conduction disorders),

• heart failure that has just occurred or has recently worsened, or you are receiving intravenous infusion treatment for circulatory shock due to acute heart failure to support heart function,

• asthma or breathing difficulties (currently or in the past),

• untreated pheochromocytoma, a tumor located in the kidneys (in the adrenal glands),

• liver function disorders,

• a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions

Tell your doctor if you have or develop any of the following conditions:

• abnormally slow heart rate,
• a type of chest pain caused by spontaneous cardiac spasms called Prinzmetal's angina,
• untreated chronic heart failure,
• first-degree heart block (a mild type of conduction disorder affecting heart rhythm),
• poor circulation in arms or legs, e.g., Raynaud's disease or syndrome, cramping pains when walking,
• prolonged breathing problems,
• diabetes: this medicine has no effect on blood sugar, but it may mask warning signs of low blood sugar (e.g., palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide),
• overactive thyroid gland: this medicine may mask signs of abnormally rapid heartbeat 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,
• if you need surgery, always inform your anesthetist before anesthesia that you are taking nebivolol.

If you have severe kidney problems, do not take nebivolol for heart failure and inform your doctor.

At the beginning of your treatment for chronic heart failure, you will be monitored regularly by an experienced physician (see section 3).

This treatment must not be stopped suddenly unless clearly evaluated and indicated by your doctor (see section 3).

Children and adolescents

Nebivolol is not recommended for use in children and adolescents due to lack of data.

Taking Nebivolol Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Certain medicines should not be used together, while others require specific adjustments (e.g., in dosage).

Always inform your doctor if, in addition to nebivolol, you are taking any of the following medicines:

• Medicines for blood pressure control or heart problems (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 stimulation on the heart and circulation).
• Sedatives and treatments for psychosis (a mental illness), e.g., barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting), and thioridazine.
• Medicines for diabetes, such as insulin or oral antidiabetics.
• Medicines used for depression, e.g., amitriptyline, paroxetine, fluoxetine.
• Medicines used for anesthesia during surgery.
• Medicines for asthma, nasal decongestants, and some medicines used to treat eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation.
• Amifostine used during cancer treatment.
• Baclofen used to treat epilepsy.

All these medicines, as well as nebivolol, may affect blood pressure and/or heart function.

• Medicines for treating excess stomach acidity or ulcers (antacids), e.g., cimetidine; nebivolol should be taken with food and the antacid between meals.

Taking Nebivolol Sandoz with food and drinks

Nebivolol can be taken with or without food, but it is best to take the tablet with some water.

Pregnancy and breastfeeding

Nebivolol should not be taken during pregnancy, unless clearly necessary.

Its use during breastfeeding is not recommended.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

This medicine may cause dizziness or fatigue. If you experience these effects, do not drive or operate machinery.

Nebivolol Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Nebivolol Sandoz

Follow exactly the instructions provided by your doctor for this nebivolol medicine. If in doubt, consult your doctor or pharmacist again.

Nebivolol may be taken before, during, or after meals, or independently of meals. It is best to take the tablet with some water.

Treatment of high blood pressure (hypertension)

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

Treatment of chronic heart failure

• Treatment must be initiated and strictly monitored by an experienced physician.
• Your doctor will start your treatment with ¼ (one quarter) of a tablet daily. This dose may be increased after 1–2 weeks to ½ (half) a tablet daily, then to 1 tablet daily, followed by 2 tablets daily until the appropriate dose for you is reached. Your doctor will prescribe the correct dose at each step, and you must follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) daily.
• Initiation of treatment and each dose increase must be performed under the supervision of an experienced physician for a period of at least 2 hours.
• If necessary, your doctor may reduce the dose.
• Do not stop treatment abruptly, as this could worsen heart failure.
• Patients with severe kidney problems should not take this medicine.
• Take your medicine once daily, preferably at the same time each day.

Instructions for splitting tablets

If your doctor has instructed you to take ¼ or ½ (two quarters) of a tablet, place the tablet on a flat, hard surface, such as a table, with the scored side facing upwards.

1. Place the tablet on a flat, hard surface, such as a table, so that the side with the four-leaf clover shape is facing upwards and the tablet's score lines align with 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock (Figure 1).

1. Place your thumb on the surface of the tablet so that it spans from 3 o'clock to 9 o'clock (Figure 2).

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

Your doctor may decide to combine nebivolol tablets with other medicines to treat your condition.

Not for use in children or adolescents.

If you take more Nebivolol Sandoz than you should

If you have accidentally taken an overdose of this medicine, consult your doctor or pharmacist immediately. The most common symptoms and signs of nebivolol overdose are very slow heartbeat (bradycardia), low blood pressure with possible fainting (hypotension), wheezing as seen in asthma (bronchospasm), and acute heart failure.

You may take activated charcoal (available from your pharmacy) while waiting for your doctor.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone 91 562 04 20 immediately, stating the medicine and the amount ingested.

If you forget to take Nebivolol Sandoz

If you forget to take a dose of nebivolol but remember shortly afterwards, take it as usual. However, if a long time has passed (e.g. several hours), such that the next dose is due soon, skip the missed dose and take the next regular dose at the usual time. Do not take a double dose. Try to avoid repeatedly forgetting to take your medication.

If you stop taking Nebivolol Sandoz

Always consult your doctor before stopping treatment with nebivolol, especially when you are taking it for high blood pressure or chronic heart failure.

Do not stop nebivolol treatment abruptly, as this could temporarily worsen your heart failure. If it becomes necessary to discontinue nebivolol treatment for chronic heart failure, 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, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

When nebivolol is used to treat high blood pressure, possible adverse effects are:

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

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

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

• decreased heart rate or other heart disturbances,
• low blood pressure,
• cramp-like pains when walking,
• blurred vision,
• impotence,
• feeling depressed,
• indigestion (dyspepsia), stomach or intestinal gas, vomiting,
• skin rash, itching,
• wheezing resembling asthma due to sudden spasms in the muscles surrounding the airways (bronchospasm),
• nightmares.

Rare adverse effects (may affect less than 1 in 10,000 people):

• fainting,
• worsening of psoriasis (a skin condition),
• scaly pink skin patches.

Frequency not known (cannot be estimated from available data):

• Hypersensitivity,
• angioneurotic oedema (swelling of the face, lips, mouth, tongue or throat),
• urticaria (skin rash).

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

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

In a clinical study for chronic heart failure, the observed adverse effects were:

Very common adverse effects (may affect more than 1 in 10 people):

• low heart rate,
• dizziness.

Common adverse effects (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 this medicine,
• a mild type of heart conduction disorder affecting heart rhythm (first-degree AV block),
• swelling of the legs (ankle swelling).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nebivolol Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after CAD/EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure how to dispose of unused medicines or their packaging, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nebivolol Sandoz

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

Appearance of the product and contents of the pack

White or almost white tablets, four-leaf clover-shaped on one side, convex on the other, quadrangular in shape on both sides, with break lines on both sides (diameter: 9 mm).

The tablets are packed in PVC/aluminum blisters and polyethylene bottles with tamper-evident seals, all contained in cardboard packaging.

Pack sizes

Blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 500 tablets.

Bottle: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Centre

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LEK S.A.

Ul. Domaniewska 50 C, 02-672 Warszawa

Poland

or

Lek Pharmaceuticals d.d.

Verovskova 57, 1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

or

Lek S.A.,

16 Podlipie Str.,

95-010 Stryków,

Poland

or

Lek Pharmaceuticals d.d.

Trimlini 2d, 9220 Lendava

Slovenia

This medicinal product is authorized in the Member States of the European Economic Area (EEA) 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 tablety

France: NEBIVOLOL Sandoz 5 mg, comprimé quadrisécable

Italy: NEBIVOLOLO SANDOZ 5 mg compresse

Netherlands: Nebivolol Sandoz 5 mg tabletten

Poland: NebivoLEK 5 MG, TABLETKI

Portugal: Nebivolol Sandoz 5 mg comprimido

United Kingdom: Nebivolol 5mg Tablets

Date of the most recent review of this leaflet: April 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/