Prospect: information for the patient

Nebivolol Sandoz 5 mg tablets EFG

Nebivolol

Read this prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult yourdoctororpharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even if they have the same symptomsas you,as it may harm them.

-If you experience any adverse effects,consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1.What is Nebivolol Sandoz and how is it used

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

3. How to take Nebivolol Sandoz

4. Possible adverse effects

5. Storage of Nebivolol Sandoz

6. Contents of the package and additional information

Nebivolol Sandoz contains nebivolol, a cardiovascular drug that belongs to the group of selective beta blockers (i.e., with selective action on the cardiovascular system). It prevents an increase in heart rate and controls the force of heart pumping. It also exerts a dilating action on blood vessels, which also 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 70 years of age or older, in association with other therapies.

Do not takeNebivolol Sandoz

• If you are allergic (hypersensitive) tonebivololor to any of the other components ofthis medication (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 heartbeats per minute),
• Other severe heart rhythm problems (e.g., second- and third-degree atrioventricular block, heart conduction disorders),
• Heart failure, which has recently occurred or has worsened recently, or is receiving intravenous treatment for acute heart failure to help the heart function,
• Asthma or breathing difficulties (current or past),
• Untreated phaeochromocytoma, 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

Inform your doctor if you have or develop any of the following problems:

• Abnormally slow heart rate,
• A type of chest pain due to spontaneous cardiac spasms called Prinzmetal's angina,
• Untreated chronic heart failure,
• First-degree heart block (a mild conduction disorder affecting heart rhythm),
• Poor circulation in arms or legs, e.g., Raynaud's disease, cramp-like pains when walking,
• Prolonged respiratory problems,
• Diabetes: This medication has no effect on blood sugar levels, but may mask signs of hypoglycemia (e.g., palpitations, rapid heart rate) and may increase the risk of severe hypoglycemia when used with certain diabetes medications called sulfonylureas (e.g., gliquidone, glimepiride, glipizide, glibenclamide, or tolbutamide),
• Overactive thyroid gland: This medication may mask signs of an abnormally fast heart rate due to this disorder,
• Allergies: This medication may intensify your reaction to pollen or other substances to which you are allergic,
• Psoriasis (a skin disease - pink scaly patches) or if you have ever had psoriasis,
• If you are to be operated on, inform your anesthetist before being anesthetized that you are takingnebivolol.

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

You will be regularly monitored by an experienced doctor at the start of your treatment for chronic heart failure (see section 3).

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

Children and adolescents

Nebivololis notrecommended for use in children and adolescents due to a lack of data.

Taking Nebivolol Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication,includingover-the-counter medications. Certain medications cannot be used at the same time, while others require specific changes (e.g., in dosage).

Inform your doctor at all times if, in addition to nebivolol, you are using any of the following medications:

• Medications for blood pressure control or heart problems (e.g., amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, felodipine, flecainide, guanfacine, hydralazine, lacidipine, lidocaine, methyldopa, mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, verapamil).
• Sympathomimetic agents (medications that mimic the effects of sympathetic activation of the heart and circulation).
• Sedatives and psychoses therapies (e.g., barbiturates, also used for epilepsy), phenothiazine (also used for vomiting and nausea), and thioridazine.
• Diabetes medications, such as insulin or oral antidiabetic agents.
• Depression medications, e.g., amitriptyline, paroxetine, fluoxetine.
• Anesthesia medications during surgery.
• Asthma medications, decongestants, and some medications for eye disorders, such as glaucoma (increased eye pressure) or pupil dilation.
• Amifostine used during cancer treatment.
• Baclofen used to treat epilepsy.

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

• Medications for treating excessive acidity or stomach ulcers (antacids), e.g., cimetidine; take nebivolol with meals and the antacid between meals.

Taking Nebivolol Sandoz with food and drinks

Nebivolol can be taken with meals or on an empty stomach, but it is best to take the tablet with a little water.

Pregnancy and breastfeeding

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

It is not recommended for use during breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant,Consult your doctor or pharmacist before using a medication.

Driving and operating machinery

This medication may cause dizziness or fatigue. If you notice it affecting you,do notdrive or operate machinery.

Nebivolol Sandoz contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the instructions for this nebivolol medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Nebivolol can be taken before, during, or after meals, as well as outside of meals. It is best to take the tablet with a little water.

Treatment of high blood pressure (hypertension)

• The recommended dose is 1 tablet per day.The dose should be taken preferably at the same time every day.
• Older patients and patients with kidney disorders usually start treatment with½ (half) tablet per day.
• The therapeutic effect on blood pressure is evident after 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 should be initiated and strictly controlled by an experienced doctor.
• Your doctor will have you start treatment with ¼ (a quarter) tablet per day. This dose may increase after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day, and then to 2 tablets per day until you reach the appropriate dose for you. Your doctor will prescribe the correct dose at each step, and you should follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) per day.
• The initiation of treatment and each dose increase will be performed under the supervision of an experienced doctor for a period of at least 2 hours.
• In case necessary, your doctor may reduce the dose.
• Do not abruptly stopthe treatment as this could worsen heart failure.
• Patients with severe kidney problems should not take this medication.
• Take your medication once a day, preferably at the same time every day.

Instructions for dividing 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 face with the grooves facing up.

1. Place the tablet on a flat, hard surface, such as a table, so that the face with the cloverleaf shape is facing up and the grooves of the tablet coincide with the 12 o'clock, 3 o'clock, 6 o'clock, and 9 o'clock marks (Figure 1).

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

1. Apply uniform pressure to the surface of the tablet until the tablet breaks.

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

Not to be used in children or adolescents.

If you take more Nebivolol Sandoz than you should

If you have accidentally taken an overdose of this medication, consultimmediatelyyour doctor or pharmacist. The most frequent symptoms and signs of a nebivolol overdose are a very slow heart rate (bradycardia), low blood pressure with possible dizziness (hypotension), labored breathing like in asthma (bronchospasm), and acute heart failure.

You can take activated charcoal (available at your pharmacy) while waiting for your doctor to arrive.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeNebivolol Sandoz

If you have forgotten to take a dose of nebivolol, but remember when you should have taken it, take it as usual. However, if a long time has passed (e.g., several hours), so that the next dose is near, skip the missed dose and take the nextusual doseat the usual time. Do not take a double dose. You should try to avoid repeated missed doses of the medication.

If you interrupt treatment with Nebivolol Sandoz

You should always consult with your doctor before stopping treatment with nebivolol, when taking it for high blood pressure or chronic heart failure.

You should not abruptly stop treatment with nebivolol as this could temporarily worsen your heart failure. If it is necessary to stop treatment with nebivolol for chronic heart failure, the daily dose should be gradually reduced, by reducing the dose by half at weekly intervals.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

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

• Headache,
• Dizziness,
• Fatigue,
• A strange itching or tingling sensation,
• Diarrhea,
• Constipation,
• Nausea,
• Shortness of breath,
• Swelling of hands or feet.

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

• Decreased heart rate or other cardiac abnormalities,
• Low blood pressure,
• Cramping pains when walking,
• Altered vision,
• Impotence,
• Sensation of depression,
• Difficulty digesting food (dyspepsia), gas in the stomach or intestines, vomiting,
• Rashes, itching,
• Labored breathing like asthma, due to sudden spasms in the muscles surrounding the respiratory system (bronchospasm),
• Nightmares.

Very rare side effects (may affect less than 1 in 10,000 people):

• Fainting,
• Worsening of psoriasis (a skin disease, scaly pink patches).

Unknown frequency (cannot be estimated from available data)

• Hypersensitivity,
• Angioneurotic edema (swelling of the face, lips, mouth, tongue, or throat),
• Urticaria (skin rash).

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

• Hallucinations,
• Psychosis,
• Confusion,
• Cold or cyanotic extremities (skin discoloration blue or purple),
• Raynaud's phenomenon (skin discoloration of fingers, toes, and occasionally other areas),
• Dry eyes,
• Formation of new connective tissue in the eyes and diaphragm (practolol-like mucocutaneous toxicity).

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

Frequent side effects (may affect more than 1 in 10 people):

• Low heart rate,
• Dizziness.

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

• Worsening of heart failure,
• Low blood pressure (like a feeling of fainting when standing up quickly),
• Impossibility of tolerating this medication,
• A mild type of cardiac conduction disorder that affects heart rhythm (first-degree AV block),
• Swelling of the legs(swelling of the ankles).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofNebivolol Sandoz

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

Appearance of the product and contents of the package

White or almost white tablets with a four-leaf clover shape on one side, convex on the other side, with a square shape on both sides, with breaking marks on both sides (diameter: 9 mm).

The tablets are packaged in PVC/aluminum blisters and polyethylene bottles with a guarantee seal packaged in a cardboard box.

Packaging 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.

It may be that not all formats are marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

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

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: April 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/