NEBIVOLOL RATIOPHARM 5 mg TABLETS

Introduction

Leaflet: information for the user

Nebivolol ratiopharm 5 mg tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Nebivolol ratiopharm and what is it used for
2. What you need to know before taking Nebivolol ratiopharm
3. How to take Nebivolol ratiopharm
4. Possible side effects
5. Storage of Nebivolol ratiopharm
6. Package contents and additional information

1. What is Nebivolol ratiopharm and what is it used for

Nebivolol ratiopharm contains nebivolol, a medication with cardiovascular action, belonging to the group of selective beta-blockers (with selective activity in the cardiovascular system). It prevents an increase in heart rate and controls the heart's pumping force. It also has a vasodilating effect on blood vessels, which in turn helps to lower blood pressure.

It is used to treat high blood pressure (hypertension).

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

2. What you need to know before taking Nebivolol ratiopharm

Do not take Nebivolol ratiopharm

• if you are allergic to nebivolol or any of the other components of this 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 beats per minute)
• other severe heart rhythm disorders (such as second- and third-degree atrioventricular block or other cardiac conduction disorders)
• you have recently had a heart failure episode or worsening of it, or are receiving intravenous treatment to help your heart work after suffering a circulatory collapse due to acute heart failure
• asthma or difficulty breathing (currently or in the past)
• pheochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), that is not being treated
• liver function disorders.
• metabolic disorders (metabolic acidosis), such as diabetic ketoacidosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take nebivolol.

Tell your doctor if you have any of the following problems:

• abnormally slow heart rate,
• a type of chest pain due to a spontaneous spasm of the heart's arteries, called Prinzmetal's angina,
• untreated chronic heart failure,
• first-degree heart block (mild cardiac conduction disorder affecting heart rhythm),
• poor circulation in arms or legs, such as Raynaud's disease or pain when walking similar to a cramp,
• chronic respiratory problems,
• diabetes: This medication has no effect on blood sugar levels, but it can mask the warning signs produced by a decrease in these levels (such as palpitations, rapid heart rate) and may increase the risk of severe hypoglycemia when used with certain antidiabetic medications called sulfonylureas (such as gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
• hyperthyroidism: This medication can mask the signs due to this condition, such as abnormally high heart rate,
• allergies: This medication can intensify your reaction to pollen or other substances you are allergic to,
• if you have or have had psoriasis (a skin disease characterized by scaly pink patches),
• if you need to undergo surgery, always inform your anesthesiologist that you are taking Nebivolol ratiopharm.

If you have severe kidney problems, consult your doctor before taking nebivolol to treat your heart failure.

At the start of treatment for chronic heart failure, you will be regularly monitored by a doctor (see section 3).

This treatment should not be stopped abruptly, unless clearly indicated and evaluated by your doctor (see section 3).

Children and adolescents

Do notrecommend the use of Nebivolol ratiopharm in children and adolescents due to the lack of data on the use of this medication in these patients.

Taking Nebivolol ratiopharm with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

It is essential that you always inform your doctor if, in addition to nebivolol, you are taking any of the following medications:

• Some medications for the heart or to control blood pressure (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).
• Sedatives and medications for psychosis (mental illness), such as barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea), and thioridazine.
• Medications for depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medications used for anesthesia during an operation.
• Medications for asthma, nasal decongestants, or some medications for treating eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (an antispastic medication); Amifostine (a protective medication used during cancer treatment).
• Medications for diabetes, such as insulin or oral antidiabetics.

All these medications, like nebivolol, can affect blood pressure and heart function.

Medications to treat excess stomach acid or ulcers (antacids): you should take nebivolol during meals, and the antacid between meals.

Taking Nebivolol ratiopharm with food and drinks

See section 3.

Pregnancy and breastfeeding

Nebivolol ratiopharm should not be administered during pregnancy unless your doctor considers it necessary.

Its use is not recommended during breastfeeding.

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

Driving and using machines

This medication can cause dizziness or fatigue. If so, do not drive or use machinery.

Nebivolol ratiopharm contains lactose

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

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

3. How to take Nebivolol ratiopharm

Follow your doctor's instructions for taking this medication exactly. If in doubt, consult your doctor or pharmacist again.

Nebivolol can be taken before, during, or after meals, but it can also be taken independently of them. It is preferable to take the tablet with a little water.

Treatment of high blood pressure (hypertension)

• The normal dose is 1 tablet per day. It is preferable to take the dose always at the same time of day.
• In elderly patients and patients with kidney problems, it is recommended to start treatment with ½ (half) tablet per day.
• The therapeutic effect on blood pressure is achieved after 1-2 weeks of treatment. Occasionally, the optimal effect is not achieved until 4 weeks.

Treatment of chronic heart failure

• Your treatment will be initiated and supervised by a doctor with experience.
• Your doctor will start your treatment with ¼ (quarter) tablet per day. The dose will be increased after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day, and finally to 2 tablets per day until the optimal dose for you is achieved. Your doctor will prescribe the correct dose for you at each time, and you should follow their instructions exactly.
• The maximum recommended dose is 2 tablets (10 mg) per day.
• The start of treatment and each dose increase will be done under the supervision of an experienced doctor for a period of 2 hours.
• Your doctor will reduce your dose if necessary.
• You should not stop treatment abruptly, as this could worsen your heart failure.
• Patient with severe kidney problems should not take this medication.
• Take the medication once a day, preferably at the same time of day.

If your doctor has indicated that you should take ¼ (quarter) or ½ (half) tablet daily, follow these instructions to split the Nebivolol ratiopharm tablets, which are scored in a cross shape.

• Place the tablets on a flat, hard surface (e.g., table or countertop), with the cross-shaped score facing up.
• Break the tablet by pressing it with the index fingers of both hands placed on either side of one of the scores (Diagrams 1 and 2).
• Proceed in the same way to split the half tablet into quarters (Diagrams 3 and 4).

Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg tablet scored in a cross shape into two halves.

Diagrams 3 and 4: Easy breaking of the half tablet of Nebivolol 5 mg scored in a cross shape into quarters.

• Your doctor will decide whether to combine nebivolol with other medications to treat your condition.
• Do not administer to children or adolescents.

If you take more Nebivolol ratiopharm than you should

If you have accidentally taken an overdose of this medication, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken. The most frequent symptoms and signs of a nebivolol overdose are very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

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

If you forget to take Nebivolol ratiopharm

If you forget to take a dose of nebivolol, but remember shortly after when you should have taken it, take the daily dose as usual. However, if a lot of time has passed (several hours), so that it is close to the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose. However, you should try to avoid repeatedly forgetting to take your medication.

If you stop taking Nebivolol ratiopharm

Always consult your doctor before stopping treatment with Nebivolol ratiopharm, whether you are taking it for high blood pressure or chronic heart failure.

Do not stop treatment abruptly, as this could temporarily worsen your heart failure. If it is necessary to stop treatment for chronic heart failure, the daily dose should be gradually decreased, starting by halving the dose, at intervals of one week.

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

4. Possible side effects

Like all medications, this medication 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,
• unusual itching or tingling sensation,
• diarrhea,
• constipation,
• nausea,
• difficulty breathing,
• swelling of hands or feet.

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

• slow heart rate or other heart disorders,
• low blood pressure,
• pain when walking similar to a cramp,
• abnormal vision,
• impotence,
• feeling of depression,
• difficulty digesting (dyspepsia), stomach or intestinal gas, vomiting,
• skin rash, itching,
• difficulty breathing like asthma, due to sudden contraction of the muscles around the airways (bronchospasm),
• nightmares.

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

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

The following side effects have been reported in only a few isolated cases during treatment with Nebivolol ratiopharm:

• allergic reactions, such as generalized skin rashes (hypersensitivity reactions),
• sudden swelling, especially in the area around the lips, eyes, and/or tongue, which may be accompanied by acute difficulty breathing (angioedema),
• skin rash characterized by pink, raised patches that cause itching, of allergic or non-allergic origin (urticaria).

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

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

• slow heart rate,
• dizziness.

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

• worsening of heart failure,
• low blood pressure (such as a feeling of fainting when standing up quickly),
• intolerance to this medication,
• mild cardiac conduction disorder affecting heart rhythm (first-degree atrioventricular block).
• swelling of the lower limbs (increase in the volume of the ankles).

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Nebivolol ratiopharm

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

Do not use this medication after the expiration date shown on the box and blister after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in 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. This will help protect the environment.

6. Package contents and additional information

Composition of Nebivolol ratiopharm

• The active ingredient is nebivolol.

Each tablet contains 5 mg of nebivolol, equivalent to 5.45 mg of nebivolol hydrochloride.

• The other ingredients are anhydrous colloidal silica, magnesium stearate, sodium croscarmellose, macrogol 6000, and lactose monohydrate.

Appearance of the product and package contents

Round, white, convex tablets, 9 mm in size, with a cross-shaped score on one face and marked with "N 5" on the other face.

The tablets can be divided into two and four equal parts.

Package sizes:

Blister: 10, 14, 28, 30, and 90 tablets.

HDPE bottle: 10, 14, 28, 30, and 90 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid

Spain

Manufacturer

Balkanpharma Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600

Bulgaria

or

Actavis Ltd.

BLB015-016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the last revision of this leaflet:May 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)