Nebivolol Ratiopharm 5 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nebivolol ratiopharm 5 mg tablets EFG

Read this entire leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Contents of this leaflet:

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

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

Nebivolol ratiopharm contains nebivolol, a cardiovascular-acting medicine belonging to the group of selective beta-blocking agents (with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's pumping force. It also exerts a vasodilating effect on blood vessels, which further contributes to lowering blood pressure.

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

Nebivolol is also used for the treatment of mild to moderate chronic heart failure in patients aged 70 years or older, administered in combination with other medicines.

2. What you need to know before taking Nebivolol ratiopharm

Do not take Nebivolol ratiopharm

• 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

• serious circulation problems in arms or legs

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

• other serious heart rhythm disorders (such as second- or third-degree atrioventricular block or other cardiac conduction disorders)

• recent episode of heart failure or worsening of heart failure, or receiving intravenous treatment to support heart function after circulatory collapse due to acute heart failure

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

• pheochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), which is not being treated

• liver function disorders

• metabolic disorders (metabolic acidosis), for example, diabetic ketoacidosis

Warnings and precautions

Consult your doctor or pharmacist before starting to take nebivolol.

Inform your doctor if you have any of the following conditions:

• abnormally slow heart rate
• a type of chest pain caused by spontaneous spasm of the heart arteries, called Prinzmetal's angina
• untreated chronic heart failure
• first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)
• poor circulation in arms or legs, such as Raynaud’s disease or syndrome, or leg pain when walking similar to cramps
• chronic respiratory problems
• diabetes: This medicine has no effect on blood sugar levels, but it may mask warning signs of low blood sugar (e.g., palpitations, rapid heartbeat) and could 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)
• overactivity of the thyroid gland: This medicine may mask symptoms of this condition, such as abnormally high heart rate
• allergies: This medicine may 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 are scheduled for surgery, always inform your anesthesiologist that you are taking Nebivolol ratiopharm

If you have severe kidney problems, consult your doctor before taking nebivolol for treatment of heart failure.

At the beginning of treatment for chronic heart failure, you should 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

Nebivolol ratiopharm is not recommended for use in children and adolescents due to lack of data on its use in this patient group.

Taking Nebivolol ratiopharm with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Certain medicines for the heart or blood pressure control (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 medicines for psychosis (mental illness), such as barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting), and thioridazine
• Medicines for depression, such as amitriptiline, paroxetine, and fluoxetine
• Medicines used for anesthesia during surgery
• Medicines for asthma, nasal decongestants, or certain eye medications used to treat glaucoma (increased eye pressure) or pupil dilation
• Baclofen (a muscle relaxant); Amifostine (a protective agent used during cancer treatment)
• Medicines for diabetes, such as insulin or oral antidiabetics

All of these medicines, like nebivolol, may affect blood pressure and heart function.

Medicines for treating excess stomach acidity or ulcers (antacids): take nebivolol with food, and take the antacid between meals.

Taking Nebivolol ratiopharm with food and drink

See section 3.

Pregnancy and breastfeeding

Nebivolol ratiopharm should not be used during pregnancy unless considered necessary by your doctor.

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 this occurs, do not drive or operate machinery.

Nebivolol ratiopharm contains lactose

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 1 mmol of sodium (23 mg) per tablet; essentially "sodium-free".

3. How to take Nebivolol ratiopharm

Follow exactly the dosing instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Nebivolol may be taken before, during, or after meals, or it may also be taken independently of meals. It is preferable to take the tablet with a small amount of water.

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet daily. It is preferable to take the dose at the same time each day.
• In elderly patients and patients with renal impairment, treatment should be initiated with ½ (half) a tablet daily.
• The therapeutic effect on blood pressure is achieved after 1–2 weeks of treatment. Occasionally, the optimal effect may not be reached until after 4 weeks.

Treatment of chronic heart failure

• Your treatment will be initiated and supervised by a physician experienced in this area.
• Your doctor will start your treatment with ¼ (one-quarter) of a tablet daily. The dose will be increased after 1–2 weeks to ½ (half) a tablet daily, then to 1 tablet daily, and subsequently to 2 tablets daily until the optimal dose for you is reached. Your doctor will prescribe the correct dose for you at each stage, 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 2 hours.
• Your doctor will reduce your dose if necessary.
• You must not stop treatment abruptly, as this could worsen your heart failure.
• Patients with severe kidney problems should not take this medicine.
• Take the medicine once daily, preferably at the same time each day.

If your doctor has instructed you to take ¼ (one-quarter) or ½ (half) a tablet daily, follow the instructions below to split the cross-scored Nebivolol ratiopharm tablets.

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

Figures 1 and 2: Easy splitting of the cross-scored Nebivolol 5 mg tablet into halves.

Figures 3 and 4: Easy splitting of the half Nebivolol 5 mg tablet into quarters.

• Your doctor will decide whether nebivolol should be combined with other medicines to treat your condition.
• Not to be administered to children or adolescents.

If you take more Nebivolol ratiopharm than you should

If you have accidentally taken an overdose of this medicine, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount taken. The most common symptoms and signs of nebivolol overdose are very slow heartbeat (bradycardia), low blood pressure possibly leading to fainting (hypotension), breathing difficulties such as in asthma (bronchospasm), and acute heart failure.

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

If you forget to take Nebivolol ratiopharm

If you forget to take a dose of nebivolol but remember shortly after the time you were supposed to take it, take the daily dose as usual. However, if a long time has passed (several hours), such that you are close to the next scheduled dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose. However, repeated forgetting of medication should be avoided.

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 for chronic heart failure.

You must not stop treatment abruptly, as this could temporarily worsen your heart failure. If it becomes necessary to discontinue 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 experiences them.

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

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

• headache,
• dizziness,
• fatigue,
• unusual itching or tingling sensation,
• diarrhoea,
• constipation,
• nausea,
• difficulty breathing,
• swelling of hands or feet.

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

• slow heartbeat or other heart disturbances,
• low blood pressure,
• cramp-like pain when walking,
• abnormal vision,
• impotence,
• feeling of depression,
• digestive difficulties (dyspepsia), stomach or intestinal gas, vomiting,
• skin rash, itching,
• breathing difficulties resembling asthma due to sudden contraction of muscles around the airways (bronchospasm),
• nightmares.

Rare adverse effects (may affect up to 1 in 10,000 people)

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

The following adverse 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 around the lips, eyes and/or tongue, possibly accompanied by acute breathing difficulty (angioedema),
• skin rash characterized by raised, itchy, pink welts, due to either allergic or non-allergic causes (urticaria).

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

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

• slow heartbeat,
• 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),
• intolerance to this medicine,
• mild disturbance in cardiac conduction affecting heart rhythm (first-degree atrioventricular block),
• swelling of the lower limbs (increased ankle volume).

Reporting of adverse effects

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

5. Storage of Nebivolol ratiopharm

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nebivolol ratiopharm

• The active substance is nebivolol.

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

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

Appearance of the product and contents of the pack

Round, white, convex tablets, 9 mm in diameter, with a cross-shaped notch on one side and marked with “N 5” on the other side.

The tablets can be divided into equal halves and quarters.

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

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 most recent revision of this leaflet: May 2025

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