Nebivolol Cinfa 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

nebivolol cinfa 5 mg tablets EFG

nebivolol hydrochloride

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What nebivolol cinfa is and what it is used for
2. What you need to know before taking nebivolol cinfa
3. How to take nebivolol cinfa
4. Possible side effects
5. How to store nebivolol cinfa

Contents of the pack and other information

1. What nebivolol cinfa is and what it is used for

Nebivolol is a cardiovascular agent belonging to the group of selective beta-blockers (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 medicinal products.

2. What you need to know before taking nebivolol cinfa

Do not take nebivolol cinfa

• 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.

• Severe 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 abnormalities.

• 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).

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

• Liver function disorders.

• Metabolic disorders characterized by metabolic acidosis (e.g. diabetic ketoacidosis).

Warnings and precautions

Talk to your doctor or pharmacist before taking nebivolol cinfa.

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.
• Chronic heart failure without treatment.
• 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 pain when walking similar to cramps.
• Chronic respiratory problems.
• Diabetes: this medicine does not affect blood sugar levels, but it may mask warning signs of low blood sugar (such as palpitations, rapid heartbeat), and may increase the risk of severe hypoglycaemia 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 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 due to undergo surgery, always inform your anaesthetist that you are taking this medicine.

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

When starting 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

The use of nebivolol is not recommended in children and adolescents due to lack of data on its use in these patient groups.

Taking nebivolol cinfa with other medicines

Tell 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 or pharmacist if, in addition to nebivolol, you are taking any of the following medicines:

• Certain medicines for the heart or for controlling 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 medicines for psychosis (mental illness), such as barbiturates (also used for epilepsy), phenothiazines (also used for vomiting and nausea), and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine and fluoxetine.
• Medicines used for anaesthesia during surgery.
• Medicines for asthma, nasal decongestants, and some medicines used to treat eye conditions such as 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 these medicines, like nebivolol, may affect blood pressure and heart function.
• Medicines for stomach acidity or ulcers (antacids), such as cimetidine: nebivolol should be taken with food, and the antacid between meals.

Taking nebivolol cinfa with food and drink

Nebivolol may be taken with or without food, but it is best to take the tablet with some water. See section 3.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

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

Breast-feeding:

Its use is not recommended during breast-feeding.

Driving and using machines

This medicine may cause dizziness or fatigue. If this occurs, refrain from driving or operating machinery.

nebivolol cinfa 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.

3. How to take nebivolol cinfa

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

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

Treatment of high blood pressure (hypertension):

• The recommended dose is 1 tablet daily. It is preferable to take the dose at the same time each day.
• In elderly patients and/or those with renal impairment, treatment should be initiated with 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 4 weeks.

Treatment of chronic heart failure

• Your treatment must always be initiated under medical supervision.
• Your doctor will start your treatment with a quarter of a tablet daily. The dose will then be increased after 1–2 weeks to 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 must not take this medicine. Take the medicine once daily, preferably at the same time each day.

If your doctor has instructed you to take a quarter or half tablet daily, follow the instructions below to split the 5 mg nebivolol tablets, which are cross-scored.

• Place the tablets on a flat, hard surface (for example, a table or countertop), with the cross-shaped score facing upwards.
• Break the tablet by pressing with the index fingers of both hands placed on either side of one of the scores.
• Repeat the same procedure to split half of the tablet into a quarter.

Your doctor will decide whether nebivolol should be combined with other medicines to treat your condition.

Do not administer to children or adolescents.

If you take more nebivolol cinfa than you should

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

It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

The most common symptoms and signs of nebivolol overdose are very slow heartbeat (bradycardia), low blood pressure possibly leading to fainting (hypotension), breathing difficulties resembling asthma (bronchospasm), and acute heart failure.

If you forget to take nebivolol cinfa

If you forget to take a dose of nebivolol cinfa but remember shortly after the time you should have taken it, take the recommended daily dose. If a long time has passed (several hours), so that it is nearly time for your next dose, skip the missed dose and take the next scheduled dose at the usual time.

Do not take a double dose to make up for missed doses.

However, repeated forgetting of medication intake should be avoided.

If you stop taking nebivolol cinfa

Always consult your doctor before stopping treatment with nebivolol, whether you are taking it for high blood pressure or 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 for the treatment of high blood pressure, the possible adverse effects are:

Common adverse effects (may affect more than 1 in 10 patients):

• Headache
• Dizziness
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Difficulty breathing / shortness of breath
• Sweating of hands and feet

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

• Slow heartbeat or other heart disturbances
• Low blood pressure
• Pain when walking similar to cramps
• Abnormal vision
• Sexual impotence
• Feeling of depression
• Difficulty digesting (dyspepsia), stomach or intestinal gas, vomiting
• Skin rash, itching
• Breathing difficulty as in asthma, due to sudden contraction of muscles around the airways (bronchospasm)
• Nightmares

Very rare adverse effects (may affect 1 in 10,000 patients):

• Fainting
• Worsening of psoriasis, a skin disease characterized by scaly pink patches

The following adverse effects have been reported in only a few isolated cases during treatment with nebivolol:

• Allergic reactions, such as generalized skin rashes (hypersensitivity reactions)
• Sudden swelling of the lips, eyelids 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 trial for chronic heart failure, the following adverse effects were observed:

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

• Slow heartbeat
• Dizziness

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

• Worsening of heart failure
• Low blood pressure (such as feeling faint when standing up quickly)
• Intolerance to this medicine
• Mild disturbance in heart 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 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 cinfa

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the outer packaging and blister after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of nebivolol cinfa

• The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (as 5.45 mg of nebivolol hydrochloride).
• The other components are: monohydrate lactose, glyceryl distearate, polysorbate 80 (E-433), hypromellose (E-464), corn starch, microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551), magnesium stearate (E-572).

Appearance of the product and contents of the pack

Nebivolol cinfa is presented as white, cylindrical, biconvex tablets, with a cross-shaped double score on one side and marked with the code "NE5" on the other side.

Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) Spain.

Date of the most recent review of this leaflet: March 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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73926/P_73926.html

QR code to: https://cima.aemps.es/cima/dochtml/p/73926/P_73926.html