NEBIVOLOL CINFA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

nebivolol cinfa 5 mg tabletsEFG

nebivolol hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

Contents of the pack and other information

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

Nebivolol is a medicine 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 action 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 over, administered in combination with other medications.

2. What you need to know before you take nebivolol cinfa

Do not take nebivolol cinfa

• If you are allergic to nebivolol or 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 severe heart rhythm disorders such as second and third degree atrioventricular block or other cardiac conduction disorders.
• You have recently suffered a heart failure episode or worsening of it, or are receiving intravenous treatment to help the 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 characterized by metabolic acidosis (such as diabetic ketoacidosis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take nebivolol cinfa

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 arteries, called

• Prinzmetal's angina.
• Chronic heart failure without treatment.
• First-degree cardiac 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 medicine has no effect on blood sugar levels, but it can mask the warning signs produced by a decrease in these levels (palpitations, fast heart rate) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic medications called sulfonylureas (such as gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• Hyperactivity of the thyroid gland: this medicine can mask the signs due to this disorder, such as abnormally high heart rate.
• Allergies: this medicine 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 are going to undergo surgery, always inform your anesthesiologist that you are taking this medicine.

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 need to 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 the lack of data on the use of this medicine in these patients.

Taking nebivolol cinfa with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• Certain heart medicines or blood pressure control medicines (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), phenothiazine (also used for vomiting and nausea) and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medicines used for anesthesia during an operation.
• Medicines for asthma, nasal decongestants, and certain medicines for treating eye disorders such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (a muscle relaxant); Amifostine (a protective medicine used during cancer treatment).
• Medicines for diabetes, such as insulin or oral antidiabetics.
• All these medicines, like nebivolol, can affect blood pressure and heart function.
• Medicines to treat excess stomach acid or ulcers (antacids), such as cimetidine: you should take nebivolol during meals, and the antacid between meals.

Taking nebivolol cinfa with food and drinks

Nebivolol can be taken with food or on an empty stomach, but it is best to take the tablet with a little water. See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:

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

Breastfeeding:

It is not recommended to use during breastfeeding.

Driving and using machines

This medicine may cause dizziness or fatigue. If this happens, do not drive or use machinery.

nebivolol cinfacontains lactose

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

3. How to take nebivolol cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 recommended dose is 1 tablet per day. It is preferable to take the dose always at the same time of day.
• In elderly patients and/or with renal disorders, it is recommended to start treatment with half a 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 must always be started under medical supervision.
• Your doctor will start your treatment with a quarter of a tablet per day. The dose will be increased after 1-2 weeks to half a 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 moment and you must 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 performed under the supervision of an experienced doctor during a period of 2 hours.
• Your doctor will reduce your dose if necessary.
• Do not stop treatment abruptly, as this could temporarily worsen your heart failure.
• Patient with severe kidney problems should not take this medicine. Take the medicine once a day, preferably at the same time of day.

If your doctor has told you to take a quarter or half tablet daily, follow these instructions to split the 5 mg nebivolol tablets, which are scored in a cross shape.

• Place the tablets on a flat, hard surface (such as a 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.
• Proceed in the same way to split the half tablet into a quarter.

Your doctor will decide if you should combine nebivolol with other medicines to treat your disease.

Do not administer to children or adolescents.

If you take more nebivolol cinfa than you should

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

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

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.

If you forget to take nebivolol cinfa

If you forget to take a dose of nebivolol cinfa, but remember shortly after when you should have taken it, take the daily recommended dose. 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 to make up for missed doses.

However, you should try to avoid repeatedly forgetting to take your medication.

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.

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 reduced, starting by halving the dose, at intervals of one week.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Headache.
• Dizziness.
• Fatigue.
• Unusual itching or tingling sensation.
• Diarrhea.
• Constipation.
• Nausea.
• Breathing difficulties / feeling of shortness of breath.
• Sweating of hands and 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), gas in the stomach or intestine, vomiting.
• Skin rash, itching.
• Breathing difficulties like asthma, due to sudden contraction of the muscles around the airways (bronchospasm).
• Nightmares.

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 isolated cases during treatment with nebivolol:

• Allergic reactions, such as generalized skin rashes (hypersensitivity reactions)
• Sudden swelling of the lip, eyelid, and/or tongue area, which may be accompanied by acute breathing difficulties (angioedema).
• Skin rash characterized by pink, raised patches, which can be itchy, 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 feeling faint when standing up quickly).
• Intolerance to this medicine.
• Mild cardiac conduction disorder affecting heart rhythm (first-degree atrioventricular block).
• Swelling of the lower limbs (increased volume of the ankles).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 special storage conditions.

Do not use this medicine after the expiry date which is stated on the packaging and blister after "CAD". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are: lactose monohydrate, glycerol distearate, polysorbate 80 (E-433), hypromellose (E-464), corn starch, microcrystalline cellulose (E-460), colloidal anhydrous silica (E-551), magnesium stearate (E-572).

Appearance of the product and pack contents

Nebivolol cinfa is presented in the form of white, cylindrical, biconvex tablets, with a double score in a cross shape on one face and marked with the code "NE5" on the other face.

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 last revision of this leaflet:March 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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