Leaflet: information for the user

nebivolol cinfa 5 mg tabletsEFG

nebivolol hydrochloride

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

Contents of the pack and additional information

Nebivolol is a cardiovascular medication, 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 force of heart pumping. It also exerts a vasodilatory action, which in turn contributes to reducing 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 or older, administered in combination with other medications.

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 conduction disorders.
• Recently experienced a heart failure episode or worsening of the same, or are receiving intravenous treatment to help the heart work, after experiencing circulatory collapse due to acute heart failure.
• Asthma or breathing difficulties (current or past).
• Phaeochromocytoma, a tumor located at the top of the kidneys (adrenal glands), that is not being treated.

• Liver function disorders.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take nebivolol cinfa.

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

• Abnormally slow heart rate.

A type of chest pain, due to spontaneous spasm of the heart arteries, called Prinzmetal's angina.

• Chronic heart failure without treatment.
• First-degree heart block (mild conduction disorder affecting heart rhythm).
• Poor circulation in arms or legs, such as Raynaud's disease or syndrome, or walking pain similar to a cramp.
• Chronic respiratory problems.
• Diabetes: this medicine has no effect on blood sugar levels, but may mask warning signs of low blood sugar (palpitations, rapid heart rate) and may increase the risk of severe hypoglycemia when used with certain diabetes medications called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• Hyperthyroidism: 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 to which you are allergic.
• If you have or have had psoriasis, a skin disease characterized by pink scaly patches.
• If you are undergoing surgery, always inform your anesthetist that you are taking this medicine.

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

You should be regularly monitored by a doctor at the start of treatment for chronic heart failure (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 is not recommended for use in children and adolescents due to the lack of data on the use of this medicine in this type of patient.

Taking nebivolol cinfa with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

• Some heart or blood pressure medications (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 psychotics (mental illness) medications, such as barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea), and thioridazine.
• Depression medications, such as amitriptyline, paroxetine, and fluoxetine.
• Anesthesia medications used during surgery.
• Asthma medications, decongestant nasal sprays, and some eye medications for conditions such as glaucoma (increased eye pressure) or pupil dilation.
• Baclofen (a muscle relaxant); Amifostine (a protective medication used during cancer treatment).
• Diabetes medications, such as insulin or oral antidiabetic medications.
• All these medicines, like nebivolol, can affect blood pressure and heart function.
• Medications for treating excessive stomach acid or ulcers (antacids), such as cimetidine: take nebivolol with food, 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 taken with a little water. See section 3.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

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

Breastfeeding:

Its use is not recommended during breastfeeding.

Driving and operating machinery

This medicine may cause dizziness or fatigue. If so, do not drive and do not operate machinery.

nebivolol cinfa contains lactose

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

Follow exactly the administration instructions for this medication as 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 at the same time every day.
• In elderly patients and/or those with renal impairment, 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 should always be initiated 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 then 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 initiation of treatment and each dose increase will be performed under the supervision of an experienced doctor for a period of 2 hours.
• Your doctor will reduce your dose if necessary.
• Do not stop treatment abruptly, as this could worsen your heart failure.
• Patients with severe kidney problems should not take this medication. Take the medication once a day, preferably at the same time every day.

If your doctor has indicated that you take a quarter or half tablet daily, follow the instructions below to split the 5 mg nebivolol tablets, scored in a cross shape.

• Place the tablets on a flat, hard surface (e.g. table or countertop), with the scored surface facing up.
• Break the tablet by pressing it with your index fingers from 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 whether to combine nebivolol with other medications 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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

The most frequent symptoms and signs of a nebivolol overdose are a very slow heart rate (bradycardia), low blood pressure with a risk of fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

If you forgot to take nebivolol cinfa

If you forgot to take a dose of nebivolol cinfa, but remember shortly after when you should have taken it, take the recommended daily dose. If a lot of time has passed (several hours), so that you are 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 compensate for the missed doses.

However, it is essential to try to avoid repeated missed doses of the medication.

If you stop treatment with nebivolol cinfa

Always consult your doctor before stopping treatment with nebivolol, whether you take 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, halving the dose at intervals of one week.

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

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

Whennebivolol is used for the treatment of high blood pressure, the possible side effects are:

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

• Headache.
• Dizziness.
• Fatigue.
• Unusual itching or tingling sensation.
• Diarrhea.
• Constipation.
• Nausea.
• Difficulty breathing / feeling of lack of air.
• Sweating of hands and feet.

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

• Slow heart rate or other cardiac abnormalities.
• Low blood pressure.
• Gait disturbance similar to cramp.
• Abnormal vision.
• Impotence.
• Feeling of depression.
• Difficulty digesting (dyspepsia), gas in the stomach or intestines, 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 1 in 10,000 patients):

• Loss of consciousness.
• 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 eruptions (hypersensitivity reactions)
• Sudden swelling of the lip, eyelid, and/or tongue area, which may be accompanied by acute respiratory difficulty (angioedema).
• Skin eruption characterized by pink, raised patches, which produce itching, of allergic or non-allergic cause (urticaria)

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

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

• Slow heart rate
• Dizziness

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

• Worsening of heart failure.
• Low blood pressure (as a feeling of fainting when standing up quickly).
• Intolerance to this medication.
• Mild alteration of cardiac conduction affecting heart rhythm (first-degree atrioventricular block).
• Swelling of the lower extremities (increased volume of ankles).

Communication 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 the Spanish System for the 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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on thecontainer and in the blister packafter “CAD”. The expiration date is the last day of the month indicated.

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

Composition of nebivolol cinfa

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

Appearance of the product and contents of the packaging

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

Each package contains 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta.

31620 Huarte (Navarra) Spain.

Last review date of this leaflet:March 2025

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

You can access detailed and updated information about this medication 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