NEBIVOLOL NORMON 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Nebivolol Normon 5 mg Tablets EFG

nebivolol

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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

It is used for the treatment of high blood pressure (hypertension). This medicine is also used for the treatment of mild and moderate chronic heart failure in patients aged 70 or over, administered in combination with other medicines.

2. What you need to know before you take Nebivolol Normon

• Do not take Nebivolol Normon

• If you are allergic to nebivolol or any of the other ingredients (listed in section 6).

• If you have any of the following conditions:

• Low blood pressure.
• Severe circulation problems in your arms or legs.
• A very slow heart rate (less than 60 beats per minute).
• Other severe heart rhythm disorders such as second- or 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 characterized by metabolic acidosis (e.g., diabetic ketoacidosis).

Warnings and precautions

Consult your doctor before starting to take Nebivolol Normon.

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

• An 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 your arms or legs, such as Raynaud's disease or pain when walking similar to a cramp.

Chronic respiratory problems.

• If you are diabetic, as nebivolol may mask the symptoms of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain oral antidiabetic medications called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
• Hyperactivity of the thyroid gland: this medicine may mask the signs due to this condition, such as an 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 need 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 Normon 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

Nebivolol Normon is not recommended for use in children and adolescents due to the lack of data on the use of this medicine in these patients.

Other medicines and Nebivolol NormonTell 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 Normon, 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 barbiturics (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 (an antispastic medicine); Amifostine (a protective medicine used during cancer treatment).
• Medicines for diabetes, such as insulin or oral antidiabetics.

All these medicines, like Nebivolol Normon, can affect blood pressure and heart function.

• Medicines to treat excess stomach acid or ulcers (antacids): you should take Nebivolol Normon during meals, and the antacid between meals.

Taking Nebivolol Normon with food and drinks

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 Normon 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 machines.

Nebivolol Normon contains lactoseThis 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 Normon

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Nebivolol Normon 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 1/2 (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 must always be started under medical supervision.
• Your doctor will start treatment with 1/4 (quarter) of a tablet per day. The dose will be increased after 1-2 weeks to 1/2 (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 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 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 medicine.
• Take the medicine once a day, preferably at the same time of day.

If your doctor has indicated that you should take 1/4 (quarter) or 1/2 (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 (e.g., table or countertop), with the cross-shaped score facing up.
• Break the tablet by pressing it with your index fingers on 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 a quarter (diagrams 3 and 4).

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

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

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

Do not give to children or adolescents.

If you take more Nebivolol Normon than you should

If you have accidentally taken an overdose of this medicine, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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

The most frequent symptoms and signs of an overdose are a 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 Normon

If you forget to take a dose of this medicine, but remember shortly after when you should have taken it, take the daily dose as usual. If a lot of time has passed (several hours), and 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 Normon

Always consult your doctor before stopping treatment with this medicine, 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 further questions on the use of this product, 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 Normon is used to treat high blood pressure, the possible side effects are:

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

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

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

• A slow heart rate or other heart disorders. Low blood pressure.
• Pain when walking similar to a cramp.
• Abnormal vision.
• Impotence.
• Feeling of depression.
• Digestive difficulties (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 have been observed:

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

• A 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 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Nebivolol Normon

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

Do not use Nebivolol Normon after the expiry date stated on the package after "EXP". The expiry date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nebivolol Normon

The active substance is nebivolol.

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

The other ingredients (excipients) are: lactose monohydrate, crospovidone Type A, poloxamer 188, povidone K30, microcrystalline cellulose, and magnesium stearate.

Appearance of the product and pack size

Nebivolol Normon 5 mg tablets are presented in the form of white, round, biconvex tablets, scored in a cross shape on one face, with a diameter of approximately 9 mm.

Nebivolol Normon 5 mg tablets can be divided into four equal parts.

Nebivolol Normon 5 mg tablets are available in packs of 28 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this leaflet:March 2025

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