Leaflet: information for the user

Nebivolol Normon 5 mg tablets EFG

nebivolol

Read this leaflet carefully before you start taking the 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, and you should not give it to others, even if they have the same symptoms, as it may harm them.

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

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

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

3. How to take Nebivolol Normon

4. Possible side effects

5. Storage of Nebivolol Normon

6. Contents of the pack and additional information

Nebivolol is a cardiovascular medication, belonging to the group of selective beta-blockers (with selective activity on 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). This medication is also used for the treatment of mild to moderate chronic heart failure in patients aged 70 or older, administered in conjunction with other medications.

• Do not take nebivolol Normon

- If you are allergic to nebivolol or any of the other components (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.

- You have recently had a heart failure episode or worsening of the same, or are receiving intravenous treatment to help the heart work, after suffering a circulatory collapse due to acute heart failure.

- Asthma or breathing difficulties (current or past).

- Phaeochromocytoma, 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.

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.

- 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 types of diabetes medications called sulfonylureas (e.g. glibenclamide, glimepiride, glipizide, gliclazide, gliquidone, tolbutamide).

- Hyperthyroidism: this medication may mask the signs due to this condition, such as abnormally high heart rate.

- Allergies: this medication 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 to undergo surgery, always inform your anesthetist that you are taking this medication.

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

At the start 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 Normon is not recommended for use in children and adolescents due to the lack of data on the use of this medication in this type of patient.

Other medications and Nebivolol NormonInform your doctor or pharmacist if you are using, have used recently or may have to use any other medication.

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

- Some heart medications or blood pressure control 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 psychoses medications (mental illness), such as barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.

- Depression medications, such as amitriptyline, paroxetine, and fluoxetine.

- Medications used for anesthesia during surgery.

- Asthma medications, nasal decongestants, and some medications for eye disorders such as glaucoma (increased eye pressure) or pupil dilation.

- Baclofen (an antispasmodic medication); Amifostine (a protective medication used during cancer treatment).

- Diabetes medications, such as insulin or oral antidiabetic medications.

All these medications, like Nebivolol Normon, may affect blood pressure and heart function.

- Medications for treating excessive stomach acid or ulcers (antacids): take Nebivolol Normon with food, and the antacid between meals.

Taking Nebivolol Normon with food and drinks

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 medication.

Pregnancy

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

Breastfeeding

It is not recommended to use this medication during breastfeeding.

Driving and operating machinery

This medication may cause dizziness or fatigue. If so, refrain from driving and operating machinery.

Nebivolol Normon contains lactoseThis medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as 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 usual dose is 1 tablet per day. It is preferable to take the dose at the same time every day

-In elderly patients and patients with renal impairment, 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 should always be initiated under medical supervision.

- Your doctor will start treatment with1/4(quarter) of a tablet per day. The dose will be increased after 1-2 weeks to1/2(half) of a tablet per day, then to1tablet 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 exactly their instructions.

- 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 abruptly stop treatment, 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 1/4 (quarter) or 1/2 (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 of both hands placed on either side of one of the scores (drawings 1 and 2).

- Proceed in the same manner to split the half tablet into a quarter (drawings 3 and 4).

Drawings 1 and 2: Easy breaking of the 5 mg nebivolol tablet scored in a cross shape into a half.

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

Your doctor will decide whether to combine Nebivolol Normon with other medications to treat your condition.

Do not administer to children or adolescents.

If you take more Nebivolol Normon than you should

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

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

The most frequent symptoms and signs of an overdose are a very slow heart rate (bradycardia), low blood pressure with a possibility of 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 medication, 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), so that it is near the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose.

However, it is essential to try to avoid repeated forgetfulness of medication intake.

If you interrupt treatment with Nebivolol Normon

Always consult your doctor before stopping treatment with this medication, whether you take it for high blood pressure or chronic heart failure.

Do not abruptly stop treatment, 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 other doubts about the use of this product, ask your doctor or pharmacist

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

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

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

- Headache.

- Dizziness.

- Fatigue.

- Unusual itching or tingling sensation.

- Diarrhea.

- Constipation.

- Nausea.

- Difficulty breathing/feeling of lack of air.

- Sweating of hands and feet.

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

-Slow heart rate or other heart rhythm disturbances.- Low blood pressure.

- Painful walking similar to a cramp.

- Abnormal vision.

- Impotence.

- Feeling of depression.

- Digestive difficulties (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 (bronchial spasm).

- Nightmares.

Very 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 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 for chronic heart failure, the following side effects have been observed:

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

- Slow heart rate.

- Dizziness.

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

- 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 the ankles).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance of Medicines for Human Use: 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.

Do not use Nebivolol Normon after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nebivolol Normon

The active ingredient is nebivolol.

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

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

Appearance of the product and size of the packaging

Nebivolol Normon 5 mg tablets are presented in the form of white, round, biconvex tablets with a cross-shaped notch on one face and 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.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet:March2025

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