Nebivolol Normon 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nebivolol Normon 5 mg tablets EFG

nebivolol

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Nebivolol is a cardiovascular medicine belonging to the group of selective beta-blocking agents (with selective activity on 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). This medicine 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 medicines.

2. What you need to know before taking Nebivolol Normon

• Do not take Nebivolol Normon

• If you are allergic to nebivolol or to any of the other ingredients (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 disorders.

• Recently experienced an episode of heart failure or worsening of heart failure, or are receiving intravenous treatment to support heart function following 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

Consult your doctor before starting Nebivolol Normon.

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 cramp-like pain when walking.

Chronic respiratory problems.

• If you have diabetes, because nebivolol may mask symptoms of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g., glipizide, gliclazide, glyburide, glimepiride, tolbutamide, or repaglinide).
• Overactive thyroid gland: this medicine may mask signs 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 scheduled for surgery, always inform your anesthetist 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 beginning 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

The use of Nebivolol Normon is not recommended in children and adolescents due to lack of data on the use of this medicine in this patient group.

Other medicines and Nebivolol Normon Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Certain medicines for the heart or blood pressure control (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 nausea and vomiting), and thioridazine.
• Medicines for depression, such as amitriptyline, paroxetine, and fluoxetine.
• Medicines used for anesthesia during surgery.
• Medicines for asthma, nasal decongestants, and some medicines used to treat eye disorders 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 of these medicines, like Nebivolol Normon, may affect blood pressure and heart function.

• Medicines for treating excess stomach acidity or ulcers (antacids): Nebivolol Normon should be taken with food, and antacids should be taken between meals.

Taking Nebivolol Normon with food and drink

See section 3.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

Use during breastfeeding is not recommended.

Driving and using machines

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

Nebivolol Normon contains lactose This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Nebivolol Normon

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

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

Treatment of high blood pressure (hypertension)

• The usual dose is 1 tablet daily. It is preferable to take the dose at the same time each day.

• In elderly patients and patients with renal impairment, treatment should be initiated with 1/2 (half) tablet daily.

• The therapeutic effect on blood pressure is achieved after 1–2 weeks of treatment. Occasionally, optimal effect may not be reached until after 4 weeks.

Treatment of chronic heart failure

• Your treatment must always be initiated under medical supervision.
• Your doctor will start treatment with 1/4 (one-quarter) of a tablet daily. The dose will be increased after 1–2 weeks to 1/2 (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 may reduce your dose if necessary.
• You must not stop treatment abruptly, as this could worsen your heart failure.
• Patients with severe kidney problems should not take this medicine.
• Take the medicine once daily, preferably at the same time each day.

If your doctor has instructed you to take 1/4 (quarter) or 1/2 (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 (e.g., 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 (Figures 1 and 2).
• Repeat the same procedure to split the half tablet into quarters (Figures 3 and 4).

Figures 1 and 2: Easy splitting of the 5 mg nebivolol tablet, cross-scored, into halves.

Figures 3 and 4: Easy splitting of the half tablet of 5 mg nebivolol, cross-scored, into quarters.

Your doctor will decide whether Nebivolol Normon should be combined with other medicines 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 medicine, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the name of the medicine and the amount taken.

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

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

You may take activated charcoal (available from your pharmacy) while waiting for medical assistance.

If you forget to take Nebivolol Normon

If you forget to take a dose of this medicine but remember shortly afterwards, take the daily dose as usual. If a significant amount of time has passed (several hours), such that you are close to the time of your next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose.

However, repeated forgetting of doses should be avoided.

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.

You must not stop treatment abruptly, as this could temporarily worsen your heart failure. If discontinuation of treatment for chronic heart failure is necessary, 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

When Nebivolol Normon is used for the treatment of high blood pressure, the possible adverse effects are:

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

• 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 people):

• Slow heartbeat or other heart disturbances.
• Low blood pressure.
• Pain when walking resembling cramps.
• Abnormal vision.
• Sexual impotence.
• Feeling of depression.
• Digestive difficulties (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 up to 1 in 10,000 people):

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

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

• Allergic reactions, such as generalized skin rashes (hypersensitivity reactions).
• Sudden swelling of the area around the lips, eyelids and/or tongue, possibly accompanied by acute breathing difficulty (angioedema).
• Skin eruption characterized by raised, itchy, pink wheals, of either allergic or non-allergic origin (urticaria).

In a clinical study for chronic heart failure, the following side effects were observed:

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

• Slow heartbeat.
• Dizziness.

Common adverse 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 disturbance in cardiac 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, pharmacist, or nurse, 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nebivolol Normon

Keep this medicine out of sight and reach of children.

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

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps 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 components (excipients) are: monohydrate lactose, 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 white, round, biconvex tablets, with a cross-shaped score on one side 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.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent review of this leaflet: March 2025

Detailed 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 package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/70928/P_70928.html