NEBIVOLOL TARBIS 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

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

Contents of the pack

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

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

This medicine contains nebivolol, 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 for the treatment of high blood pressure (hypertension) in adults.

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 Tarbis

Do not take Nebivolol Tarbis

• If you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• If you have any of the following conditions:

• Low blood pressure.
• Severe circulation problems in your arms or legs.
• Very slow heart rate (less than 60 beats per minute).
• Other severe heart rhythm disorders (e.g. second- or third-degree atrioventricular block or other cardiac conduction disorders).
• You have recently had a heart attack or your heart failure has worsened, or you are receiving intravenous treatment to help your heart work after suffering a circulatory collapse due to acute heart failure.
• Asthma or breathing difficulties (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 (metabolic acidosis), e.g. diabetic ketoacidosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nebivolol Tarbis.

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 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.
• Diabetes: this medicine has no effect on blood sugar levels, but it can mask the warning signs of low blood sugar levels (palpitations, rapid heart rate) and may increase the risk of severe hypoglycemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• Hyperthyroidism: this medicine can mask the signs of this condition.
• Allergies: this medicine can increase 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 have surgery, always inform your anesthesiologist that you are taking this medicine.

If you have severe kidney problems, consult your doctor before taking this medicine 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 this medicine is not recommended in children and adolescents due to the lack of data on the use of this medicine in these patients.

Using Nebivolol Tarbis with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• Medicines for the heart or to control blood pressure (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, decongestants, and some medicines for treating eye disorders such as glaucoma (increased eye pressure) or dilation (enlargement) of the pupil.
• 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 Tarbis, can affect blood pressure and/or heart function.

• Medicines to treat excess stomach acid or ulcers (antacids), such as cimetidine: you should take this medicine during meals, and the antacid between meals.

Taking Nebivolol Tarbis with food and drinks

See section 3.

Pregnancy and breastfeeding

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

Driving and using machines

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

Nebivolol Tarbis contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take Nebivolol Tarbis

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Nebivolol Tarbis can be taken before, during, or after meals, but as an alternative, it can also be taken independently of them. It is preferable to take the tablet with a little water.

The tablet can be divided into four equal parts (4 doses of 1.25 mg).

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (1 tablet) per day. It is preferable to take the dose always at the same time of day.
• In elderly patients and in patients with kidney problems, it is recommended to start treatment with ½ (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 your treatment with 1/4 (quarter) of a tablet per day. The dose may be increased to ½ (half) tablet per day after 1-2 weeks, then up to 1 tablet per day and then up 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 carried out 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.
• 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 ¼ (quarter) or ½ (half) tablet daily, follow these instructions to divide the 5 mg Nebivolol Tarbis tablets, 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 divide the half tablet into a quarter (diagrams 3 and 4).

Diagrams 1 and 2: Easy division into two of the 5 mg Nebivolol Tarbis tablet, scored in a cross shape.

Diagrams 3 and 4: Easy division into four of the 5 mg Nebivolol Tarbis tablet, scored in a cross shape, into a quarter.

• Your doctor will decide whether to combine Nebivolol Tarbis with other medicines to treat your condition.
• Do not use in children or adolescents.

.

If you take more Nebivolol Tarbis than you should

If you have accidentally taken an overdose of this medicine, inform your doctor or pharmacist immediately, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. The most frequent symptoms and signs of an overdose of Nebivolol Tarbis are 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 (which can be obtained from your pharmacy) while waiting for the doctor to arrive.

If you forget to take Nebivolol Tarbis

If you forget to take a dose of Nebivolol Tarbis, but remember soon 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 close to the next dose, skip the missed dose and take the next scheduled doseat 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 Tarbis

Always consult your doctor before stopping treatment with Nebivolol Tarbis, whether you are taking it for high blood pressure or chronic heart failure.

Do not stop treatment with Nebivolol Tarbis abruptly, as this could temporarily worsen your heart failure.

If it is necessary to stop treatment with Nebivolol Tarbis 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 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 Tarbis is used to treat high blood pressure, the possible side effects are:

Common(may affect up to 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(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(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 only a few 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 difficulty breathing (angioedema).
• Skin rash characterized by pink, raised patches, which may 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(may affect more than 1 in 10 people):

• Slow heart rate
• Dizziness

Common(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. 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 Tarbis

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

This medicine does not require any special storage conditions.

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

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

6. Contents of the pack and other information

Composition of Nebivolol Tarbis

• The active substance is nebivolol. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride).
• The other ingredients are: lactose monohydrate, corn starch, croscarmellose sodium, hydroxypropyl methylcellulose (type 2910, 5 cps), polysorbate 80, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and pack contents

Nebivolol Tarbis is presented in the form of white to off-white, round, biconvex tablets, approximately 9 mm in diameter, scored in a cross shape on one face and with an "H" engraved on the other, available in packs of 28, 30, 50, 60, 90, and 100 tablets.

The tablets are packaged in PVC/PVdC-aluminum blister packs.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma S.L.,

Gran Vía Carlos III, 94,

08028 Barcelona,

Spain

Manufacturer

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola, PLA 3000

Malta

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Nebivolol Amarox 5 mg Tablets

Spain Nebivolol Tarbis 5 mg Tablets EFG

France NEBIVOLOL AMAROX 5 mg scored tablet

Italy Nebivololo Amarox

Netherlands Nebivolol Amarox 5 mg tablets

Date of the last review of this prospectus:March 2025.

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