Nebivolol Tarbis 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nebivolol Tarbis 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 as 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents

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

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

This medicine contains nebivolol, a cardiovascular agent belonging to the group of selective beta-blockers (with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's force of contraction. It also exerts a blood vessel dilating effect, which further contributes to lowering 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 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 Tarbis

Do not take Nebivolol Tarbis

• If you are allergic to nebivolol or to 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 serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block or other cardiac conduction disorders).

• Recent episode of heart failure or worsening of heart failure, or receiving intravenous treatment to support heart function after circulatory collapse due to acute heart failure.

• Asthma or difficulty breathing (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 (metabolic acidosis), e.g. diabetic ketoacidosis.

Warnings and precautions

Talk to your doctor or pharmacist before taking Nebivolol Tarbis.

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 (mild cardiac conduction disorder affecting heart rhythm).
• Poor circulation in arms or legs, such as Raynaud's disease or syndrome, or pain when walking similar to cramps.
• Chronic respiratory problems.
• Diabetes: this medicine does not affect blood sugar levels, but it may mask warning signs of low blood sugar (such as palpitations, rapid heartbeat), 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).
• Overactive thyroid gland: this medicine may mask symptoms caused by this condition.
• 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 anaesthetist that you are taking this medicine.

If you have severe kidney problems, consult your doctor before taking this medicine for 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

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

Taking Nebivolol Tarbis with other medicines

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

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

• Medicines for the heart or for controlling 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), for example 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 anaesthesia during surgery.
• Medicines for asthma, nasal decongestants, and some medicines used to treat eye disorders such as glaucoma (increased eye pressure) or dilation (widening) of the pupil.
• Baclofen (a muscle relaxant);
  • Amifostine (a protective medicine used during cancer treatment).
  • Medicines for diabetes, such as insulin or oral antidiabetics.

All these medicines, like Nebivolol Tarbis, may affect blood pressure and/or heart function.

• Medicines used to treat excess stomach acidity or ulcers (antacids), such as cimetidine: this medicine should be taken with food, and the antacid between meals.

Taking Nebivolol Tarbis with food and drink

See section 3.

Pregnancy and breastfeeding

Nebivolol should not be administered during pregnancy unless considered necessary by your doctor. Its use is not recommended during breastfeeding.

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

Driving and using machines

This medicine may cause dizziness or fatigue. If this occurs, do not drive and avoid using machinery.

Nebivolol Tarbis contains lactose and sodium

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

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

Nebivolol Tarbis may be taken before, during, or after meals, but alternatively, it may also be taken independently of meals. It is preferable to take the tablet with a small amount of water.

The tablet may 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) daily. It is preferable to take the dose at the same time each day.

• In elderly patients and in patients with renal impairment, treatment should be initiated with ½ (half) tablet daily.

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

Treatment of chronic heart failure

• Your treatment must always be initiated under medical supervision.
• Your doctor will start your treatment with 1/4 (one quarter) of a tablet daily. The dose may be increased to ½ (half) tablet daily after 1–2 weeks, then to 1 tablet daily, and subsequently up 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.
• The 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 will reduce your dose if necessary.
• You must not abruptly stop treatment, 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 ¼ (one quarter) or ½ (half) tablet daily, follow the instructions below to split the 5 mg Nebivolol Tarbis 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 alongside one of the scores (pictures 1 and 2).
• Repeat the same procedure to split the half tablet into quarters (pictures 3 and 4).

Pictures 1 and 2: Easy splitting of the 5 mg Nebivolol Tarbis tablet, cross-scored, into halves.

Pictures 3 and 4: Easy splitting of the 5 mg Nebivolol Tarbis tablet, cross-scored, into quarters.

• Your doctor will decide whether Nebivolol Tarbis should be combined with other medicines to treat your condition.
• Not intended for 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 at telephone number 91 562 04 20, indicating the medicine and the amount taken. The most frequent symptoms and signs of a Nebivolol Tarbis 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 the doctor.

If you forget to take Nebivolol Tarbis

If you forget to take a dose of Nebivolol Tarbis but remember shortly after the time you were supposed to take it, take the daily dose as usual. If a long time has passed (several hours), so that it is almost time for your 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 treatment with Nebivolol Tarbis is interrupted

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

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

If it becomes necessary to discontinue treatment with Nebivolol Tarbis for chronic heart failure, 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 cause adverse effects, although not everyone will experience them.

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

Common (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 (may affect up to 1 in 100 people):

• Slow heartbeat or other heart disturbances.
• Low blood pressure.
• Cramp-like pain when walking.
• Abnormal vision.
• Sexual impotence.
• Feeling of depression.
• Difficulty digesting (dyspepsia), stomach or intestinal gas, vomiting.
• Skin rash, itching.
• Difficulty breathing as in asthma, due to sudden contraction of the muscles around the airways (bronchospasm).
• Nightmares.

Very rare (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 been reported only in a few isolated cases during treatment with Nebivolol:

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

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

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

• Slow heartbeat
• 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 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 or pharmacist, 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 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 stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help 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 components are: lactose monohydrate, corn starch, sodium croscarmellose, hydroxypropyl methylcellulose (type 2910, 5 cps), polysorbate 80, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Nebivolol Tarbis is presented as white to off-white, round, biconvex tablets, approximately 9 mm in diameter, with a cross-shaped score on one side and an engraved "H" on the other. It is available in packs containing 28, 30, 50, 60, 90, and 100 tablets, and in perforated unit dose blisters containing 30 x 1 and 90 x 1 tablets.

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

Only certain 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany Nebivolol Amarox 5 mg Tabletten

Spain Nebivolol Tarbis 5 mg tablets EFG

France NEBIVOLOL AMAROX 5 mg comprimé sécable

Italy Nebivololo Amarox

Netherlands Nebivolol Amarox 5 mg tabletten

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)