Package Insert: Information for the User

Nebivolol Tarbis 5 mg Tablets EFG

Nebivolol

Read this package insert carefully before starting to take the medicine, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication contains nebivolol, a cardiovascular medication, 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 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) in adults.

This medication is also used for the treatment of mild to moderate chronic heart failure in patients 70 years of age or older, administered in conjunction with other medications.

Do not take NebivololTarbis

• If you are allergic to nebivolol or any of the other components of this medication (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 (e.g. 2nd and 3rd degree atrioventricular block or other conduction disorders).

-Recently experienced a heart failure episode or worsening of the same, or receiving intravenous treatment to help the heart work, after experiencing 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), 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 NebivololTarbis

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.
• Untreated chronic heart failure.
• 1st degree heart block (mild conduction disorder affecting heart rhythm).
• Poor circulation in arms or legs, such as Raynaud's disease or pain while walking similar to a cramp.
• Chronic respiratory problems.
• Diabetes: this medication has no effect on blood sugar levels, but may mask warning signs of hypoglycemia (palpitations, rapid heart rate) 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 symptoms of this condition.
• Allergies: this medication may intensify your reaction to pollen or other substances to which you are allergic.
• Psoriasis (a skin disease characterized by scaly pink patches): if you have or have had psoriasis.
• If you are undergoing surgery, inform your anesthetist that you are taking this medication.

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

You should be regularly monitored by a doctor during the initial treatment of chronic heart failure (see section 3).

This treatment should not be stopped abruptly, unless clearly indicated and evaluated by your doctor (see section 3).

Children and adolescents

This medication is not recommended for use in children and adolescents due to the absence of data on the use of this medication in this type of patient.

Use of Nebivolol Tarbis with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

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

-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 psychiatric medications (e.g. barbiturates, also used for epilepsy), phenothiazine (also used for vomiting and nausea), and thioridazine.

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

-Anesthesia medications used during surgery.

-Asthma medications, 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 Tarbis, may affect blood pressure and/or heart function.

• Medications for treating excessive stomach acid or ulcers (antacids), such as cimetidine: take this medication with food, and the antacid between meals.

Taking Nebivolol Tarbis with food and drinks

See section 3.

Pregnancy and breastfeeding

Nebivolol should not be administered during pregnancy unless your doctor considers it necessary. It is not recommended for use during breastfeeding.

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

Driving and operating machinery

This medication may cause dizziness or fatigue. If so,do not drive and do not operate machinery.

Nebivolol Tarbis contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance,consult with them before takingthis medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

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 at the same time every day.
• In elderly patients and patients with renal impairment, 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 should always be initiated under medical supervision.
• Your doctor will start your treatment with 1/4 (quarter) tablet per day. The dose may be increased to ½ (half) tablet per day after 1-2 weeks, then to 1 tablet 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 their instructions exactly.
• 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 ¼ (a quarter) or ½ (half) tablet per day, follow the instructions below to split 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 the index fingers of both hands placed on either side of one of the scores (drawings 1 and 2).
• Proceed in the same way to split the half tablet into a quarter (drawings 3 and 4).

Drawings 1 and 2: Easy division of the 5 mg Nebivolol Tarbis tablet scored in a cross shape by half.

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

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

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If you take more Nebivolol Tarbis than you should

If you have accidentally taken an overdose of this medication, inform your doctor or pharmacistimmediately, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.The most frequent symptoms and signs of a Nebivolol Tarbis overdose are 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 (which you can purchase 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 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 you are close to the next dose, skip the missed dose and take the nextplanned doseat the usual time. Do not take a double dose. However, you should try to avoid repeated forgetting of the medication intake.

If you stop treatment with 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 abruptly stop treatment with Nebivolol Tarbis, 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, 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 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.
• Difficulty breathing/feeling of lack of air.
• Sweating of hands and feet.

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

• Slow heart rate or other heart rhythm changes.
• Low blood pressure.
• Painful walking similar to a cramp.
• Abnormal vision.
• Impotence.
• Feeling of depression.
• Difficulty digesting (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 (bronchospasm).
• Nightmares.

Very rare(may affect up to 1 in 10,000 people):

• Loss of consciousness.
• 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 rash (hypersensitivity reactions).
• Sudden swelling of the lip, eyelid, and/or tongue area, which may be accompanied by acute difficulty breathing (angioedema).
• Skin rash characterized by pink, raised patches, which cause itching, of allergic or non-allergic cause (urticaria).

In a clinical study forchronic 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 (as feeling of fainting when standing up quickly)
• Intolerance to this medicine
• Mild alteration of cardiac conduction affecting heart rhythm (first-degree atrioventricular block).
• Swelling of the lower extremities (increase in volume of the ankles)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and the blister after CAD. The expiration date is the last day of the month indicated.

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

Composition of Nebivolol Tarbis

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturingand holder of the marketing authorization

Holder of the marketing authorization

Tarbis Farma S.L.,

Gran Vía Carlos III, 94,

08028 Barcelona,

Spain

Responsible for manufacturing

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 with the following names:

GermanyNebivolol Amarox 5 mg Tabletten

SpainNebivolol Tarbis 5 mg comprimidos EFG

FranceNEBIVOLOL AMAROX 5 mg comprimé sécable

ItalyNebivololo Amarox

NetherlandsNebivolol Amarox 5 mg tabletten

Last review date of this leaflet:March 2025.

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