NEBIVOLOL VIATRIS 5 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Nebivolol Viatris 5 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

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

Contents of the Package Leaflet

1. What is Nebivolol Viatris and what is it used for
2. What you need to know before taking Nebivolol Viatris
3. How to take Nebivolol Viatris
4. Possible side effects
5. Storage of Nebivolol Viatris
6. Package contents and additional information

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

Nebivolol belongs to a group of medications called selective beta-blockers, which are used to lower blood pressure.

Nebivolol is indicated for the treatment of:

• High blood pressure (hypertension).
• Mild to moderate heart failure in elderly patients, in combination with other medications (such as diuretics, digoxin, ACE inhibitors, angiotensin II antagonists).

2. What you need to know before taking Nebivolol Viatris

Do not take Nebivolol Viatris if:

• You are allergic to nebivolol or any of the other components of this medication (listed in section 6). An allergic reaction can cause a rash, itching, swelling, or difficulty breathing.
• You have liver problems.
• You have had a heart attack, have heart failure that may be worsening, or are being treated intravenously for heart failure.
• You have been diagnosed with other severe heart rhythm disorders (such as sick sinus syndrome, sinoatrial block, or second- or third-degree heart block) and do not have a functioning pacemaker.
• You have asthma or severe breathing difficulties.
• You have a tumor of the adrenal gland called pheochromocytoma that is not being treated.
• You have metabolic acidosis.
• You have a very slow heart rate (less than 60 beats per minute, known as bradycardia).
• You have low blood pressure or poor blood circulation.
• You are taking medications that contain both floctafenine and sultoprida.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nebivolol Viatris if:

• You have heart problems and are not being treated, as nebivolol may worsen them.
• You have Raynaud's disease, poor circulation in your arms or legs, or experience periods of difficulty walking, including episodes of lameness, as nebivolol may worsen them.
• Your doctor has informed you that you have a first-degree heart block (feeling of lost pulse), as nebivolol may worsen or slow your heart rate. Your doctor may want to monitor your heart rate and adjust the dose as needed.
• You suffer from Prinzmetal's angina, as nebivolol may worsen heart attacks.
• You have diabetes, as although nebivolol does not affect blood sugar levels, it can mask signs of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain oral antidiabetic medications called sulfonylureas (such as gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
• You have hyperthyroidism, as nebivolol may mask signs of this condition, such as an abnormally high heart rate (tachycardia).
• You have respiratory problems, as nebivolol may cause breathing difficulties. Your doctor will advise you if you are at risk for this reason.
• You have a skin condition called psoriasis or suffer from hay fever or other allergies, as nebivolol may worsen them. Consult your doctor if you are unsure about taking this medication.
• You wear contact lenses, as nebivolol may cause dry eyes.

Taking Nebivolol Viatris with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription.

Do not take nebivolol if you are taking medications that contain both floctafenine and sultoprida (see section "Do not take Nebivolol Viatris if").

Taking nebivolol with certain medications may lower your blood pressure too much or cause heart problems:

• Medications to lower blood pressure, such as verapamil, diltiazem, clonidine, guanfacine, moxonidine, methyldopa, rilmenidine, amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine.
• Medications for diabetes, such as insulin or oral antidiabetics.
• Medications for the treatment of heart rhythm disorders (irregular heartbeat) such as amiodarone, quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone.
• Medications used to treat depression or other mental health problems, such as paroxetine, fluoxetine, thioridazine.
• Barbiturates (used for epilepsy, anxiety, or insomnia).
• Baclofen (muscle relaxant).
• Amifostine (used in anticancer therapy).
• Mefloquine (antimalarial medication).
• Organic nitrates (for the treatment of angina pectoris).
• Quinidine (to slow the heart rate).
• Terbinafine (for the treatment of fungal and yeast infections).
• Bupropion (to help quit smoking).
• Chloroquine (for the treatment of malaria or rheumatoid arthritis).
• Levomepromazine (for the treatment of mental health problems).

Also:

• Stimulants that contain dopamine or decongestants that contain ephedrine, as they may increase blood pressure too much or cause heart problems.
• Insulin or any oral antidiabetic medication, as nebivolol may mask symptoms of hypoglycemia (low blood sugar levels), such as tachycardia or palpitations.

Surgery

Nebivolol may interact with certain anesthetics used in operations. If you need to undergo surgery, inform your doctor, dentist, or hospital staff that you are taking nebivolol.

Pregnancy and breastfeeding

Nebivolol should not be administered to pregnant or breastfeeding women unless the benefits of the medication for the mother outweigh the risks to the fetus or baby.

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

Driving and using machines

When driving vehicles or operating machinery, consider that dizziness and fatigue may occur due to decreased blood pressure. In these cases, do not drive or use machines. These effects are more likely to occur at the start of treatment or after a dose increase (see also section 4).

Nebivolol Viatris contains lactose and sodium

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

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

3. How to take Nebivolol Viatris

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

Always check that you have enough tablets and will not run out of medication. Try to take the tablets at the same time each day. The tablets should be swallowed with a glass of water. The tablets can be taken with or without food.

The tablet can be divided into 4 equal doses.

Treatment of high blood pressure:

Adult use:the usual dose is 5 mg of nebivolol per day. The effect of lowering blood pressure is evident after 1-2 weeks of treatment. In some cases, the optimal effect is achieved only after 4 weeks of treatment.

Elderly patients:if you are 65 years or older and taking nebivolol to lower your blood pressure, the initial dose is usually 2.5 mg per day. If necessary, your doctor may increase the dose to 5 mg of nebivolol per day.

Patient with renal insufficiency:the recommended initial dose is 2.5 mg of nebivolol per day. If necessary, your doctor may increase the dose to 5 mg of nebivolol per day.

Taking Nebivolol Viatris with other medication to lower blood pressure:

The usual daily dose of nebivolol is 5 mg if taken with hydrochlorothiazide, at a dose of 12.5 mg to 25 mg per day.

Treatment of heart failure:

Adult and elderly use:your doctor will start treatment with a low dose that will be gradually increased at intervals of 1 to 2 weeks until your condition stabilizes. Initially, you will be given 1.25 mg of nebivolol for one or two weeks, then 2.5 mg of nebivolol once a day, followed by 5 mg once a day, and then 10 mg once a day. Your doctor will inform you of the amount to take.

Patient with renal insufficiency:

Nebivolol is not recommended for patients with severe renal insufficiency. Your doctor will indicate if you should take nebivolol.

Patient with hepatic insufficiency:

If you have hepatic insufficiency, do nottake nebivolol.

Use in children and adolescents:

Nebivolol is not recommended for use in children and adolescents under 18 years of age.

If you take more Nebivolol Viatris than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

An accidental overdose may cause a decrease in heart rate, lowering of blood pressure, difficulty breathing, and sudden heart problems.

If you forget to take Nebivolol Viatris

If you forget to take your medication, do nottake a double dose to make up for the missed doses. Take the next dose normally. Contact your doctor if you forget to take several doses.

If you stop taking Nebivolol Viatris

If you suddenly stop taking nebivolol, you may experience side effects or your condition may worsen. If you stop treatment, your doctor will gradually reduce your dose over a period of 2 weeks.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop taking nebivolol and inform your doctor or go to the emergency department of the nearest hospital immediately:

• Chest tightness and difficulty breathing.
• Severe allergic reactions that can cause skin rash, itching, urticaria, or swelling of the face, lips, mouth, or throat, which can make breathing or swallowing difficult.
• Heart failure that can cause difficulty breathing, tiredness after light physical activity, or swelling of the feet or legs due to fluid retention.
• Abnormalities in heart activity causing a feeling of lost pulse.
• Eye problems, such as inflammation, dryness, redness, or a feeling of a foreign body in the eyelid that could cause eye damage.
• Mental health problems (psychosis) that can cause the patient to hear, see, or feel things that do not exist (hallucinations), have false beliefs (delusional ideas), be confused, have disturbing or unusual thoughts, or exhibit disturbing or unusual behavior.

Other possible side effects include:

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

• Headaches.
• Itching or tingling sensation.
• Fainting when standing up.
• Constipation, nausea, or diarrhea.
• Fatigue.
• Fluid retention (swelling).
• Breathing difficulties.

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

• Nightmares.
• Feelings of depression.
• Vision problems.
• Slow heart rate or other heart problems.
• Other heart function disorders that can be detected during cardiac examinations.
• Low blood pressure.
• Difficulty or pain when walking, including muscle cramps or lameness.
• Shortness of breath, such as with asthma, due to sudden muscle spasms in the airways (bronchospasm).
• Indigestion, gas, vomiting.
• Difficulty having or maintaining an erection.
• Skin rash, itching.

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

• Fainting.
• Worsening of psoriasis or a rash similar to psoriasis (red patches on the skin, often with silvery scales).

Frequency not known(cannot be estimated from available data):

• Allergic reactions throughout the body, with a generalized skin rash (hypersensitivity reactions).
• Sudden swelling, especially around the lips, eyes, or tongue, with possible sudden difficulty breathing (angioedema).
• A type of skin rash characterized by itchy, raised, and red patches caused by allergic or non-allergic reasons (urticaria).

The following side effects have been reported with medications of the same type as nebivolol, so they may also occur with this medication. The frequency cannot be estimated from available data.

• Cold and bluish-colored fingers and toes (Raynaud's phenomenon).
• Dry eyes.

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

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

• Dizziness.
• Low heart rate.

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

• Worsening of heart failure.
• Low blood pressure (such as a feeling of fainting when standing up).
• Intolerance to nebivolol.
• A type of mild heart conduction disorder that affects the heart rate (first-degree AV block).
• Swelling of the lower limbs (such as swollen ankles).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nebivolol Viatris

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

Do not use this medication after the expiration date stated on the blister, box, or label of the bottle after the abbreviation CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not take this medication if you notice any discoloration of the tablets.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Nebivolol Viatris

The active ingredient is nebivolol. Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5 mg of nebivolol.

The other ingredients are: lactose monohydrate (see section 2 "Nebivolol Viatris contains lactose and sodium"), sodium croscarmellose, corn starch, polysorbate 80, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the Product and Packaging Contents

White, oval, 9.5 mm x 8.5 mm, cross-scored tablets, smooth with beveled edges. Each tablet is marked with 'N' in the upper left quadrant and an 'L' in the upper right quadrant on one side only.

This medication is available in packs with PVC/PVdC - Alu blisters of 7, 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets, in opaque plastic bottles of 100 or 500 tablets, or in PVC/PVdC - Alu unit-dose blisters of 28 x 1, 56 x 1, 100 x 1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

McDermott Laboratories Limited t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13

Ireland

Or

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

Or

Viatris Santé

1 Rue de Turin

69007 Lyon

France

Further information about this medication can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Spain Nebivolol Viatris 5 mg tablets EFG

France Nebivolol Viatris Santé 5 mg quadriscored tablet

Italy NIVOLON 5 mg tablets

Portugal Nebivolol Mylan 5 mg tablets

United Kingdom Nebivolol 5 mg Tablets

Date of the Last Revision of this Leaflet:March 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/