Package Insert: Information for the Patient

Nebivolol Viatris 5 mg Tablets EFG

Read this package insert carefully before starting to take this medication,because it contains important information for you.

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

-This medication has been prescribedonlyfor you and should not be given to others, even if they have the same symptomsas you,as it may harm them.

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

Nebivolol belongs to a group of medicines called selective beta-blockers that is used to lower blood pressure.

Nebivolol is indicated for the treatment of:

• High blood pressure (hypertension).
• Mild to moderate heart failure, in elderly patients, associated with other medication treatment (for example, diuretics, digoxin, ACE inhibitors, angiotensin II antagonists).

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 rash, itching, swelling, or difficulty breathing.
• You have liver problems.
• You have had a heart attack, have heart failure that may be getting worse, or are being treated intravenously for heart failure.
• You have been diagnosed with other severe heart rhythm disorders (such as Wolff-Parkinson-White syndrome, sinoatrial block, or third-degree heart block) and do not have a functioning pacemaker.
• You have or have had asthma or severe difficulty breathing.
• You have a tumor of the adrenal gland called pheochromocytoma that is not being treated.
• You have metabolic acidosis.
• You have very slow heartbeats (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 flecainide and sultopride.

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 gait disturbance, as nebivolol may worsen them.
• Your doctor has informed you that you have a first-degree heart block (sensation of loss of 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 nebivolol does not affect blood sugar levels, but may mask symptoms of low blood sugar (hypoglycemia).
• You have hyperthyroidism, as nebivolol may mask symptoms such as 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 known as psoriasis or if you suffer from hay fever or other allergies, as nebivolol may worsen them. Consult your doctor if you are unsure whether to take 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 taken recently, or may need to take any other medication, including those purchased without a prescription.

Do not take nebivolol if you are taking any medication that contains flecainide or sultopride (see section “Do not take Nebivolol Viatris if”).

The administration of nebivolol with any of the following medications may reduce your blood pressure too much or cause heart problems:

• Medications to reduce blood pressure such as verapamil, diltiazem, clonidine, guanfacine, moxonidine, methyldopa, rilmenidine, amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine.
• Medications used to treat heart arrhythmias (irregular heart rhythm) 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 cancer therapy).
• Mefloquine (antimalarial medication).
• Organic nitrates (used to treat angina).
• Quinidine (to slow heart rate).
• Terbinafine (used to treat fungal and yeast infections).
• Bupropion (to help quit smoking).
• Chloroquine (used to treat malaria or rheumatoid arthritis).
• Levomepromazine (used to treat mental health problems).

Also:

• Stimulants containing dopamine or decongestants containing 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), such as tachycardia or palpitations.

Surgery

Nebivolol may interact with certain anesthetics used in operations. If you require any type of surgical intervention, inform your doctor, dentist, or hospital staff that you are taking nebivolol.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

When driving vehicles or operating machinery, be aware that dizziness and fatigue due to decreased blood pressure may occur. In these cases, do not drive or operate machinery. These effects are more likely to occur at the beginning 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 a certain sugar intolerance, 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”.

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

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

The tablet can be divided into 4 equal doses.

Hypertension treatment:

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

Older patients:If you are 65 years or older and take nebivolol to reduce your blood pressure, the usual starting dose is 2.5 mg per day. If necessary, your doctor may increase your dose to 5 mg of nebivolol per day.

Patients with renal insufficiency:The recommended initial dose is 2.5 mg of nebivolol per day. If necessary, your doctor may increase your 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, in doses of 12.5 mg-25 mg per day.

Heart failure treatment:

Use in adults and older patients:Your doctor will start treatment with a low dose that will gradually increase in intervals of 1 to 2 weeks until your condition stabilizes. Initially, you will be administered 1.25 mg of nebivolol for one or two weeks, increasing to 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 you should take.

Patients with renal insufficiency:

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

Patients with liver insufficiency:

If you have liver insufficiency, you should not take nebivolol.

Use in children and adolescents:

Neurobivolol is not recommended for use in children and adolescents under 18 years old.

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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

An accidental overdose could lead to a decrease in heart rate, low blood pressure, difficulty breathing, and sudden cardiac problems.

If you forget to take Nebivolol Viatris:

If you forget to take your medication, do not take a double dose to compensate for the missed doses. Take the next regular dose. Contact your doctor if you forget to take several doses.

If you interrupt treatment with Nebivolol Viatris:

If you suddenly stop treatment with nebivolol, you may experience adverse reactions or your condition may worsen. If you interrupt treatment, your doctor will gradually reduce your dose over a period of 2 weeks.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Chest tightness and difficulty breathing.
• Severe allergic reactions that may cause skin rash, itching, hives, or swelling of the face, lips, mouth, or throat, which may make it difficult to breathe or swallow.
• Heart failure that may cause difficulty breathing, easy fatigue after light physical activity, or swelling of the feet or legs due to fluid retention.
• Abnormal heart rhythm causing a sensation of loss of pulse.
• Eye problems, such as inflammation, dryness, redness, or a sensation of a foreign body in the eyelid that could cause eye injury.
• Mental health problems (psychosis) that may cause the patient to hear, see, or feel things that do not exist (hallucinations), have false beliefs (delusions), be confused, experience annoying or unusual thoughts, or exhibit annoying or unusual behavior.

Other possible side effects include:

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

• Headache.
• Itching or tingling sensation.
• Dizziness when standing up.
• Constipation, nausea, or diarrhea.
• Fatigue.
• Fluid retention (swelling).
• Difficulty breathing.

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

• Nightmares.
• Depressive feelings.
• Visual problems.
• Slow heart rate or other heart problems.
• Other heart function abnormalities that may be detected during cardiac examinations.
• Low blood pressure.
• Difficulty or pain when walking, including muscle cramps or limping.
• Lack of air, like asthma, due to sudden muscle cramps in the airway muscles (bronchospasm).
• Indigestion, gas, vomiting.
• Difficulty achieving or maintaining an erection.
• Rash, skin itching.

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

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

Unknown frequency (cannot be estimated from available data):

• Generalized skin rash (hypersensitivity reactions).
• Rapid swelling, especially around the lips, eyes, or tongue, with possible sudden difficulty breathing (angioedema).
• A type of skin rash that stands out due to its protuberances with itching, elevated, and pale red color 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 medicine.The frequency cannot be estimated from available data.

• Cold hands and feet with blue-colored skin (Raynaud's phenomenon).
• Eye dryness.

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

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

• Dizziness.
• Low heart rate.

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

• Worsening of heart failure.
• Low blood pressure (such as dizziness when standing up quickly).
• Intolerance to nebivolol.
• A type of mild heart conduction disorder that affects heart rhythm (first-degree AV block).
• Swelling of the lower extremities (e.g., swollen 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: https://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.

Do not use this medication after the expiration date that appears on the blister pack, 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 detect any discoloration of the tablets.

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

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 components are: lactose monohydrate (see section 2 “Nebivolol Viatris contains lactose and sodium”),croscarmellose sodium, cornstarch, polisorbate 80, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

White, oval-shaped tablets, 9.5 mm x 8.5 mm, cross-scored, smooth with beveled edges. Each tablet ismarked with‘N’in the upper left quadrant and a‘L’in the upper right quadrant on one side only.

This medication is available in packages 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 perforated single-dose PVC/PVdC – Alu blisters of 28 x 1, 56 x 1, 100 x 1 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 with the following names:

BelgiumNebivolol Mylan 5 mg tabletten

SpainNebivolol Viatris 5 mg comprimidos EFG

FranceNebivolol Viatris Santé 5 mg comprimé quadrisécable

IrelandNelet 5 mg Tablets

ItalyNIVOLON 5 mg compresse

NetherlandsNebivolol Mylan 5 mg tabletten

PortugalNebivolol Mylan 5 mg comprimidos

United KingdomNebivolol 5 mg Tablets

Last review date of this leaflet:January 2023

Further detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/