NEBIVOLOL STADA 5 mg TABLETS

Introduction

Patient Information Leaflet

Nebivolol Stada 5 mg film-coated tablets EFG

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

• Keep this 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 leaflet. See section 4.

Contents of the Leaflet

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

1. What you need to know before taking Nebivolol Stada
2. How to take Nebivolol Stada
3. Possible side effects

1. Storage of Nebivolol Stada
2. Contents of the pack and further information

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

Nebivolol Stada contains nebivolol hydrochloride, a medication 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 effect on blood vessels, which in turn helps to lower blood pressure.

It is used to treat high blood pressure (hypertension).

Nebivolol Stada is also used to treat mild to moderate chronic heart failure in patients aged 70 or older, in combination with other medications.

2. What you need to know before taking Nebivolol Stada

Do not take Nebivolol Stada:

• If you are allergic to the active substance or to 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) or irregular heartbeat (sinoatrial disease).
• other severe heart rhythm disorders (e.g., 2nd and 3rd degree atrioventricular block, sinoatrial block).
• you have recently suffered from heart failure or have worsened, or have had a shock caused by worsening of the same (cardiogenic shock), or are receiving intravenous treatment to help your heart work after suffering a circulatory collapse due to acute heart failure.

• asthma, wheezing, or a disease that affects your breathing (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 (characterized by metabolic acidosis), such as diabetic ketoacidosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nebivolol Stada. Especially if you have:

• abnormally slow heart rate.

• a type of chest pain due to a spontaneous spasm of the heart's arteries, called Prinzmetal's angina.
• untreated chronic heart failure and ischemic heart disease (limitation in blood circulation)
• 1st degree heart block (a type of mild conduction disorder that affects heart rhythm).
• poor circulation in arms or legs, such as Raynaud's disease or syndrome, or pain when walking similar to a cramp.
• diabetes: this medication does not affect blood sugar levels, but it can mask warning signs produced by low blood sugar levels (e.g., palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain antidiabetic medications called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

• hyperthyroidism: this medication can mask signs due to this condition, such as abnormally high heart rate.
• allergies: this medication can intensify your reaction to pollen or other substances you are allergic to.
• respiratory problems combined with cough (if you have chronic obstructive pulmonary disease [COPD])
• if you have or have had psoriasis (a skin disease characterized by scaly pink patches).
• you need to undergo surgery, always inform the anesthesiologist before the operation that you are taking Nebivolol Stada.

If you have severe kidney problems, do not take Nebivolol Stada to treat heart failure, and consult your doctor.

At the start of treatment for chronic heart failure, you will be monitored periodically 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

Nebivolol Stada is not recommended for use in children and adolescents under 18 years of age due to the lack of data on its use in the pediatric population.

Other medications and Nebivolol Stada

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

Some medications should not be taken at the same time, while others require specific changes (e.g., in dosage).

Always inform your doctor if, in addition to Nebivolol Stada, you are using any of the following medications:

• medications to control blood pressure or heart problems (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 medications for psychosis (mental illness), such as barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea), and thioridazine
• medications for depression, such as amitriptyline, paroxetine, and fluoxetine

• baclofen (antispasmodic medication), amifostine (cancer treatment medication)
• medications used for anesthesia during an operation
• medications for asthma, nasal decongestants, and some medications for treating eye disorders such as glaucoma (increased eye pressure) or dilation (enlargement) of the pupil

All these medications, like nebivolol, can affect blood pressure and/or heart function.

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

• medications for diabetes, such as insulin or oral antidiabetics. Although nebivolol does not affect glucose levels, concomitant use may mask some symptoms of hypoglycemia (rapid heartbeat).

Taking Nebivolol Stada with food and drinks

Nebivolol Stada can be taken with food or on an empty stomach, but it is best to take the tablet with water.

Pregnancy and 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 medication.

Nebivolol Stada should not be used during pregnancy, unless absolutely necessary.

The use of Nebivolol Stada is not recommended during breastfeeding.

Driving and using machines

This medication can cause dizziness or fatigue. If so, avoiddriving or using machinery.

This medication contains lactose and sodium

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

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

3. How to take Nebivolol Stada

Follow the administration instructions for this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Nebivolol Stada can be taken before, during, or after meals, but it can also be taken without food. It is preferable to take the tablet with a little water (e.g., a glass of water).

Treatment of high blood pressure (hypertension)

• the recommended dose is 1 tablet per day. It is preferable to take the dose at the same time every day.
• patients over 65 years of age and patients with kidney problems usually start treatment with ½ (half) tablet per day. If necessary, the daily dose can be increased to 1 tablet.

• the therapeutic effect on blood pressure is achieved after 1-2 weeks of treatment. Occasionally, the optimal effect is achieved after 4 weeks.

Treatment of chronic heart failure

• your treatment will be initiated and supervised by a doctor

• the doctor will start your treatment with ¼ (quarter) tablet per day. The dose will be increased after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day, and finally to 2 tablets per day to achieve the optimal dose for you. The 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 start of treatment and each dose increase will be done under the supervision of a doctor for at least a period of 2 hours
• your doctor may reduce your dose if necessary
• do not stop treatment abruptly, as this could worsen your heart failure

• take the medication once a day, preferably at the same time every day

Patient with severe kidney problems should not take Nebivolol Stada as there is no clinical experience with these patients.

If your doctor has told you to take ¼ (quarter) or ½ (half) tablet daily, you will need to divide the tablet along the lines before taking it. The tablet can be divided into equal doses. Follow the following instructions to split the Nebivolol Stada tablets.

• place the tablets on a hard surface with the score line facing up
• apply pressure on the top with your thumb and the tablet will break into four equal parts

Your doctor will decide if you should combine Nebivolol Stada with other medications to treat your condition.

Use in children and adolescents

Do not use Nebivolol Stada in children and adolescents under 18 years of age.

If you take more Nebivolol Stada 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.

It is recommended to take the package and leaflet of the medication to the healthcare professional.

The most frequent symptoms and signs of a Nebivolol Stada overdose are very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

If you forget to take Nebivolol Stada

If you forget to take a dose of Nebivolol STADA, but remember shortly after when you should have taken it, take the daily dose as usual. However, 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 to make up for missed doses. Try to avoid repeated forgetfulness in taking medication.

If you stop treatment with Nebivolol Stada

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

Do not stop treatment with Nebivolol Stada abruptly, as this could temporarily worsen your heart failure. If it is necessary to stop treatment with Nebivolol Stada for chronic heart failure, the daily dose should be gradually reduced, reducing the dose by half at weekly intervals.

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

4. Possible side effects

Like all medications, Nebivolol Stada can cause side effects, although not everyone will experience them.

When using Nebivolol Stada to treat high blood pressure, the possible side effects are:

Frequentside effects (may affect up to 1 in 10 people)

• headache

• dizziness
• fatigue

• unusual itching or tingling sensation (paresthesia)
• diarrhea

• constipation
• nausea
• breathing difficulties

• fluid accumulation in the body that causes swelling, especially in the legs and ankles (edema).

Uncommonside effects (may affect up to 1 in 100 people)

• slow heart rate or other heart disorders

• low blood pressure
• leg pain when walking similar to a cramp (intermittent claudication)

• abnormal vision
• impotence
• feeling of depression
• gastrointestinal disorders (dyspepsia), stomach or intestinal gas, vomiting

• skin rash, itching
• breathing difficulties like asthma, due to sudden contraction of the muscles around the airways (bronchospasm)
• nightmares

Rareside effects (may affect up to 1 in 10,000 people)

• fainting

• worsening of psoriasis (a skin disease characterized by scaly pink patches).

Unknown frequencyside effects (frequency cannot be estimated from available data)

• swelling of lips, eyes, or tongue (angioedema), with possible sudden breathing difficulties
• allergic reactions.

• hives

Other side effects observed with medications similar to Nebivolol are: hallucinations, mental disorders, and confusion, cold fingers and toes that are sometimes pale or blue, dry eyes, and a severe eye and mouth disorder.

In a clinical trial for chronic heart failure, the following side effects were observed:

Very commonside effects (may affect more than 1 in 10 people)

• slow heart rate

• dizziness

Commonside effects (may affect up to 1 in 10 people)

• worsening of heart failure

• low blood pressure (such as dizziness when standing up quickly)
• intolerance to this medication
• mild heart conduction disorder that affects heart rhythm (1st degree atrioventricular block)
• swelling of the lower limbs (swollen ankles)

Reporting side effects:

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

5. Storage of Nebivolol Stada

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the carton and blister pack after “EXP.”. The expiration date is the last day of the month indicated.

Do not store above 30 ºC.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Contents and Additional Information

Nebivolol Stada Composition

• The active ingredient is nebivolol. Each tablet contains nebivolol hydrochloride equivalent to 5 mg of nebivolol.
• The other components are povidone K30; lactose monohydrate; pregelatinized corn starch; sodium croscarmellose; anhydrous colloidal silica; magnesium stearate and crospovidone.

Product Appearance and Packaging Contents

There is only one dose of Nebivolol Stada. The tablets are white, round, cross-scored and come in blisters of 28 and 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18,

D-61118 Bad Vilbel

Germany

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

Bulgaria: Cardiostad 5 mg tablets

Netherlands: Nebivolol STADA 5 mg tabletten

Spain: Nebivolol STADA 5 mg EFG tablets

Date of the last revision of this leaflet:April 2025

Detailed and updated 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/