Package Insert: Information for the Patient

Nebivolol Stada 5 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as 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 prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

1. Storage of Nebivolol Stada
2. Contents of the package and additional information

Nebivolol Stada contains nebivolol hydrochloride, 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 on blood vessels, which in turn contributes to lowering blood pressure.

It is used for the treatment of high blood pressure (hypertension).

Nebivolol Stada is also used for the treatment of chronic stable mild to moderate heart failure in patients 70 years of age or older, administered in combination with other medications.

Do not take Nebivolol Stada:

• If you are allergic to the active ingredient 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.

• Asthma, wheezing, or a respiratory disease (present or past).
• Phaeochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), not being treated.
• Liver function disorders.
• Metabolic disorders (characterized by metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions

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

• Abnormally slow heart rate.

• Angina of Prinzmetal, a type of chest pain due to spontaneous spasm of the coronary arteries.
• Chronic heart failure without treatment and coronary heart disease (circulation limitation).
• First-degree heart block (a mild alteration of cardiac conduction that affects heart rhythm).
• Poor circulation in arms or legs, for example, Raynaud's disease, walking pain similar to cramp.
• Diabetes: This medication has no effect on blood sugar levels, but may mask warning signs of low blood sugar (e.g. palpitations, rapid heart rate) and may increase the risk of severe hypoglycemia when used with certain types of diabetes medications called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

• Hyperthyroidism: This medication may mask signs due to this alteration, such as abnormally high heart rate.
• Allergies: This medication may intensify your reaction to pollen or other substances to which you are allergic.
• Respiratory problems combined with cough (if you have chronic obstructive pulmonary disease [COPD]).
• Have had or have psoriasis (a skin disease characterized by scaly, pink patches).
• Must undergo surgery, inform your anesthesiologist that you are taking Nebivolol Stada.

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

You will be monitored periodically by a doctor (see section 3) at the beginning of treatment for chronic heart failure.

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 due to the lack of data on its use in the pediatric population.

Other medications and Nebivolol Stada

Inform your doctor or pharmacist if you are taking, have taken recently, 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. dose).

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 (e.g. 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, e.g. amitriptyline, paroxetine, and fluoxetine.

• Baclofen (antispasmodic medication), amifostine (cancer treatment medication)
• Medications used for anesthesia during surgery
• Medications for asthma, nasal decongestants, and some medications for eye disorders such as glaucoma (increased eye pressure) or pupil dilation.

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

• Medications for treating excessive stomach acid or ulcers (anti-acid medications), such as cimetidine: Take Nebivolol Stada with food and the anti-acid between meals.

• Medications for diabetes, such as insulin or oral antidiabetic medications. Although nebivolol does not affect blood sugar levels, concomitant use may mask some symptoms of hypoglycemia (rapid heart rate).

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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Nebivolol Stada is not recommended for use during breastfeeding.

Driving and operating machinery

This medication may cause dizziness or fatigue. If so,avoiddriving or operating machinery.

This medication contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance,consult with them beforetaking this medication.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 and patients with renal impairment 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. In some cases, 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 then to 2 tablets per day until the optimal dose for you is achieved. 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 initiation 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

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

If your doctor has prescribed ¼ (quarter) or ½ (half) tablet per day, you will have to divide the tablet through the lines before taking it. The tablet can be divided into equal doses. Follow the instructions below to split the Nebivolol Stada tablets.

• Place the tablets on a hard surface with the groove facing up
• Apply pressure to the top with your thumb and the tablet will be divided 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.

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 ingested.

It is recommended to bring the packaging and the medication leaflet 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 a possibility of fainting (hypotension), breathing difficulties like asthma (bronchospasm), and acute heart failure.

If you forgot to take Nebivolol Stada

If you forgot 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 you are near the next dose, skip the missed dose and take the nextdose scheduled, at the usual time. Do not take a double dose to compensate for the missed doses. Try to avoid repeated forgetting of medication intake.

If you stop treatment with Nebivolol Stada

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

Do not stop treatment abruptly with Nebivolol Stada, as this could temporarily worsen your heart failure. If 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Nebivolol Stada may cause side effects, although not everyone will experience them.

When used for the treatment of high blood pressure with Nebivolol Stada, the possible side effects are:

Side effectsfrequent(may affect up to 1 in 10 people)

• headache

• dizziness
• fatigue

• unusual itching or tingling sensation (paresthesia)
• diarrhea

• constipation
• nausea
• difficulty breathing

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

Side effectsinfrequent(may affect up to 1 in 100 people)

• slow heart rate or other cardiac abnormalities

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

• abnormal vision
• impotence
• feeling of depression
• digestive disorders (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

Side effectsvery rare(may affect up to 1 in 10,000 people)

• syncope

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

Side effects ofunknown frequency(the frequency cannot be estimated from current data)

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

• urticaria

Other side effects observed in similar medications 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:

Side effectsvery frequent(may affect more than 1 in 10 people)

• slow heart rate

• dizziness

Side effectsfrequent(may affect up to 1 in 10 people)

• Worsening of heart failure

• Low blood pressure (like dizziness when standing up quickly)
• Intolerance to this medication
• Mild alteration of cardiac conduction that affects heart rhythm (first-degree atrioventricular block)
• Swelling of the lower extremities (swollen ankles)

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of 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 medication.

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

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

Do not store above 30 °C.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Nebivolol Stada

• 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 cornstarch; sodium croscarmellose; anhydrous colloidal silica; magnesium stearate and crospovidone.

Appearance of the product and content of the container

There is only one dose of Nebivolol Stada. The tablets are white, round, cross-scored and are presented in a blister pack of 28 and 30 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse 2-18,

D-61118 Bad Vilbel

Germany

This medicine is authorized in the member states of the European Economic Area with the following names:

Bulgaria: Cardiostad 5 mg tablets

Netherlands: Nebivolol STADA 5 mg tabletten

Spain: Nebivolol STADA 5 mg EFG tablets

Last review date of this leaflet:April 2025

More 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/