NEBIVOLOL PENSA 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Nebivolol Pensa 5 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is Nebivolol Pensa and what is it used for
2. What you need to know before you take Nebivolol Pensa
3. How to take Nebivolol Pensa
4. Possible side effects
5. Storage of Nebivolol Pensa
6. Contents of the pack and further information

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

Nebivolol Pensa contains nebivolol, which is a selective beta-blocker and vasodilator. It is indicated for the treatment of high blood pressure (hypertension).

Nebivolol Pensa is also used in the treatment of chronic heart failure in patients 70 years or older.

2. What you need to know before you take Nebivolol Pensa

Do not take Nebivolol Pensa:

• If you are allergic (hypersensitive) to nebivolol or any of the other ingredients of Nebivolol Pensa (see section 6),
• If you have low blood pressure (systolic blood pressure or "the high one" is below 90 mmHg)
• If you have severe circulatory problems in your arms or legs
• If you have a very slow heart rate (less than 60 heartbeats per minute before starting treatment with this medicine)
• If you have been diagnosed with conduction disorders in your heart (such as sick sinus syndrome or atrioventricular block) and you do not have a pacemaker in operation.
• If you have acute heart failure or are receiving intravenous treatment (by drip) to help your heart.
• If you have severe breathing difficulties or wheezing (currently or in the past)
• If you have a tumor of the adrenal gland called pheochromocytoma
• If you have severe liver failure or liver function disorders
• If you have metabolic acidosis (in diabetic patients when blood sugar has risen too high and the blood becomes too acidic)

Warnings and precautions

Consult your doctor before taking Nebivolol Pensa.

Tell your doctor if you have or develop any of the following conditions:

• heart failure (the heart's inability to pump enough blood to meet the body's needs)
• moderate atrioventricular block (first degree) in your heart (a type of mild cardiac conduction disorder that affects heart rhythm)
• chest pain caused by spasms of the coronary arteries (called Prinzmetal's angina or variant angina)
• poor circulation in arms and legs, i.e., Raynaud's disease or syndrome, cramp-like pains when walking
• prolonged breathing difficulties
• diabetes: if you are diabetic, as nebivolol may mask the symptoms of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain oral antidiabetic medications called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide)

• overactive thyroid gland, as Nebivolol Pensa may mask the signs of an abnormally fast heart rate due to this condition.
• allergy, as allergic reactions may be stronger
• a skin condition known as psoriasis, as Nebivolol Pensa may worsen symptoms
• wearing contact lenses, as Nebivolol Pensa may reduce tear production and cause dry eyes.

In these cases, it may be necessary for your doctor to adjust the treatment you are receiving or for you to undergo medical check-ups more frequently.

Children and adolescents

Nebivolol Pensa is not recommended for use in children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

If you are going to have surgery and need anesthesia, inform your surgeon or dentist that you are taking this medicine. If you have severe kidney problems, you should not take this medicine for heart failure and inform your doctor.

Other medicines and Nebivolol Pensa

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Always tell your doctor or pharmacist if you are using or receiving any of the following medicines at the same time as Nebivolol Pensa:

• diltiazem or verapamil (used for high blood pressure and other heart problems). During treatment with Nebivolol Pensa, verapamil should not be injected into a vein.
• other calcium channel blockers for the treatment of high blood pressure or other heart problems, such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, nitrendipine
• other antihypertensive medications or organic nitrates for the treatment of chest pain
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used for the treatment of high blood pressure
• medicines for cardiac arrhythmias (irregular heart rhythm) such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone
• tricyclic antidepressants (for depression), phenothiazines (for psychosis), or barbiturates (for epilepsy)
• medicines for diabetes, such as insulin or oral antidiabetics
• digoxin or other medications called digitalis glycosides (for the treatment of heart failure)
• medicines for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation
• anesthetics: always inform your anesthesiologist that you are being treated with Nebivolol Pensa before being anesthetized
• cimetidine (to treat excessive stomach acidity) - you should take Nebivolol Pensa during meals, and the antacid between meals
• medicines that affect the metabolism of nebivolol such as terbinafine (for fungal or yeast infections), bupropion (to help quit smoking), chloroquine (for malaria or rheumatoid arthritis), levomepromazine (for psychosis), paroxetine, fluoxetine, thioridazine (for depression)
• amifostine (a protective substance administered during chemotherapy or radiotherapy)
• baclofen (muscle relaxant)

Taking Nebivolol Pensa with food and drinks

Nebivolol Pensa should be taken with or without food. The tablets or their parts should be swallowed with water or any other liquid.

Pregnancy and Breastfeeding

Pregnancy

Nebivolol Pensa should not be used during pregnancy, unless clearly necessary.

Breastfeeding

Breastfeeding is not recommended during the administration of Nebivolol Pensa.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

This medicine may cause dizziness or fatigue. In these cases, DO NOT drive or use machines.

Important information about some of the ingredients of Nebivolol Pensa

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Nebivolol Pensa

Follow the instructions for administration of Nebivolol Pensa indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Treatment of high blood pressure (hypertension)

• The normal dose is 5 mg (1 tablet) per day. The dose should be taken preferably at the same time of day.
• In elderly patients or patients with renal impairment, treatment will usually start with 2.5 mg (½ tablet) per day
• The therapeutic effect on blood pressure becomes apparent after one or two weeks of treatment. In some cases, the optimal effect is only achieved after 4 weeks of treatment.

Treatment of chronic heart failure

• Your treatment should be initiated and monitored by an experienced doctor
• Your doctor will start treatment with 1.25 mg (¼ tablet) per day. This dose may be increased after 1-2 weeks to 2.5 mg (½ tablet) per day, followed by 5 mg (1 tablet) per day and then 10 mg (2 tablets) per day until the optimal dose for you is reached.
• The maximum recommended dose is 10 mg (2 tablets per day)
• You will need to be under the supervision of an experienced doctor for 2 hours when you start treatment and each time the dose is increased.
• Your doctor may reduce the dose if necessary, and you should not stop treatment abruptly as this could worsen heart failure.
• Patient with severe kidney problems should not take this medicine.

Take your medicine once a day, preferably always at the same time of day.

Your doctor may decide to combine your tablets with other medicines for your condition. Nebivolol Pensa is not recommended in children and adolescents.

If you take more Nebivolol Pensa than you should:

If you accidentally take too many tablets (overdose), you may experience a decrease in heart rate, low blood pressure, or other heart problems, or difficulty breathing or asthma.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring the package with the remaining tablets.

If you forget to take Nebivolol Pensa:

If you have forgotten to take your medicine, but remember within a short period, take the next tablet normally. However, if there is a long delay (i.e., all day), skip the missed dose and take the medicine the next day at the usual time. Do not take a double dose or a larger dose to make up for the missed dose. You should try to avoid repeatedly forgetting to take your medicine.

If you stop taking Nebivolol Pensa:

Do not stop taking Nebivolol Pensa without consulting your doctor. If you stop the medication abruptly, patients may experience a dangerous worsening of symptoms. This is especially true for patients with angina pectoris.

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

4. Possible side effects

Like all medicines, Nebivolol Pensa can have side effects, although not everyone gets them.

When Nebivolol Pensa is used to treat hypertension, the possible side effects that occur are the following:

Common side effects (more than 1 in 100 people treated but less than 1 in 10 people treated):

• headache
• dizziness
• fatigue
• unusual itching or tingling sensation
• diarrhea
• constipation
• nausea
• breathing difficulties
• swelling of hands or feet

Uncommon side effects (more than 1 in 1,000 people treated but less than 1 in 100 people treated):

• decreased heart rate or other heart disorders
• low blood pressure
• spasmodic pains in the legs when walking
• abnormal vision
• impotence (difficulty having an erection)
• depression
• digestive difficulties (dyspepsia), stomach or intestinal gas, vomiting
• skin rash, itching
• asthma-like breathing difficulties caused by sudden spasms in the muscles surrounding the airways (bronchospasm)
• nightmares

Rare side effects (less than 1 in 10,000 people treated):

• fainting
• worsening of psoriasis (a skin condition characterized by the presence of scaly pink patches)

The following side effects have been reported only in isolated cases during treatment with NEBIVOLOL PENSA:

• allergic reactions throughout the body with generalized skin rash (hypersensitivity reactions);
• rapid onset edema, especially around the lips, eyes, or tongue, and with possible sudden breathing difficulties (angioedema)

In a clinical study of chronic heart failure, the following side effects have been observed:

Very common side effects (more than 1 in 10 people treated):

• reduced heart rate
• dizziness

Common side effects (more than 1 in 100 people treated but less than 1 in 10 people treated):

• worsening of heart failure
• drop in blood pressure (such as a feeling of fainting when standing up quickly)
• inability to tolerate the medicine
• a type of mild cardiac conduction disorder that affects heart rhythm (first-degree atrioventricular block)
• edema in the lower limbs (such as ankle edema)

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Nebivolol Pensa

Keep out of the sight and reach of children.

Do not use Nebivolol Pensa after the expiration date stated on the packaging after . The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Nebivolol Pensa

The active substance is nebivolol.

Each tablet contains 5 mg of nebivolol equivalent to 5.45 mg of nebivolol hydrochloride.

The other ingredients (excipients) are: lactose monohydrate, crospovidone type A, poloxamer 188, povidone K 30, microcrystalline cellulose, magnesium stearate.

Appearance of the product and pack size

Nebivolol Pensa are white, round, biconvex tablets with a cross-shaped notch on one side and a diameter of approximately 9 mm.

Nebivolol Pensa can be divided into four equal parts.

Nebivolol Pensa 5 mg is available in PVC/PE/PVDC/Aluminum blisters of 7 and 14. Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Fine Foods & Pharmaceuticals N.T.M S.P.A.

Via R. Follereau, 25

24027 Nembro

Italy

Or

Fine Foods & Pharmaceuticals N.T.M S.P.A.

Via Grignano, 43

24041 Brembate

Italy

Date of last revision of this leaflet:February 2025

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