Nebivolol Pensa 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nebivolol Pensa 5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents:

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

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

Nebivolol Pensa contains nebivolol, which is a selective beta-blocker and dilates blood vessels (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 aged 70 years or older.

2. What you need to know before taking Nebivolol Pensa

Do not take Nebivolol Pensa:

• If you are allergic (hypersensitive) to nebivolol or to any of the other components of Nebivolol Pensa (see section 6),
• If you have low blood pressure (systolic blood pressure or "the high" is less than 90 mmHg)
• If you suffer from severe circulatory problems in 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 do not have a functioning pacemaker.
• If you have acute heart failure, or are receiving intravenous (IV infusion) treatment to support your heart.
• If you have severe difficulty breathing 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 impaired liver function
• If you have metabolic acidosis (in diabetic patients when blood sugar has risen too high and blood becomes too acidic)

Warnings and precautions

Consult your doctor before taking Nebivolol Pensa.

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

• Heart failure (inability of the heart 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 affecting 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

• Long-standing breathing problems

• Diabetes: if you are diabetic, since nebivolol may mask symptoms of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used together with certain types of antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide)

• Overactive thyroid gland, since Nebivolol Pensa may mask signs of abnormally increased heart rate due to this condition.

• Allergies, as allergic reactions may be more severe

• A skin disorder known as psoriasis, since Nebivolol Pensa may worsen symptoms

• Wearing contact lenses, since Nebivolol Pensa may reduce tear production and cause dry eyes.

In these cases, your doctor may need to adjust your treatment or perform 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 lack of safety and efficacy data.

If you are undergoing surgery and require anesthesia, inform your surgeon or dentist that you are taking this medicine. If you have severe renal impairment, you should not take this medicine for heart failure and must inform your doctor.

Other medicines and Nebivolol Pensa

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.

Always inform 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 administered intravenously.
• Other medicines known as calcium channel blockers for the treatment of high blood pressure or other heart problems, such as amlodipine, felodipine, lacidipino, nifedipine, nicardipine, nimodipine, nitrendipine
• Other antihypertensive medicines or organic nitrates for treating 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 medicines 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
• Anesthetic: always inform your anesthesiologist that you are being treated with Nebivolol Pensa before receiving anesthesia
• Cimetidine (to treat excessive stomach acidity) – you should take Nebivolol Pensa with meals, and the antacid between meals
• Medicines that affect the metabolism of nebivolol such as terbinafine (for fungal or yeast infections), bupropion (to help stop smoking), chloroquine (for malaria or rheumatoid arthritis), levomepromazine (for psychosis), paroxetine, fluoxetine, thioridazine (for depression)
• Amifostine (a protective agent administered during chemotherapy or radiotherapy)
• Baclofen (muscle relaxant)

Taking Nebivolol Pensa with food and drinks

Nebivolol Pensa may 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 treatment with 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 medicinal product may cause dizziness or fatigue. In such cases, DO NOT drive or use machines.

Important information about some of the components of Nebivolol Pensa

This medicinal product contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicinal product.

3. How to take Nebivolol Pensa

Follow exactly the instructions for using Nebivolol Pensa as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (1 tablet) once daily. The dose should preferably be taken at the same time each day.
• In elderly patients or patients with renal impairment, treatment usually starts at 2.5 mg (½ tablet) once daily.
• The therapeutic effect on blood pressure becomes clearly evident 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 physician.
• Your doctor will start your treatment with 1.25 mg (¼ tablet) once daily. This dose may be increased after 1–2 weeks to 2.5 mg (½ tablet) once daily, followed by 5 mg (1 tablet) once daily, and subsequently to 10 mg (2 tablets) once daily, until the optimal dose for you is reached.
• The maximum recommended dose is 10 mg (2 tablets daily).
• You will need to be under the supervision of an experienced physician for 2 hours when starting treatment and each time your dose is increased.
• Your doctor may reduce your dose if necessary. You must not stop the treatment abruptly, as this could worsen heart failure.
• Patients with severe renal problems must not take this medicine.

Take your medicine once daily, 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 for children and adolescents.

If you take more Nebivolol Pensa than you should:

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medicine and the amount taken. Bring the packaging with any remaining tablets.

If you forget to take Nebivolol Pensa:

If you forget to take your medicine but remember shortly afterwards, take the tablet as usual. However, if a long delay has occurred (i.e., the entire day), skip the missed dose and take the next dose at your usual time the following day. Do not take a double or larger dose to make up for the missed dose. Repeatedly forgetting to take the medicine should be avoided.

If you stop taking Nebivolol Pensa:

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

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

4. Possible adverse effects

Like all medicines, Nebivolol Pensa may have adverse effects, although not everyone gets them.

When Nebivolol Pensa is used in the treatment of hypertension, the possible side effects are as follows:

Common adverse 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
• Difficulty breathing
• Swelling of hands or feet

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

• Decrease in heart rate or other cardiac disturbances
• Low blood pressure
• Cramping pain in the legs when walking
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Depression
• Digestive difficulties (dyspepsia), stomach or intestinal gas, vomiting
• Skin rash, pruritus
• Asthma-like shortness of breath caused by sudden cramps in the muscles surrounding the airways (bronchospasm)
• Nightmares

Very rare adverse effects (less than 1 in 10,000 people treated):

• Fainting
• Worsening of psoriasis (a skin disease characterized by scaly pink plaques)

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

• Generalized allergic reactions with widespread skin rash (hypersensitivity reactions);
• Rapid-onset swelling, especially around the lips, eyes or tongue, possibly with sudden breathing difficulties (angioedema)

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

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

• Slowing of the heart rate
• Dizziness

Common adverse 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 faintness when standing up quickly)
• Inability to tolerate the medicine
• A mild type of heart conduction disorder affecting heart rhythm (first-degree atrioventricular block)
• Edema in the lower limbs (such as malleolar edema)

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform 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 expiry date stated on the packaging after . The expiry date refers to 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 properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other 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 components (excipients) are: monohydrate lactose, crospovidone type A, poloxamer 188, povidone K 30, microcrystalline cellulose, magnesium stearate.

Appearance of the medicine and pack size

Nebivolol Pensa are white, round, biconvex tablets, with a cross-shaped score line 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 tablets. Each package 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 Grignano, 43

24041 Brembate

Italy

Date of the most recent revision of this leaflet: February 2025

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