Leaflet: information for the user

Nebivolol pensa 5 mg tablets EFG

Read this leaflet carefully before you start taking the 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 prescribedonlyfor you, and you must not give it to others, even if they have the same symptomsas you, as it may harm them.

• Ifyou experienceside effects,consultyour doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

1. What isNebivolol Pensaand what it is used for

2. What you need to know beforestarting totakeNebivolol Pensa

3. How to takeNebivolol Pensa

4. Possible side effects

5. Storage ofNebivolol Pensa

6. Contents of the pack and additional information

Nebivolol Pensacontains nebivolol which is a selective beta blocker and dilates blood vessels (vasodilator). It is indicated for the treatment of high blood pressure (hypertension).

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

Do not takeNebivolol Pensa:

• If you are allergic (hypersensitive) to nebivolol or to any of the other components ofNebivolol Pensa(see section 6),

• If you have low blood pressure (systolic blood pressure or "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 medication)

• If you have been diagnosed with heart conduction disorders (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 treatment (through a vein) to help 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 dysfunction or liver function abnormalities

• If you have metabolic acidosis (in diabetic patients when blood sugar has increased too much and the 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 in your heart (a type of mild heart conduction disorder that affects heart rate)
• chest pain caused by coronary artery spasms (called Prinzmetal's angina or variant angina)
• poor circulation in arms and legs, i.e., Raynaud's disease or syndrome, leg cramps
• prolonged respiratory problems
• diabetes: if you are diabetic, as nebivolol may mask symptoms of low blood sugar (hypoglycemia) and may increase the risk of severe hypoglycemia when used with certain types of diabetes medications called sulfonylureas (e.g., glipizide, glimepiride, or tolbutamide)

• hyperactive thyroid gland, as Nebivolol Pensa may mask signs of an abnormal increase in heart rate due to this alteration.
• allergy, as allergic reactions may be more severe
• a skin condition known as psoriasis, as Nebivolol Pensa may exacerbate symptoms
• wearing contact lenses, as Nebivolol Pensa may reduce tear production and cause dry eyes.

In these cases, your doctor may need to adjust your treatment or have you undergo more frequent medical check-ups.

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

Other medications and Nebivolol Pensa

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription.

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

• diltiazem or verapamil (used to treat high blood pressure and other heart problems). During treatment with Nebivolol Pensa, verapamil should not be injected intravenously.
• other medications known as calcium channel blockers for the treatment of high blood pressure and other heart problems, such as amlodipine, felodipine, lacidipine, nifedipine, nicardipine, nimodipine, or nitrendipine
• other anti-hypertensive medications or organic nitrates for treating chest pain
• clonidine, guanfacine, moxonidine, methyldopa, rilmenidine used to treat high blood pressure
• medications for cardiac arrhythmias (irregular heart rate) such as quinidine, hydroquinidine, amiodarone, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, or propafenone
• tricyclic antidepressants (for depression), phenothiazines (for psychosis), or barbiturates (for epilepsy)
• diabetes medications, such as insulin or oral antidiabetic medications
• digoxin or other medications called digitalis glycosides (for treating heart failure)
• medications for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation
• anesthetic: always inform your anesthesiologist that you are taking Nebivolol Pensa before being anesthetized
• cimetidine (for treating excessive stomach acid) - you should take Nebivolol Pensa with food, and the antacid between meals
• medications that affect nebivolol metabolism 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 radiation therapy)
• 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, except if clearly necessary.

Breastfeeding

It is not recommended to breastfeed while taking Nebivolol Pensa.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

This medication may cause dizziness or fatigue. In these cases, DO NOT drive or operate machinery.

Important information about some of the components of Nebivolol Pensa

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

Follow exactly the administration instructions forNebivolol Pensaas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Treatment of high blood pressure (hypertension)

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 can 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 starting treatment and each time your dose is increased.
• Your doctor may reduce your dose if necessary, and you should not stop treatment abruptly as this could worsen heart failure.
• Patients with severe renal impairment should not take this medication.

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

Your doctor may decide to combine your tablets with other medications for your condition.Nebivolol Pensais not recommended for children and adolescents.

If you takeNebivolol Pensamore than you should:

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

cardiac problems, or difficulty breathing or asthma.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken. Bring with you the packaging with the remaining tablets.

If you forget to takeNebivolol Pensa:

If you have forgotten to take your medication, but remember in a short time, take the next tablet normally. However, if there is a long delay (i.e., all day), skip the missed dose and take the medication the next day at the usual time. Do not take a double or larger dose to compensate for the missed dose. It is essential to avoid repeated missed doses of medication.

If you interrupt treatment with Nebivolol Pensa:

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

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

Like all medicationsNebivolol Pensamay have side effects, although not everyone will experience them.

WhenNebivolol Pensais used to treat hypertension, the possible side effects that may occur are as follows:

Frequent side effects (more than one in 100 people treated but less than one in 10 people treated):

• Headache
• Dizziness
• Fatigue
• Unusual itching or tingling sensation
• Diarrhea
• Constipation
• Nausea
• Difficulty breathing
• Swelling of hands or feet

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

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

Very rare side effects (less than one in 10,000 people treated):

• Loss of consciousness
• Worsening of psoriasis (a skin condition characterized by the presence of scaly, pink plaques)

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

• Generalized skin rash with widespread skin eruption (hypersensitivity reactions);
• Rapid-onset edema, especially around the lips, eyes, or tongue, and possible sudden difficulty breathing (angioedema)

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

Frequent side effects (more than one in 10 people treated):

• Reduced heart rate
• Dizziness

Frequent side effects (more than one in 100 people treated but less than one in 10 people treated):

• Worsening of heart failure
• Decreased blood pressure (as a feeling of dizziness when standing up quickly)
• Inability to tolerate the medication
• A mild type of cardiac conduction disorder that affects heart rhythm (first-degree atrioventricular block)
• Edema in the lower extremities (such as ankle edema)

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of sight and reach of children.

Do not useNebivolol Pensaafter the expiration date that appears on the packaging after . The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Nebivolol Pensa

The active ingredient is nebivolol.

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

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

Appearance of the product and packaging size

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

.

Nebivolol Pensa can be divided into four equal parts.

Nebivolol Pensa 5 mg is presented in a PVC/PE/PVDC/Aluminum blister of 7 and 14. Each package contains 28 tablets

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing:

Specifar S.A.

1, 28 Octovriou str., Ag. Varvara,

123 51 Athens

Greece

Or

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

Last review date of this leaflet:February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/