Package Insert: Information for the User

Insucor 5 mg Tablets EFG

nebivolol

Read this package insert carefully before you start taking this medicine, because 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 medicine 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Insucor contains nebivolol, 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 dilating action on blood vessels, which in turn contributes to lowering blood pressure.

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

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

Do not takeInsucor

•if you are allergic to nebivolol or any of the other ingredients of this medication (listed in section6).

•if you have any of the following conditions:

-low blood pressure

-serious circulation problems in arms or legs

-slow heart rate (less than 60 beats per minute)

-other serious heart rhythm disorders (e.g. second- and third-degree atrioventricular block, cardiac conduction disorders)

-heart failure, which has worsened recently, or if you are receiving intravenous treatment to help your heart work, after suffering a circulatory collapse due to acute heart failure.

-asthma or breathing difficulties (current or past), phaeochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands) that is not being treated.

-liver function disorder

-metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis

Warnings and precautions

Consult your doctor or pharmacist before starting to takeInsucor.

Inform your doctorif you have or develop any of the following problems:

•abnormally slow heart rate

•type of chest pain due to spontaneous spasm of the coronary arteries, called Prinzmetal's angina

•chronic heart failure without treatment

•first-degree heart block (a mild type of cardiac conduction disorder that affects the heart rhythm)

•poor circulation in arms or legs, such as Raynaud's disease or syndrome, or walking pain similar to a cramp

•chronic respiratory problems

•diabetes: this medication has no effect on blood sugar levels, but may mask warning signs of a decrease in these levels (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. glibenclamide, glimepiride, glipizide, gliquidone, tolbutamide)

•hyperthyroidism: this medication may mask symptoms of rapid heart rate due to this disorder.

•allergy: this medication may intensify your reaction to pollen or other substances to which you are allergic.

•if you have or have had psoriasis, a skin disease characterized by scaly pink patches.

•if you are undergoing surgery, inform your anesthesiologist that you are taking this medication.

If you have severe kidney problems, consult your doctor before taking Insucor to treat heart failure.

At the beginning of treatment for chronic heart failure, you will need to be regularly monitored by a doctor (see section 3).

This treatment should not be stopped abruptly, unless it is clearly indicated and evaluated by your doctor (see section 3).

Children and adolescents

Insucor is not recommended for use in children and adolescents due to the lack of data on the use of this medication in this type of patient.

Other medications and Insucor

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication

Inform your doctor at all times if, in addition to Insucor, you are using any of the following medications:

• Medications to control blood pressure or medications used to treat heart disease (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 therapies used in the treatment of psychosis (mental illness) e.g. barbiturates (also used to treat epilepsy), phenothiazine (also used to treat vomiting and nausea) and thioridazine.
• Medications used to treat depression e.g. amitriptyline, paroxetine and fluoxetine.
• Medications used for anesthesia during surgery.
• Medications used to treat asthma, nasal congestion or certain eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation.

• Baclofen (an antispasmodic medication); amifostine (a medication used during cancer treatment).

• Medications for diabetes, such as insulin or oral antidiabetic medications.

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

• Antimalarials (mefloquine).
• Medications to treat excessive acidity in the stomach or ulcers (antacids): take Insucor with food, and the antacid between meals.

Insucor with food and drinks

See section 3.

Pregnancy and breastfeeding

Pregnancy

Insucor should not be administered during pregnancy unless clearly necessary.

Breastfeeding

Its use is not recommended during breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication may cause dizziness or fatigue. If this occurs,do notdrive or operate machinery.

Insucor contains lactose

This medication containslactose. Ifyour doctor has told you that you have a certain sugar intolerance,consultbefore taking this medication.

Insucor contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per coated 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.

Insucor can be taken before, during, or after meals, but it can also be taken independently of them. It is preferable to take the tablet with a little water.

Treatment of high blood pressure (hypertension)

Treatment of chronic heart failure

Your doctor will closely monitor your treatment.

Your doctor may decide that it is necessary to combine these tablets with other medications to treat your condition.

If your doctor has instructed you to take ½ (half) tablet daily, consult the instructions below on how to break Insucor 2.5 mg and Insucor 5 mg tablets into equal doses.

• Place the tablets on a flat, hard surface (e.g., a table or countertop), with the score line facing upwards.

• Break the tablet by pushing it with your index fingers from both hands along the score line (Diagrams 1 and 2).

Diagram 1Diagram 2

Diagrams 1 and 2: easy breaking of Insucor 2.5 mg and Insucor 5 mg tablets into equal doses.

Use in children and adolescents

Do not use in children and adolescents.

If you take more Insucor than you should

If you have accidentally taken an overdose of this medication, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount taken. The symptoms and signs most frequently reported with an overdose are related to a very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), difficulty breathing such as in asthma (bronchospasm), and acute heart failure.

You can take activated charcoal (available at your pharmacy) while waiting for help to arrive.

If you forget to take Insucor

If you forget to take a dose of Insucor, but remember shortly after when you should have taken it, take the dose as usual. On the other hand, if a lot of time has passed (several hours), so that it is near the next dose, skip the missed dose and take the next scheduled dose at the usual time. Do not take a double dose. However, you should try to avoid repeated forgetfulness of medication intake.

If you interrupt treatment with Insucor

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

You must not stop treatment abruptly. Always consult your doctor before interrupting treatment with Insucor, whether you are taking it for high blood pressure or chronic heart failure.

If it is necessary to interrupt treatment for chronic heart failure, the daily dose should be gradually reduced, halving the dose at weekly intervals. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking nebivolol and talk to your doctor immediately if you have any of the following side effects:

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

Frequent side effects (may affect up to 1 in 10 people):

• Headache.
• Dizziness.
• Fatigue.
• Unusual sensation of itching or tingling.
• Diarrhea.
• Constipation.
• Nausea.
• Feeling of lack of air.
• Swelling of the hands or feet.

Rare side effects (may affect up to 1 in 100 people):

• Slow heart rate or other cardiac abnormalities.
• Low blood pressure.
• Painful walking similar to a cramp.
• Abnormal vision.
• Impotence (difficulty achieving an erection).
• Depressive feelings.
• Digestive difficulties (dyspepsia), gas in the stomach or intestines (indigestion).
• Vomiting.
• Skin eruption, itching.
• Difficulty breathing like asthma, due to a sudden contraction of the muscles surrounding the airways. Feeling of tightness in the chest, difficulty breathing, or respiratory wheezing (bronchospasm).
• Nightmares.

Very rare side effects (may affect up to 1 in 10,000 people):

• Loss of consciousness.
• Worsening of psoriasis (a skin disease characterized by scaly, pink patches).

The following side effects have been reported only in isolated cases during treatment with this medicine:

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

Frequent side effects (may affect more than 1 in 10 people):

• Slow heart rate.
• Dizziness.

Frequent side effects (may affect up to 1 in 10 people):

• Worsening of heart failure.
• Low blood pressure (such as feeling dizzy when standing up quickly).
• Intolerance to this medicine.
• Mild alteration of cardiac conduction that affects heart rate (first-degree atrioventricular block).
• Swelling of the lower extremities (such as swelling of ankles).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Vigilance 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 medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD.

The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.If the medication loses its color or shows any signs of deterioration, ask your pharmacist for advice, who will tell you what to do.

Composition of Insucor

The active ingredient is nebivolol.

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

The other components are:

Lactose monohydrate, cornstarch, sodium croscarmellose, hypromellose, microcrystalline cellulose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the package

Biconvex, non-coated, circular tablets with a white color, with the legend “N” and “L” engraved on opposite sides of a groove on one side, and smooth on the other. The tablets can be divided into equal doses.

Insucor 5 mg tablets are presented in blisters containing 14, 28, 30, 50, 90, 98, 100 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143

56617 Vysoke Myto

Czech Republic

Glenmark Generics (Europe) Ltd.

The Old Sawmill, Hatfield Park

Hatfield, Herts., AL9 5PG

United Kingdom

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

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

GermanyNebivolol Glenmark 5 mg Tabletten

HungaryNebitrix 5 mg

NetherlandsNebivolol Glenmark 5 mg tabletten

SlovakiaNebitrix 5 mg

SpainINSUCOR 5 mg tablets

Last review date of this leaflet: April 2025

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