Package Insert: Information for the User

INSUCOR 10 mg Tablets

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 for you only, 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, pharmacist, or nurse even if they are not listed in this package insert. See section 4.

INSUCOR contains nebivolol, a cardiovascular drug that belongs to the group of selective beta-blockers (i.e., with selective action on the cardiovascular system). It prevents high heart rate, controls the intensity of cardiac pumping. It also exerts a dilatory action on blood vessels, which contributes to lowering blood pressure.

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

INSUCORis also used to treat mild to moderate chronic heart failure in patients aged 70 years or older, in combination with other therapies.

Do not takeINSUCOR

• if you are allergic to nebivolol or any of the other ingredients of this medication (listed in section 6).

• if you have one or more of the following conditions:

- low blood pressure

- severe circulation problems in the arms or legs.

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

- certain severe heart rhythm disorders (e.g. 2nd and 3rd degree atrioventricular block, cardiac conduction disorders).

- heart failure that has recently occurred or has recently worsened, or is receiving treatment for acute heart failure by intravenous infusion to help your heart function.

- asthma or wheezing (now or in the past), phaeochromocytoma without treatment, a tumor located in the upper part of the kidneys (in the adrenal glands).

- liver dysfunction.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take INSUCOR.

Inform your doctor if you suffer or present any of the following conditions:

• abnormally slow heart rate.

• a type of chest pain caused by a spontaneous heart muscle cramp, called Prinzmetal's angina.

• untreated chronic heart failure.

• 1st degree heart block (a mild cardiac conduction disorder that affects heart rate).

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

• prolonged respiratory problems.

• diabetes: this medication has no effect on blood sugar levels, but may mask the 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, glimepiride, glipizide, glibenclamide, or tolbutamide).

• hyperthyroidism, as this medication may mask the signs of an abnormally fast heart rate caused by this disorder.

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

• if you have or have had psoriasis (a skin disease - pink scaly patches).

• if you are to undergo an intervention, inform your doctor that you are taking INSUCOR before undergoing any intervention.

If you have a severe kidney problem do not take INSUCOR for heart failure and consult your doctor.

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

This treatment should not be stopped abruptly unless recommended by your doctor (see section 3).

Children and adolescents

INSUCOR is not recommended for use in children and adolescents due to a lack of data on the use of this medication.

Other medications and INSUCOR

Inform your doctor or pharmacist if you are using, have used recently or may use any other medication, even those acquired without a prescription. Inform your doctor if you are using or receiving any of the following medications, in addition to INSUCOR:

• 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 (a mental disorder) e.g. barbiturates (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.
• Medications used to treat depression e.g. amitriptyline, paroxetine, fluoxetine.
• Medications used for anesthesia during surgery.
• Medications used to treat asthma, nasal congestion or certain eye disorders such as glaucoma (elevated eye pressure) or dilation (enlargement) of the pupil.
• Baclofen (an antispasmodic); amifostine (a protector used during cancer treatment).
• Medications for diabetes, such as insulin or oral antidiabetic medications.

All these medications, as well as nebivolol, may affect blood pressure and/or heart function.

• Medications used to treat excessive stomach acid or ulcers (antacids), take this medication with a meal or take the antacid between meals. Antimalarials (mefloquine)

INSUCOR with food and drinks

See section 3.

Pregnancy and breastfeeding

Pregnancy

INSUCOR should not be taken during pregnancy unless clearly necessary.

Breastfeeding

INSUCOR is not recommended during breastfeeding

If you are pregnant or breastfeeding, believe 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 not drive or operate machinery.

INSUCOR contains lactose

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

INSUCOR contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

INSUCORcan be taken before, during or after meals. Alternatively, you can take this medication regardless of meals. It is best to take this medication with water.

Treatment of high blood pressure (hypertension)

*Also available in the market are INSUCOR 2.5 mg and 5 mg tablets.

• The therapeutic effect on blood pressure becomes apparent after 1-2 weeks of treatment. Occasionally, the optimal effect is achieved only after 4 weeks.

Treatment of chronic heart failure

Your treatment should be initiated and closely monitored by your doctor. Your doctor will start treatment with 1.25 mg per day. For this dose, a presentation of these tablets containing a different amount of active ingredient (2.5 mg) is required. Your doctor may increase the dose to 2.5 mg (half a tablet) per day; then to 5 mg (one tablet) per day and, subsequently, to 10 mg (two tablets) per day until the correct dose for you is reached. Your doctor will prescribe the correct dose for you at each time and you should follow their instructions exactly.

Use in children and adolescents

Do not use in children and adolescents.

If you take more INSUCORthan you should

If you accidentally take an overdose of this medication, tell your doctor or pharmacistimmediately. 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 the pharmacy), while waiting for the doctor to arrive.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take INSUCOR

If you forgot to take a dose of INSUCOR but remember shortly after when you should have taken it, take the daily dose as usual. If a lot of time has passed (several hours), so that you are 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, it should be avoided to repeatedly forget to take the medication.

If you interrupt the treatment withINSUCOR

You should always talk to your doctor before interrupting treatment with INSUCOR, whether it is for high blood pressure or chronic heart failure.

You should not interrupt treatment with INSUCORabruptly as this may temporarily worsen your heart failure.

If it is necessary to interrupt treatment with INSUCORfor 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, this medicine may cause side effects, although not everyone will experience them.

When INSUCORis used to treat 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.
• Sensation of lack of air.
• Swelling of the hands or feet.

The following side effects have been reported only in isolated cases during treatment with nebivolol (contact your doctor immediately)

• Generalized skin eruption (hypersensitivity reactions)

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

• Slow heart rate or other heart problems.
• Low blood pressure.
• Cramping pain in the legs when walking.
• Visual anomalies.
• Impotence (difficulty achieving an erection).
• Feeling of depression.
• Digestive difficulties (dyspepsia), gas in the stomach or intestines (indigestion).
• Vomiting.
• Skin eruption, itching.
• Difficulty breathing like asthma, due to sudden muscle cramps around the breathing passages. Chest tightness, difficulty breathing or 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 – scaly pink patches).

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

In a clinical study onchronic 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 (like fainting when standing up quickly).
• Inability to tolerate this medicine.
• A mild type of cardiac conduction disorder that affects heart rate (first-degree atrioventricular block).
• Swelling of the lower extremities (such as swollen ankles).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://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 and EXP, respectively. 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 the 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 the 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 10 mg of nebivolol, equivalent to 10.9 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, bearing the legend “G” and “N” engraved on opposite sides of a groove on one side, and smooth on the other. The tablet can be divided into two equal halves.

INSUCOR tablets are presented in blisters containing 14, 28, 30, 50, and 100 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Responsible manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova 143,

56617 Vysoké Mýto

Czech Republic

Glenmark Pharmaceuticals Europe Ltd

Building 2 Croxley Green Business Park

Hertfordshire WD 18 8YA

United Kingdom

Tillomed Laboratories Limited

3 Howard Road Eaton Socon

St. Neots Cambridgeshire PE19 8ET

United Kingdom

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta

28045 Madrid

Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Ireland Nebivolol 10 mg Tablets

Spain INSUCOR 10 mg tablets

This leaflet was approved in: SeptemberMarch 2025.

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