INSUCOR 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

INSUCOR 10 mg Tablets

nebivolol

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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is INSUCOR and what is it used for

INSUCOR contains nebivolol, a cardiovascular medicine that belongs to the group of selective beta-blockers (i.e., with selective action on the cardiovascular system). It prevents increased heart rate, controls the intensity of heart pumping. It also has a vasodilating effect, which helps to lower blood pressure.

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

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

2. What you need to know before you take INSUCOR

Do not takeINSUCOR

• if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in section 6).
• if you have one or more of the following disorders:
  • low blood pressure
  • severe circulation problems in your arms or legs.
  • very slow heart rate (less than 60 beats per minute)
  • certain serious heart rhythm problems (e.g. second and third degree atrioventricular block, cardiac conduction disorders).
  • heart failure that has recently occurred or has recently worsened, or you are receiving treatment for shock due to acute heart failure by intravenous drip to help your heart work.
  • asthma or wheezing (now or in the past), untreated pheochromocytoma, a tumor located in the upper part of the kidneys (in the adrenal glands).
  • liver function disorder.
  • a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to take INSUCOR.

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

• abnormally slow heart rate.
• a type of chest pain caused by a heart cramp that occurs spontaneously, called Prinzmetal's angina.
• untreated chronic heart failure.
• first-degree heart block (a type of mild cardiac conduction disorder that affects the heart rate).
• poor circulation in arms or legs, such as Raynaud's disease or syndrome, or walking pain similar to cramps.
• prolonged respiratory problems.
• diabetes: this medicine does not affect blood sugar, but it can 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 antidiabetic medications called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• hyperactivity of the thyroid gland, as this medicine can mask the signs of an abnormally fast heart rate caused by this disorder.
• allergy, this medicine can increase your reaction to pollen or other substances you may be allergic to.
• if you have or have had psoriasis (a skin disease - pink scaly patches) in the past.
• if you are going to undergo surgery, inform your doctor that you are taking INSUCOR before undergoing any surgery.

If you have severe kidney problems, do not take INSUCOR for heart failure and ask your doctor for advice.

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 your doctor recommends it (see section 3).

Children and adolescents

INSUCOR is notrecommended for use in children and adolescents due to lack of data on the use of this medicine.

Other medicines and INSUCOR

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. Always tell your doctor if you are using or receiving any of the following medicines, in addition to INSUCOR:

• Medicines to control blood pressure or medicines used to treat heart diseases (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 illness) e.g. barbiturics (also used for epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.
• Medicines used to treat depression e.g. amitriptyline, paroxetine, fluoxetine.
• Medicines used for anesthesia during an operation.
• Medicines used to treat asthma, nasal congestion or certain eye disorders such as glaucoma (high pressure in the eye) or dilation (enlargement) of the pupil.
• Baclofen (an antispastic medicine); amifostine (a protector used during cancer treatment).
• Medicines for diabetes, such as insulin or oral antidiabetics.

All these medicines, as well as nebivolol, can affect blood pressure and/or heart function.

• Medicines used to treat excessive stomach acid or ulcers (antacids), you should take this medicine during a meal or take the antacid between meals. Antimalarials (mefloquine)

TakingINSUCORwith food and drinks

See section 3.

Pregnancy and breastfeeding

Pregnancy

INSUCOR should not be taken during pregnancy unless clearly necessary.

Breastfeeding

It is not recommended for use during breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Driving and using machines

This medicine may cause dizziness or fatigue. If this happens, do not drive or use machines.

INSUCOR contains lactose

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

INSUCOR contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

3. How to take INSUCOR

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

INSUCOR can be taken before, during or after a meal. Alternatively, you can take this medicine regardless of meals. It is best to take this medicine with water.

Treatment of high blood pressure (hypertension)

• The normal dose is 5 mg (half of a 10 mg tablet, one 5 mg tablet or two 2.5 mg tablets) per day*. It is preferable to take the dose always at the same time of day.
• In elderly patients and/or with renal impairment, it is recommended to start treatment with 2.5 mg (half of a 5 mg tablet or one 2.5 mg tablet) per day*.

*INSUCOR 2.5 mg and 5 mg tablets are also available on the market.

• 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 must be started 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 medicine is needed (2.5 mg). 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 moment and you must follow their instructions exactly.
  • The maximum recommended dose is 10 mg.
  • When starting treatment and each time the dose is increased, it will be necessary for an experienced doctor to closely monitor you for two hours.
  • Your doctor may decrease the dose if necessary.
  • You should not stop taking the medicine abruptly, as this could lead to a temporary worsening of heart failure.
  • Patients with severe kidney problems should not take this medicine.
  • Take your medicine once a day, preferably at the same time each day.
  • Your doctor may decide that it is necessary to combine these tablets with other medicines to treat your disease.

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 medicine, tell your doctor or pharmacist immediately. The symptoms and signs most frequently reported in cases of overdose are related to 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 Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take INSUCOR

If you forget to take a dose of INSUCOR but remember soon after when you should have taken it, take the daily dose as usual. If a lot of time has passed (several hours), so that it is close to 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 repeatedly forgetting to take the medication.

If you stop takingINSUCOR

You should always talk to your doctor before stopping treatment with INSUCOR, whether you are taking it for high blood pressure or chronic heart failure.

You should not stop treatment with INSUCOR abruptly, as this can cause your heart failure to worsen temporarily.

If it is necessary to stop treatment with INSUCOR for heart failure, the daily dose should be gradually reduced, reducing the dose by half at weekly intervals. If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When INSUCOR is 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 tingling or pricking.
• Diarrhea.
• Constipation.
• Nausea.
• Shortness of breath.
• Swelling of hands or feet.

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

• Whole-body allergic reaction, with generalized rash (hypersensitivity reactions)

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

• Slow heart rate or other heart problems.
• Low blood pressure.
• Pain similar to cramps in the legs when walking.
• Vision disturbances.
• Impotence (difficulty achieving an erection).
• Feeling of depression.
• Digestive difficulties (dyspepsia), stomach or intestinal gas (indigestion).
• Vomiting.
• Skin rash, itching.
• Difficulty breathing like in asthma, due to sudden cramps in the muscles around the airways. Feeling of tightness in the chest, difficulty breathing or wheezing (bronchospasm).
• Nightmares.

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

• Fainting.
• Worsening of psoriasis (a skin disease - pink scaly patches).

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

• whole-body allergic reactions, with generalized skin rash (hypersensitivity reactions)
• sudden onset of swelling, especially around the lips, eyes or tongue with sudden difficulty breathing (angioedema).
• skin rash characterized by pink, raised, itchy patches, of allergic or non-allergic origin (urticaria)

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

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

• Slow heart rate.
• Dizziness.

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

• Worsening of heart failure.
• Low blood pressure (such as fainting when standing up quickly).
• Inability to tolerate this medicine.
• A type of mild cardiac conduction disorder that affects the heart rate (first-degree atrioventricular block).
• Swelling of the lower limbs (such as swollen ankles).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Information System: http://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing INSUCOR

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

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

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

If the medicine loses its color or shows any signs of deterioration, ask your pharmacist for advice on what to do.

6. Contents of the pack and other information

Composition of INSUCOR

The active substance is nebivolol.

Each tablet contains 10 mg of nebivolol, equivalent to 10.9 mg of nebivolol hydrochloride.

The other ingredients are:

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

Appearance of the product and pack contents

Biconvex, uncoated, circular, white tablets with the inscription “G” and “N” engraved on either side of a score line on one side, and smooth on the other. The tablet can be divided into two equal halves.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

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

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Glenmark 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.

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//