Insucor 10 mg tablets

Package leaflet: Information for the user

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

Leaflet contents:

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

1. What INSUCOR is and what it is used for

INSUCOR contains nebivolol, a cardiovascular medicine belonging to the group of selective beta-blocking agents (i.e., with selective action on the cardiovascular system). It prevents elevated heart rate and controls the force of cardiac contraction. It also exerts a vasodilating effect on blood vessels, which helps lower blood pressure.

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

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

2. What you need to know before taking INSUCOR

Do not take INSUCOR

• if you are allergic to nebivolol or to any of the other ingredients of this medicine (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 serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders)
  • heart failure that has just occurred or has recently worsened, or you are receiving treatment for circulatory shock due to acute heart failure via intravenous infusion to help your heart function
  • asthma or wheezing (now or in the past), untreated pheochromocytoma, a tumour located in the upper part of the kidneys (in the adrenal glands)
  • impaired liver function
  • a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis

Warnings and precautions

Talk to your doctor or pharmacist before you start taking INSUCOR.

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

• abnormally slow heart rate
• a type of chest pain caused by spontaneous cardiac spasm, known as Prinzmetal's angina
• untreated chronic heart failure
• first-degree heart block (a type of mild cardiac conduction disorder affecting heart rhythm)
• poor circulation in arms or legs, such as, for example, Raynaud's disease or syndrome, or pain when walking similar to cramps
• prolonged respiratory problems
• diabetes: this medicine has no effect on blood sugar, but it may mask the warning signs of low blood sugar (e.g. palpitations, rapid heartbeat) and could increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulfonylureas (for example, glipizide, gliclazide, glibenclamide, glimepiride, tolbutamide or gliquidone)
• overactivity of the thyroid gland, as this medicine may mask the signs of abnormally fast heartbeat caused by this condition
• allergies, as this medicine may intensify your reaction to pollen or other substances to which you may be allergic
• if you have or have previously had psoriasis (a skin disease – scaly, red patches)
• if you are due to undergo surgery, inform your doctor that you are taking INSUCOR before any procedure

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

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

This treatment should not be stopped suddenly unless your doctor advises you to do so (see section 3).

Children and adolescents

INSUCOR is not recommended 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 inform your doctor if you are taking or receiving any of the following medicines in addition to INSUCOR:

• Medicines to control blood pressure or used to treat heart conditions (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 treatments used in the management of psychosis (a mental illness), e.g. barbiturates (also used for epilepsy), phenothiazines (also used for nausea and vomiting) and thioridazine
• Medicines used to treat depression, e.g. amitriptyline, paroxetine, fluoxetine
• Medicines used for anaesthesia during surgery
• 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 (a muscle relaxant); amifostine (a protective agent used during cancer treatment)
• Medicines for diabetes, such as insulin or oral antidiabetics

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

• Medicines used to treat excessive stomach acidity or ulcers (antacids): you should take this medicine with food or take the antacid between meals. Antimalarials (mefloquine)

Taking INSUCOR with food and drink

See section 3.

Pregnancy and breastfeeding

Pregnancy

INSUCOR should not be taken during pregnancy unless clearly necessary.

Breastfeeding

Use during breastfeeding is not recommended.

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

Driving and using machines

This medicine may cause dizziness or fatigue. If this occurs, do not drive or operate machinery.

INSUCOR contains lactose

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

INSUCOR contains sodium

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

3. How to take INSUCOR

Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.

INSUCOR may be taken before, during, or after meals. Alternatively, you may take this medicine independently of meals. It is best to take this medicine with water.

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (half a 10 mg tablet, one 5 mg tablet, or two 2.5 mg tablets) once daily*. It is preferable to take the dose at the same time each day.
• In elderly patients and/or those with renal impairment, treatment should be initiated at 2.5 mg (half a 5 mg tablet or one 2.5 mg tablet) once daily*.

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

• The therapeutic effect on blood pressure becomes evident after 1–2 weeks of treatment. Occasionally, the optimal effect may only be achieved after 4 weeks.

Treatment of chronic heart failure

• Your treatment must be initiated and closely monitored by your doctor. Your doctor will start treatment with 1.25 mg daily. For this dose, a different tablet strength (2.5 mg) is required. Your doctor may increase your dose to 2.5 mg (half a tablet) daily, then to 5 mg (one tablet) daily, and subsequently to 10 mg (two tablets) daily, until the appropriate dose for you is reached. Your doctor will prescribe the correct dose for you at each stage, and you must strictly follow their instructions.
  • The maximum recommended dose is 10 mg.
  • When starting treatment and each time the dose is increased, close supervision by an experienced physician for two hours is required.
  • Your doctor may reduce the dose if necessary.
  • You must not stop taking the medicine abruptly, as this could worsen your heart failure.
  • Patients with severe renal impairment must not take this medicine.
  • Take your medicine once daily, 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 condition.

Use in children and adolescents

Do not use in children and adolescents.

If you take more INSUCOR than you should

If you accidentally take an overdose of this medicine, tell your doctor or pharmacist immediately. The most frequently reported symptoms and signs of overdose include very slow heart rate (bradycardia), low blood pressure with possible fainting (hypotension), difficulty breathing such as in asthma (bronchospasm), and acute heart failure.

You may take activated charcoal (available from the pharmacy) while waiting for medical help.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take INSUCOR

If you forget to take a dose of INSUCOR but remember shortly afterwards, take your daily dose as usual. If several hours have passed and it is nearly time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose. However, repeated missed doses should be avoided.

If you stop taking INSUCOR

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

You must not stop treatment with INSUCOR abruptly, as this may temporarily worsen your heart failure.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

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

• Headache
• Dizziness
• Fatigue
• Unusual sensation of itching or tingling
• Diarrhea
• Constipation
• Nausea
• Shortness of breath
• Swelling of the hands or feet

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

• Systemic allergic reaction with generalized rash (hypersensitivity reactions)

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

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

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

• Fainting
• Worsening of psoriasis (a skin disease – scaly, reddish patches)

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

• systemic allergic reactions with generalized skin rash (hypersensitivity reactions)
• rapid onset of swelling, especially around the lips, eyes or tongue, with sudden difficulty in breathing (angioedema)
• skin rash characterized by raised, itchy, pink wheals, either due to allergy or non-allergic causes (urticaria)

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

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

• Slow heart rate
• Dizziness

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

• Worsening of heart failure
• Low blood pressure (such as faintness upon standing up quickly)
• Inability to tolerate this medicine
• A mild type of cardiac conduction disorder affecting heart rhythm (first-degree atrioventricular block)
• Swelling of the lower limbs (such as swollen ankles)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of INSUCOR

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

Do not use this medicine after the expiry date stated on the carton and blister after CAD and EXP, respectively. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

If the medicine loses its colour or shows any signs of deterioration, consult 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 components are:

Monohydrate lactose, corn starch, sodium croscarmellose, hypromellose, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.

Appearance of the product and contents of the pack

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

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

Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in 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 has been approved in: September March 2025.

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