Insucor 2.5 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Insucor 2.5 mg tablets

nebivolol

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Insucor 2.5 mg tablets are and what they are used for

2. What you need to know before taking Insucor 2.5 mg tablets

3. How to take Insucor 2.5 mg tablets

4. Possible side effects

5. How to store Insucor 2.5 mg tablets

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 (with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's pumping force. It also exerts a vasodilatory effect on blood vessels, which further 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 aged 70 years or older, administered in combination with other medicines.

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 components of this medicine (listed in section 6).
• if you have one or more of the following conditions:
  • low blood pressure
  • severe circulation problems in arms or legs
  • very slow heart rate (less than 60 beats per minute)
  • other serious heart rhythm disorders (e.g. second- or third-degree atrioventricular block, cardiac conduction disorders)
  • heart failure that has recently occurred or worsened, or if you are receiving intravenous treatment to help the heart function following circulatory collapse due to acute heart failure
  • asthma or breathing difficulties (currently or in the past), phaeochromocytoma (a tumor 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

Talk to your doctor or pharmacist before starting to take Insucor.

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

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

If you have severe kidney problems, consult your doctor before taking Insucor for treatment of heart failure.

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

This treatment should not be stopped abruptly unless 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 lack of data on the use of this medicine in these patient groups.

Other medicines and Insucor

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Always inform your doctor if, in addition to Insucor, you are taking any of the following medicines:

• 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 for psychosis (mental illness), e.g. barbiturates (also used to treat epilepsy), phenothiazines (also used for nausea and vomiting), and thioridazine
• Medicines used to treat depression, e.g. amitriptyline, paroxetine, and fluoxetine
• Medicines used for anesthesia during surgery
• Medicines used to treat asthma, nasal congestion, or certain eye disorders such as glaucoma (increased pressure in the eye) or pupil dilation
• 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, like nebivolol, may affect blood pressure and/or heart function.

• Antimalarials (mefloquine)
• Medicines for treating excess stomach acidity or ulcers (antacids): Insucor should be taken with food, and antacids should be taken between meals.

Taking Insucor with food and drink

See section 3.

Pregnancy and breastfeeding

Pregnancy

Insucor should not be used during pregnancy unless clearly necessary.

Breastfeeding

Use during breastfeeding is not recommended.

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 told you that you have an intolerance to certain sugars, please consult them before taking this medicine.

Insucor contains sodium

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

3. How to take Insucor

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (two tablets) per day. 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 with one tablet of 2.5 mg per day.

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

• If you are over 75 years old, you may require closer monitoring by your doctor.

Treatment of chronic heart failure

Your doctor will closely monitor your treatment.

• Your doctor will start treatment with 1.25 mg (half a tablet) per day. This dose may be increased after one to two weeks to 2.5 mg (one 2.5 mg tablet) per day; then to 5 mg (two tablets) per day, and subsequently to 10 mg (four tablets) per day, until the correct dose for you is reached. Your doctor will prescribe the appropriate dose for you at each step, and you must carefully follow your doctor's instructions.

• 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 supervise you closely for two hours.

• Your doctor may reduce the dose if necessary.

• You must not stop taking the medicine abruptly, as this could lead to worsening of heart failure.

• Patients with severe renal problems 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.

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

• Place the tablets on a flat, hard surface (for example, a table or countertop), with the score line facing upwards.
• Break the tablet by pressing with the index fingers of both hands placed along the score line (Diagrams 1 and 2).

Diagram 1 Diagram 2

Diagrams 1 and 2: Easy splitting of Insucor 2.5 mg and Insucor 5 mg tablets into equal doses.

Use in children and adolescents

Do not use in children or adolescents.

If you take more Insucor than you should

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

You may take activated charcoal (available from your pharmacy) while waiting for your doctor to arrive.

If you forget to take Insucor

If you forget to take a dose of Insucor, but remember shortly after the time you should have taken it, take the daily dose as usual. If a long time has passed (several hours), such that you are 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, repeated forgetting of medication intake should be avoided.

If you stop taking Insucor

Always consult 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 abruptly, as this could temporarily worsen your heart failure.

If it becomes necessary to discontinue treatment for chronic heart failure, the daily dose should be gradually reduced, 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 will experience them.

Stop taking nebivolol and speak to your doctor immediately if you experience any of the following adverse effects:

• Generalized allergic reactions with widespread skin rash (hypersensitivity reactions)
• Sudden swelling, especially around the lips, eyelids and/or tongue, possibly accompanied by acute breathing difficulty (angioedema)
• Skin rash characterized by raised, itchy, pink welts, either allergic or non-allergic in origin (urticaria)
• Difficulty breathing resembling asthma, due to sudden contraction of the muscles surrounding the airways. Sensation of tightness in the chest, difficulty breathing, or wheezing (bronchospasm)

When Insucor is used for the treatment of high blood pressure, possible adverse effects include:

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

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

• Slow heartbeat or other heart disturbances
• Low blood pressure
• Pain when walking resembling cramps
• Abnormal vision
• Impotence (difficulty achieving an erection)
• Feelings of depression
• Digestive difficulties (dyspepsia), gas in the stomach or intestines (indigestion)
• Vomiting
• Skin rash, itching
• Difficulty breathing resembling asthma, due to sudden contraction of the muscles surrounding the airways. Sensation of tightness in the chest, difficulty breathing, or wheezing (bronchospasm)
• Nightmares

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

• Fainting
• Worsening of psoriasis (a skin disease characterized by scaly, pink patches)

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

• Generalized allergic reactions with widespread skin rash (hypersensitivity reactions)
• Sudden swelling, especially around the lips, eyelids and/or tongue, possibly accompanied by acute breathing difficulty (angioedema)
• Skin rash characterized by raised, itchy, pink welts, either allergic or non-allergic in origin (urticaria)

In a clinical study for 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 dizziness upon standing quickly)
• Intolerance to this medicine
• Mild disturbance in cardiac conduction affecting heart rhythm (first-degree atrioventricular block)
• Swelling of the lower limbs (e.g., swollen ankles)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://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 EXP.

The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. 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 2.5 mg of nebivolol, equivalent to 2.725 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

White, biconvex, uncoated capsule-shaped tablets, with a score line on one side and smooth on the other.

The tablet can be divided into equal doses.

Insucor tablets are available in blister packs containing 14, 28, 30, 50, 90, 98, and 100 tablets.

Only certain pack sizes may be commercially available.

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 Vysoke Myto
Czech Republic

Glenmark Generics (Europe) Ltd.
The Old Sawmill, Hatfield Park
Hatfield, Herts., AL9 5PG
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 member states under the following names:

Germany: Nebivolol Glenmark 2.5 mg tabletten
Hungary: Nebitrix 2.5 mg
Netherlands: Nebivolol Glenmark 2.5 mg tabletten
Slovakia: Nebitrix 2.5 mg
Spain: INSUCOR 2.5 mg tablets

Date of the most recent review of this leaflet: April 2025

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