Insucor 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Insucor 5 mg tablets EFG

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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects 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 (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 vasodilating 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. Before taking/using 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 support heart function following circulatory collapse due to acute heart failure
  • asthma or difficulty breathing (currently or in the past), phaeochromocytoma (a tumour 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

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

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

• abnormally slow heartbeat
• 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 breathing 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 hypoglycaemia when used with certain types of antidiabetic medicines called sulphonylureas (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 characterised by scaly pink patches
• if you are due to undergo surgery, always inform your anaesthetist 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 start of treatment for chronic heart failure, you must 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 its use in this patient group.

Other medicines and Insucor

Inform 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 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 to treat 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, fluoxetine

• Medicines used for anaesthesia 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 antidiabetic agents

All these medicines, like nebivolol, may affect blood pressure and/or heart function.

• Antimalarials (mefloquine)
• Medicines used to treat 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 breast-feeding

Pregnancy

Insucor should not be administered during pregnancy unless clearly necessary.

Breast-feeding

Its use during breast-feeding is not recommended.

If you are pregnant or breast-feeding, 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/her before taking this medicine.

Insucor contains sodium

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

3. How to take Insucor

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

Treatment of high blood pressure (hypertension)

• The usual dose is 5 mg (one tablet) 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 a dose of 2.5 mg (half a 5 mg tablet) once daily.
• The therapeutic effect on blood pressure is achieved after 1 to 2 weeks of treatment. Occasionally, the optimal effect may only be achieved after 4 weeks.
• If you are over 75 years of age, 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 a dose of 1.25 mg daily. For this dose, a different tablet strength (2.5 mg) is required. Your doctor may increase the 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 reaching the correct dose for you. Your doctor will prescribe the appropriate dose 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, close supervision by an experienced physician for two hours is required.

• Your doctor may reduce the dose if necessary.

• You must not stop taking this medicine abruptly, as this could lead to worsening of 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 it is necessary to combine these tablets with other medicines to treat your condition.

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

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

If you take more Insucor than you should

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

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

If you forget to take Insucor

If you forget to take a dose of Insucor but remember shortly afterwards, take the dose as usual. However, if a long time has passed (several hours), such that it is close to the time of 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 doses 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.

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

If it becomes necessary to discontinue treatment for chronic 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.

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 as in 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, 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

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 as in 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 (for example, 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 via the Spanish Pharmacovigilance System for Human Medicines: 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. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

If the medicine loses its colour or shows any signs of deterioration, consult your pharmacist, who will advise you on what to do.

6. Contents of the pack and other information

Composition of Insucor

The active substance is nebivolol.

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

The other components are:

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

Appearance of the product and contents of the pack

White, biconvex, uncoated, circular tablets, with the letters “N” and “L” engraved on either side of a central groove on one side, and smooth on the other.

The tablet can be divided into equal doses.

Insucor 5 mg tablets are available in blister packs containing 14, 28, 30, 50, 90, 98, or 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 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 5 mg Tabletten
Hungary Nebitrix 5 mg
Netherlands Nebivolol Glenmark 5 mg tabletten
Slovakia Nebitrix 5 mg
Spain INSUCOR 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//