ISOSORBIDE MONONITRATE NORMON 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Isosorbide Mononitrate Normon 40 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What Isosorbide Mononitrate Normon is and what it is used for
2. What you need to know before taking Isosorbide Mononitrate Normon
3. How to take Isosorbide Mononitrate Normon
4. Possible side effects
5. Storage of Isosorbide Mononitrate Normon
6. Package contents and additional information

1. What Isosorbide Mononitrate Normon is and what it is used for

Isosorbide Mononitrate Normon contains isosorbide mononitrate as the active ingredient, which belongs to a group of medications known as nitrates that have vasodilatory properties on the coronary arteries of the heart (arteries that supply blood to the heart muscle).

This medication is indicated for the treatment and prevention of angina pectoris (chest pain and feeling of oppression in the chest that occurs when the heart does not receive enough blood).

2. What you need to know before taking Isosorbide Mononitrate Normon

Do not take Isosorbide Mononitrate Normon

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6),
• in case of shock (potentially life-threatening effect that occurs when the body does not receive enough blood, which can damage multiple organs), cardiocirculatory collapse (paralysis of blood circulation), very low blood pressure (maximum less than 90 mm Hg) or acute myocardial infarction (heart attack),
• if you have severe anemia, cerebral trauma or cerebral hemorrhage,
• if you are taking any medication that contains a 5-phosphodiesterase inhibitor such as sildenafil (medication used for erectile dysfunction).

Warnings and precautions

• consult your doctor if you have any of the following diseases: hypertrophic cardiomyopathy (heart disease characterized by thickening of the heart walls), constrictive pericarditis (inflammation of the sac that surrounds the heart), cardiac tamponade (compression of the heart due to accumulation of blood or fluid), mitral and/or aortic stenosis of the heart, orthostatic circulatory regulation disorders (feeling of dizziness when standing up) or increased intracranial pressure.
• Isosorbide Mononitrate Normon is not suitable for the treatment of sudden angina pectoris attacks; your doctor has probably prescribed another medication for these cases.

Other medications and Isosorbide Mononitrate Normon

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription.

Due to the possibility of potentiation of the hypotensive effect (decrease in blood pressure), caution should be exercised when administering Isosorbide Mononitrate Normon with antihypertensive medications (medications that reduce high blood pressure, such as calcium antagonists, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptic medications (medications for mental illness) or tricyclic antidepressants (medications for depression).

With alcohol, in addition to hypotension, the decrease in reaction capacity may be accentuated.

Nitrates can give false negatives (results that should be positive but are negative due to error) in cholesterol determination reactions in blood by the Zlatkis-Zak method.

Isosorbide Mononitrate Normon may increase the hypertensive effect of dihydroergotamine (medication used for headache).

The concomitant administration of Isosorbide Mononitrate Normon with 5-phosphodiesterase inhibitors such as sildenafil (medication used for erectile dysfunction) may lead to life-threatening heart complications in sensitive individuals.

Taking Isosorbide Mononitrate Normon with food and beverages

Do not take this medication with alcohol, as it potentiates the vasodilatory effect of isosorbide mononitrate, which may cause a rapid decrease in blood pressure.

The tablets should be taken after meals without chewing and with a large amount of liquid (a glass of water).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Isosorbide Mononitrate Normon should not be taken during pregnancy, unless, in the strict opinion of the doctor, the benefit justifies the potential risks.

Isosorbide Mononitrate Normon should not be used during breastfeeding, as it is unknown whether it passes into breast milk.

Use in children

The use of Isosorbide Mononitrate Normon is not recommended in children because its safety and efficacy have not been established in this population.

Driving and using machines

Do not drive, as Isosorbide Mononitrate Normon may impair your ability to drive safely. This may be accentuated with alcohol consumption, when starting treatment, when starting a new medication, or when changing from one medication to another.

Isosorbide Mononitrate Normon contains lactose

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

Use in athletes

Athletes are informed that this medication contains a component that may result in a positive doping test.

3. How to take Isosorbide Mononitrate Normon

Follow the administration instructions for Isosorbide Mononitrate Normon exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any questions.

The normal dose of Isosorbide Mononitrate Normon is one 40 mg tablet, two to three times a day.

The tablets should be taken after meals without chewing and with a large amount of liquid (a glass of water).

The tablets are scored and can be easily broken into two halves to allow for dose adjustment.

In patients not accustomed to nitrate treatment, and to prevent or minimize possible headache, during the start of treatment, your doctor will recommend starting with a low dose (e.g., half a tablet of Isosorbide Mononitrate Normon 20 mg, twice a day), which will be gradually increased later.

If you think the effect of Isosorbide Mononitrate Normon 40 mg tablets is too strong or too weak, tell your doctor or pharmacist.

During therapy with Isosorbide Mononitrate Normon, tolerance (decrease in effect) may develop. It is recommended to maintain the lowest possible dose and allow the maximum possible time interval between doses to recover sensitivity (first dose in the morning and last dose in the late afternoon).

It is advisable to take this medication while sitting, especially at the beginning of treatment, if you are taking high doses, or if you are over 65 years old.

It is essential to start and stop treatment with Isosorbide Mononitrate Normon gradually and never abruptly. Your doctor will indicate how to gradually increase and decrease the dose.

Your doctor will indicate the duration of your treatment with this medication. Do not stop treatment before, as a sudden increase in blood pressure may occur.

If you take more Isosorbide Mononitrate Normon than you should

If you have taken more Isosorbide Mononitrate Normon than you should, consult your doctor or pharmacist immediately.

The main symptoms in case of overdose are: headache, decrease in blood pressure with dizziness when standing up, tachycardia (increased heart rate) and cyanosis (bluish discoloration of the skin due to insufficient oxygenation of the blood).

It is recommended to keep the patient lying down with their legs elevated to correct the drop in blood pressure.

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

If you forget to take Isosorbide Mononitrate Normon

Do not take a double dose to make up for forgotten doses.

Take the tablet at the time you remember on that day and continue with the usual dose.

4. Possible side effects

Like all medications, Isosorbide Mononitrate Normon can have side effects, although not everyone will experience them.

During the use of Isosorbide Mononitrate Normon, the following side effects have been observed, whose frequency could not be established with precision.

In certain cases, especially with high doses or at the beginning of treatment, orthostatic hypotension (dizziness when standing up) may occur. In particularly sensitive patients, hypotension may lead to syncope (fainting), which could be confused with the symptoms of a heart attack.

Occasionally, especially when used for the first time, gastrointestinal disorders such as nausea and/or vomiting may appear.

In patients with a history of coronary artery disease (narrowing of the arteries that supply blood to the heart), ischemia (temporary or permanent reduction in blood flow) may occur.

In patients with methemoglobin reductase deficiency or abnormal hemoglobin structure, a blood disorder (methemoglobin formation) may occur, resulting in lower oxygen content in the blood, which may cause bluish discoloration of the skin and mucous membranes, headache, fatigue, difficulty breathing, and lack of energy.

Rarely, it may cause skin rashes and/or exfoliative dermatitis (peeling of the skin).

Other side effects are: headache, flushing or feeling of facial heat, dizziness, palpitations, fatigue. Generally, all these effects, including hypotension, disappear with continued treatment or, in any case, with a decrease in dose.

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Isosorbide Mononitrate Normon

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Isosorbide Mononitrate Normon after the expiration date stated on the packaging after "EXP.". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Isosorbide Mononitrate Normon

• The active ingredient of Isosorbide Mononitrate Normon is isosorbide mononitrate.
• The other components are: lactose, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, and colloidal silicon dioxide.

Appearance of the product and package contents

Isosorbide Mononitrate Normon 40 mg tablets are presented in the form of white or slightly creamy, round, biconvex, scored, and serigraphed tablets

Isosorbide Mononitrate Normon 40 mg tablets are presented in packages of 20 and 40 tablets.

Marketing authorization holder and manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

• 28760 Tres Cantos – Madrid

(SPAIN)

Other presentations

Isosorbide Mononitrate Normon 20 mg tablets

This package leaflet was approved in February 2022

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