Isosorbide mononitrate Normon 20 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Isosorbide mononitrate NORMON 20 mg tablets

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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What is Mononitrato de isosorbida Normon and what is it used for

Mononitrato de isosorbida Normon contains isosorbide mononitrate as the active substance, which belongs to a group of medicines known as nitrates that have vasodilating properties on the coronary arteries of the heart (arteries that supply blood to the heart muscle).

This medicine is indicated for the treatment and prevention of angina pectoris (chest pain and sensation of tightness that occurs when insufficient blood reaches the heart).

2. What you need to know before taking Mononitrato de isosorbida Normon

Do not take Mononitrato de isosorbida Normon

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you have shock (a potentially life-threatening condition occurring when the body does not receive enough blood, which may damage multiple organs), cardiocirculatory collapse (cessation of blood circulation), very low blood pressure (systolic pressure below 90 mm Hg), or acute myocardial infarction (heart attack),
• if you have severe anemia, cerebral trauma (brain injury) or cerebral hemorrhage,
• if you are taking any medicine containing a 5-phosphodiesterase inhibitor such as sildenafil (a medicine used for erectile dysfunction).

Warnings and precautions

• consult your doctor if you have any of the following conditions: obstructive hypertrophic cardiomyopathy (a heart disease characterized by thickening of the heart walls), constrictive pericarditis (inflammation of the sac surrounding the heart), cardiac tamponade (compression of the heart due to accumulation of blood or fluid), mitral and/or aortic valve stenosis (narrowing of heart valves), orthostatic disturbances in circulatory regulation (dizziness upon standing), or increased intracranial pressure.
• Mononitrato de isosorbida Normon is not suitable for the treatment of sudden angina attacks; your doctor has likely prescribed another medicine for such episodes.

Other medicines and Mononitrato de isosorbida Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Due to the potential enhancement of the hypotensive effect (lowering of blood pressure), caution should be exercised when administering Mononitrato de isosorbida Normon concomitantly with antihypertensive medicines (medicines that reduce high blood pressure, e.g.: calcium antagonists, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptic drugs (medicines for mental disorders), or tricyclic antidepressants (medicines for depression).

Alcohol may not only increase hypotension but also further impair reaction capacity.

Nitrates may cause false-negative results (results that should be positive but incorrectly appear negative) in blood cholesterol determination using the Zlatkis-Zak method.

Mononitrato de isosorbida Normon may increase the hypertensive effect of dihydroergotamine (a medicine used for headache).

Concomitant administration of Mononitrato de isosorbida Normon with 5-phosphodiesterase inhibitors such as sildenafil (a medicine used for erectile dysfunction) may lead to life-threatening cardiac complications in sensitive individuals.

Taking Mononitrato de isosorbida Normon with food and drinks

Do not take this medicine with alcohol, as alcohol enhances the vasodilatory effect of isosorbide mononitrate, potentially causing a rapid drop in blood pressure.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Mononitrato de isosorbida Normon should not be taken during pregnancy unless, in the strict judgment of the physician, the benefit justifies the potential risks.

Mononitrato de isosorbida Normon should not be used during breastfeeding, as it is unknown whether it passes into breast milk.

Use in children

The use of Mononitrato de isosorbida Normon is not recommended in children, as safety and efficacy have not been established in this population group.

Driving and use of machines

Do not drive, as Mononitrato de isosorbida Normon may impair your ability to drive safely. This effect may be worsened by alcohol consumption, at the beginning of treatment, when starting a new concomitant medication, or when switching from one medication to another.

Mononitrato de isosorbida Normon contains lactose

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

Use in athletes

Athletes should be informed that this medicine contains a component that may lead to a positive analytical finding in doping control tests.

3. How to take Isosorbide Mononitrate Normon

Follow exactly the instructions for use of Isosorbide Mononitrate Normon as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose of Isosorbide Mononitrate Normon is one 20 mg tablet two to three times daily.

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

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

If the response obtained is not sufficient, the dose may be increased up to 40 mg (two tablets) two or three times daily.

In patients not previously treated with nitrates, and to prevent or minimize possible headache, your doctor will recommend starting with a low dose at the beginning of treatment (for example, half a tablet of Isosorbide Mononitrate Normon 20 mg twice daily), which will then be gradually increased.

If you feel that the effect of Isosorbide Mononitrate Normon 20 mg tablets is too strong or too weak, inform your doctor or pharmacist.

During treatment with Isosorbide Mononitrate Normon, tolerance (reduction in effect) may develop. It is recommended to keep the dose as low as possible and to allow the longest possible interval between doses to restore sensitivity (first dose in the morning and last dose in the late afternoon).

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

It is important that you start and stop treatment with Isosorbide Mononitrate Normon gradually and never abruptly. Your doctor will instruct you on how to gradually increase and reduce the dose.

Your doctor will tell you how long your treatment with this medicine should last. Do not stop treatment prematurely, as this could lead to a sudden increase in blood pressure.

If you take more Isosorbide Mononitrate Normon than you should

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

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.

Take the tablet as soon as you remember on that day, and then continue with your usual dosing schedule.

4. Possible adverse effects

Like all medicines, isosorbide mononitrate Normon may have adverse effects, although not everyone experiences them.

The following adverse effects have been observed during the period of use of isosorbide mononitrate Normon, although their frequency cannot be accurately determined.

In certain cases, especially with high doses or at the beginning of treatment, orthostatic hypotension (dizziness upon standing) may occur. In particularly sensitive patients, hypotension may lead to syncope (fainting), which could be mistaken, due to symptoms, for acute myocardial infarction.

Occasionally, and especially when first used, gastrointestinal disturbances such as nausea and/or vomiting may occur.

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

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

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

Other adverse effects include: headache, facial flushing or sensation of warmth, dizziness, palpitations, and fatigue. Generally, all these effects, including hypotension, disappear with continued treatment or, at least, when the dose is reduced.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Isosorbide Mononitrate Normon

Keep out of the sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your usual pharmacy. Ask your pharmacist how to properly discard medicines and packaging you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Mononitrato de isosorbida Normon

• The active substance of Mononitrato de isosorbida Normon is isosorbide mononitrate.
• The other components are: lactose, microcrystalline cellulose, pregelatinized corn starch, magnesium stearate, colloidal silicon dioxide.

Appearance of the product and contents of the container

Mononitrato de isosorbida Normon 20 mg tablets are presented as white or slightly cream-colored, flat, round, scored tablets with printed markings.

Mononitrato de isosorbida Normon 20 mg tablets are available in packs of 40 and 80 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

• 28760 Tres Cantos – Madrid

(SPAIN)

Other presentations

Mononitrato de isosorbida Normon 40 mg tablets

This Patient Information Leaflet was approved in February 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/