Leaflet: information for the user

Isosorbide Mononitrate NORMON 20 mg tablets

Read this leaflet carefully before you start taking the medicine, because 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 others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Isosorbide Mononitrate Normon 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. Contents of the pack and additional information

Normon Isosorbide Mononitrate contains isosorbide mononitrate as the active ingredient, which belongs to a group of medicines known as nitrates that have vasodilating properties on the coronary arteries of the heart (arteries that irrigate the heart muscle tissue).

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

Do not take Normon Isosorbide Mononitrate

• 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 (a potentially fatal effect that appears 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),
• if you have severe anemia, head trauma or cerebral hemorrhage,
• if you are taking any medication that contains a 5-phosphodiesterase inhibitor such as sildenafil (a medication used for erectile dysfunction).

Warnings and Precautions

• consult your doctor if you have any of the following diseases: hypertrophic obstructive cardiomyopathy (a heart disease characterized by the thickening of its walls), constrictive pericarditis (inflammation of the heart's covering), cardiac tamponade (compression of the heart by accumulation of blood or fluid), mitral and/or aortic valve stenosis (narrowing) of the heart, orthostatic alterations of circulatory regulation (dizziness when standing) or elevated intracranial pressure.
• Normon Isosorbide Mononitrate is not suitable for the treatment of sudden angina attack, your doctor may have prescribed another medication for those cases.

Other Medications and Normon Isosorbide Mononitrate

Inform 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 in the concomitant administration of Normon Isosorbide Mononitrate with anti-hypertensive medications (medications that reduce elevated blood pressure, for example: calcium antagonists, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptic drugs (medications for mental illness treatment) or tricyclic antidepressants (medications for depression).

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

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

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

The concomitant administration of Normon Isosorbide Mononitrate with 5-phosphodiesterase inhibitors such as sildenafil (a medication used for erectile dysfunction) may lead to complications in the heart that put the patient's life at risk in sensitive individuals.

Taking Normon Isosorbide Mononitrate 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.

Normon Isosorbide Mononitrate should not be taken during pregnancy, unless, at strict medical discretion, the benefit justifies the potential risks.

Normon Isosorbide Mononitrate should not be used during breastfeeding as its passage into breast milk is unknown.

Use in Children

Use of Normon Isosorbide Mononitrate in children is not recommended as its safety and efficacy have not been established in this population.

Driving and Operating Machines

Do not drive as Normon Isosorbide Mononitrate may prevent you from driving safely. This may be accentuated with alcohol consumption, at the start of treatment, at the start of a new medication or when switching from one medication to another.

Normon Isosorbide Mononitrate contains Lactose

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

Use in Athletes

Inform athletes that this medication contains a component that may establish an analytical control result for doping as positive.

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

The normal dose of Normon Isosorbide Mononitrate is one 20 mg tablet taken 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 in half to allow for dose adjustment.

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

In patients not accustomed to treatment with nitrates, and to prevent or minimize possible headaches, your doctor will recommend starting with a low dose (for example, half a 20 mg Normon Isosorbide Mononitrate tablet, taken twice a day), which will be gradually increased afterwards.

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

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

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

It is essential to start and end treatment with Normon Isosorbide Mononitrate gradually and never abruptly. Your doctor will indicate the way to gradually increase and reduce the dose.

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

If you take more Normon Isosorbide Mononitrate than you should

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

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

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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Normon Isosorbide Mononitrate

Do not take a double dose to compensate for the missed doses.

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

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

During the period of use of Isosorbide Mononitrate Normon, the following adverse effects have been observed, whose frequency has not been established with precision.

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

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

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

In patients with metahemoglobinreductase deficiency or abnormal hemoglobin structure, a blood disorder (metahemoglobin formation) may occur, resulting in reduced oxygen content in the blood, which may cause blue discoloration of the skin and mucous membranes, headache, fatigue, respiratory difficulty, and lack of energy.

In rare cases, it may cause skin eruptions and/or exfoliative dermatitis (skin peeling).

Other adverse effects include: headache, facial flushing or warmth, dizziness, palpitations, fatigue. In general, all these effects, including hypotension, disappear when treatment continues or, in any case, when the dose is reduced.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Isosorbide Mononitrate Normon after the expiration date that appears on the packaging after “CAD.” The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at your local SIGRE collection point.Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help maintain the environment.

Composition of Normon Mononitrato de isosorbida

• The active ingredient of Normon Mononitrato de isosorbida is mononitrato de isosorbida.
• The other components are: lactose, microcrystalline cellulose, pregelatinized cornstarch, magnesium stearate, colloidal silicon dioxide.

Appearance of the product and contents of the package

Normon Mononitrato de isosorbida 20 mg tablets are presented in the form of white or slightly cream-colored, flat, round, scored, and printed tablets.

Normon Mononitrato de isosorbida 20 mg tablets are presented in packages of 40 and 80 tablets.

Holder of the marketing authorization and responsible manufacturer

Normon, S.A. Laboratories

Ronda de Valdecarrizo, 6

– 28760 Tres Cantos – Madrid

(SPAIN)

Other presentations

Normon Mononitrato de isosorbida 40 mg tablets

This prospectus was approved in February 2022

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/