Leaflet: information for the user

Isosorbide Mononitrate Normon 40 mg tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 to 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 of the heart, orthostatic alterations of circulatory regulation (dizziness when standing up) or elevated intracranial pressure.
• Normon Isosorbide Mononitrate is not suitable for the treatment of sudden angina attacks, your doctor may have prescribed another medication for these 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, 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 drinks

Do not take this medication with alcohol, as it potentiates the vasodilating 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 possible risks.

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

Use in children

Normon Isosorbide Mononitrate is not recommended for use in children 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, when starting treatment, when starting 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 as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

Tablets are scored and can be easily divided into two halves to allow for dose adjustment.

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 Normon Isosorbide Mononitrate 20 mg tablet, taken twice a day), which will be gradually increased afterwards.

If you estimate that the effect of Normon Isosorbide Mononitrate 40 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 lowest possible dose and allow for 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 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 decrease the dose.

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

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, decrease in blood pressure with a feeling of dizziness when standing 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 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 to protect 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 and colloidal silica.

Appearance of the product and content of the packaging

Normon Mononitrato de isosorbida 40 mg tablets are presented in the form of white or slightly cream-colored, round, biconvex, scored and printed tablets.

Normon Mononitrato de isosorbida 40 mg tablets are presented in packs of 20 and 40 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 20 mg tablets

This leaflet was approved in February 2022

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