Coronur 20 mg comprimidos

Label: Information for the User

Coronur 20mg tablets

Isosorbide Mononitrate

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to 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 you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

CORONUR contains isosorbide mononitrate as the active ingredient, which belongs to a group of medications known as nitrates that have vasodilating properties on the coronary arteries of the heart.

This medication is indicated for the treatment and prevention of angina pectoris.

Do not take Coronur

• if you are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate, or any other component of this medication,
• in case of shock (potentially fatal condition 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, head trauma, or cerebral hemorrhage,
• if you are taking any medication that contains a 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 obstructive cardiomyopathy (heart disease characterized by the thickening of its walls), constrictive pericarditis (inflammation of the heart's covering), cardiac tamponade (compression of the heart by accumulated 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.

This medication is not suitable for the treatment of sudden angina attacks, your doctor may have prescribed another medication for those cases.

Coronur with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication.

Due to the possibility of potentiation of the hypotensive effect (decrease in blood pressure), caution will be exercised in the concomitant administration of this medication with antihypertensive 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).

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

This medication may increase the hypertensive effect of dihydroergotamine (medication used for headache).

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

Coronur with food, drinks, and alcohol

Do not take this medication with alcohol, as it potentiates the vasodilating effect of isosorbide mononitrate, potentially causing a rapid decrease in blood pressure. With alcohol, in addition to hypotension, the decrease in reaction capacity may be accentuated.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be taken during pregnancy, unless, at strict medical discretion, the benefit justifies the potential risks.

This medication should not be used during breastfeeding as it is unknown whether it passes into breast milk.

Children and adolescents

This medication is not recommended for use in children because its safety and efficacy have not been established in this population.

Driving and operating machinery

Observe your response to the medication because in some cases you may see a reduction in your ability to drive vehicles or use machinery due to a decrease in your reflexes, especially at the beginning of treatment, when changing the dose, or if you consume alcohol at the same time. Therefore, avoid driving or using potentially hazardous machinery until you check how you tolerate the medication.

Coronur contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of isosorbide mononitrate is one 20 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.

If the response obtained is not sufficient, the dose may be increased up 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 Coronur 20 mg tablet, taken twice a day), which will be gradually increased afterwards.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

During therapy with this medication, 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 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 Coronur than you should

If you have taken more 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 Coronur

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, this medication may produce adverse effects, although not all people will experience them.

During the period of use of isosorbide mononitrate, 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, orthostatic hypotension (dizziness when standing up) may occur. In particularly sensitive patients, hypotension may lead to syncope (fainting), which could be confused with acute myocardial infarction 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 a deficiency of methemoglobin reductase or abnormal hemoglobin structure, a blood disorder (methemoglobin 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.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication 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.Deposit empty packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of unused packaging and medications.By doing so, you will help protect the environment.

Composition of Coronur

• The active principle of Coronur is isosorbide mononitrate.

• The other components are: anhydrous lactose, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

Coronuris presented in the form ofscored, white tablets.

Coronuris presented in packaging of 40 and 80 tablets.

Other presentations

Coronur 40 mg tablets

Coronur retard 40 mg prolonged-release coated tablets

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Date of the last review of this leaflet: March 2008.

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