CORONUR 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Coronur 40mg Tablets

Isosorbide Mononitrate

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

1. What is Coronur and what is it used for

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

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

2. What you need to know before you take Coronur

Do not take Coronur

• if you are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate, or any of the other ingredients of this medicine,
• 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 medicine that contains a 5-phosphodiesterase inhibitor such as sildenafil (medicine used for erectile dysfunction).

Warnings and precautions

Talk to your doctor if you have any of the following diseases: hypertrophic obstructive cardiomyopathy (heart disease characterized by thickening of the heart walls), constrictive pericarditis (inflammation of the heart lining), cardiac tamponade (compression of the heart due to blood or fluid accumulation), mitral and/or aortic valve stenosis, orthostatic circulatory regulation disorders (dizziness when standing up), or increased intracranial pressure.

This medicine is not suitable for the treatment of sudden angina attacks; your doctor has probably prescribed another medicine for these cases.

Taking Coronur with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Due to the possibility of potentiation of the hypotensive effect (decrease in blood pressure), caution should be exercised when administering this medicine 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 illness treatment), or tricyclic antidepressants (medicines for depression).

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

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

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

Taking Coronur with food, drinks, and alcohol

Do not take this medicine with alcohol, as it potentiates the vasodilatory effect of isosorbide mononitrate, which may cause a rapid drop 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine should not be taken during pregnancy, unless, in the strict opinion of the doctor, the benefit justifies the potential risks.

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

Children and adolescents

The use of this medicine is not recommended in children, as its safety and efficacy have not been established in this population.

Driving and using machines

Observe your response to the medication, as it may reduce your ability to drive vehicles or operate machines due to decreased reflexes, especially at the start of treatment, when changing the dose, or if you also consume alcohol. Therefore, avoid driving or using potentially hazardous machinery until you verify how you tolerate the medicine.

Coronur contains lactose

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

3. How to take Coronur

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

The recommended dose of isosorbide mononitrate 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 Coronur 20 mg tablet, twice a day), which will be gradually increased later.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

During therapy with this medicine, tolerance (decreased effect) may develop. It is recommended to maintain the dose as low as possible 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 medicine 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 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 medicine. Do not stop treatment before, as it could cause a sudden increase in blood pressure.

If you take more Coronurthan you should

If you have taken more isosorbide mononitrate than you should, consult your doctor or pharmacist immediately.

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

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 medicine and the amount ingested.

If you forget to take Coronur

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 your usual dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the use of isosorbide mononitrate, 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 an acute myocardial infarction.

Occasionally, and 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 the heart), ischemia (transient or permanent reduction of 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 skin and mucous membrane coloration, headache, fatigue, difficulty breathing, and lack of energy.

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

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 dose reduction.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Coronur

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after "EXP.". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and further information

Composition of Coronur

• The active substance of Coronur is isosorbide mononitrate.

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

Appearance of the product and package contents

Coronur is presented in the form of scored, white tablets.

Coronur is presented in packages of 40 tablets.

Other presentations

Coronur 20 mg tablets

Coronur retard 40 mg prolonged-release coated tablets

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet:March 2008

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