PATIENT INFORMATION LEAFLET

Coronur retard 40 mg prolonged-release coated tablets

Isosorbide mononitrate

In this leaflet:

1. What Coronur retard is and what it is used for
2. Before taking Coronur retard
3. How to take Coronur retard
4. Possible side effects
5. Storage of Coronur retard
6. Further information

Coronur retard 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 (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 Coronur retard

• if you are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate, or any other component of Coronur retard,
• in case of shock (a potentially fatal condition that occurs when the body does not receive enough blood, which can damage multiple organs), cardiac-circulatory collapse (paralysis of blood circulation), very low blood pressure (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 (a medication used for erectile dysfunction).

Be especially careful with Coronur retard

• consult your doctor if you have any of the following conditions: 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 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.
• Coronur retard is not suitable for the treatment of sudden angina attacks, your doctor may have prescribed another medication for these cases.

Use of other medications

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 potential potentiation of hypotensive action, caution should be exercised in the concomitant administration of Coronur retard with antihypertensive medications (medications that reduce elevated blood pressure, e.g., calcium channel blockers, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptic medications (medications for mental illness) 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 incorrectly negative) in blood cholesterol determination reactions by the Zlatkis-Zak method.

Coronur retard may increase the hypertensive effect of dihydroergotamine (a medication used for headaches).

The concomitant administration of Coronur retard with 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 Coronur retard with food and beverages

Do not take this medication with alcohol, as it potentiates 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 large amount of liquid (a glass of water).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Coronur retard should not be taken during pregnancy, unless, at strict medical discretion, the benefits outweigh the potential risks.

Coronur retard should not be used during breastfeeding as its passage into breast milk is unknown.

Use in children

The use of Coronur retard in children is not recommended 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, your ability to drive vehicles or operate machinery may be reduced due to decreased reflexes, especially at the beginning of treatment, when changing the dose, or if you consume alcohol at the same time. Therefore, avoid driving or operating potentially hazardous machinery until you check how you tolerate the medication.

Important information about some components of Coronur retard

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

It is reported to athletes that this medication contains a component that may establish an analytical result of doping control as positive.

Follow exactly the administration instructions for Coronur retard tablets as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose of Coronur retard is one tablet (40 mg of isosorbide mononitrate), once a day in the morning or at night before going to bed if your doctor has recommended this because you experience crises at night.

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

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

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

During therapy with Coronur, tolerance (decrease in effect) may develop. It is recommended to maintain the dose as low as possible and allow a 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 you are taking high doses or if you are over 65 years old.

It is essential to start and end treatment with Coronur retard 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 suspend treatment beforehand, as a sudden increase in blood pressure may occur.

If you take more Coronur retard than you should

If you have taken more Coronur retard 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 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 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Coronur retard

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, Coronur retard may produce adverse effects, although not all people may experience them.

During the period of use of Coronur retard, 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 sensation of heat, dizziness, palpitations, fatigue. In general, all these effects, including hypotension, disappear when continuing treatment or, in any case, when reducing the dose.

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 reach and sight of children.

No special storage conditions are required.

Do not use Coronur retard 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. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help to protect the environment.

Composition of Coronur retard

• The active principle of Coronur retard is isosorbide mononitrate.
• The other components are: In the core: anhydrous lactose, E wax, povidone K25, anhydrous colloidal silica, and magnesium stearate. In the coating: sucrose, methacrylic acid copolymer, talc, heavy kaolin, macrogol 35000, titanium dioxide, glucose liquid, E wax, and povidone K25.

Appearance of the product and contents of the package

Coronur retard is presented in the form of round and white tablets.

Coronur retard is presented in packages of 30 tablets.

Other presentations

Coronur 20 mg tablets

Coronur 40 mg tablets

Holder of the marketing authorization and responsible manufacturer

KERN PHARMA, S.L.

Colón II Industrial Estate

Venus, 72

08228 Terrassa (Barcelona)

This leaflet has been reviewed

January 2010