Coronur Retard 40 mg prolonged-release film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Coronur retard 40 mg prolonged-release coated tablets
Isosorbide mononitrate
Read the entire patient information leaflet carefully before you start taking this medicine.
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In this leaflet:
- What Coronur retard is and what it is used for
- Before taking Coronur retard
- How to take Coronur retard
- Possible side effects
- Storage of Coronur retard
- Further information
1. What Coronur retard is and what it is used for
Coronur retard 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 (the arteries that supply blood to the heart muscle).
This medicine is indicated for the treatment and prevention of angina pectoris (chest pain and sensation of tightness in the chest that occurs when insufficient blood reaches the heart).
2. Before taking Coronur retard
Do not take Coronur retard
- if you are allergic (hypersensitive) to isosorbide mononitrate, isosorbide dinitrate, or any of the other components of Coronur retard,
- in case of shock (a potentially fatal condition occurring when the body does not receive enough blood flow, which may damage multiple organs), cardiocirculatory collapse (cessation of blood circulation), very low blood pressure (systolic below 90 mm Hg), or acute myocardial infarction (heart attack),
- if you have severe anemia, cerebral trauma (brain injury), or cerebral hemorrhage,
- if you are taking any medication containing a 5-phosphodiesterase inhibitor such as sildenafil (a medicine used for erectile dysfunction).
Take special care with Coronur retard
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consult your doctor if you suffer from any of the following conditions: obstructive hypertrophic cardiomyopathy (a heart disease characterized by thickening of the heart walls), constrictive pericarditis (inflammation of the sac surrounding the heart), cardiac tamponade (compression of the heart due to accumulation of blood or fluid), mitral and/or aortic valve stenosis (narrowing of heart valves), orthostatic circulatory regulation disorders (dizziness upon standing), or increased intracranial pressure.
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Coronur retard is not suitable for the treatment of sudden angina attacks; your doctor has likely prescribed another medication for such cases.
Use of other medicines
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Due to the possibility of enhanced hypotensive action (lowering of blood pressure), caution should be exercised when administering Coronur retard together with antihypertensive drugs (medicines that reduce high blood pressure, e.g.: calcium antagonists, beta-blockers, diuretics, angiotensin-converting enzyme inhibitors), vasodilators, neuroleptic drugs (medicines for mental disorders), or tricyclic antidepressants (medicines for depression).
With alcohol, in addition to hypotension, the reduction in reaction capacity may be intensified.
Nitrates may cause false negatives (results that should be positive but incorrectly appear negative) in cholesterol blood tests using the Zlatkis-Zak method.
Coronur retard may increase the hypertensive effect of dihydroergotamine (a medicine used for headache).
Concomitant administration of Coronur retard with 5-phosphodiesterase inhibitors such as sildenafil (a medicine used for erectile dysfunction) may lead to life-threatening cardiac complications in susceptible individuals.
Taking Coronur retard with food and drinks
Do not take this medicine with alcohol, as alcohol enhances 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 sufficient amount of liquid (a glass of water).
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
Coronur retard should not be taken during pregnancy unless, in the strict opinion of the physician, the benefit justifies the possible risks.
Coronur retard should not be used during breastfeeding, as it is unknown whether it passes into breast milk.
Use in children
The use of Coronur retard in children is not recommended, as safety and efficacy have not been established in this population group.
Driving and using machines
Observe your response to the medication, as in some cases your ability to drive or operate machinery may be reduced due to decreased reflexes, especially at the beginning of treatment, when adjusting the dose, or if you consume alcohol simultaneously. Therefore, avoid driving or operating potentially dangerous machinery until you know how you tolerate the medicine.
Important information about some components of Coronur retard
This medicine contains lactose, glucose, and sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.
Athletes are advised that this medicine contains a component that may lead to a positive analytical result in doping control tests.
3. How to take Coronur retard
Follow exactly the administration instructions for Coronur retard tablets provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
The usual dose of Coronur retard is one tablet (40 mg of isosorbide mononitrate) once daily in the morning or at night before going to bed, if your doctor has recommended this due to experiencing episodes during the night.
The tablets should be taken after meals, without chewing, and with a sufficient amount of liquid (a glass of water).
In patients not accustomed to nitrate therapy, and to prevent or minimize possible headaches, your doctor may recommend starting treatment with a low dose (for example, half a tablet of Coronur 20 mg twice daily), which will then be gradually increased.
If you feel that the effect of Coronur retard is too strong or too weak, inform your doctor or pharmacist.
During treatment with Coronur, tolerance (reduced effect) may develop. It is recommended to keep the dose as low as possible and allow the longest possible interval between doses to restore sensitivity (first dose in the morning and last dose in the late afternoon).
It is advisable to take this medicine while sitting down, especially at the beginning of treatment, if you are taking high doses, or if you are over 65 years of age.
It is important that treatment with Coronur retard is started and discontinued gradually, never abruptly. Your doctor will advise you on how to gradually increase and reduce the dose.
Your doctor will determine the duration of your treatment with this medicine. Do not stop treatment prematurely, as this could lead to a sudden increase in blood pressure.
If you take more Coronur retard than you should
If you have taken more Coronur retard than you should, contact your doctor or pharmacist immediately.
The main symptoms of overdose are: headache, decreased blood pressure with dizziness upon standing, tachycardia (increased heart rate), and cyanosis (bluish discoloration of the skin due to inadequate blood oxygenation).
It is recommended to keep the patient lying down with legs elevated to help correct low blood pressure.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the name of the medicine and the amount ingested.
If you forget to take Coronur retard
Do not take a double dose to make up for missed doses.
Take the tablet as soon as you remember on the same day, and then continue with your regular dosing schedule.
4. Possible adverse effects
Like all medicines, Coronur retard may cause adverse effects, although not everyone will experience them.
During the period of use of Coronur retard, the following adverse effects have been observed, although their frequency cannot be accurately determined.
In some cases, especially with high doses or at the beginning of treatment, orthostatic hypotension (dizziness upon standing) may occur. In particularly sensitive patients, hypotension may lead to syncope (fainting), which could be mistaken, due to symptoms, for acute myocardial infarction.
Occasionally, and especially when first used, gastrointestinal disturbances such as nausea and/or vomiting may appear.
In patients with a history of coronary artery disease (narrowing of the arteries supplying the heart), ischemia (temporary or permanent reduction in blood flow) may occur.
In patients with methemoglobin reductase deficiency or abnormal hemoglobin structure, a blood disorder (formation of methemoglobin) may occur, resulting in reduced oxygen content in the blood, potentially causing bluish discoloration of the skin and mucous membranes, headache, fatigue, shortness of breath, and lack of energy.
Rarely, it may cause skin eruptions and/or exfoliative dermatitis (skin peeling).
Other adverse effects include: headache, facial flushing or sensation of warmth, dizziness, palpitations, and fatigue. Generally, all of these effects, including hypotension, disappear with continued treatment or, at the very least, when the dose is reduced.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
5. Storage of Coronur retard
Keep out of the reach and sight of children.
No special storage conditions are required.
Do not use Coronur retard after the expiry date stated on the packaging after "EXP.". The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Additional Information
Composition of Coronur retard
- The active substance in Coronur retard is isosorbide mononitrate.
- The other components are: In the core: anhydrous lactose, wax E, povidone K25, anhydrous colloidal silica, and magnesium stearate. In the coating: sucrose, methacrylic acid copolymer, talc, heavy kaolin, macrogol 35000, titanium dioxide, glucose liquid, wax E, povidone K25.
Appearance of the medicinal product and contents of the pack
Coronur retard is presented as white, round tablets.
Coronur retard is available in packs of 30 tablets.
Other presentations
Coronur 20 mg tablets
Coronur 40 mg tablets
Marketing Authorization Holder and Manufacturer
KERN PHARMA, S.L.
Polígono Ind. Colón II
Venus, 72
08228 Terrassa (Barcelona)
This leaflet has been reviewed
January 2010