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| effox |
effox 40 Tablet Rest of pamphlet
The active substance is: isosorbide
mononitrate
Each tablet contains:
40 mg isosorbide morionitrate (INN)
The other ingredients are: lactose monohydrate, microcrystalline cellulose, potato starch, talc, colloidal silicon dioxide, aluminium stearate
Therapeutic indications:
• Long-term treatment of coronary artery disease;
• Long-term treatment and prevention of angina pectoris (even after treated myocardial infarction);
• Long-term treatment of chronic heart
failure in combination with cardiac
glycosides, diuretics, ACE-inhibitors
or arterial vasodilators;
• Pulmonary hypertension
Posology and mode of administration:
Unless otherwise described:
Oral use:
• 1 tablet daily or twice daily without chewing and with a sufficient amount of fluid, the second dose should be taken 8 hours after the first dose. There is no evidence to suggest an adjustment of the dosage in elderly patients.
The safety and efficacy of effox has yet to be established in children.
The active substance is: isosorbide
mononitrate
Each tablet contains:
40 mg isosorbide morionitrate (INN)
The other ingredients are: lactose monohydrate, microcrystalline cellulose, potato starch, talc, colloidal silicon dioxide, aluminium stearate
Therapeutic indications:
• Long-term treatment of coronary artery disease;
• Long-term treatment and prevention of angina pectoris (even after treated myocardial infarction);
• Long-term treatment of chronic heart
failure in combination with cardiac
glycosides, diuretics, ACE-inhibitors
or arterial vasodilators;
• Pulmonary hypertension
Posology and mode of administration:
Unless otherwise described:
Oral use:
• 1 tablet daily or twice daily without chewing and with a sufficient amount of fluid, the second dose should be taken 8 hours after the first dose. There is no evidence to suggest an adjustment of the dosage in elderly patients.
The safety and efficacy of effox has yet to be established in children.
To dMde a tablet, place it with partition upward
on hard surface and apply slight thumb pressure.
Contra-indications:
• Hypersensitivity to isosorbide mononitrate, other nitro compounds or other ingredients
• Cardiogenic shock (unless a sufficient end-diastolic pressure is maintained by appropriate measures)
• Acute circulatory failure (shock, collapse)
• Severe hypotension (systolic pressure less than 90 mm Hg)
• During nitrate therapy, phosphodiesterase inhibitors (e.g. sildenafil) must not be used (see section interactions with other medicaments and other forms of interaction).
Special warnings and special precautions for use:
Eftox should be used only with particular caution and under medical supervision in:
• Hypertrophic obstructive cardiomyopathy
• Constrictive pericarditis
• Cardiac tamponade
• Low filling pressures e.g. in acute myocardial infarction, impaired left ventricular function (left ventricular failure)
• Aortic and/or mitral stenosis
• Diseases associated with an increased intracranial pressure
• Orthostatic dysfunction The onset of action of effox is not
Contra-indications:
• Hypersensitivity to isosorbide mononitrate, other nitro compounds or other ingredients
• Cardiogenic shock (unless a sufficient end-diastolic pressure is maintained by appropriate measures)
• Acute circulatory failure (shock, collapse)
• Severe hypotension (systolic pressure less than 90 mm Hg)
• During nitrate therapy, phosphodiesterase inhibitors (e.g. sildenafil) must not be used (see section interactions with other medicaments and other forms of interaction).
Special warnings and special precautions for use:
Eftox should be used only with particular caution and under medical supervision in:
• Hypertrophic obstructive cardiomyopathy
• Constrictive pericarditis
• Cardiac tamponade
• Low filling pressures e.g. in acute myocardial infarction, impaired left ventricular function (left ventricular failure)
• Aortic and/or mitral stenosis
• Diseases associated with an increased intracranial pressure
• Orthostatic dysfunction The onset of action of effox is not
sufficiently rapid to be useful to treat an
acute anginal attack.
The development of tolerance (decrease in efficacy) as well as cross tolerance towards other nitrate-type drugs (decrease in effect in case of a prior therapy with another nitrate drug) has been described. For a decrease in, or loss of. effect to be prevented, continuously high dosages should be avoided.Patients who undergo a maintenance treatment with effox should be informed that they must not use phosphodiesterase inhibitors (e.g. sildenafil)-containing products. Effox therapy should not be interrupted to take phosphodiesterase inhibitors (e.g. sildenafil)-containing products, because the risk of inducing an attack of angina pectoris could increase by doing so (see section interactions with other medicaments and other forms of interaction).
For reasons of particular caution, isosorbide mononitrate should be used only at a physician’s special order during pregnancy and lactation, as there is no sufficient experience with its use in pregnant or nursing women. Animal experiments have not yielded any indication of fetal damage.
Interactions with other medicaments and other forms of interaction:
Concurrent intake of drugs with blood pressure lowering properties, e.g. beta-blockers, calcium channel antagonists,vasodilators etc, and/or
The development of tolerance (decrease in efficacy) as well as cross tolerance towards other nitrate-type drugs (decrease in effect in case of a prior therapy with another nitrate drug) has been described. For a decrease in, or loss of. effect to be prevented, continuously high dosages should be avoided.Patients who undergo a maintenance treatment with effox should be informed that they must not use phosphodiesterase inhibitors (e.g. sildenafil)-containing products. Effox therapy should not be interrupted to take phosphodiesterase inhibitors (e.g. sildenafil)-containing products, because the risk of inducing an attack of angina pectoris could increase by doing so (see section interactions with other medicaments and other forms of interaction).
For reasons of particular caution, isosorbide mononitrate should be used only at a physician’s special order during pregnancy and lactation, as there is no sufficient experience with its use in pregnant or nursing women. Animal experiments have not yielded any indication of fetal damage.
Interactions with other medicaments and other forms of interaction:
Concurrent intake of drugs with blood pressure lowering properties, e.g. beta-blockers, calcium channel antagonists,vasodilators etc, and/or
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