effox _

effox

effox
The active substance is: isosorbide 
mononitrate 
Each tablet contains: 
40 mg isosorbide mononitrate (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 pectons (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 isosorbi mononitrate, other nitro compounds or other ingredients 
• Cardiogenic shock (unless a sufficient end-diastolic pressure is maintained by approprtate measures) 
• Acute circulatory failure (shock, collapse) 
• Severe hypotension (systolic pressure less than 90 mm Hg) 
• During nitrate therapy, phosphodiesterase inhibitors (e.g. sildenaf ii) must not be used (see section interactions with other medicaments and other forms of interaction). 
Special warnings and special precautions for use: 
Effox 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 phosphodiesteraae inhibitors (e.g. sildenafll)-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

alcohol may potentiate the hypotensive effect of effox. This might also occur with neuroleptics and tricydic antidepressants. A blood pressure loweflng effect of effox will be increased, if used together with phosphodiesterase inhibitors (e.g. sildenafil) which is used for erectile dysfunction (see special warnings and contra-indications). This might lead to life-threatening cardiovascular Complications. Patients who are on effox therapy therefore must not use phosphodiesterase inhibitors (e.g. sildonafil) 
Reports suggest, that, when administered concomitantly, effox may increase the blood level of dihydroergotamine and its hypertensive effect. 
Effox may affect the patient’s reactivity to an extent that her/his ability to drive or to operate machines is impaired. 
This effect is increased in combination with alcohol. 
Undesirable effects: 
A very common (>10% of patients) adverse reaction to effox is headache. The incidence of headache diminishes gradually with time and continued use. 
At the start of therapy or when the dosage is increased, hypotension and/or light-headedness on standing are observed commonly (i.e. in 1- 10% of patients). These symptoms may be associated with dizziness, drowsiness, reflex tachycardia, and a feeling of weakness.

Uncommonly (i.e. in less than 1% of patients), nausea, vomiting, flush and allergic skin reaction (e.g. rash), which may be sometimes severe may uncommonly occur. In single cases exfoliative dermatitis may occur. Very rare Stevens JohnsonSyndrom may occur. Angioedema is observed in very rare cases. Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration. Uncommonly collapse may occur (sometimes accompanied by bradyarrhythmia and syncope).Uncommonly severe hypotension may lead to enhanced angina symptoms. 
A few reports on heartburn most likely due to a nitrate-induced sphincter relaxation have been recorded. 
During the treatment with effox, a temporary hypoxemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease this may lead to a myocardial hypoxia. 
Medicine should be kept out of the reach of children 
Room temperature not to exceed 3d’C 
Package size and presentation: 
Boxes of 20 tablets

MIP.JAPHARFA Under Ucence Of SCHWARZ 
PHARMA

M.INAPHARN