Source: Υπουργείο Υγείας (CY) Revision Year: 2019 Publisher: Remedica Ltd, Aharnon Street, Limassol Industrial Estate, 3056 Limassol, Cyprus
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Monorem should not be used in cases of acute myocardial infarction with low filling pressure, acute circulatory failure (shock, vascular collapse), or very low blood pressure (systolic blood pressure below 90 mmHg), hypertrophic obstructive cardiomyopathy (HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling pressures, aortic/mitral valve stenosis and diseases associated with a raised intra-cranial pressure e.g. following a head trauma and including cerebral haemorrhage.
Monorem should not be used in patients with severe anaemia, severe hypotension, closed angle glaucoma or severe hypovolaemia.
Phosphodiesterase type-5-inhibitors (e.g. sildenafil, tadalafil and vardenafil) have been shown to potentiate the hypotensive effects of nitrates and their co-administration with nitrates or nitric oxide donors is therefore contra-indicated (see section 4.4 and 4.5).
During nitrate therapy, the soluble guanylate cyclase stimulator riociguat must not be used (see section 4.5).
This product may give rise to postural hypotension and syncope in some patients. Severe postural hypotension with light-headedness and dizziness is frequently observed after the consumption of alcohol.
Monorem should be used with caution in patients who have a recent history of myocardial infarction low filling pressures e.g. in acute infraction, impaired left ventricular function (left ventricular failure) or orthostatic dysfunction. Reducing systolic blood-pressure below 90 mmHg must be avoided.
It should also be used with caution in patients who are suffering from hypothyroidism, hypothermia, malnutrition and severe liver or renal disease.
Symptoms of circulatory collapse may arise after first dose, particularly in patients with labile circulation.
Hypotension induced by nitrates may be accompanied by paradoxical bradycardia and increased angina.
In the event of an acute angina attack, a sublingual treatment such as a GTN spray or tablet should be used instead of Monorem tablets. The onset of action of Monorem is not sufficiently rapid to be useful to treat an acute angina attack.
If the tablets are not taken as indicated (see section 4.2) tolerance to the medication could develop. The lowest effective dose should be used.
Treatment with Monorem, as with any other nitrate, should not be stopped suddenly. Both the dosage and frequency should be tapered gradually (see section 4.2).
In patients with decreased gastrointestinal transit time, a decrease in release of the active ingredient may occur. Patients who undergo a maintenance treatment with Monorem should be informed that they must not use phosphodiesterase inhibitor-containing products (e.g. sildenafil, tadalafil, vardenafil).
Monorem therapy should not be interrupted to take phosphodiesterase inhibitor-containing products (e.g. sildenafil, tadalafil, vardenafil), because the risk of inducing an attack of angina pectoris could increase by doing so (see section 4.3 and 4.5).
Caution should be exercised in patients with hypoxaemia and ventilation/perfusion imbalance due to lung disease or ischaemic heart failure.
As a potent vasodilator, isosorbide mononitrate could result in increased perfusion of poorly ventilated areas, worsening of the ventilation/perfusion imbalance and a further decrease in arterial partial pressure of oxygen.
During treatment with isosorbide mononitrate, alcohol should be avoided as it may potentiate the hypotensive effect of isosorbide mononitrate (see section 4.5).
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Concurrent adminitration of drugs with blood pressure lowering properties e.g. beta-blockers, calcium channel blockers, vasodilators, alprostadil, aldesleukin, ACE-inhibitors, monoamine oxidase inhibitors, angiotensin II receptor antagonist etc and/or alcohol may potentiate the hypotensive effect of Monorem. This may also occur with neuroleptics and tricyclic antidepressants.
The concurrent intake of ISMN with ACE-inhibitors or arterial vasodilators could be a desirable interaction, unless the antihypertensive effects are excessive in which case consider reducing the dose of one or both drugs.
Any blood pressure lowering effect of Monorem will be increased if used together with phosphodiesterase type-5 inhibitors which are used for erectile dysfunction (see section 4.3 and 4.4). This might lead to life threatening cardiovascular complications. Patients who are on Monorem therapy therefore must not use phosphodiesterase type-5 inhibitors (e.g. sildenafil, tadalafil, vardenafil).
The use of isosorbide mononitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated (see section 4.3) since concomitant use can cause hypotension.
Reports suggest that concomitant administration of isosorbide mononitrate may increase the blood level of dihydroergotamine and its hypertensive effect.
Sapropterine (Tetrahydrobiopterine, BH4) is a cofactor for nitric oxide synthetase. Caution is recommended during concomitant use of sapropterine-containing medicine with all agents that cause vasodilation by affecting nitric oxide (NO) metabolism or action, including classical NO donors (e.g. glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), isosorbide 5-mononitrate (5-ISMN) and others).
Safety in pregnancy has not been established for isosorbide mononitarte. There is data that nitrates are excreted in breast milk and may cause methemoglobinemia in infants.
Therefore, Monorem should only be used in pregnancy and during lactation if, in the opinion of the physician, the possible benefits of treatment outweigh the hazards.
The extent of excretion of isosorbide mononitrate in human breast milk has not been determined. Therefore, caution should be exercised when administered to nursing women.
There is no data on the effect of isosorbide mononitrate on fertility in humans.
Dizziness, tiredness or blurred vision might occur at the start of treatment. If affected, do not drive or operate machinery. This effect may be increased by alcohol.
Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100<1/10), uncommon (≥1/1,000<1/100), rare (≥1/10,000<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
During administration of Monorem the following undesirable effects may be observed:
very common: headache.
common: dizziness (including dizziness postural), somnolence.
common: tachycardia.
uncommon: angina pectoris aggravated.
common: orthostatic hypotension.
uncommon: circulatory collapse (sometimes accompanied by bradyarrhythmia and syncope).
not known: hypotension.
uncommon: nausea, vomiting.
very rare: heartburn.
uncommon: allergic skin reactions (e.g. rash), flushing.
not known: dermatitis exfoliative.
not known: angioedema.
common: asthenia.
Severe hypotensive responses have been reported for organic nitrates and include nausea, vomiting, restlessness, pallor and excessive perspiration.
During treatment with Monorem, 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.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.
Not applicable.
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