Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: ROWEX LTD, Newtown, Bantry, Co Cork, Ireland
Hypersensitivity to the active substance, to nitrates or to any of the excipients listed in section 6.1
Patients treated with Isomonit Retard must not be given Phosphodiesterase Type 5 (PDE-5) inhibitors e.g. sildenafil.
Isomonit Retard tablets should not be used in patients with acute myocardial infarction with low filling pressure, marked anaemia, head trauma, cerebral haemorrhage, severe hypotension or hypovolaemia, constrictive cardiomyopathy and pericarditis
Use in patients with severe cerebrovascular insufficiency is contraindicated.
Isomonit contains lactose monohydrate.
Patients with the rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take Isomonit Retard.
Isosorbide mononitrate should be used with caution in patients suffering from hypothyroidism, hypothermia, malnutrition, severe renal or liver disease.
Nitrates may give rise to symptoms of collapse after the first dose in patients with labile circulation. These symptoms can largely be avoided if the treatment is started with a 30mg dose.
In cases of recent myocardial infarction or acute heart failure, isosorbide mononitrate should only be used cautiously under strict medical surveillance and/or hemodynamic monitoring. More severe cases are contraindicated, see section 4.3.
Other special warnings and precautions with Isosorbide mononitrate:
Hypertrophic obstructive cardiomyopathy, severe cerebral sclerosis.
When transferring the patient on long-term therapy to another form of medication, isosorbide mononitrate should be gradually withdrawn and overlapping treatment should be started to avoid the risk of angina pectoris.
The safety and efficacy of Isosorbide mononitrate has not been established in children.
Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil)
Concomitant administration of isosorbide mononitrate and Phosphodiesterase Type 5 Inhibitors can potentiate the vasodilatory effect of isosorbide mononitrate with the potential results of serious side effects such as syncope or myocardial infarction. Therefore, Isomonit Retard and Phosphodiesterase Type 5 Inhibitors (e.g. sildenafil) must not be given concomitantly.
Some of the effects of alcohol and other vasodilators may be potentiated by this agent.
Concurrent intake of other vasodilators, antihypertensives, ACE inhibitors, beta-blockers, calcium antagonists, and diuretics can increase the antihypertensive effect of Isomonit Retard.
Concurrent administration of isosorbide mononitrate with dihydroergotamine may increase the bioavailability of dihydroergotamine. This warrants special attention in patients with coronary artery disease, because dihydroergotamine antagonizes the effect of nitrates and may lead to coronary vasoconstriction.
The possibility that acetylsalicylic acid and NSAIDs might diminish the therapeutic response to isosorbide mononitrate cannot be excluded.
The safety and efficacy of Isomonit Retard during pregnancy or lactation has not been established.
Isomonit Retard tablets should not be used during pregnancy or lactation unless considered essential by the physician.
There is a limited amount of data from the use of isosorbide-5-mononitrate in pregnant patients. Limited animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Isosorbide mononitrate should be given to a pregnant woman only if clearly needed and the benefit outweighs the risk.
It is not known whether isosorbide mononitrate is secreted in human milk. The benefits for the mother must be weighed against the risks for the child.
There is no data available on the effect of isosorbide-5-mononitrate on fertility in humans.
Patients may develop dizziness when first using Isomonit Retard. Patients should be advised to determine how they react to Isomonit Retard before they drive or operate machinery.
Most of the adverse reactions are pharmacodynamically mediated and dose dependent. Headache may occur when treatment is initiated, but usually disappears during continued treatment. Hypotension, with symptoms such as dizziness and nausea with syncope in isolated cases, has occasionally been reported. These symptoms generally disappear during continued treatment.
The following definitions of frequencies are used: Very common (1/10), Common (1/100 to <1/10), Uncommon (1/1,000 to <1/100), Rare (1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).
Common: Hypotension, tachycardia
Common: nausea
Uncommon: vomiting, diarrhoea
Common: headache, dizziness
Rare: fainting
Rare: rash, pruritus
Very rare: myalgia
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; HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
Not applicable.
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