Summary of Product Characteristics (SmPC) - Eumon 30XL
1 NAME OF THE MEDICINAL PRODUCT
Eumon 30 XL
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isosorbide-5-mononitrate 30 mg
International non-proprietary name (INN): Isosorbide mononitrate
Isosorbide Mononitrate is also referred to as ISMN
Chemical name:
1,4:3,6 dianhydro-D-glucitol-5-mononitrate
3 PHARMACEUTICAL FORM
Tablets (modified release)
Round, cream-coloured tablets, with“IM30” marked on the one side
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylactic treatment of angina pectoris.
4.2 Posology and method of administration
Adults: One tablet (30 mg) once daily given in the morning. The dose may be increased to two tablets (60 mg), the whole dose to be given together. The tablets should not be chewed or crushed and should be swallowed with half a glass of fluid.
Children: The safety and efficacy of Eumon 30 XL modified release tablets has not been established.
Elderly: No need for routine dosage adjustment in the elderly has been found, but special care may be needed in those with increased susceptibility to hypotension or marked hepatic or renal insufficiency.
4.3 Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Severe cerebrovascular insufficiency. Hypotension.
Sildenafil has been shown to potentiate the hypotensive effects of nitrates and its coadministration with nitrate or nitric oxide donors is therefore contraindicated.
Co-administration with riociguat (see section 4.5).
4.4 Special warnings and precautions for use
Eumon 30 XL modified release tablets are not indicated for relief of acute anginal attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
4.5 Interaction with other medicinal products and other forms of interaction
There is a possibility that Eumon 30 XL modified release tablets may enhance the hypotensive effect of hydralazine.
The hypotensive effects of nitrates are potentiated by concurrent administration of sildenafil.
The use of Isosorbide Mononitrate with riociguat, a stimulator of soluble guanylate cyclase, is contra-indicated (see section 4.3), since concomitant use can cause hypotension.
4.6 Fertility, Pregnancy and lactation
The safety and efficacy of Eumon 30 XL modified release tablets during pregnancy or lactation has not been established.
4.7 Effects on ability to drive and use machines
The patient should be warned not to drive or operate machinery if hypotension or dizziness occurs.
4.8 Undesirable effects
Headache may occur when treatment is initiated, but usually disappears after 1-2 weeks of treatment. Hypotension with symptoms such as dizziness or nausea has occasionally been reported. These symptoms generally disappear during long-term treatment.
4.9 Overdose
Treatment should be symptomatic. The main symptom is likely to be hypotension.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Organic nitrates (including GTN, ISDN and ISMN) are potent relaxers of smooth muscle. They have a powerful effect on vascular smooth muscle with less effect on bronchiolar, gastrointestinal, ureteral and uterine smooth muscle. Low concentrations dilate both arteries and veins.
Venous dilatation pools blood in the periphery leading to a decrease in venous return, central blood volume, and ventricular filling volumes and pressures. Cardiat output may remain unchanged or it may decline as a result of the decrease in venous return. Arterial blood pressure usually declines secondary to a decrease in cardiac output or arteriolar vasodilatation, or both. A modest reflex increase in heart rate results from the decrease in arterial blood pressure. Nitrates can dilate epicardial coronary arteries including atherosclerotic stenoses.
The cellular mechanism of nitrate-induced smooth muscle relaxation has been apparent in recent years. Nitrates enter the smooth muscle cell and are cleaved to inorganic nitrate and eventually to nitric oxide. This cleavage requires the presence of sulphydryl groups, which apparently come from the amino acid cysteine. Nitric oxide undergoes further reduction to nitrosothiol by further interaction with sulphydryl groups. Nitrosothiol activates guanylate cyclase in the vascular smooth muscle cells, thereby generating cyclic guanosine monophosphate (CGMP). It is this latter compound, CGMP, that produces smooth muscle relaxation by accelerating the release of calcium from these cells.
5.2 Pharmacokinetic properties
Absorption
Isosorbide-5-mononitrate is readily absorbed from the gastro-intestinal tract.
Distribution
Following oral administration of conventional tablets, peak plasma levels are reached in about 1 hour. Unlike isosorbide dinitrate, ISMN does not undergo first-pass hepatic metabolism and bioavailability is 100%. ISMN has a volume of distribution of about 40 litres and is not significantly protein bound.
Elimination
ISMN is metabolised to inactive metabolites including isosorbide and isosorbide glucuronide.
The pharmacokinetics are unaffected by the presence of heart failure, renal or hepatic insufficiency. Only 20% of ISMN is excreted unchanged in the urine. An elimination half life of about 4-5 hours has been reported.
5.3 Preclinical safety data
No relevant data are available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Stearic acid, carnauba wax, hypromellose, lactose, magnesium stearate, talc, silica colloidal anhydrous, macrogol 4000, E171 and E172.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
The tablets are packed in blisters which consist of 250 µm PVC with a 25 µm PVdC coating which is sealed to 25 µm thick aluminium foil with 20 µm PVdC sealing lacquer. The tablets are packed in boxes of 28, 30, 56, 60 or 100.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Activase Pharmaceuticals Limited
11 Boumpoulinas
Nicosia
1060
Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 28444/0209
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/03/2005
10 DATE OF REVISION OF THE TEXT
25/06/2026