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EUMON 25XL

Active substance(s): ISOSORBIDE 5-MONONITRATE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Eumon 25 XL

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Isosorbide-5-mononitrate 25 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)

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Prophylactic treatment of angina pectoris.

4.2

Posology and method of administration
Adults: One tablet (25 mg) once daily given in the morning. The dose may be
increased to two tablets (50 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 25 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
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.

4.4

Special warnings and precautions for use
Eumon 25 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 25 XL modified release tablets may enhance the
hypotensive effect of hydralazine.
The hypotensive effects of nitrates are potentiated by concurrent administration of
sildenafil.

4.6

Pregnancy and lactation
The safety and efficacy of Eumon 25 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 round, creamcoloured tablets, with the marking “IM25” on one side of the tablet.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St. Neots
Cambs. PE19 8ET

8

MARKETING AUTHORISATION NUMBER(S)
PL 11311/0453

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
23/03/2005

10

DATE OF REVISION OF THE TEXT
13/08/2008

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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