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MONOMIL 40 MG TABLETS

Active substance(s): ISOSORBIDE 5-MONONITRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Monomil 40 mg Tablets
Carmil 40 mg Tablets
Isosorbide Mononitrate 40 mg Tablets.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Isosorbide-5-mononitrate Ph. Eur. 40 mg/tablet.

3.

PHARMACEUTICAL FORM
Tablet.
White to off-white, round flat tablets with ‘I16’ embossing on one side.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the prophylaxis of angina pectoris
As adjunctive therapy in congestive heart failure not responding to cardiac
glycosides or diuretics.

4.2.

Posology and method of administration
For oral administration

Adults: One tablet to be taken asymmetrically (to allow a nitrate low period) two or
three times a day. For patients not already receiving prophylactic nitrate therapy it
is recommended that the initial dose of isosorbide mononitrate be 40mg twice a
day. The dosage may be increased to 120mg per day.
The lowest effective dose should be used.

Children: The safety and efficacy of Isosorbide Mononitrate 40mg tablets in
children has not been established.
Elderly: There is no evidence to suggest that an adjustment of the dosage is
necessary.
Treatment with Isosorbide mononitrate tablets, as with any other nitrate, should not
be stopped suddenly. Both the dosage and frequency should be tapered gradually
(see section 4.4)

4.3.

Contraindications

Isosorbide mononitrate tablets should not be used in cases of acute myocardial
infarction with low filling pressures, acute circulatory failure (shock, vascular
collapse), or very low blood pressure, hypertrophic obstructive cardiomyopathy
(HOCM), constrictive pericarditis, cardiac tamponade, low cardiac filling
pressures, aortic/mitral valve stenosis and diseases associated with a raised intracranial pressure e.g. following a head trauma and including cerebral haemorrhage.
This product should not be given to patients with a known sensitivity to isosorbide
mononitrate, the listed ingredients or other nitrates.
Isosorbide mononitrate Tablets should not be used in patients with marked
anaemia, severe hypotension, closed angle glaucoma or hypovolaemia.
Phosphodiesterase type-5 inhibitors (e.g. sildenafil, tadalafil and vardenafil) have
been shown to potentiate the hypotensive effects of nitrates, and their coadministration with nitrates or nitric oxide donors is therefore contraindicated (see
section 4.5)

4.4.

Special warnings and precautions for use

Isosorbide mononitrate Tablets should be used with caution in patients who have
recent history of myocardial infarction, or 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.

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.
Hypotension induced by nitrates may be accompanied by paradoxical bradycardia
and increased angina.
Isosorbide mononitrate Tablets contain lactose and therefore should not be used in
patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption.
In the event of an acute angina attack, a sublingual treatment such as a GTN spray
or tablet should be used instead of Isosorbide mononitrate Tablets.
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 Isosorbide mononitrate, as with any other nitrate, should not be
stopped suddenly. Both the dosage and frequency should be tapered gradually (see
section 4.2)

4.5.

Interactions with other medicinal products and other forms of interaction
Concurrent administration of drugs with blood pressure lowering properties,
e.g. beta-blockers, calcium channel blockers, vasodilators, alprostadil,
aldesleukin, angiotensin II receptor antagonists etc. and/or alcohol may
potentiate the hypotensive effects of Isosorbide mononitrate Tablets. This may
occur with neuroleptics and tricyclic antidepressants.
Any blood pressure lowering effect of Isosorbide mononitrate tablets will be
increased if used together with phosphodiesterase type-5- inhibitors, which are
used for erectile dysfunction (see special warning and contraindications). This
may lead to life threatening cardiovascular complications. Patients who are on
Isosorbide mononitrate therapy therefore must not use phosphodiesterase type5 inhibitors.
Reports suggest that concomitant administration of Isosorbide mononitrate
tablets may increase the blood levels of dihydroergotamine and its
hypertensive effects.

4.6 Fertility, pregnancy and lactation
There is inadequate evidence of safety in human pregnancy and lactation and use
during pregnancy and lactation is not recommended unless considered essential by
the patient’s physician.

4.7.

Effects on ability to drive and use machines

Dizziness, tiredness or blurred vision might occur at the start of the treatment. The
patient should therefore be advised that if affected, they should not drive or operate
machinery. This effect may be increased by alcohol.

4.8

Undesirable effects
A very common (>10% of patients) adverse reaction to Isosorbide mononitrate
Tablets is throbbing 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 in the upright position are commonly observed (i.e. in 1-10%
of patients). These symptoms may be associated with dizziness, drowsiness,
reflex tachycardia and a feeling of weakness.
Infrequently (i.e. in less than 1% patients) nausea, vomiting, flushing and
allergic skin reactions (e. g. rash) may occur sometimes severely. In single
cases exfoliative dermatitis may occur.
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 of heartburn most likely due to a nitrate induced sphincter
relaxation have been reported.
Tachycardia and paroxysmal bradycardia have been reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
products 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 Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.

4.9.

Overdose
Symptoms and signs: Headache, hypotension, nausea, vomiting, sweating,
tachycardia, vertigo, restlessness, warm flushed skin, blurred vision and
syncope. A rise in intracranial pressure with confusion and neurological
deficits can sometimes occur. Methaemoglobinaemia (cyanosis, hypoxaemia,
restlessness, respiratory depression, convulsions, cardiac arrhythmias,
circulatory failure, raised intracranial pressure) occurs rarely.
Management:
Consider oral activated charcoal if ingestion of a potentially toxic amount has
occurred within 1 hour. Observe for at least 12 hours after the overdose.
Monitor blood pressure and pulse. Correct hypotension by raising the foot of
the bed and /or by expanding the intravascular volume. Other measures as
indicated by the patient’s clinical condition. If severe hypotension persists
despite the above measures consider use of inotropes.
If methaemoglobinaemia (symptoms or >30% methaemoglobin), IV
administration of methylene blue 1-2mg/kg body-weight. If therapy fails with
second dose after 1 hour or contraindicated, consider red blood cell
concentrates or exchange transfusion. In case of cerebral convulsions,
diazepam or clonazepam IV, or if therapy fails, phenobarbital, phenytoin or
propofol anaesthesia.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
ATC code: C01D A14 Vasodilatator used in cardiac diseases
Isosorbide mononitrate is an organic nitrate, which, in common with other
cardioactive nitrates, is a vasodilator. It produces decreased left and right
ventricular end-diastolic pressures to a greater extent than the decrease in
systemic arterial pressure, thereby reducing afterload and especially the
preload of the heart.
Isosorbide mononitrate influences the oxygen supply to ischaemic
myocardium by causing the redistribution of blood flow along collateral
channels and from epicardial to endocardial regions by selective dilation of
large epicardial vessels.
It reduces the requirements of the myocardium for oxygen by increasing
venous capacitance, causing a pooling of blood in peripheral veins, thereby
reducing ventricular volume and heart wall distension.

5.2.

Pharmacokinetic Properties

Isosorbide 5—mononitrate is rapidly absorbed and peak plasma levels occur
approx. 1 hour following oral dosing.
Isosorbide-5-mononitrate is completely bioavailable after oral doses and is not
subject to pre-systemic elimination processes.
Isosorbide-5-mononitrate is eliminated from the plasma with a half-life of about
5.1 hours. It is metabolised to Isosrbide-5-mn-2-glucoronide, which has a half-life
of approximately 2.5 hours. As well as being excreted unchanged in the urine.
After multiple oral dosing plasma concentrations are similar to those that can be
predicted from single dose kinetic parameters.

5.3.

Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies
of single and repeated dose toxicity, genotoxicity, oncogenicity and toxicity to
reproduction.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients
Microcrystalline cellulose Ph. Eur., Lactose Monohydrate Ph. Eur., Colloidal
Anhydrous Silica Ph. Eur., Maize starch Ph. Eur., Talc Ph. Eur. and
Magnesium stearate Ph. Eur.

6.2.

Incompatibilities
None known.

6.3.

Shelf Life
3 years.

6.4.

Special Precautions for Storage
Do not store above 25ºC.

6.5.

Nature and Contents of Container
PVC/Aluminium foil blisters on a cardboard carton.
Each sheet of blisters contains 10 tablets and there are six sheets of ten tablets
per carton (60’s pack).
Each strip of blister contains 14 tablets and there are four such strips per carton
(56’s pack).

6.6.

Instructions for Use/Handling
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Milpharm Limited,
Ares,
Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD,
United Kingdom

8.

MARKETING AUTHORISATION NUMBER
PL 16363/0002

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21/09/2008

10

DATE OF REVISION OF THE TEXT
06/03/2015

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