Source: Health Products Regulatory Authority (IE) Revision Year: 2016 Publisher: ROWEX LTD, Newtown, Bantry, Co Cork, Ireland
Prophylactic management of angina pectoris. Isomonit Retard is not indicated in the management of acute attacks of angina pectoris.
Oral.
Isomonit Retard once daily, to be taken in the morning. The dose may be increased to 120mg daily, the whole dose to be given together in the morning. This will produce effective nitrate blood levels during the day with low blood levels at night to prevent the development of tolerance.
The dose may be titrated to minimise the possibility of headache, by initiating treatment with a 30mg dose, for the first two to four days.
Whole Isomonit Retard, or if needed, the divided halves, must not be chewed or crushed. They should be swallowed together with half a glass of water.
Note that Isomonit Retard is not indicated for the relief of acute attacks, in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.
Children: The safety and efficacy of Isomonit Retard tablets in children has not been established.
Elderly: No evidence of a 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.
An additional anti-anginal effect has been achieved when Isomonit Retard has been used in combination with betablockers.
The matrix of the tablets is insoluble but disintegrates when the active substance is released. Occasionally, the matrix may pass through the gastrointestinal tract without disintegrating and may be visible in the stool but this does not indicate that the drug has a reduced effect.
Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.
Excessive dosage of all nitrates may, on rare occasions, provoke methemoglobinemia
Overdosage should be treated symptomatically.
Induction of emesis, activated charcoal. In case of pronounced hypotension, the patients should first be placed in the supine position with legs raised. If necessary intravenous fluids should be administered.
4 years.
Do not store above 25°C.
PVC/Aluminium blister packs.
Pack size: 30 tablets.
No special requirements.
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