MONOREM Prolonged-release tablet Ref.[27871] Active ingredients: Isosorbide mononitrate

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str, Limassol Industrial Estate, 3056 Limassol, Cyprus

4.1. Therapeutic indications

Prophylactic treatment of angina pectoris.

Monorem R is not indicated for relief of acute angina attacks; in the event of an acute attack, sublingual or buccal glyceryl trinitrate tablets should be used.

4.2. Posology and method of administration

Posology

Adults

Monorem R 60 mg (one tablet) once daily given in the morning. The dose may be increased to 120 mg (two tablets) daily, both to be taken once daily 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 can be titrated to minimise the possibility of headache, by initiating treatment with 30 mg (half a tablet) for the first 2-4 days.

Paediatric population

The safety and efficacy of Monorem R in children has not yet been established.

Older people

No evidence of a need for routine dosage adjustment in older people 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 Monorem R has been used in combination with beta-blockers.

The matrix of the tablet 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.

Method of administration

Monorem R 60 mg prolonged-release tablets (the whole tablets or the divided halves) must not be chewed. They should be swallowed whole with half a glass of water.

4.9. Overdose

Symptoms

Pulsing headache. More serious symptoms are excitation, flushing, cold perspiration, nausea, vomiting, vertigo, syncope, tachycardia and a fall in blood pressure.

Management

Induction of emesis, activated charcoal. In case of pronounced hypotension the patient should first be placed in the supine position with legs raised. If necessary fluids should be administered intravenously.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

Aluminium/PVC blisters. Pack sizes of 30 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.