ISOSORBIDE MONONITRATE / CARMIL / MONOMIL Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Monomil 20 mg Tablets. Carmil 20 mg Tablets. Isosorbide Mononitrate 20 mg tablets.
Qualitative and quantitative composition
Isosorbide-5-mononitrate Ph. Eur. 20 mg/tablet.
Pharmaceutical form
Tablets. White to off-white, round flat tablets with I15 embossing on one side.
Therapeutic indications
For the prophylaxis of angina pectoris. As adjunctive therapy in congestive heart failure not responding to cardiac glycosides or diuretics.
Posology and method of 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 ...
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 ...
Special warnings and precautions for use
Isosorbide mononitrate Tablets should be used with caution in patients who have recent history of myocardial infarction, low filling pressures e.g. in acute myocardial infarction, impaired left ventricular ...
Interaction 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. ...
Fertility, pregnancy and lactation
Pregnancy No data have been reported which would indicate the possibility of adverse effects resulting from the use of isosorbide mononitrate in pregnancy. Safety in pregnancy however has not been established, ...
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 ...
Undesirable effects
Undesirable effects frequencies are defined as: very common (≥1/10), common (≥1/100<1/10), uncommon (≥1/1,000<1/100), rare (≥1/10,000<1/1,000), very rare (<10,000), not known (cannot be estimated from ...
Overdose
Symptoms and signs Fall of blood pressure ≤90 mmHg, headache, paleness, weak pulse, light headedness on standing, weakness, dizziness, diarrhoea, hypotension, nausea, vomiting, sweating, tachycardia, vertigo, ...
Pharmacodynamic properties
ATC code: C01DA14 Pharmacotherapeutic group: Vasodilator used in cardiac diseases Isosorbide mononitrate is an organic nitrate, which, in common with other cardioactive nitrates, is a vasodilator. It produces ...
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 ...
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.
List of excipients
Microcrystalline cellulose Ph. Eur. Lactose monohydrate Ph. Eur. Colloidal anhydrous silica Ph. Eur. Maize starch Ph. Eur. Talc Ph. Eur. Magnesium stearate Ph. Eur.
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
Do not store above 25°C.
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 (60s pack). Each strip of blister contains 14 tablets and ...
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
Marketing authorization number(s)
PL 16363/0001
Date of first authorization / renewal of the authorization
21/09/2008
Date of revision of the text
22/03/2019
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