MIRTAZAPINE Orodispersible tablet (2018)
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Περιεχόμενα
Name of the medicinal product
Mirtazapine 15 mg orodispersible tablets.
Qualitative and quantitative composition
Each tablet contains 15 mg of mirtazapine. Excipient(s): 6 mg of Aspartame (E951). For a full list of excipients, see section 6.1.
Pharmaceutical form
Orodispersible tablet. The tablets are white or almost white, 8 mm round, biconvex, uncoated tablets and marked M1.
Therapeutic indications
Treatment of episodes of major depression.
Posology and method of administration
Posology Adults The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment. Treatment with ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of mirtazapine with monoamine oxidase (MAO) inhibitors (see section 4.5).
Special warnings and precautions for use
Paediatric population Mirtazapine should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy. In the opposite way about two weeks ...
Fertility, pregnancy and lactation
Pregnancy Limited data of the use of mirtazapine in pregnant women do not indicate an increased risk for congenital malformations. Studies in animals have not shown any teratogenic effects of clinical ...
Effects on ability to drive and use machines
Mirtazapine has minor or moderate influence on the ability to drive and use machines. Mirtazapine may impair concentration and alertness (particularly in the initial phase of treatment). Patients should ...
Undesirable effects
Depressed patients display a number of symptoms that are associated with the illness itself. It is therefore sometimes difficult to ascertain which symptoms are a result of the illness itself and which ...
Overdose
Present experience concerning overdose with Mirtazapine alone indicates that symptoms are usually mild. Depression of the central nervous system with disorientation and prolonged sedation have been reported, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other Antidepressants ATC code: NO6AX11 Mechanism of action/pharmacodynamic effects Mirtazapine is a centrally active presynaptic α<sub>2</sub>-antagonist, which increases central ...
Pharmacokinetic properties
Absorption After oral administration of Mirtazapine, the active mirtazapine is rapidly and well absorbed (bioavailability ≈50%), reaching peak plasma levels after aproximately 2 hours. Food intake has ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development. ...
List of excipients
Mannitol DC Microcrystalline cellulose Crospovidone Hydroxylpropyl cellulose low substituted Magnesium carbonate heavy Silica colloidal anhydrous Methionine Purified water Magnesium stearate Guar Gum ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C. Blister: Store in the original package in order to protect from light and moisture. Tablet Container: Keep the tablet container tightly closed in order to protect from light and ...
Nature and contents of container
Al/Al Blister, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98 and 100 Tablets. Al/Al Blister with peel off foil, pack sizes: 5, 6, 7, 10, 14, 15, 20, 21, 28, 30, 50, 56, 60, 84, ...
Special precautions for disposal and other handling
No special precautions.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0695
Date of first authorization / renewal of the authorization
Date of first authorisation: 13/07/2011 Date of latest renewal: 23/07/2012
Date of revision of the text
01/11/2018
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