MIANSERIN Film-coated tablet (2017)
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Περιεχόμενα
Name of the medicinal product
Mianserin 10 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 10 mg mianserin hydrochloride. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. Round, white film-coated convex tablet marked MI 10 on one side and G on reverse.
Therapeutic indications
Mianserin Tablets are indicated for symptoms of depressive illness.
Posology and method of administration
Posology The daily dose can be taken either in divided doses or as a single dose at night (due to the favourable effect on sleep). It is often advantageous to maintain antidepressant treatment for several ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Mania. Severe liver disease.
Special warnings and precautions for use
Use in children & adolescents under 18 years of age Mianserin should not be used in the treatment of children and adolescents under the age of 18 years. Suicide-related behaviours (suicide attempts and ...
Interaction with other medicinal products and other forms of interaction
Mianserin may potentiate the central nervous depressant action of alcohol, anxiolytics, hypnotics and antipsychotics. Mianserin should not be started within two weeks of cessation of therapy of Mono Amine ...
Pregnancy and lactation
Pregnancy Do not use during pregnancy unless there are compelling reasons. There is no evidence of safety in human pregnancy. Animal studies have not shown hazard. Breastfeeding Mianserin is contraindicated ...
Effects on ability to drive and use machines
The most commonly occurring side effect is drowsiness, particularly during the first few days of treatment. Patients should be warned of the possible hazard in driving or operating machinery. Any drowsiness ...
Undesirable effects
The frequency and severity of depression-related symptoms such as blurred vision, dry mouth and constipation do not usually increase during treatment with mianserin; in fact an actual decrease has been ...
Overdose
Symptoms Symptoms of overdosage may include nausea and vomiting; dry mouth; constricted or dilated pupils; nystagmus; dizziness; ataxia; slow tendon reflexes; drowsiness; convulsions and coma. Cardiovascular ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antidepressants, other antidepressants ATC code: N06AX03 Mianserin is a tetracyclic antidepressant. It does not appear to have significant anti-cholinergic properties, but has ...
Pharmacokinetic properties
Absorption Mianserin is readily absorbed from the gastro-intestinal tract, but its bioavailability is reduced to about 70% by extensive first-pass metabolism in the liver. Distribution Mianserin is widely ...
Preclinical safety data
There are no preclinical safety data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
The tablet contains: Maize starch, pregelatinised Silica, colloidal anhydrous Cellulose, microcrystalline Calcium hydrogen phosphate Magnesium stearate The film coat contains: Talc Titanium dioxide (E171) ...
Incompatibilities
None stated.
Shelf life
Shelf life: 2 years.
Special precautions for storage
Store below 25°C. Protect from light.
Nature and contents of container
Mianserin film-coated tablets are available in polypropylene containers with polyethylene caps (with optional polyethylene ullage filler) and PVC/foil blister packs of 28, 30, 56, 60, 84, 90, 100, 112, ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Generics [UK] Limited, t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL
Marketing authorization number(s)
PL 04569/0170
Date of first authorization / renewal of the authorization
Date of first authorisation: 2 November 1987 Date of last renewal: 13 May 2003
Date of revision of the text
05/2017
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