TRIMIPRAMINE Film-coated tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Trimipramine 10mg Tablets.
Qualitative and quantitative composition
Each tablet contains 14mg of trimipramine maleate equivalent to 10mg of trimipramine. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White to pale yellow, circular, biconvex, film coated tablet, embossed TM above 10 on one side. The scoreline is only to facilitate breaking for ease of swallowing and not to divide ...
Therapeutic indications
Trimipramine has a potent antidepressant action similar to that of other tricyclic antidepressants. It also possesses pronounced sedative action. It is, therefore, indicated in the treatment of depressive ...
Posology and method of administration
Adults For depression 50-75 mg/day initially increasing to 150-300 mg/day in divided doses or one dose at night. The maintenance dose is 75-150 mg/day. Elderly 10-25 mg three times a day initially. The ...
Contraindications
Recent myocardial infarction Any degree of heart block or other cardiac arrhythmias Mania. Severe liver disease During breast feeding Hypersensitivity to trimipramine maleate or to any of the excipients ...
Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant ...
Interaction with other medicinal products and other forms of interaction
Trimipramine should not be given concurrently with, or within 2 weeks of cessation of, therapy with monoamine oxidase inhibitors. Trimipramine may decrease the antihypertensive effect of guanethidine, ...
Pregnancy and lactation
Do not use in pregnancy especially during the first and last trimesters unless there are compelling reasons. There is no evidence from animal work that it is free from hazard. Trimipramine is contraindicated ...
Effects on ability to drive and use machines
Trimipramine may initially impair alertness. Patients should be warned of the possible hazard when driving or operating machinery.
Undesirable effects
Cases of suicidal ideation and suicidal behaviours have been reported during trimipramine therapy or early after treatment discontinuation (see section 4.4). Cardiac arrhythmias and severe hypotension ...
Overdose
Acute overdosage may be accompanied by hypotensive collapse, convulsions, coma, QT interval prolongation, torsades de pointes. Overdose may result in a fatal outcome. Provided coma is not present, gastric ...
Pharmacodynamic properties
Pharmacotherapeutic Group: Psychoanaleptics; Non-selective monoamine reuptake inhibitors ATC Code: N06AA06 Trimiparamine is a tricyclic antidepressant. It has marked sedative properties.
Pharmacokinetic properties
Trimipramine undergoes high first-pass hepatic clearance, with a mean value for bioavailability of about 41% after oral administration. The absolute volume of distribution is 31 litres/kg and total metabolic ...
Preclinical safety data
No additional pre-clinical data of relevance to the prescriber.
List of excipients
Tablet Core: Calcium hydrogen phosphate Starch potato Magnesium stearate Talc Tablet Coat (Opadry OY-L-28900): Lactose monohydrate Hypromellose Titanium dioxide Macrogol 4000
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Keep the blister in the outer carton in order to protect from light.
Nature and contents of container
HDPE bottles or Securitainers of 50 tablets and cartons containing PVDC/coated UPVC/aluminium foil blister packs of 56, 84 or 28 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
Marketing authorization number(s)
PL 17780/0636
Date of first authorization / renewal of the authorization
Date of first authorisation: 6 April 1973 Date of latest renewal: 3 May 2002
Date of revision of the text
09/07/2020
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