SERTRALINE Film coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Sertraline 100mg Film coated Tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 100mg sertraline (as sertraline hydrochloride). For a full list of excipients, see section 6.1.
Pharmaceutical form
Film coated Tablet. White coloured, biconvex, capsule shaped, film coated tablets debossed with IJ on one side and plain on other side.
Therapeutic indications
Sertraline is indicated for the treatment of: Major depressive episodes. Prevention of recurrence of major depressive episodes. Panic disorder, with or without agoraphobia. Obsessive compulsive disorder ...
Posology and method of administration
Posology Initial treatment Depression and OCD Sertraline treatment should be started at a dose of 50 mg/day. Panic Disorder, PTSD, and Social Anxiety Disorder Therapy should be initiated at 25 mg/day. ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Concomitant treatment with irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated due to the risk ...
Special warnings and precautions for use
Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) The development of potentially life-threatening syndromes like serotonin syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) has been reported ...
Interaction with other medicinal products and other forms of interaction
Contraindicated Monoamine Oxidase Inhibitors Irreversible MAOIs (e.g. selegiline): Sertraline must not be used in combination with irreversible MAOIs such as selegiline. Sertraline must not be initiated ...
Fertility, pregnancy and lactation
Pregnancy There are no well controlled studies in pregnant women. However, a substantial amount of data did not reveal evidence of induction of congenital malformations by sertraline. Animal studies showed ...
Effects on ability to drive and use machines
Clinical pharmacology studies have shown that sertraline has no effect on psychomotor performance. However, as psychotropic drugs may impair the mental or physical abilities required for the performance ...
Undesirable effects
Nausea is the most common undesirable effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) in men occurred in 14% for sertraline vs 0% in placebo. These undesirable ...
Overdose
Toxicity Sertraline has a margin of safety dependent on patient population and/or concomitant medication. Deaths have been reported involving overdoses of sertraline, alone or in combination with other ...
Pharmacodynamic properties
Pharmacotherapeutic Group: Antidepressants, Selective serotonin reuptake inhibitors (SSRI) ATC code: N06AB06 Mechanism of action Sertraline is a potent and specific inhibitor of neuronal serotonin (5 HT) ...
Pharmacokinetic properties
Absorption Sertraline exhibits dose proportional pharmacokinetics in the range of 50 to 200 mg. In man, following an oral once-daily dosage of 50 to 200 mg for 14 days, peak plasma concentrations of sertraline ...
Preclinical safety data
Preclinical data does not indicate any special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenesis. Reproduction toxicity studies ...
List of excipients
Core tablets: Calcium hydrogen phosphate dihydrate Cellulose microcrystalline HydroxypropylcelluloseSodium starch glycolate (Type A) Magnesium stearate Film coating: Opadry White OY-S-7355 containing: ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Store in the original package. This medicinal product does not require any special storage conditions.
Nature and contents of container
White opaque PVC – Aluminium blister or white opaque PVdC – PVC Aluminium blisters. Packs of 10, 14, 28, 30, 42, 50, 56, 84, 100 film-coated tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused product or waste material should be disposed off in accordance with local requirements.
Marketing authorization holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0068
Date of first authorization / renewal of the authorization
28/07/2008
Date of revision of the text
04/02/2019
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