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SPC, UK: SERTRALINE Film coated tablets (2019)

Αναφορές

Βιβλιογραφική αναφορά

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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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