SEROXAT Film-coated tablet / Oral suspension (2019)
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Περιεχόμενα
Name of the medicinal product
Seroxat 10 mg film-coated tablets. Seroxat 20 mg film-coated tablets. Seroxat 30 mg film-coated tablets. Seroxat 20 mg/10 ml oral suspension.
Qualitative and quantitative composition
Each film-coated tablet contains 10 mg/20 mg/30 mg paroxetine (as paroxetine hydrochloride hemihydrate). Each 10 ml of oral suspension contains 20 mg paroxetine (as paroxetine hydrochloride hemihydrate). ...
Pharmaceutical form
Film-coated tablet. Oral suspension. 10 mg tablet: White to pinkish-white, film-coated, oval tablets, debossed FC1 and break bar on one side and debossed GS and break bar on the other side. The 10 mg tablet ...
Therapeutic indications
Treatment of: Major Depressive Episode Obsessive Compulsive Disorder Panic Disorder with and without agoraphobia Social Anxiety Disorders/Social phobia Generalised Anxiety Disorder Post-Traumatic Stress ...
Posology and method of administration
Posology Major depressive episode The recommended dose is 20 mg daily. In general, improvement in patients starts after one week but may only become evident from the second week of therapy. As with all ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs). In exceptional circumstances, ...
Special warnings and precautions for use
Treatment with paroxetine should be initiated cautiously two weeks after terminating treatment with an irreversible MAOI or 24 hours after terminating treatment with a reversible MAO inhibitor. Dosage ...
Interaction with other medicinal products and other forms of interaction
Serotonergic drugs As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome: see Section 4.4 Special warnings and precautions ...
Fertility, pregnancy and lactation
Pregnancy Some epidemiological studies suggest an increased risk of congenital malformations, particularly cardiovascular (e.g. ventricular and atrial septum defects), associated with the use of paroxetine ...
Effects on ability to drive and use machines
Clinical experience has shown that therapy with paroxetine is not associated with impairment of cognitive or psychomotor function. However, as with all psychoactive drugs, patients should be cautioned ...
Undesirable effects
Some of the adverse drug reactions listed below may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy. Adverse drug reactions are listed below ...
Overdose
Symptoms and Signs A wide margin of safety is evident from available overdose information on paroxetine. Experience of paroxetine in overdose has indicated that, in addition to those symptoms mentioned ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antidepressants – selective serotonin reuptake inhibitors ATC code: N06AB05 Mechanism of Action Paroxetine is a potent and selective inhibitor of 5-hydroxytryptamine (5-HT, serotonin) ...
Pharmacokinetic properties
Absorption Paroxetine is well absorbed after oral dosing and undergoes first-pass metabolism. Due to first-pass metabolism, the amount of paroxetine available to the systemic circulation is less than that ...
Preclinical safety data
Toxicology studies have been conducted in rhesus monkeys and albino rats; in both, the metabolic pathway is similar to that described for humans. As expected with lipophilic amines, including tricyclic ...
List of excipients
10 mg tablet Tablet core: Dibasic calcium phosphate dihydrate (E341) Sodium starch glycolate (Type A) Magnesium stearate (E470b) Tablet coating: Hypromellose (E464) Macrogol 400 Polysorbate 80 (E433) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life 10/20/30 mg tablet: 3 years. Oral suspension: 2 years (1 month after opening).
Special precautions for storage
10/20/30 mg tablet: Do not store above 30°C. Store in the original package in order to protect from light. Oral suspension: Do not store above 25°C.
Nature and contents of container
10 mg tablet: Child-resistant blister packs comprising opaque polyvinyl chloride (PVC) backed with aluminium foil laminated with paper. Pack sizes: 14 and 28 tablets. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
SmithKline Beecham Limited, Great West Road, Brentford, Middlesex TW8 9GS. trading as: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex UB11 1BT
Marketing authorization number(s)
Seroxat Tablets 10 mg: 10592/0218 Seroxat Tablets 20 mg: 10592/0001 Seroxat Tablets 30 mg: 10592/0002 Seroxat Oral suspension: 10592/0092
Date of first authorization / renewal of the authorization
Seroxat Tablets 10 mg: Date of first authorisation: 29/07/2005 Date of latest renewal: 27/09/2010 Seroxat Tablets 20 mg and 30 mg: Date of first authorisation: 11/12/1990 Date of latest renewal: 27/09/2010 ...
Date of revision of the text
13 February 2019
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