Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms3
Succinct Safety Information3
Important Information for Seroxat®
Contraindications: Known hypersensitivity to paroxetine, Combination use with monoamine oxidase (MAO) inhibitors (including linezolid, methylene blue) or within two weeks of terminating treatment with MAO inhibitors, thioridazine & pimozide. Seroxat is not indicated for the patients below the age of 18 years. Young adults, especially those with MDD, may be at increased risk for suicidal behaviour during treatment with paroxetine. Development of a potentially life-threatening serotonin syndrome/Neuroleptic malignant syndrome like reactions have been reported when paroxetine is administered with other serotoninergic drugs like other SSRIs or SNRIs, anti-migraine drugs like triptans, drugs which impair metabolism of serotonin (including MAOIs) or with antipsychotics or other dopamine antagonists. Abrupt discontinuation of paroxetine should be avoided. Some studies have shown that the efficacy of tamoxifen, as measured by the risk of breast cancer relapse/mortality, may be reduced when co-prescribed with paroxetine as a result of paroxetine’s irreversible inhibition of CYP2D6. Drugs metabolized by CYP2D6 should be administered with caution in patients. Pregnancy – Epidemiological studies have shown that infants exposed to paroxetine in first trimester of pregnancy have an increased risk of cardiovascular malformations. Pregnancy category D. Paroxetine is secreted in human milk Caution should be exercised during pregnancy and lactation. For additional information please refer to your local label.
SEROXAT ABRIDGED PRESCRIBING INFORMATIONPlease refer to full Summary of Product Characteristics (SPC) before prescribing.
TRADE NAME: SEROXAT. ACTIVE INGREDIENT: Paroxetine. PHARMACEUTICAL FORM: Film-coated tablets, 20 mg. THERAPEUTIC INDICATIONS: Major Depressive Episode, Obsessive Compulsive Disorder, Panic Disorder with and without agoraphobia, Social Anxiety Disorders/Social phobia, Generalised Anxiety Disorder, Post-traumatic Stress Disorder. POSOLOGY AND METHOD OF ADMINISTRATION: Administer once daily in the morning with food. Refer to full SPC for dosing information for specific conditions. Withdrawal symptoms seen on discontinuation of Paroxetine: abrupt discontinuation should be avoided. Elderly: maximum dose should not exceed 40 mg daily. Children and adolescents: Should not be used. Renal/hepatic impairment: Dose should be restricted to lower end of dosage range. CONTRAINDICATIONS: Hypersensitivity. Should not be used in combination with MAOIs, thioridazine or pimozide. PRECAUTIONS FOR USE: Treatment to be initiated 2 weeks after terminating treatment with an irreversible MAOI or 24 hours with a reversible MAOI. Do not use in children and adolescents under the age of 18 years. Suicidal thoughts or clinical worsening: an improvement may not occur in the first few weeks of treatment. Akathisia. Serotonin syndrome/neuroleptic malignant syndrome may develop rarely: discontinue if such events occur. History of mania, renal and hepatic impairment, diabetes and in epilepsy, narrow angle glaucoma or history of glaucoma, patients with cardiac conditions or at risk of hyponatraemia, concomitant use with oral anticoagulants or drugs that increase risk of bleeding, history of bleeding disorders. Paroxetine may lead to reduced concentrations of endoxifen, one of the most important active metabolites of tamoxifen: concomitant use should be avoided. Withdrawal symptoms may occur on discontinuation of Paroxetine treatment. DRUG INTERACTIONS: Caution for use in combination with serotonergic drugs like St John’s Wort, L-tryptophan, tramadol, linezolid, methylthioninium chloride, triptans, SSRIs, pethidine and lithium. Concomitant use with MAOI’s is contraindicated. Caution with pimozide, anticonvulsants and with drugs metabolised by CYP 2D6. Reduced efficacy of tamoxifen. Caution in patients at an increased risk of bleeding and in patients on oral anticoagulants, NSAIDs, acetylsalicylic acid and antiplatelet agents. Adjust Seroxat dosage if necessary when given with drug metabolising enzyme inducers or with fosamprenavir/ritonavir. Concomitant use of alcohol is not advised. PREGNANCY AND LACTATION:Fertility: SSRIs may affect sperm quality but this is reversible following discontinuation of treatment. Pregnancy: Use in pregnancy only when strictly indicated (see full SPC for more detail). Lactation: Use during lactation can be considered. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Patients should be cautioned about their ability to drive a car and operate machinery. UNDESIRABLE EFFECTS:Very Common (≥ 1/10): Nausea, Sexual dysfunction; Common (≥ 1/100, <1/10): Increases in cholesterol levels, decreased appetite, somnolence, insomnia, agitation, abnormal dreams (including nightmares), dizziness, tremor, headache, blurred vision, impaired concentration, yawning, constipation, diarrhea, vomiting, dry mouth, sweating, asthenia, body weight gain.
Increased risk of bone fractures in patients receiving SSRIs and TCAs. Common withdrawal symptoms include: dizziness, sensory disturbances, sleep disturbances, anxiety and headache. Adverse events from paediatric clinical trials: Increased suicidal related behaviours (including suicide attempts and suicidal thoughts), self-harm behaviours and increased hostility. Refer to full SPC for the full list of adverse reactions.
LOCAL PRESENTATION: Seroxat Tablets (by 30 tablets) MARKETING AUTHORISATION HOLDER: SmithKline Beecham Ltd. MARKERTING AUTHORISATION NUMBERS: MA172/00201. DATE OF PREPARATION: April 2015
IN ORDER TO ENSURE THAT THIS PRODUCT INFORMATION REFLECTS THE MOST UP-TO-DATE CLINICAL AND POST-MARKETING SURVEILLANCE DATA, PLEASE ALWAYS REFER TO THE LATEST SPC, WHICH IS AVAILABLE FROM: GSK (MALTA) LIMITED (TEL: 21238131)
REPORTING ADVERSE EVENTS (AEs):
If you become aware of any AEs, medication errors and/or use during pregnancy in association with GSK products, please report the event promptly to: GSK (Malta) Limited, 1, De la Cruz Avenue, Qormi QRM 2458, Malta (Tel: +356 21238131)
Alternatively, any suspected AEs and medication errors can also be reported via the national Adverse Drug Reactions (ADRs) reporting system: Report forms can be downloaded from www.medicinesauthority.gov.mt/adrportal and posted to the Malta Medicines Authority, Post-licensing Directorate, 203, Level 3, Rue D’Argens, Gżira GŻR 1368, MALTA, or sent by email to postlicensing.medicinesauthority@gov.mt
Reference: 1. Gelenberg AJ, Freeman MP, Markowitz JC, Rosenbaum JF, Thase ME, Trivedi MH et al. Practice guideline for the treatment of patients with major depressive disorder (Third Edition) American Psychiatric Association 2010. (Last accessed August 2012). 2. Baldwin et al. Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology Journal of Psychopharmacology 1–37 2014. 3. Seroxat SPC January 2015.
Job No: MLT_GIB/PXT/0002/16 Prepared: February 2016
