Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
SERTRALINE AS HYDROCHLORIDE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
N06AB06
FILM COATED TABLETS
SERTRALINE AS HYDROCHLORIDE 50 MG
PER OS
Required
PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY
SERTRALINE
For the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is effective in prevention relapse of the initial episode of depression or recurrence of further depressive episodes.
2020-11-30
Lustral tablets 50 mg and 100 mg, PIL, Israel, CC 080823 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only LUSTRAL ® TABLETS 50 MG LUSTRAL ® TABLETS 100 MG FILM-COATED TABLETS EACH TABLET CONTAINS: SERTRALINE (AS HYDROCHLORIDE) 50 MG OR 100 MG Inactive ingredients and allergens: See section 2 under 'Important information about some of this medicine's ingredients' and section 6 'Further information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. This medicine is not intended for use in children and adolescents under 18 years of age. WHAT SHOULD I KNOW ABOUT THE MEDICINE? Antidepressants and anti-anxiety medicines increase the risk of suicidal behavior and thoughts in children, adolescents and young adults up to the age of 25. When starting treatment with the medicine, patients of all ages and their relatives should monitor behavioral changes such as: worsening of depression, suicidal thoughts, aggression and the like. If changes such as these occur, refer to the doctor immediately (see section 2). 1. WHAT IS THIS MEDICINE INTENDED FOR? A medicine intended for the treatment of symptoms of depression in patients with or without a history of mania. After achieving a satisfactory response, continued treatment with the medicine is effective in preventing relapse of the initial depressive episode or recurrence of further depressive episodes. THERAPEUTIC GROUP: This medicine belongs to the SSRI group, selective serotonin reuptake inhibitors. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient or any of the additional ingredients contained in t Olvassa el a teljes dokumentumot
Lustral tablets 50 mg and 100 mg, LPD, Israel, CC 080823 Page 1 of 20 LUSTRAL ® TABLETS 50MG LUSTRAL ® TABLETS 100MG WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 25; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (4.4)]. In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (4.4)]. 1. NAME OF THE MEDICINAL PRODUCT Lustral ® tablets 50 mg Lustral ® tablets 100 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains sertraline hydrochloride equivalent to 50 mg or 100mg sertraline. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Sertraline 50 mg film-coated tablets are white, capsular shaped, film-coated scored tablets marked ‘ZLT 50’ on one side and ‘PFIZER’ on the other. The tablet can be divided into equal doses. Sertraline 100 mg film-coated tablets are white, capsular shaped, film-coated tablets marked 'ZLT 100' on one side and 'PFIZER' on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sertraline is indicated for the treatment of symptoms of depression in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is Lustral tablets 50 mg and 100 mg, LPD, Israel, CC 080823 Page 2 of 20 effective in prevention relapse of the initial episode of depression or recurrence of further depressive episodes. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _ _ _Initial treatment _ _ _ Sertraline treatment should be star Olvassa el a teljes dokumentumot