Country: Իսրայել
language: անգլերեն
source: Ministry of Health
CITALOPRAM AS HYDROBROMIDE
LUNDBECK ISRAEL LTD.
N06AB04
FILM COATED TABLETS
CITALOPRAM AS HYDROBROMIDE 20 MG
PER OS
Required
H.LUNDBECK A/S, DENMARK
CITALOPRAM
CITALOPRAM
For the treatment of states of depression and panic disorder.
2021-10-31
PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed by a doctor’s prescription only CIPRAMIL® 20 MG Tablets CIPRAMIL® 40 MG Tablets COMPOSITION: EACH FILM-COATED TABLET OF CIPRAMIL 20 MG CONTAINS: The active ingredient Citalopram Hydrobromide, equivalent to 20 mg Citalopram EACH FILM-COATED TABLET OF CIPRAMIL 40 MG CONTAINS: The active ingredient Citalopram Hydrobromide, equivalent to 40 mg Citalopram INACTIVE INGREDIENTS: see section 6 and section "Important information about some of the ingredients of Cipramil". - READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or the pharmacist. - IT IS RECOMMENDED TO LET A FAMILY MEMBER OR ANOTHER PERSON WHO IS CLOSE TO YOU TO READ THIS LEAFLET. - This medicine was prescribed for you. Do not pass it on to others. It can harm them even if it seems to you that their medical state is similar. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants and anti-anxiety medications increase the risk of suicidal thoughts and behaviour in children, adolescents, and young adults up to 25 years old. In patients of all ages who start taking this medicine, the patients and their relatives should monitor behavioural changes such as worsening of depression, suicidal thoughts, aggression and other similar changes. In case such changes occur, contact your doctor immediately. 1. WHAT IS THE MEDICINE INTENDED FOR? THERAPEUTIC ACTIVITY: for the treatment of depression and panic disorder. Cipramil belongs to a group of antidepressants called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines increase the serotonin level in the brain. Disturbances in the serotonin-system in the brain are considered an important factor in the development of depression and related diseases. PHARMACOTHERAPEUTIC GROUP: Selective Serotonin Reuptake Inhibitors (SSRI). 2. BEFORE USING THE MEDICINE SPECIAL WARNING read_full_document
Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAMES OF THE MEDICINAL PRODUCTS Cipramil 20 mg tablets , film coated Cipramil 40 mg tablets, film coated 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cipramil 20 mg tablet: Each tablet contains 20 mg citalopram (as 24.98 mg citalopram hydrobromide). Cipramil 40 mg: Each tablet contains 40 mg citalopram (as 49.96 mg citalopram hydrobromide). Excipients with known effect: Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Cipramil 20 mg tablet: White, oval, scored, film-c oated tablet marked “C” and “N” symmetrically around the score. The tablet can be divided into equal doses. Cipramil 40 mg: White, oval, scored, film-coated tablets marked “C” and “R” symmetrically around the score. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of states of depression and panic disorder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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)]. Page 2 of 18 POSOLOGY DEPRESSION Citalopram should be administered as a single oral dose of 20 mg daily. Dependent on individual patient response this may be increased to a maximum of 40 mg daily. Duration of treatment The antidepressant effect usually sets in after 2 to 4 weeks. Treatment with antidepressants is sym read_full_document