البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ESCITALOPRAM AS OXALATE
LUNDBECK ISRAEL LTD.
N06AB10
FILM COATED TABLETS
ESCITALOPRAM AS OXALATE 10 MG
PER OS
Required
H. LUNDBECK A/S, DENMARK
ESCITALOPRAM
ESCITALOPRAM
Treatment of depression and panic disorder. Treatment of generalized anxiety disorder (GAD) treatment of social anxiety disorder (social phobia). Treatment of obsessive - compulsive disorder.
2022-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS, 1986) The medicine is marketed according to a doctor’s prescription only. CIPRALEX ® Tablets 10 MG, 15 MG, 20 MG COMPOSITION: THE ACTIVE INGREDIENT AND ITS QUANTITY: - Cipralex 10 mg: each film coated tablet contains 10 mg escitalopram (as oxalate) - Cipralex 15 mg: each film coated tablet contains 15 mg escitalopram (as oxalate) - Cipralex 20 mg: each film coated tablet contains 20 mg escitalopram (as oxalate) INACTIVE INGREDIENTS: See section 6. - 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. - 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. - The medicine is not usually intended for children and adolescents under the age of 18. 1. WHAT IS THE MEDICINE INTENDED FOR? Cipralex is an antidepressant that belongs to the selective serotonin reuptake inhibitors (SSRIs) group. These medicines act on the serotonin-system in the brain by increasing the serotonin level. Cipralex is used to treat the following conditions: Depression . Panic Disorder . Generalized Anxiety Disorder (GAD). Social anxiety disorder (SAD) (Social Phobia). Obsessive-compulsive disorder. It may take a few weeks until you start to feel better. Continue taking the medicine even if it takes some time before you feel any improvement. Consult with your doctor if you do not feel any improvement or if you feel worse. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: - You are sensitive (allergic) to the active ingredient or any of the other ingredients that the medicine contains (see the list of inactive ingredients in section 6). Antidepressants and anti-anxiety medications increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults up to 25 years old. In patients of all ages who sta اقرأ الوثيقة كاملة
Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CIPRALEX 10 mg tablets CIPRALEX 15 mg tablets CIPRALEX 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Cipralex 10 mg: Each tablet contains 10 mg escitalopram (as 12.77 mg escitalopram oxalate) Cipralex 15 mg: Each tablet contains 15 mg escitalopram (as 19.16 mg escitalopram oxalate) Cipralex 20 mg: Each tablet contains 20 mg escitalopram (as 25.54 mg escitalopram oxalate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Cipralex 10 mg: Oval, white, scored, film-coated tablet of 8x5.5 mm marked with "E” and “L" on each side of the score on one side of the tablet. Cipralex 15 mg: Oval, white, scored, film-coated tablet of 9.8x6.3 mm marked with "E” and “M" on each side of the score on one side of the tablet. Cipralex 20 mg: Oval, white, scored, film-coated tablet of 11.5x7 mm marked with "E” and “N" on each side of the score on one side of the tablet. The tablets can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of depression. Treatment of panic disorder. Treatment of generalised anxiety disorder (GAD). • 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 14 Treatment of social anxiety disorder (SAD, social phobia). Treatment of obsessive-compulsive اقرأ الوثيقة كاملة