Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
DULOXETINE AS HYDROCHLORIDE
ELI LILLY ISRAEL LTD, ISRAEL
N06AX21
CAPSULES
DULOXETINE AS HYDROCHLORIDE 40 MG
PER OS
Required
LILLY S.A., SPAIN
DULOXETINE
Yentreve is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
2020-03-31
I YENTCP A 12 Page 1 of 8 PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only YENTREVE 20 MG Capsules YENTREVE 40 MG Capsules ACTIVE INGREDIENT: Duloxetine 20 mg ACTIVE INGREDIENT: Duloxetine 40 mg INACTIVE INGREDIENTS AND ALLERGENS: See section 6 “_Additional information_” and section 2 “_Important information about some of this medicine's ingredients”._ READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, please contact your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. This medicine is intended for women above the age of 18. Even though YENTREVE is not indicated to treat depression, the active ingredient in this preparation (duloxetine) is used as an antidepressant. Antidepressants and antianxiety medicines increase the risk of suicidal behavior and thoughts among children, adolescents and young adults up to 25 years of age. When beginning treatment with this medicine, patients of all ages and their relatives, must monitor behavioral changes such as worsening of depression, suicidal thoughts, aggressiveness etc. If changes such as these occur, contact the doctor immediately. 1. WHAT IS THIS MEDICINE INTENDED FOR? Yentreve is intended to treat moderate to severe Stress Urinary Incontinence (SUI) in women. THERAPEUTIC GROUP: Serotonin and norepinephrine reuptake inhibitors (SNRIs). Stress urinary incontinence is a medical condition in which patients have accidental loss or leakage of urine during physical exertion or activities such as laughing, coughing, sneezing, lifting, or exercise. Yentreve is believed to work by increasing the strength of the muscle that holds back urine when you laugh, sneeze, or perform physical activities. The efficacy of Ye Olvassa el a teljes dokumentumot
X YENTCP A 13 Page 1 of 17 1. NAME OF THE MEDICINAL PRODUCT YENTREVE 20 mg hard gastro-resistant capsules YENTREVE 40 mg hard gastro-resistant capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg or 40 mg of duloxetine (as hydrochloride). Excipient(s) with known effect: Each 20mg capsule contains 12 mg sucrose and 27 mg sugar spheres. Each 40mg capsule contains 24.2 mg sucrose and 54 mg sugar spheres. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard gastro-resistant capsules. YENTREVE 20 mg Opaque blue body, imprinted with ‘20 mg’ and an opaque blue cap, imprinted with ‘9544’. YENTREVE 40 mg Opaque orange body, imprinted with ’40 mg’ and an opaque blue cap, imprinted with ‘9545’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Although Yentreve is not indicated for the treatment of depression, it’s active ingredient (duloxetine) also exists in antidepressant medicinal products. 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 duloxetine or other 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)]. X YENTCP A 13 Page 2 of 17 YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI). YENTREVE is indicated in adults. For further information see section 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Swallow YENTREVE whole. Do not chew or crush. Do not open the capsu Olvassa el a teljes dokumentumot