Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
FLUOXETINE AS HYDROCHLORIDE
ELI LILLY ISRAEL LTD, ISRAEL
N06AB03
CAPSULES
FLUOXETINE AS HYDROCHLORIDE 20 MG
PER OS
Required
PATHEON FRANCE S.A.S.,FRANCE
FLUOXETINE
Adults:Major depressive episodes.Obsessive-compulsive disorder (OCD).Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.Children and adolescents aged 8 years and above:Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.
2015-02-28
I PROZCP P 13 Page 1 of 11 PATIENT PACKAGE LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only Prozac Capsules Active ingredient: Each capsule contains fluoxetine (as hydrochloride) 20 mg Inactive ingredients and allergens: see section 6 “Additional Information”. Read this entire leaflet carefully before you start using this medicine. This leaflet contains concise information about this medicine. If you have any further questions, ask 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 you think that their illness is the same as yours. 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? Prozac is indicated for the treatment of: Adults: Major depressive episodes Obsessive-compulsive disorder (OCD) Bulimia Nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. Children and adolescents aged 8 years and above: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy. Therapeutic group: Prozac belongs to a group of medicines called Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants. How Prozac works Everyone has a substance called serotonin in their brain. People who are depressed or have obsessive-compulsive d Citiți documentul complet
X PROZCP P 13 Page 1 of 18 1. NAME OF THE MEDICINAL PRODUCT Prozac 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of fluoxetine (as fluoxetine hydrochloride). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. The capsules are green and yellow, printed ‘Lilly 3105’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS: Major depressive episodes. Obsessive-compulsive disorder (OCD). Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity. CHILDREN AND ADOLESCENTS AGED 8 YEARS AND ABOVE: Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4–6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy. 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 Special warnings and precautions for use (section 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 Special warnings and precautions for use (section 4.4)]. X PROZCP P 13 Page 2 of 18 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ _Major Depressive Disorder _ Adults and the elderly: The recommended dose is 20 mg daily. Dosage should be reviewed and adjusted if necessary within 3 to 4 weeks of initiation of therapy and thereafter as judged clinically appropriate. Although there may be a Citiți documentul complet