Land: Malta
Sprache: Englisch
Quelle: Medicines Authority
FLUOXETINE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
N06AB03
FLUOXETINE 20 mg
HARD CAPSULE
FLUOXETINE 20 mg
POM
PSYCHOANALEPTICS
Authorised
2014-07-24
Page 1 of 11 PACKAGE LEAFLET: INFORMATION FOR THE USER FLUOXETINE AUROBINDO 20 MG CAPSULES, HARD FLUOXETINE AUROBINDO 60 MG CAPSULES, HARD fluoxetine hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Fluoxetine Aurobindo is and what is used for 2. What you need to know before you take Fluoxetine Aurobindo 3. How to take Fluoxetine Aurobindo 4. Possible side effects 5. How to store Fluoxetine Aurobindo 6. Contents of the pack and other information 1. WHAT FLUOXETINE AUROBINDO IS AND WHAT IS USED FOR Fluoxetine Aurobindo contains fluoxetine which is one of a group of medicines called selective serotonin re-uptake inhibitors (SSRI) antidepressants. This medicine is used to treat the following conditions: _ _ _Adults: _ • Major depressive episodes • Obsessive-compulsive disorder • Bulimia nervosa: Fluoxetine Aurobindo is used alongside psychotherapy for the reduction of binge- eating and purging. _ _ _Children and adolescents aged 8 years and above: _ Moderate to severe major depressive disorder, if the depression does not respond to psychological therapy after 4-6 sessions. Fluoxetine Aurobindo should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy. HOW FLUOXETINE AUROBINDO WORKS Everyone has a substance called serotonin in their brain. People who are depressed or have obsessive- compulsive disorder or bulimia nervosa have lower levels of serotonin than others. It is not fully understood how Fl Lesen Sie das vollständige Dokument
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fluoxetine 20 mg capsules, hard 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 22.357 mg fluoxetine hydrochloride equivalent to 20 mg of Fluoxetine. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule, hard. Opaque green cap/yellow body, size “4” hard gelatin capsule filled with white to off-white powder and imprinted with ‘J’ on opaque green cap and ‘96’ on yellow body with black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Major depressive episodes. Obsessive-compulsive disorder. 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults _ _ _ MAJOR DEPRESSIVE EPISODES _Adults and the elderly:_ The recommended dose is 20mg 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 an increased potential for undesirable effects at higher doses, in some patients, with insufficient response to 20 mg, the dose may be increased gradually up to a maximum of 60 mg (see section 5.1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. Page 2 of 15 Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms. _ _ OBSESSIVE-COMPULSIVE DISORDER(OCD) _Adults and the elderly:_ The recommended dose is 20mg daily. Although there may be an i Lesen Sie das vollständige Dokument