Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Fluoxetine
Bristol Laboratories Limited
N06AB; N06AB03
Fluoxetine
20 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; fluoxetine
Not marketed
2012-07-13
SAME SIZE ARTWORK 480 x 240 MM Front Ir PACKAGE LEAFLET: INFORMATION FOR USER FLUOXETINE 20 MG HARD CAPSULES FLUOXETINE 60 MG HARD CAPSULES (FLUOXETINE) EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE FLUOXETINE TREATS DEPRESSION AND ANXIETY DISORDERS. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment. FLUOXETINE IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18. See section 2, _ Use_ _in children and adolescents aged 8 to 18 years._ FLUOXETINE WON’T WORK STRAIGHT AWAY. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better. See section 3, _How to take Fluoxetine capsules_ SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING THEMSELVES. If you start to feel worse, or think of harming or killing yourself, SEE YOUR DOCTOR OR GO TO A HOSPITAL STRAIGHT AWAY. See section 2. DON’T STOP TAKING FLUOXETINE WITHOUT TALKING TO YOUR DOCTOR. If you stop taking Fluoxetine suddenly or miss a dose, you may get withdrawal effects. See section 3 for further information. IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL, TELL YOUR DOCTOR. Increasing the dose of Fluoxetine may make these feelings worse. See section 4, _Possible_ _side-effects._ TAKING SOME OTHER MEDICINES WITH FLUOXETINE CAN CAUSE PROBLEMS. You may need to talk to your doctor. See section 2, _Other medicines and Fluoxetine capsules._ IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT, talk to your doctor. See section 2 _Pregnancy, breast-feeding and fertility._ 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 read_full_document
Health Products Regulatory Authority 02 October 2019 CRN00980R Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluoxetine 20mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Fluoxetine 20mg capsule contains 20mg of fluoxetine as fluoxetine hydrochloride. Excipient with known effect: Sunset Yellow (E110) 0.0014 mg per capsule For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule Hard (capsules) Hard gelatin capsules, size '4', having green coloured cap and cream coloured body filled with white to off-white powder. 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_: A dose of 20 mg/day is recommended. 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 20mg, the dose may be increased gradually up to a maximum of 3 capsules (60mg) (see section 5.1). Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. 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_ Adults and the elderly: The recom read_full_document