国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
McDermott Laboratories Ltd., T/A Gerard Laboratories
N06AB; N06AB03
FLUOXETINE HYDROCHLORIDE
20 milligram(s)
Capsule, hard
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; fluoxetine
Not marketed
1999-02-19
PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GEROZAC 20 MG CAPSULES, HARD fluoxetine 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 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 Gerozac is and what it is used for 2. What you need to know before you take Gerozac 3. How to take Gerozac 4. Possible side effects 5. How to store Gerozac 6. Contents of the pack and other information. 1. WHAT GEROZAC IS AND WHAT IT IS USED FOR The name of your medicine is Gerozac 20 mg Capsules, hard. It contains the active substance fluoxetine. Gerozac belongs to a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants. Gerozac can be given to treat the following conditions: _Adults: _ Major depressive episodes The symptoms of a condition called obsessive-compulsive disorder (OCD) The eating disorder bulimia nervosa. This medicine 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. Gerozac should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GEROZAC DO NOT TAKE GEROZAC: if you are allergic to fluoxetine or any of the other ingredients of this medicine (listed in section 6). IF YOU DEVELOP A RASH OR OTHER ALLERGIC REACTIONS (LIKE ITCHING, SWOLLEN LIPS OR FACE OR 阅读完整的文件
Health Products Regulatory Authority 16 July 2021 CRN009X9Z Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gerozac 20 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20mg fluoxetine as fluoxetine hydrochloride. Excipient with known effect Each capsule contains 139.64mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard A hard gelatin capsule with a light green opaque body and a purple opaque cap; printed “FL20” on the body and “α” on the cap in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Adults:_ Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: Gerozac 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 _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 20mg, the dose may be increased gradually up to a maximum of 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 recommended dose is 20mg daily. Although there may b 阅读完整的文件