Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Eli Lilly Nederland B.V.
N06AB; N06AB03
FLUOXETINE HYDROCHLORIDE
20 mg/5ml
Oral solution
Product subject to prescription which may not be renewed (A)
Selective serotonin reuptake inhibitors; fluoxetine
Not marketed
1994-02-23
1 PACKAGE LEAFLET: INFORMATION FOR THE USER PROZAC 20 MG PER 5 ML ORAL SOLUTION _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 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 Prozac oral solution is and what it is used for 2. What you need to know before you take Prozac oral solution 3. How to take Prozac oral solution 4. Possible side effects 5. How to store Prozac oral solution 6. Content of the pack and other information 1. WHAT PROZAC ORAL SOLUTION IS AND WHAT IT IS USED FOR Prozac 20 mg per 5 mL oral solution contains the active substance 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: Prozac 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. Prozac should be offered to a child or young person with moderate to severe major depressive disorder ONLY in combination with psychological therapy. How Prozac 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 Prozac and other SSRIs work but they may help by increasing the level of ser Đọc toàn bộ tài liệu
Health Products Regulatory Authority 26 March 2021 CRN00C4WS Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozac 20 mg per 5 ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 mL of oral solution contains 20 mg of fluoxetine (as fluoxetine hydrochloride). Excipients with known effect Contains 3 g of sucrose, 2.5 mg benzoic acid(E 210), 9.56 mg of ethanol and traces of benzyl alcohol in each 5 mL dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution The solution is clear, colourless, mint odoured. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Adults: Major depressive episodes. Obsessive-compulsive disorder. Bulimia nervosa: Prozac 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 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 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. 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 _ Health Products Regulatory Authority 26 March 2021 CRN00C4WS Page Đọc toàn bộ tài liệu