Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
FLUOXETINE HYDROCHLORIDE
Niche Generics Limited
N06AB03
FLUOXETINE HYDROCHLORIDE
20 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
fluoxetine
Marketed
2001-05-04
PA1063/12/1 1 July-2015 PACKAGE LEAFLET: INFORMATION FOR THE USER PROZIT 20MG HARD CAPSULES Fluoxetine (as 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. If you are a carer or are helping someone else to take their capsules, please read this leaflet before you give the first dose. WHAT IS IN THIS LEAFLET 1. What Prozit Hard Capsules are and what they are used for 2. What you need to know before you take Prozit Hard Capsules 3. How to take Prozit Hard Capsules 4. Possible side effects 5. How to store Prozit Hard Capsules 6. Contents of the pack and other information 1. What PROZIT HARD CAPSULES ARE AND WHAT THEY ARE USED FOR Prozit Hard Capsules contain fluoxetine which is one of a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants. Prozit Hard Capsules are used in the treatment of: Adults: Severe depression Anxiety disorders with compulsive thoughts or actions, which means that you may have uncontrollable thoughts or carry out repetitive actions. This condition is known as obsessive compulsive disorder. Binge-eating (bulimia nervosa), alongside psychotherapy, in order to avoid binge-eating and vomiting 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 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 KN Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozit 20mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 22.36 mg fluoxetine hydrochloride equivalent to 20 mg fluoxetine. Excipient with known effect: 58 mg of lactose monohydrate per capsule. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsules hard. Olive/green capsules marked FLE 20. 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 _Major depressive episodes_ Adults and older people: 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_ Adults and older people: The recommended dose is 20 mg daily. Although there may be an increased potential for H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Lesen Sie das vollständige Dokument