Pajjiż: Ingilterra
Lingwa: Ingliż
Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluoxetine hydrochloride
Waymade Healthcare Plc
N06AB03
Fluoxetine hydrochloride
20mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300
TEXTE TEXTE 1 3 VERSO RECTO Recto DÉFILEMENT PACKAGE LEAFLET: INFORMATION FOR THE USER PROZAC ® 20 MG HARD CAPSULES _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 hard capsules are and what they are used for 2. What you need to know before you take Prozac hard capsules 3. How to take Prozac hard capsules 4. Possible side effects 5. How to store Prozac hard capsules 6. Content of the pack and other information 1. WHAT PROZAC HARD CAPSULES ARE AND WHAT THEY ARE USED FOR Prozac 20 mg hard capsules contain 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 b Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Prozac 20 mg hard capsules SUMMARY OF PRODUCT CHARACTERISTICS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg of fluoxetine (as fluoxetine hydrochloride). For the full list of excipients, see section 6.1. SUMMARY OF PRODUCT CHARACTERISTICS 3. PHARMACEUTICAL FORM Hard capsules. The capsules are green and yellow, printed ‘Lilly 3105’. 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 _ Adults and the elderly: The recommended dose is 20 mg daily. Although there may be an increased potential for undesirable effects at higher doses, in some patients, if after two weeks there is insufficient response to 20 mg Aqra d-dokument sħiħ