国: マレーシア
言語: 英語
ソース: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Fluoxetine Hydrochloride.
ZUELLIG PHARMA SDN BHD
Fluoxetine Hydrochloride.
28 Capsule Capsules
PATHEON FRANCE S.A.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ PROZAC ® CAPSULE Fluoxetine (20mg) ________________________________________________________________________________________________________________________ __________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET? 1. What Prozac is used for 2. How Prozac works 3. Before you use Prozac 4. How to use Prozac 5. While you are using it 6. Side effects 7. Storage and Disposal of Prozac 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT PROZAC IS USED FOR _Depression:_ Prozac is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms. _Obsessive-compulsive disorder_ , _ _ which is anxiety disorder characterised by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviours (compulsion). _ _ _Pre-mestrual _ _Dysphoroc _ _Disorder _ _(PMDD)_ , a severe form of premenstrual syndrome that affects a woman’s daily activities and relationship with others before menstruation. HOW PROZAC WORKS Prozac 20 mg hard capsules contains the active substance fluoxetine, which is one of a group of medicines called selective serotonin re-uptake inhibitors (SSRI) antidepressants. It is not fully understood how Prozac and other SSRIs work, but they may help by increasing the level of serotonin in the brain which are involved in controlling mood. BEFORE YOU USE PROZAC - _When you must not use it_ DO NOT TAKE PROZAC IF YOU ARE: • allergic to fluoxetine or any of the other ingredients of this medicine (see PRODUCT DESCRIPTION ). • taking other medicines known as monoamine oxidase inhibitors (MAOIs), since serious or fatal reaction (e.g. serotonin syndrome, see SIDE EFFECT ) can occur. Examples of MAOIs include medicines used to treat: - depression (such as nialamide, iproniazide and moclobemide), - infections (such as linezolid) - a blood disorder called methaemoglobinaemia (high levels of alt 完全なドキュメントを読む
Prozac_PI_EUSPC 22 Dec 2020 and AUS PMDD 17 May 2016_23 Feb 2021 PROZAC ® 1. NAME OF THE MEDICINAL PRODUCT PROZAC ® 20mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITIO N Each capsule contains 20mg of fluoxetine (as fluoxetine hydrochloride) For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Hard capsules. The capsules are green and yellow printed ‘Lilly 3105’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ _Depression: _ Prozac is indicated for the treatment of the symptoms of depressive illness, with or without associated anxiety symptoms. _ _ _Obsessive-compulsive disorder _ _ _ _Pre-menstrual Dysphoric Disorder (PMDD):_ Prozac is indicated for the treatment of pre- menstrual dysphoric disorder. _Diagnosis of PMDD:_ The essential diagnostic features of PMDD are clear and established cyclicity (occurring during the last week of the luteal phase in most menstrual cycles) of symptoms such as depressed mood, anxiety, affective liability, accompany by impairment in social and/or occupational function and physical symptoms (such as breast tenderness or swelling, headaches, joint or muscle pain, a sensation of bloating, weight gain) – all of which must be severe. This syndrome should be distinguished from the commoner “pre-menstrual tension (distinguished from PMDD by milder symptoms and less impact on normal activities)” and from any co-existing psychiatric disorder. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration to adults only. _ _ _Depression, with or without associated anxiety symptoms _ 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 20 mg, the dose may be increased gradually up to a maximum of 60 mg (see section 5.1). Dosage adjustments should be made car 完全なドキュメントを読む