Страна: Новая Зеландия
Язык: английский
Источник: Medsafe (Medicines Safety Authority)
Fluoxetine hydrochloride 22.36mg equivalent to fluoxetine 20 mg
Eli Lilly and Company (NZ) Limited
N06AB03
Fluoxetine hydrochloride 22.36 mg (equivalent to fluoxetine 20 mg)
20 mg
Capsule
Active: Fluoxetine hydrochloride 22.36mg equivalent to fluoxetine 20 mg Excipient: Dimeticone Gelatin Ink Iron oxide yellow Patent blue V Starch Titanium dioxide
Capsules: Each pack contains 28 capsules
Prescription
Prescription
Siegfried Ltd
· Depression and it's associated anxiety · Bulimia nervosa · Obsessive-Compulsive disorder and Premenstrual dysphoric disorder - a severe form of PMS. Diagnosis of PMDD: The essential features of PMDD are clear and established cyclicity of symptoms (occurring during the last week of the luteal phase in most menstrual cycles) such as depressed mood, anxiety, affective lability, and physical symptoms such as breast tenderness or swelling, headaches, joint or muscle pain, bloating, and weight gain. PMDD is a severe clinical entity and is distinguished from the broader premenstrual syndrome by the intensity of its symptoms (particularly mood symptoms) and the extent to which it interferes with social and/or occupational function
Package - Contents - Shelf Life: Blister pack, sample pack - 7 capsules - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 28 capsules - 36 months from date of manufacture stored at or below 30°C
1988-02-04
PROZAC ® _fluoxetine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PROZAC. It does not contain all the available information . It does not take the place of talking with your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PROZAC against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THIS MEDICINE. You may need to read it again. WHAT PROZAC IS USED FOR PROZAC is used to treat: • depression • obsessive compulsive disorder (OCD) • premenstrual dysphoric disorder (PMDD) ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PROZAC HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed PROZAC for another reason. PROZAC belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). SSRIs are thought to work by their action on brain chemicals called amines which are involved in controlling mood. PROZAC is available only with a doctor’s prescription. PROZAC is not recommended for use in children and adolescents under 18 years of age. BEFORE YOU TAKE PROZAC _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE PROZAC IF YOU ARE ALLERGIC TO • ANY MEDICINES CONTAINING FLUOXETINE • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. DO NOT TAKE PROZAC IF YOU ARE TAKING ANOTHER MEDICINE FOR DEPRESSION CALLED A MONOAMINE OXIDASE Прочитать полный документ
NEW ZEALAND DATA SHEET Prozac-ds-vA14_28Sep2022 SUPERSEDES: Prozac-ds-vA13.0_18Feb21 Page 1 of 14 1. PROZAC ® PROZAC 20 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 20 mg fluoxetine. For the full list of excipients, see Section 6.1 List of excipients 3. PHARMACEUTICAL FORM PROZAC 20 capsules are presented as size 3, green/cream capsules bearing the identicode “Lilly 3105” printed in black ink on both the capsule cap and base. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Depression and its associated anxiety, Bulimia nervosa, Obsessive-Compulsive disorder and Premenstrual dysphoric disorder - a severe form of PMS. Diagnosis of PMDD: The essential features of PMDD are clear and established cyclicity of symptoms (occurring during the last week of the luteal phase in most menstrual cycles) such as depressed mood, anxiety, affective lability, and physical symptoms such as breast tenderness or swelling, headaches, joint or muscle pain, bloating, and weight gain. PMDD is a severe clinical entity and is distinguished from the broader premenstrual syndrome by the intensity of its symptoms (particularly mood symptoms) and the extent to which it interferes with social and/or occupational function._ _ 4.2 DOSE AND METHOD OF ADMINISTRATION Dose Depression - 20 mg per day is the recommended initial dose. Bulimia Nervosa - 60 mg per day is the recommended dose. Obsessive-Compulsive Disorder - 20 mg to 60 mg per day is the recommended dose. Premenstrual Dysphoric Disorder - 20 mg per day is recommended continuously throughout the menstrual cycle. Initial treatment should be limited to six months, after which patients should be reassessed regarding the benefit of continued therapy. _All indications_ - The recommended dose may be increased or decreased. Doses above 80 mg/day have not been systematically evaluated. NEW ZEALAND DATA SHEET Prozac-ds-vA14_28Sep2022 SUPERSEDES: Prozac-ds-vA13.0_18Feb21 Page 2 of 14 _Age_ There are no data to suggest tha Прочитать полный документ