Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluoxetine hydrochloride
DE Pharmaceuticals
N06AB03
Fluoxetine hydrochloride
20mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300
296x210 Leaflet Reel Fed Bi Fold Profile (BST) Dimensions: Component: Date Sent: Technologist: TECHNICALLY APPROVED Pharmacode: JDE No.: Fluoxetine, 20mg, Capsules, 30s - UK 296x210 (Reel Fed) 50982559 Leaflet for Blisters 2892 RH 13-11-19 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. GTIN 13: EU-Artwork-Support@accord-healthcare.com FLUOXETINE 20MG 30 CAPSULES PIL - UK Black Profile BBBA6939 S.Anson 14.11.19 296 x 210 7pt Accord Barnstaple n/a n/a 1 Version 3 05.11.2019 page 4 page 1 50982559 BBBA6939 _continued top of next column_ _continued top of next column_ _continued over page_ FLUOXETINE 20MG CAPSULES (fluoxetine hydrochloride) PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE CAPSULES • FLUOXETINE CAPSULES TREAT DEPRESSION AND ANXIETY DISORDERS. • Like all medicines, it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment. • FLUOXETINE CAPSULES ARE NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18. See section 2, _Use in children and adolescents aged 8 _ _to 18 years. _ • FLUOXETINE CAPSULES WON’T WORK STRAIGHT AWAY. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you haven’t started feeling better. See section 3, _How to take Fluoxetine capsules. _ • SOME PEOPLE WHO ARE DEPRESSED OR ANXIOUS THINK OF HARMING OR KILLING THEMSELVES. If you start to feel worse, or think of harming or killing yourself, SEE Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fluoxetine 20 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 20 mg Fluoxetine as the hydrochloride Excipient(s) with known effect Each capsule contains 146.6 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Hard capsule (green) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ADULTS: • Major depressive episodes. • Obsessive-compulsive disorder. • Bulimia nervosa: Fluoxetine 20 mg capsules 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: 20 mg/day to 60 mg/day. A dose of 20 mg/day is recommended as the initial dose. 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. In agreement with the consensus statement of the WHO, antidepressant medication should be continued for at least 6 months to ensure that they are free from symptoms. _Obsessive-compulsive disorder _ Adults and the elderly: 20 mg/day to 60 mg/day. A dose of 20 mg/day is recommended as the initial dose. Although there may be an increased potential for side-effects at h Đọc toàn bộ tài liệu