Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluoxetine hydrochloride
Viatris UK Healthcare Ltd
N06AB03
Fluoxetine hydrochloride
60mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300; GTIN: 5016695320427
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUOXETINE 60 MG CAPSULES, HARD (fluoxetine) EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT FLUOXETINE. Please read all of this leaflet. It includes a lot of additional important information about this medicine. • FLUOXETINE TREATS 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. See section 4 ‘Possible side effects’, inside this leaflet. • FLUOXETINE IS NOT FOR USE IN CHILDREN UNDER 8 YEARS. • FLUOXETINE 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 have started feeling better. See section 3, ‘How to take Fluoxetine’. • 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 your doctor or go to a hospital straight away. See section 2 ‘What you need to know before you take Fluoxetine’. • DON’T STOP TAKING FLUOXETINE WITHOUT TALKING TO YOUR DOCTOR. If you stop taking Fluoxetine suddenly or miss a dose, you may get withdrawal effects. See section 3, ‘If you stop taking Fluoxetine’. • IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL, TELL YOUR DOCTOR. Increasing the dose of Fluoxetine may make these feelings worse. See section 4, ‘Possible side effects’. • TAKING SOME OTHER MEDICINES WITH FLUOXETINE CAN CAUSE PROBLEMS: You may need to talk to your doctor. See section 2, ‘Other medicines and Fluoxetine’. • IF YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT, talk to your doctor. See section 2, ‘Pregnancy, breast-feeding and fertility’. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this read_full_document
1 NAME OF THE MEDICINAL PRODUCT Fluoxetine 60 mg Capsules, Hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains fluoxetine hydrochloride equivalent to 60mg of fluoxetine. Excipient with known effect: Each capsule contains 256.92 mg lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard. Capsule size 1 with a light yellow opaque body and cap, printed “FL60” on the body and “G” on the cap in black ink. 4.1 THERAPEUTIC INDICATIONS Fluoxetine 60 mg capsules are indicated for: _ _ _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 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 patient read_full_document