Χώρα: Μάλτα
Γλώσσα: Αγγλικά
Πηγή: Malta Medicines Authority
FLUOXETINE
Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus
N06AB03
FLUOXETINE 20 mg
CAPSULE
FLUOXETINE 20 mg
POM
PSYCHOANALEPTICS
Authorised
2007-03-13
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MAGRILAN 20MG CAPSULES Fluoxetine EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT MAGRILAN • MAGRILAN 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. • MAGRILAN IS NOT FOR USE IN CHILDREN AND ADOLESCENTS UNDER 18 . See section 2, Use in children and adolescents aged 8 to 18 years. • MAGRILAN 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. • 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. • DON’T STOP TAKING MAGRILAN WITHOUT TALKING TO YOUR DOCTOR . If you stop taking Magrilan suddenly or miss a dose, you may get withdrawal effects. See section 3 for further information. • IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL, TELL YOUR DOCTOR . Increasing the dose of Magrilan may make these feelings worse. See section 4. • TAKING SOME OTHER MEDICINES WITH MAGRILAN CAN CAUSE PROBLEMS . You may need to talk to your doctor. See section 2. • IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT, TALK TO YOUR DOCTOR . See section 2. 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 Διαβάστε το πλήρες έγγραφο
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Magrilan 20mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Magrilan 20mg capsule, contains Fluoxetine Hydrochloride equivalent to 20mg of Fluoxetine base. Excipients with known effect: lactose monohydrate. Each capsule contains 105.0 mg lactose monohydrate. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Hard gelatine capsules, size “4”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _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. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Major depressive episode_ _Adults and 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 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 Elderly: _ The recommended dose is 20mg daily. Although there may be an increased potential for undesirable effects at higher doses, in some patients, if after two weeks t Διαβάστε το πλήρες έγγραφο