Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
Viatris Healthcare Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN , Ireland
N06AB08
FLUVOXAMINE MALEATE 50 mg
FILM-COATED TABLET
FLUVOXAMINE MALEATE 50 mg
POM
PSYCHOANALEPTICS
Authorised
2007-05-16
FAVERIN ® 50 MG AND 100 MG FILM-COATED TABLETS fluvoxamine maleate • FAVERIN TREATS DEPRESSION AND OBSESSIVE COMPULSIVE DISORDER (OCD). 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. • FAVERIN SHOULD NOT BE USED TO TREAT DEPRESSION IN CHILDREN AND ADOLESCENTS UNDER 18. See section 2, Use in Children and adolescents under 18. • FAVERIN WON’T WORK STRAIGHT AWAY. Some people taking antidepressants feel worse before feeling better. Your doctor should see you regularly during your course of treatment. Tell your doctor if you haven’t started feeling better. • 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. • DON’T STOP TAKING FAVERIN WITHOUT TALKING TO YOUR DOCTOR. If you stop taking Faverin suddenly or miss a dose, you may get withdrawal effects. See Section 3, How to take Faverin. • IF YOU FEEL RESTLESS AND FEEL LIKE YOU CAN’T SIT OR STAND STILL, TELL YOUR DOCTOR. Increasing the dose of Faverin may make these feelings worse. • TAKING SOME OTHER MEDICINES WITH FAVERIN CAN CAUSE PROBLEMS. You may need to talk to your doctor. See section 2, Are you taking any other medicines. • IF YOU ARE PREGNANT OR PLANNING TO GET PREGNANT , talk to your doctor. See section 2, Pregnancy and breastfeeding. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. WHAT FAVERIN IS AND WH Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Faverin 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg fluvoxamine maleate. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet Round, biconvex, scored, white to off-white film coated tablets imprinted '291' on both sides of the score. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Major depressive episode - Obsessive Compulsive Disorder (OCD) 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Depression _ _Adults _ The recommended dose is 100 mg daily. Patients should start on 50 or 100 mg, given as a single dose in the evening. 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, if after some weeks on the recommended dose insufficient response is seen some patients may benefit from having their dose increased gradually up to a maximum of 300 mg a day (see section 5.1). Doses up to 150 mg can be given as a single dose, preferably in the evening. It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses. 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. _Children/adolescents _ Faverin should not be used in children and adolescents under the age of 18 years for the treatment of major depressive episode. The efficacy and safety of Faverin have not been established in the treatment of paediatric major depressive episode (see section 4.4). _Obsessive Compulsive Disorder _ _Adults _ The recommended dose is between 100-300 mg daily. Patients should start at 50 mg per day. Although there may be an inc Přečtěte si celý dokument