Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Fluvoxamine maleate
Viatris UK Healthcare Ltd
N06AB08
Fluvoxamine maleate
50mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04030300; GTIN: 5012781038504
Colours Non-Print Colours Date: Time: Dimensions Main Font Body Text Size 8.5 pt Min Text Size used 8.5 pt Helvetica Neue 1 Page Count 1 No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info 3D Render ID Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs Equivalent Pantone+ Color Bridge Coated colours Faverin, 50 mg, 100 mg, 30, 60 Leaflet (Insert) 1898304 1820846 1898304 PL46302/0034-0033 Mylan Laboratories SAS (Chatillon sur Chalaronne - FR) 50072205 3963 400540709, 400540689 3 United Kingdom Flat - 158X630 mm - SPE 97922 N.A. N.A. N.A. 10:52 22 AUG 2019 158X630mm v3/July 2017 P. Process Black U Cutting Die (Not Printed) FRONT pharmacode > > > folding pharmacode > > > folding 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 t Baca dokumen lengkapnya
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 increas Baca dokumen lengkapnya