País: Regne Unit
Idioma: anglès
Font: myHealthbox
Sodium Valproate
Wockhardt UK Ltd
N03AG01
Sodium Valproate
200mg
Enteric coated tablet
Oral use
bottles containing 100 tablets; pack sizes of 10, 50, 60 or 100 tablets
POM - Prescription Only Medicine
Desitin Arzneimittel
Antiepileptics
in the treatment of generalised, partial or other epilepsy.
Authorised
2007-07-24
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used Wockhardt UK Limited Sodium Valproate tablet leaflet 103995/8 See uploaded pdf 210 x 297mm matt.pirie-scott 2 20/05/2015 570085 Process Black Keyline (non-printing) artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. UK English 8pt (main body) / 8pt (variables) N/A PACKAGE LEAFLET INFORMATION FOR THE USER SODIUM VALPROATE 200MG AND 500MG GASTRO-RESISTANT TABLETS _SODIUM VALPROATE_ THIS MEDICINE IS SUBJECT TO ADDITIONAL MONITORING. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. WARNING Valproate can cause birth defects and problems with early development of the child if it is taken during pregnancy. If you are a female of childbearing age you should use an effective method of contraception throughout your treatment. Your doctor will discuss this with you but you should also follow the advice in section 2 of this leaflet. Tell your doctor at once if you become pregnant or think you might be pregnant. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get Llegiu el document complet
Orlept 200mg GastroResistant Tablets Summary of Product Characteristics Updated 21Aug2015 | Wockhardt UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Orlept 200mg GastroResistant Tablets Sodium Valproate Wockhardt 200mg GastroResistant Tablets 2. Qualitative and quantitative composition Each tablet contains 200mg of Sodium Valproate For a full list of excipients, see section 6.1 3. Pharmaceutical form Gastroresistant tablets. White to faintly yellowish round bevel edged tablets. 4. Clinical particulars 4.1 Therapeutic indications For oral administration in the treatment of generalised, partial or other epilepsy. 4.2 Posology and method of administration Sodium Valproate 200mg GastroResistant Tablets are for oral administration. Daily dosage requirements vary according to age and body weight. Tablets may be given twice daily. Tablets should be swallowed whole and not crushed or chewed. _Dosage:_ Usual requirements are as follows: Adults: Dosage should start at 600mg daily increasing by 200mg at threeday intervals until control is achieved. This is generally within the dosage range 1000mg to 2000mg per day i.e. 2030mg/kg body weight daily. Where adequate control is not achieved within this range the dose may be further increased to a maximum of 2500mg per day. Children over 20kg: Initial dosage should be 400mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range 2030mg/kg body weight per day. Where adequate control is not achieved within this range the dose may be i Llegiu el document complet