国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Valproate semisodium
Sanofi
N03AG01
Valproate semisodium
500mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020300; GTIN: 5000283609148 05000283660378
PAG 4 PAG 1 Avance bobina 170 x 315 mm 688590-G-697411 PACKAGE LEAFLET: INFORMATION FOR THE USER DEPAKOTE® 250MG AND 500MG TABLETS valproic acid (as valproate semisodium) IS THIS LEAFLET HARD TO SEE OR READ? PHONE 0845 372 7101 FOR HELP. 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. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Depakote is and what it is used for 2. What you need to know before you take Depakote 3. How to take Depakote 4. Possible side effects 5. How to store Depakote 6. Contents of the pack and other information 1. WHAT DEPAKOTE IS AND WHAT IT IS USED FOR The name of your medicine is Depakote 250mg or 500mg Tablets (called Depakote in this leaflet). Depakote contains a medicine called valproate semisodium. This belongs to a group of medicines called mood stabilisers. It works by stabilising the levels of chemicals in your brain that affect your mood. Depakote can be used to manage or control mania (feeling highly excited, enthusiastic, being over-active and easily irritated or distracted) caused by bipolar disorder. Bipolar disorder is where the mood changes between feeling very high (mania) and very low (depression). Depakote can be used when lithium cannot be used. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPAKOTE DO NOT TAKE DEPAKOTE AND TELL YOUR DOCTOR IF: X You are allergic (hypersensitive) t 完全なドキュメントを読む
OBJECT 1 DEPAKOTE 500MG TABLETS Summary of Product Characteristics Updated 11-May-2018 | SANOFI 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 Depakote 500 mg Tablets 2. Qualitative and quantitative composition Containing 538.20 mg of valproate semisodium* per tablet (equivalent to 500 mg of valproic acid). *Valproate semisodium is a stable coordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship. It is also known as divalproex sodium (USAN). For a full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant tablet Oval, lilac pink gastro-resistant tablets. 4. Clinical particulars 4.1 Therapeutic indications Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. The continuation of treatment after manic episode could be considered in patients who have responded to Depakote for acute mania. 4.2 Posology and method of administration For oral administration. The tablets should be swallowed whole with a drink of water, and not crushed or chewed. The daily dosage should be established according to age and body weight. The wide variation in individual sensitivity to Depakote should also be considered. _Dosage_ Manic episodes in bipolar disorder: Adults The daily dosage should be established and controlled individually by the treating physician. The initial recommended daily dose is 750 mg. In addition, in clinical trials a starting dose of 20 mg valproate/kg body weight has also shown an acceptable safety profile. Prolonged-release formulations can be given once or twice daily. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose which produces the desired clinical effect. The daily dose should be adapted to the clinical response to establish 完全なドキュメントを読む