国: イギリス
言語: 英語
ソース: myHealthbox
Pregabalin
Sandoz GmbH
N03AX16
Pregabalin
200 mg
Hard capsule
Oral use
21, 28, 84 or 100 hard capsules
POM - Prescription Only Medicine
Anti-epileptics, other anti-epileptics
It is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation and for the treatment of Generalised Anxiety Disorder (GAD) in adults
Authorised
2015-06-19
Pregabalin Sandoz GmbH 200 mg hard capsules Summary of Product Characteristics Updated 25Jun2015 | Sandoz Limited 1. Name of the medicinal product Pregabalin Sandoz GmbH 200 mg hard capsules 2. Qualitative and quantitative composition Each hard capsule contains 200 mg of pregabalin. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Hard capsule. Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder. 4. Clinical particulars 4.1 Therapeutic indications Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. 4.2 Posology and method of administration Posology The dose range is 150 to 600 mg per day given in either two or three divided doses. _Epilepsy_ Pregabalin treatment can be started with a dose of 150 mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. The maximum dose of 600 mg per day may be achieved after an additional week. _Generalised Anxiety Disorder_ The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual patient response and tolerability, the dose may be increased to 300 mg per day after 1 week. Following an additional week the dose may be increased to 450 mg per day. The maximum dose of 600 mg per day may be achieved after an additional week. _Discontinuation of pregabalin_ I 完全なドキュメントを読む