Ülke: Birleşik Krallık
Dil: İngilizce
Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)
Galantamine hydrobromide
Accord-UK Ltd
N06DA04
Galantamine hydrobromide
8mg
Modified-release capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04110000; GTIN: 5012617022165
_Continued top of next column_ BBBA3313 * Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@accord-healthcare.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details GALANTAMINE LOTPROSTIN XL 8MG, 16MG & 24MG PROLONGED-RELEASE HARD CAPSULES PIL - UK Black BBBA3313 S.Anson 01.11.18 07.11.18 S.Anson 170 x390 7pt Pharmathen 01.11.18 06.11.18 2 Version 2 01.11.2017 _Continued on next page_ 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, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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. • The full name of this medicine is Lotprosin XL 8mg, 16mg and 24mg Prolonged-release Capsules, hard but within the leaflet it will be referred to as Lotprosin XL capsules. WHAT IS IN THIS LEAFLET: 1 WHAT LOTPROSIN XL CAPSULES ARE AND WHAT THEY ARE USED FOR 2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE LOTPROSIN XL CAPSULES 3 HOW TO TAKE LOTPROSIN XL CAPSULES 4 POSSIBLE SIDE EFFECTS 5 HOW TO STORE LOTPROSIN XL CAPSULES 6 CONTENTS OF THE PACK AND OTHER INFORMATION 1 WHAT LOTPROSIN XL CAPSULES ARE AND WHAT THEY ARE USED FOR Lotprosin XL capsules contains the active substance ‘galantamine’, an antidementia medicine. It is used in adults to treat the symptoms of mild to moderately Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lotprosin XL 8mg Prolonged-release Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8mg capsule contains 8mg galantamine (as hydrobromide). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged release capsule, hard 8mg: Opaque white size 2 hard gelatine capsules containing one round biconvex tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lotprosin XL 8mg Prolonged-release Capsule is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults/Elderly _ _Before start of treatment_ The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4). _Starting dose_ The recommended starting dose is 8 mg/day for 4 weeks. _Maintenance dose_ • The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient's tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. • The initial maintenance dose is 16 mg/day and patients should be maintained on 16 mg/day for at least 4 weeks. • An increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment including evaluation of clinical benefit and tolerability. • In individual patients not showing an increased response or not tolerating 24 mg/day, a dose reduction to 16 mg/day should be considered. _Treatment withdrawal _ • There is no rebound effect aft Belgenin tamamını okuyun