Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Meloxicam
Waymade Healthcare Plc
M01AC06
Meloxicam
15mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100
REGULATORY AUTHORITY APPROVAL CONFIRMATION Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Waymade Plc have license approval to distribute this component for sale in the relevent market. Accept Artwork ................................................................ Reject Artwork ................................................................. Signature .......................................................................... Name ................................................................................ Date ................................................................................... PAGE 1 OF 2 Received Date: 10/08/2016 CDL JOB No. : 62321 Required By : 10/08/2016 PRODUCT NAME: Meloxicam Tabs 7.5 mg & 15 mg PIP CODE: GB 724-8255-APIL COMPONENT: Leaflet SIZE: 210x543 mm MARKET: Great Britain PRODUCT SITE: TBC SCALE: 100% COLOURS: Black DATE: 10/08/2016 FONT SIZE: 10 pt VERSION NO: 6 AMENDED BY: CH PROJECT: Sovereign Medical READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Please 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 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. WHAT IS IN THIS LEAFLET 1. What Meloxicam Tablets are and what they are used for 2. What you need to know before you take Meloxicam Tablets 3. How to take Meloxicam Tablets 4. Possible side effects 5. How to store Meloxicam Tablets 6. Contents of the pack and other information 1. WHAT MELOXICAM TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Meloxicam 7.5 mg and 15 mg Tablets (referred to as Meloxicam Tablets in this leaflet). M Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Meloxicam 15 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 15 mg meloxicam _ _ Excipients of known effect: Each tablet contains 86 mg of lactose monohydrate. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Yellow, round, flat, uncoated tablet with bevelled edge. Scored from one side, flat from the other side. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Short-term symptomatic treatment of exacerbations of osteoarthrosis. Long term symptomatic treatment of rheumatoid arthritis or ankylosing spondylitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Exacerbations of osteoarthrosis:_ 7.5 mg/day. If necessary, in the absence of improvement, the dose may be increased to 15 mg/day. _Rheumatoid arthritis, ankylosing spondylitis: _15 mg/day. According to the therapeutic response, the dose may be reduced to 7.5 mg/day (see also section ‘Special populations’ below). DO NOT EXCEED THE DOSE OF 15MG/DAY. Special populations _Elderly: _ The elderly are at an increased risk of the consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. _ _ _Elderly patients and patients with increased risks for adverse reaction (see section 5.2):_ The recommended dose for long term treatment of rheumatoid arthritis and ankylosing spondylitis in elderly patients is 7.5 mg per day. Patients with increased risks for adverse reactions should start treatment with 7.5 mg per day (see section 4.4). _Renal impairment (see section 5.2):_ In dialysis patients with severe renal failure, the dose should not exceed 7.5 mg per day. No dose reduction is required in patients with mild to moderate renal impairment (i.e. patients with a creatinine clearance of greater than 25 ml/min). (For pati Przeczytaj cały dokument