Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Aceclofenac
CST Pharma Ltd
M01AB16
Aceclofenac
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5055946801100
ARTWORK INFORMATION PANEL DESCRIPTION: PRINTING COLOURS NON PRINTING COLOURS INLINE CONTROL CODE COLOUR REFERENCE IN PMS BRIDGE EQUATE WITH CMYK PROOF: REGULATORY TEXT: ITEM NUMBER: MATERIAL SIZE: DESIGNER: FONTS: DATE: MANUFACTURER’S TECHNICAL CHECK: Manufacturer confirms the printability and technical compliance of this packaging material for correct use during packaging process. Date and Signature PIL Preservex 60 tab GB Mock Up uk-pl-preservex-04.2018.docx Graphik semibold, Graphik medium, Graphik regular, Graphik light Laura Garcia - LuDesign Mock Up 160x250 (x2) 12.11.2018 4 Die cut Black 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Preservex is and what it is used for 2. What you need to know before you take Preservex 3. How to take Preservex 4. Possible side effect 5. How to store Preservex 6. Contents of the pack and other information 1. WHAT PRESERVEX IS AND WHAT IT IS USED FOR Preservex belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). They have anti-inflammatory and painkiller properties causing a lowering of swelling, redness (inflammation) and pain. The medicine/active ingredient of Preservex is aceclofenac. Preservex works by blocking the production of hormone-like substances called prostaglandins. Prostaglandins have many functions in the body including an important role in both the way the body responds to inflammation and also the reabsorption of calcium in some diseases of the bone Preservex is used to relieve pai Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PRESERVEX® 100 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of aceclofenac. 3 PHARMACEUTICAL FORM Preservex film-coated tablets 100 mg are presented as white round film-coated tablets, 8 mm in diameter. 4.1 THERAPEUTIC INDICATIONS Preservex is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Preservex film-coated tablets are supplied for oral administration. Posology When Preservex was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4 Special warnings and precautions for use). ADULTS The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening. PAEDIATRIC POPULATION There are no clinical data on the use of Preservex in children and therefore it is not recommended for use in children. ELDERLY The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of the serious 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. The pharmacokinetics of Preservex are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency. RENAL INSUFFICIENCY There is no evidence that the dosage of Preservex needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see also Precautions). HEPATIC INSUFFICIENCY There is some evidence that the dose of Prese Διαβάστε το πλήρες έγγραφο