FELDENE 20MG CAP; piroxicam, anti inflammatory agents .
ACTIVE-INGREDIENT OF FELDENE 20MG CAP
Each hard gelatin capsule contains : 20 mg Piroxicam.
INDICATION OF FELDENE 20MG CAP
Piroxicam is indicated for the symptomatic treatment of osteoarthritis, rheumatoid polyarthritis and ankylosing spondylitis in childern over 16 years, adults and elderly patients less than 80 years. Due to its tolerability profile , piroxicam should not be used as a first line treatment when NSAID treatment is indicated. The decision to prescribe a medicinal product containing piroxicam should be based on an assessment of all the risks specific to each patient
DOSAGE OF FELDENE 20MG CAP
Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet
Ask your pharmacist or doctor for help if you do not understand the instructions on the box .
The recommended dose is : –
medicinal products containing piroxicam should be prescribed by doctors with experiencein diagnosing and treating patients with inflammatory and degenerative rheumatic diseases . The maximum recommended daily dose is 20 mg. undesirable effects can be minimised by using the lowest possible dose to relieve the symptoms during the shortest treatment period. the treatment’s benefit and the safety of use should be reassessed within 14 days . if continuation of treatment is required , then treatment should be frequently reassessed. since piroxicam has been associated with an increased risk of gastrointestinal complications , the option of using a treatment to protect the gastric mucosa (such as misoprostoi or a proton pumb inhibitor ) should be seriously considered , particularly in elderly patients . feldene gel 0.5 % the quantity of feldene 0.5 % gel to be used depends on the surface of the area to be treated . a maximum of 3 cm of gel should be applied 3-4 times / day . general recommendation / use in elderly patients over 60 years : as with all NSAIDs , titration for minimal effective dose and evaluation of the opportunity to pursue treatment in time are recommended , especially in case of long term therapy . such rational therapeutic approach often helps minimize the implications of undesirable effects . this is especially true when treating elderly patients over 60 years and / or patients in poor health who represent a population at risk that may present with a pathology predisponsing to complications , notably of the digestive system . in elderly patients , the lowest effective dosage should be used . therapy should be initiated with a dose of 10 mg daily . a dosage regimen of 20 mg daily is only acceptable if the response to the 10 mg dose is insufficient and has to be limited to a short term treatment because of the higher risk for haemorrhages and GI ulcers piroxicam should not be used in elderly patients over 80 years of age .renal impairment lower doses of piroxicam should be considered in patients with impaired renal function , and they should be carefully monitored . – paediatric populations : dosage recommendations and indications for use in children under age 16 have not been established . dosage recommendations for children over 16 years are the same as for adults . feldene 0.5 % gel may be used in children over 12 years of age . – combined use : the combined total daily dosage of piroxicam administrated as hard capsules , dispersible tablets , flash tablets , suppositories and solution for injection should not exceed the maximum recommended daily deosage as indicated above .
OVER-DOSAGE OF FELDENE 20MG CAP
CONTRA-INDICATION OF FELDENE 20MG CAP
hypersensitivity to active substance , and history of cutaneous reaction ( regardless of severity ) to piroxicam , other NSAIDs , acetysalicylic acid or other drugs or to any the excipients . Antecedents of symptoms of asthma , nasal polyps ,angioedema further a treatment with piroxicam , other AINS or acetysalicylic acid . Antecedents of any type of severe allergic drug reaction , particularly cutanenous reactions such as erthyema multiforme, stevens-johnson syndrome and toxic epidermal necrolysis (lyell’s syndrome ) . history of gastrointestinal ulcer , haemorrahage or perforation . patients presenting a history gastrointestinal disorders predisposing them to haemorrhagic problems such as ulcerative colitis , crohn’s disease , gastrointestinal cancers or diverticulitis . patients presenting progressive peptic ulcer , an inflammatory gastrointestinal disorder or gastrointestinal haemorrhage . concomitant use of other NSAIDS ; including COX -2 selective inhibitors and acetylsalicylic acid , at analgesic doses . concomitant use of anticoagulants . – patients with sever heart failure . – patients with sever renal failure .-patients with sever hepatic failure .-treatment of peri-operative pain in the setting of coronary artery bypass graft (GABG) surgery . – during the first and third trimesters of pregnancy .
STORAGE OF FELDENE 20MG CAP
Keep out of the sight and reach of children. For storage conditions : please look at the outer label.
PACK OF FELDENE 20MG CAP
Carton box containing 2 (PVC/Aluminium) blisters and inner leaflet.
FELDENE 20MG CAP MANUFACTURED BY
Catalent UK Swindon Zydis Limited, Frankland road, Bisgrove, Swindon, Wiltshire, SN5 8RU – United Kingdom. Manufacutred packed & released by: Plizer, Egypt.