DOLPHIN K 50MG CAP; diclofenac sodium, anti inflammatory agents .
ACTIVE-INGREDIENT OF DOLPHIN K 50MG CAP
50 mg Diclofenac potassium .
INDICATION OF DOLPHIN K 50MG CAP
rheumatoid arthritis . Osteoarthrrosis . Low back pain . Migraine attacks . Acute musculo-skeletal disorders and trauma such as periarthritis ( especially frozen shoulder ) , tendinitis , tenosynovitis , bursitis , sprains , strains and dislocations ; relief of pain in fractures . ankylosing spondylitis . acute gout . control of pain and inflammation in orthropaediatric , dental and other minor surgery . pyrophosphate arthropathy and associated disorders .
DOSAGE OF DOLPHIN K 50MG 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 : –
posology and method of administration : for oral administration . To be taken preferably with or after food . The tablets should be swallowed whole with liquid . Undersirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms . in migraine an initial dose of 50 mg should be taken at the first signs of an impending attack . in cases where relief 2 hours after the first dose is not sufficient , a further dose of 50 mg may be taken . if needed , further doses of 50 mg may be taken at intervals of 4-6 hours , not exceeding a total dose of 200 mg per day . -adults : the recommended daily dose is 100 -150 mg in two or three divided doses , for milder cases , 75 – 100 mg , daily in two or three divided doses is usually sufficient . – children : for children over 14 years of age , the recommended daily dose is 75 – 100 mg in two or three divided doses , for the short term treatment of fever related to infections of the ear , nose or throat ( ENT ) and post – operative pain the following dosage should be given : children aged 9 years ( min, 35 kg BW ) or over and adolescents : should be given up to 2 mg/kg body weight per day in 3 divided doses , depending on the severity of the disorder . the use of diclofenac potassium 25 , 50 mg tablets in migraine attacks has not been established in children . elderly : the elderly 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 . children : for children of 12 years and over , the recommended daily dose is 75 – 100 mg in two or three divided doses . dolphin k 50 mg tablets should not be indicated for use in children less than 12 years of age .
OVER-DOSAGE OF DOLPHIN K 50MG CAP
symptoms : symptoms include headach , nausea , vomiting , epigastric pain , gastrointestinal bleeding , rarely diarrhoea , disorientation , excitation , coma , drowsiness , tinnitus , fainting , and occasionally convulsions , in rare cases of significant poisoning acute renal failure and liver damage are possible . therapeutic measure : patients should be treated symptomatically as required . within one hour of ingestion of a potentially toxic amount , activated charcoal should be considered . alternatively , in adults , gastric lavage should be considerd within one hour of ingestion of a potentially life-threatening overdose . good urine output should be ensured . renal and liver function should be closely monitored . patients should be observed for at least four hours after ingestion of potentially toxic amounts . frequent or prolonged convulsions should be treated with intravenous diazepam . other measures may be indicated by the patient’s clinical condition .
CONTRA-INDICATION OF DOLPHIN K 50MG CAP
hypersensitiviy to diclofenac or any of the excipients . Active , or history or recurrent peptic ulcer / haemorrhage ( two or more distinct episodes of proven ulceration or bleeding ) . NSAIDs are contraindicated in patients who have previously shown hypersensitivity reactioins ( e.g . asthma , rhinitis , angioedema , or ureticaria ) in response to ibuprofen , asprinin , or other non – steroidal anti inflammatory drugs . severe heart failure , hepatic failure and renal failure . history of gastro – intestinal bleeding or perforation , relating to previous NSAID therapy . during the last trimester of pregnancy .
STORAGE OF DOLPHIN K 50MG CAP
Store at temperature not exceeding 25 °C in a dry place .
PACK OF DOLPHIN K 50MG CAP
carton box containing 1,2,3,4,5,6& 10 strips (AL/PVC) each one contains 10 tablets + insert leaflet .
DOLPHIN K 50MG CAP MANUFACTURED BY
DELTA PHARMA S.A.E Tenth of Ramadan City , A.R.E.