(and dosage form):
Each capsule contains 200 mg Ketoprofen in a controlled release delivery system.
A.3.1 Anti-rheumatics (anti-inflammatory agents).
Ketoprofen has analgesic, anti-inflammatory, and antipyretic properties and is an inhibitor of prostaglandin synthetase.
Ketoprofen is used in the treatment of rheumatic disorders such as ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis, other forms of non-infectious arthropathy, acute articular and periarticular disorders.
Ketoprofen should be used with caution in patients with a history of peptic ulcer and in those with impaired hepatic function. It should not be given to patients sensitive to ketoprofen, aspirin or to other non-steroidal anti-inflammatory agents known to inhibit prostaglandin synthesis. Ketoprofen should not be given to patients with a history of bronchial asthma or allergic disease.
MYPROFLAM* should be used with extreme caution in the elderly, particularly in patients with impaired renal function where dosage should be assessed individually.
Serious interactions have been reported after the use of high dose methotrexate with ketoprofen.
PREGNANCY AND LACTATION:
Safety in pregnancy and lactation has not been established.
Regular use of NSAIDs during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.
DOSAGE AND DIRECTIONS FOR USE:
The total daily dose of MYPROFLAM* should not exceed 200 mg i.e one capsule. The capsule should be swallowed whole with a full glass of water.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The most frequent adverse effects occurring with ketoprofen are gastro-intestinal disturbances; reactions range from abdominal discomfort, nausea and vomiting, and abdominal pain to serious gastro-intestinal bleeding or activation of peptic ulcer.
CNS-related side-effects include headache, dizziness, nervousness, tinnitus, depression, drowsiness, and insomnia. Hypersensitivity reactions may occur occasionally and include fever and rashes. Hepatotoxicity and aseptic meningitis which occur rarely may also be hypersensitivity reactions.
Ketoprofen can provoke bronchospasm in patients with asthma. Ketoprofen and other non-steroidal anti-inflammatory drugs may cause cystitis and haematuria. They may also cause acute renal failure, interstitial nephritis, and nephrotic syndrome.
Other adverse effects include anaemias, thrombocytopenia, neutropenia, eosinophilia, agranulocytosis, abnormalities in liver function tests, blurred vision, changes in visual colour perception, and toxic amblyopia.
In view of the products inherent potential to cause oedema, heart failure may be precipitated in some compromised patients.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.
Size "1" hard gelatine capsule with opaque pink cap and colourless transparent body containing white to whitish pellets.
Blisterpacks of 10, 30, or 60 capsules.
Store below 25°C. Protect from light and moisture. KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
South Africa: 25 May 1995
New addition to this site: May 2004
Source: Pharmaceutical Industry
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