INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo IBUNATE 200 mg TABLETS

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

IBUNATE 200 mg TABLETS

COMPOSITION:
Each tablet contains 200 mg
Ibuprofen

PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Antirheumatics (anti-inflammatory agents)

PHARMACOLOGICAL ACTION:
Ibuprofen is a propionic acid derivative and has anti-inflammatory, analgesic and anti-pyretic properties. Ibuprofen is absorbed following oral administration, and peak concentrations are observed after 1 to 2 hours. The half-life in plasma is about 2 hours. Ibuprofen is extensively bound to plasma-proteins. It is rapidly excreted in the urine, approximately 90% of the dose being recovered as metabolites and their conjugates. Ibuprofen passes slowly into the synovial spaces, remaining there in higher concentrations, as the plasma concentration of Ibuprofen declines.

INDICATIONS:
Osteoarthritis, rheumatoid arthritis and other musculoskeletal disorders

CONTRA-INDICATIONS:
Hypersensitivity to Ibuprofen. Use in Pregnancy and lactation is not recommended. Heart failure. History of gastro-intestinal bleeding or perforations (PUBs) related to previous NSAIDs. Active or history of recurrent ulcer/haemorrhage/perforations.

WARNING:
Ibunate 200 mg Tablets should be given with care to patients with asthma or bronchospasm, cardiovascular disease, peptic ulceration, bleeding disorders or a history of such ulceration, renal failure and in those receiving coumarin anticoagulants. Because of the possibility of cross-sensitivity due to structural relationships, which exist among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds. Serious interactions have been reported after the use of high dose methotrexate with Ibuprofen. Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with Ibunate 200 mg tablets. The risk of gastrointestinal bleeding or perforation (PUBs) is higher with increasing doses of Ibunate 200 mg tablets, in patients with a history of ulcers, and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving Ibunate 200 mg tablets, treatment with Ibunate 200 mg tablets should be stopped. Ibunate 200mg tablets should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. Ibunate 200mg tablets should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation (PUBs) which may be fatal.

INTERACTIONS
Serious interactions have been reported for the use of high dose methotrexate with Ibuprofen.
NSAIDs: Use of two or more NSAIDs concomitantly could result in an increase in side-effects.
Corticosteroids: Increased risk of gastrointestinal-ulceration or bleeding (PUBs).
Anti-coagulants: Ibunate 200mg tablets may enhance the effects of anti-coagulants such as warfarin.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding.

PREGNANCY AND LACTATION:
Use in Pregnancy and lactation is not recommended. Regular use of non-steroidal anti-inflammatory drugs 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 new born. The onset of labour may be delayed and its duration increased.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Acute: 1 200 mg to 2 400 mg per day in divided doses.
Maintenance: 600 mg to 1 200 mg per day in divided doses.
The total daily doses should not exceed 2 400 mg per day. The tablets should be taken with food or milk to minimise gastro-intestinal side effects. If gastro-intestinal disturbance occurs, Ibunate 200 mg Tablets should be given with food or milk. Use the lowest effective dose for the shortest possible duration of treatment.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The most commonly observed side effects are gastro-intestinal in nature: Peptic ulceration and gastro-intestinal bleeding (sometimes fatal), nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, gastritis. Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Other side effects include headache, dizziness, nervousness, skin rashes, pruritis, tinnitus, depression, drowsiness, insomniaand blurred vision and other ocular reactions, oedema, hypertension and cardiac failure.Hypersensitivity reactions, bronchoconstrictionespecially in asthmatics, abnormalities of liver function tests,impairment of renal function including interstitial nephritis or the nephrotic reversible renal failure has been reported. In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The most likely symptoms are epigastric pain and nausea.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Pink, round, biconvex, film coated tablets
.

PRESENTATION:
Patient ready packs of 15 and 84.
Plastic Containers of 20, 30, 100, 500 and 1000 tablets.

STORAGE INSTRUCTIONS:
Store in a cool dry place below 25ºC. Protect from light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
29/3.1/0727

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION: (NAAM EN BESIGHEIDADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT)
Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300

www.gulfdrug.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
OCTOBER 1994

New addition to this site: July 2010
Source: Pharmaceutical Industry

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