INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
IBULEVE™ GEL

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

IBULEVE™ GEL

COMPOSITION:
Each 100 g of gel contains 5 g Ibuprofen
PHARMACOLOGICAL CLASSIFICATION:
A 3.1 Anti-rheumatics (anti-inflammatory)

PHARMACOLOGICAL ACTION:
Ibuprofen is a prostaglandin synthetase inhibitor, with analgesic and anti-inflammatory activities when applied topically.

INDICATIONS:
IBULEVE GEL is recommended as a topical anti-inflammatory and analgesic intended for the symptomatic relief of acute painful musculo-skeletal conditions caused by trauma such as sports injuries, sprains, strains and contusions.

CONTRA-INDICATIONS:
Not to be used in cases of hypersensitivity to any of the ingredients, particularly asthmatics and those who have previously shown hypersensitivity to aspirin or ibuprofen.
Not to be used on broken skin.
IBULEVE GEL is not recommended for use in children under the age of 14 years.
Not to be used during pregnancy or lactation.

WARNINGS:
Not to be used on broken skin and mucous membranes.

DOSAGE AND DIRECTIONS FOR USE:
Apply the gel to the affected areas, up to three times daily, or as directed by the physician. On each occasion apply only enough gel to thinly cover the affected area, and gently massage well into the skin, until completely absorbed. Do not use excessively. Do not cover the skin with bandages, plasters or any other dressings. Treatment should not normally continue for more than two weeks, unless recommended by a doctor.
The same dosage and dosage schedule applies to adults and children over 14 years of age.
Seek medical advice if symptoms persist.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Treatment should be discontinued if skin rashes or irritation occur. If IBULEVE GEL is applied to relatively large areas of skin, and over a prolonged period, the possibility of systematic effects cannot be excluded. When systematically absorbed, ibuprofen can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. For these reasons, patients with an active peptic ulcer, asthma, a history of renal problems, or intolerance to aspirin or ibuprofen taken orally, should seek medical advice before using IBULEVE GEL. Non-steroidal anti-inflammatory agents may interact with blood pressure lowering medicines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In the event of accidental overdosage, treatment is symptomatic and supportive.
Discontinue use if sensitivity reactions occur.

IDENTIFICATION:
Clear or translucent, aqueous, alcoholic gel. Odour slightly of alcohol.

PRESENTATION:
Membrane sealed, epoxy resin coated, collapsible aluminium tube, fitted with a screw cap (50 g of product).

STORAGE INSTRUCTIONS:
Store in a cool place (not exceeding 25°C) with the cap replaced tightly.
Keep out of reach of children.

REGISTRATION NUMBER:
31/3.1/0086

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 February 1997

New addition to this site: January 2005
Source: Pharmaceutical Industry
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