ADVIL® TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ADVIL® TABLETS

COMPOSITION:
Each tablet contains:
Ibuprofe 200 mg
n
PHARMACOLOGICAL CLASSIFICATION:
A.2.7 Antipyretic and anti-inflammatory analgesics.

PHARMACOLOGICAL ACTION:
ADVIL is a non-steroidal compound with analgesic, anti-inflammatory and antipyretic activities.

INDICATIONS:
ADVIL is indicated for the relief of dental pain, menstrual pain, headache from musculo-skeletal origin, feverishness, and
muscular aches and pain.

CONTRA-INDICATIONS:
ADVIL is not recommended for use by pregnant women.

WARNINGS:
ADVIL should not be given to patients with bleeding disorders, cardiovascular disease, peptic ulceration or a history of
such ulceration. Caution is advised to those patients who are receiving coumarin anticoagulants. If you are breast-feeding,
seek the advice of a health professional before using this product. Patients who are allergic or sensitive to aspirin should
not be given ADVIL.

DOSAGE AND DIRECTIONS FOR USE:

Adults and Children over 12 years.
Initial Two tablets taken with water. Then if necessary, 1 or 2 tablets every four hours. Do not exceed 6 tablets in any 24
dose: hours. ADVIL must be taken with food or after meals.
Not to be given to children under 12 years.
Do not use continuously for more than 3 days for fever or more than 7 days for pain without consulting a doctor.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Dyspepsia, gastro-intestinal intolerance and bleeding may occur. Other side-effects include nervousness, skin rash, pruritus,
tinnitus, oedema, depression, drowsiness, insomnia, blurred vision and other visual field defects. Sensitivity reactions,
abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have been observed.
Acute reversible renal failure has been reported. ADVIL should be used with care in patients with impaired renal function.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

The most likely symptoms of overdosage are epigastric pain and nausea. If recently taken, gastric lavage will remove any
unabsorbed ibuprofen. Electrolytes may be corrected by intravenous infusions, if necessary. Dialysis may be done as Ibuprofen is
not strongly protein bound. There is no specific antidote to ADVIL.

IDENTIFICATION:
Pink, biconvex, film-coated tablets with a diameter of about 10,5 mm.

PRESENTATION:
Blister packs of 10, 20 and 30 tablets.

STORAGE INSTRUCTIONS:
Store in a well-closed container below 25 °C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
L/2.7/354
NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
[Co. Reg. No. 92/04769/07]Robbie de Lange Road, Wilsonia, EAST LONDON 5201