IBUPROFEN 200 BIOTECH TABLET

מדינה: דרום אפריקה

שפה: אנגלית

מקור: South African Health Products Regulatory Authority (SAHPRA)

זמין מ:

Biotech Laboratories (Pty) Ltd

כמות:

See ingredients

טופס פרצבטיות:

TABLET

הרכב:

EACH TABLET CONTAINS IBUPROFEN 200,0 mg

מצב אישור:

Registered

תאריך אישור:

1991-11-11

מאפייני מוצר

BIOTECH LABORATORIES (PTY) LTD
IBUPROFEN 200 BIOTECH
Each tablet contains 200 mg ibuprofen
1.3.1.1 Approved PI
Page 1 of 15
PROFESSIONAL INFORMATION FOR IBUPROFEN 200 BIOTECH
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
IBUPROFEN 200 BIOTECH tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg ibuprofen.
_Excipient with known effect:_
Contains sugar (30,0 mg lactose monohydrate per tablet).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Round biconvex, pink film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IBUPROFEN 200 BIOTECH is indicated for the treatment of mild to
moderate pain of inflammatory
origin and fever, including:
•
Soft tissue injuries such as sprains and pains
•
Headache
•
Back pain of musculo-skeletal origin
•
Fever
•
Muscular aches and pains
•
Menstrual pain
BIOTECH LABORATORIES (PTY) LTD
IBUPROFEN 200 BIOTECH
Each tablet contains 200 mg ibuprofen
1.3.1.1 Approved PI
Page 2 of 15
•
Dental pain
•
Pain associated with migraine
•
Earache.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
_ADULTS AND CHILDREN OVER 12 YEARS:_
Use the lowest effective dose for the shortest possible duration of
treatment.
The recommended dosage of IBUPROFEN 200 BIOTECH is 1 200 mg daily in
divided doses (1 to 2
tablets every four hours) for the relief of:
1)
Mild to moderate pain of:
•
Soft tissue injuries such as sprains and strains
•
Dental pain
•
Back pain of musculo-skeletal origin
•
Earache
•
Pain associated with migraine
•
Muscular aches and pains.
2)
Fever
3)
Menstrual pain
DO NOT EXCEED 6 TABLETS (1 200 MG) IN ANY 24 HOURS.
Once the acute phase has been brought under control, it is normal
practice to revert to a maintenance
dosage.
If symptoms persist for more than 7 days, consult your doctor.
_CHILDREN: _
Not to be given to children under 12 years.
_ _
METHOD OF ADMINISTRATION:
BIOTECH LABORATORIES (PTY) LTD
IBUPROFEN 200 BIOTECH
Each tablet contains 200 mg ibuprofen
1.3.1.1 Approved PI
Page 3 of