INTAFLAM Tablets 400/325

Country: Տանզանիա

language: անգլերեն

source: Tanzania Medicinces & Medical Devices Authority

active_ingredient:

Ibuprofen , Paracetamol

MAH:

Intas Pharmaceuticals Limited, INDIA

INN:

Ibuprofen + Paracetamol

dosage:

400/325

pharmaceutical_form:

Tablets

manufactured_by:

Intas Pharmaceuticals Limited , INDIA

leaflet_short:

Physical description: White to off white, coloured, oblong shaped, biconvex uncoated tablet with scoring line on one side of the tablet; Local technical representative: Metro Pharmaceuticals Co. Limited (2698)

authorization_status:

Registered/Compliant

authorization_date:

2021-03-29

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Intaflam (Ibuprofen & Paracetamol Tablets)
2.
QUALITATIVE & QUANTITATIVE COMPOSITION
Each uncoated tablet contains:
Ibuprofen BP
400.0 mg
Paracetamol BP
325.0 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White to off white, colored, oblong shaped, biconvex uncoated, tablet
with bisecting line on
one side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For
the
temporary relief
of
mild
to
moderate pain
associated
with
migraine,
headache,
backache,
period
pain,
dental
pain,
rheumatic
and
muscular
pain,
pain
of
non-serious
arthritis, cold and flu symptoms, sore throat and fever. This product
is especially suitable for
pain which requires stronger analgesia than ibuprofen or paracetamol
alone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY
For short term-use only.
Undesirable effects may be minimized by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
The patient should consult a doctor if the symptoms persist or worsen
or if the product is
required for more than 3 days.
ADULTS
One tablet to be taken up to three times per day with water. Leave at
least six hours between
doses. If the one tablet dose does not control symptoms, a maximum of
two tablets may be
taken up to three times a day. Leave at least six hours between doses.
Do not take more than six tablets (3000mg Paracetamol, 1200mg
Ibuprofen) in any 24 hours
period. To minimize side effects, it is recommended that patients take
Intaflam with food.
ELDERLY
No special dosage modifications are required (see section 4.4).
The elderly are at increased risk of the serious consequences of
adverse reactions. If an NSAID
is considered necessary, the lowest effective dose should be used for
the shortest possible
duration.
The patient should
be monitored regularly for gastrointestinal bleeding during
NSAID therapy.
Not for use by children under 18 years.
METHOD OF ADMINISTRATION
For oral administratio