RETAFYLLIN 200MG TABLET (CONTROLLED RELEASE)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

THEOPHYLLINE

Available from:

ORION PHARMA (MY) SDN. BHD.

INN (International Name):

THEOPHYLLINE

Units in package:

100 Tablets

Manufactured by:

ORION CORP

Patient Information leaflet

Not applicable

Summary of Product characteristics

1. NAME OF THE MEDICINAL
PRODUCT
RETAFYLLIN 200MG TABLET
(CONTROLLED RELEASE)
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
200 mg controlled release tablet: theophylline
anhydrate 200 mg
Excipient(s) with known effect:
One
200
mg
controlled
release
tablet
contains up to 10 mg hydrogenated castor
oil. For the full list of excipients, see section
6.1.
3. PHARMACEUTICAL FORMS
Retafyllin 200 mg controlled release tablets
are white, flat beveled edge tablets with a
score line. Each tablet contains anhydrous
theophylline 200 mg in a controlled- release
formulation.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For relief and for prevention of symptoms
from asthma and reversible bronchospasm
associated
with
chronic
bronchitis
and
emphysema.
4.2 POSOLOGY AND METHOD OF
ADMINISTRATION
Posology
_Adults:_
For the initial 3 days, 300 mg should be given
twice daily. After three days, the effect should
be assessed and the dose can be increased
to 450 mg twice a day or reduced to 150 mg
twice a day, according to the response of the
patient.
Some patients, whose symptoms worsen at
night or who have wheezing mainly in the
morning, may also benefit from once daily
dosing by taking the entire daily dose in the
evening.
_Hepatic _
_impairment, _
_cardiac _
_insufficiency, _
_viral infection and fever states:_
Recommended
initial
dose
for
patients
with
impaired
hepatic
function,
cardiac
insufficiency,
viral
infection
or
fever
condition is 200 mg two times a day, and the
subsequent incrementation should be made
at 100 mg steps. Careful monitoring of serum
theophylline concentration is recommended
(see section 4.4).
_Paediatric population:_
Children below 6 years: Retafyllin tablets
should not be used in children below 6 years
of age. Other dosage forms are available
that are more suitable for children aged less
than 6 years (8).
Administration at 8-hour intervals may be
needed
in
some
children
with
markedly
rapid
hepatic
metabolism
of
theophylline.
Following recommendation, based on the
body weight, can be used to initiate the
tre