Unicontin 600 controlled release tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

THEOPHYLLINE

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

THEOPHYLLINE

Unit dalam pakej:

100Tablet Tablets

Dikeluarkan oleh:

MODI-MUNDIPHARMA PRIVATE LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
UNICONTIN
TM CONTROLLED RELEASE
TABLETS
Theophylline (400mg, 600mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Unicontin
TM
_ _is used for
2.
How Unicontin
TM
works
3.
Before you use Unicontin
TM
4.
How to use Unicontin
TM
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Unicontin
TM
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT UNICONTIN
TM
IS USED FOR
Unicontin
TM
is used to treat and prevent
asthma
and
other
conditions
where
breathing is difficult.
HOW UNICONTIN
TM
WORKS
Unicontin
TM
contains
the
active
ingredient
theophylline,
which
causes
the airway muscle to relax and prevents
inflammation.
BEFORE YOU USE UNICONTIN
TM
-
_When you must not use it _
Do not take Unicontin
TM
tablets:

if you are allergic to theophylline,
aminophylline
or
to
any
ingredients of this medicine (listed
in Product Description).

if you have porphyria (inherited
genetic condition)

in children under 6 years of age
(less than 22kg) using medicine
called ephedrine.

in
children
under
6
months
of
age.
-
_Before you start use it _
Tell your doctor if you have allergies to
any
other
medicines,
foods,
preservatives
or
dyes
and
/or
if
you
have
or
ever
had
any
other
health
problems, including:

irregular or rapid heartbeat or any
other heart problems

any liver problems

any lung or breathing problems

thyroid problems

fever

any viral infections

any
stomach
problems
such
as
ulcer or acid reflux

seizures

very high blood pressure

you have taken large amounts of
alcohol or other substances which
can
affect
your
level
of
consciousness.

elderly
males
that
has
urinary
retention or at risk of developing
one,
for
example
in
individual
with prostate enlargement.
Your doctor or pharmacist can discuss
with
you
the
risks
and
benefits
involved.
_Pregnancy and Lactation _
This medicine is not recommended for
use in pregnancy.
Consult
your
doctor
before
taking
Unicontin
TM
tablets if you are

Ciri produk

For the use only of a Registered Medical Practitioner or a Hospital or
a Laboratory
R
x
Controlled Release Tablets of
Theophylline
UNICONTIN
TM 400/600
CONTINUS
TM
controlled release system
DESCRIPTION
UNICONTIN
TM
400/600 CONTINUS
TM
tablets for oral administration contain 400/600mg of
theophylline BP in a controlled release system which allows a 24-hour
dosing interval for appropriate
patients.
Unicontin 400:
Each white, round, flat, bevelled edges, scored uncoated tablets
engraved with ‘MM’ logo on one of
the facets and 'U/400' on the other.
Unicontin 600:
Each white, biconvex, scored uncoated caplets engraved with ‘MM’
logo on one of the facets and
'U/600' on the other.
CLINICAL PHARMACOLOGY
Theophylline has two distinct actions: smooth muscle relaxation (e.g.
bronchodilation) and
suppression of the response of the airways to stimuli (i.e.
non-bronchodilator prophylactic effects).
Studies suggest that bronchodilation is mediated by the inhibition of
two isozymes of
phosphodiesterase (PDE III and to a lesser extent, PDE IV) while
nonbronchodilator prophylactic
actions are probably mediated through one or more different molecular
mechanisms, that do not
involve inhibition of PDE III or antagonism of adenosine receptors.
Theophylline increases the force
of contraction of diaphragmatic muscles. This action appears to be due
to enhancement of calcium
uptake through an adenosine-mediated channel.
Serum Concentration-Effect Relationship: Theophylline is often thought
of as a drug which has a
particularly well-defined therapeutic range with concentration from
5-20 mcg/ml giving an optimum
compromise between efficacy and toxicity. Maintaining the peak serum
theophylline concentration
between 10-15 mcg/ml, will achieve most of the drug therapeutic
benefit with minimal risk &
adverse effect. At serum theophylline concentrations >20mcg/mL, both
the frequency and severity
of adverse reactions increase.
The pharmacokinetics of theophylline vary widely among similar
patients and cannot be predicted
by age, sex, body