ACTIMIN TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Boleh didapati daripada:

DUOPHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Unit dalam pakej:

1000 Tablets

Dikeluarkan oleh:

DUOPHARMA (M) SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RIMUP) _
1
ACTIMIN TABLET
Triprolidine Hydrochloride / Pseudoephedrine Hydrochloride (2.5mg /
60mg)
WHAT IS IN THE LEAFLET?
1.
What ACTIMIN is used for
2.
How ACTIMIN works
3.
Before you use ACTIMIN
4.
How to use ACTIMIN
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ACTIMIN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
WHAT ACTIMIN IS USED FOR
This medicine is used to treat
all
disorders
of
the
upper
respiratory tract. These include:
•
Allergic rhinitis
(inflammation of nasal
airways)
•
Nasal congestion
•
Hay fever
•
Common cold
•
Otitis media
(middle ear infection)
HOW ACTIMIN WORKS
The
tablets
contain
pseudoephedrine hydrochloride,
which
is
a
decongestant
that
relieves
nasal
and
sinus
congestion
and
triprolidine
hydrochloride
which
is
an
antihistamine
that
helps
stop
sneezing,
runny
nose
and
watery eyes.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you. Your doctor may have
prescribed it for another reason.
BEFORE YOU USE ACTIMIN
_When you must not take it _
Do not take this medicine if
you have an allergy to:
•
Tripolidine hydrochloride,
pseudoephedrine
hydrochloride or any of
the other ingredients listed
at the end of this leaflet
under Product description
•
any
other
similar
medicines
Do not take ACTIMIN if you:
•
have
very
high
blood
pressure
•
have severe heart disease
•
have
ever
had
a
bad
reaction
to
any
of
the
ingredients
•
are taking, or have taken in
the last two weeks, drugs
for
depression
known
as
Monoamine
Oxidase
Inhibitors (MAOIs).
•
are taking furazolidone (an
antibacterial agent)
If any of these apply to you,
get
advice
from
a
doctor
or
pharmacist.
Do not take this medicine after
the expiry date printed on the
pack or if the packaging is torn
or shows signs of tampering. If
it has expired or is damaged,
return it to your pharmacist for
disposal.
If you are not sure whether you
should
start
taking
this
medicine, talk t

Ciri produk

[DUOPHARMA (M) SDN BHD]
ACTIMIN
DESCRIPTION: ACTIMIN TABLET is a 7mm, round, blue tablet, scored on
one side and marking ‘d’ on the other side.
COMPOSITION: Each tablet contains Triprolidine Hydrochloride 2.5mg and
Pseudoephedrine Hydrochloride 60mg.
PHARMACOLOGY: Antihistamine and decongestant.
TRIPROLIDINE: Absorption and Fate: In general, antihistamines are
readily absorbed from the gastro-intestinal tract, metabolised in the
liver, and excreted usually
mainly as metabolites in the urine.
PSEUDOEPHEDRINE: Absorption and Fate: Pseudoephedrine is readily and
completely absorbed from gastro-intestinal tract. It is resistant to
metabolism by
monoamine oxidase and is largely excreted unchanged in the urine. It
has a half-life of several hours; elimination is enhanced and
half-life accordingly shorter in
acid urine.
INDICATIONS: Indicated in all disorders of the upper respiratory tract
including the sinuses, and Eustachian tubes which are benefited by
taking a potent
decongestant and antihistamine. These include allergic (seasonal)
rhinitis, vasomotor (perennial) rhinitis, hay fever, nasal congestion,
and the common cold.
Actimin may be of value in the conservative management of secretory
otitis media (“glue ear” and in helping to minimize gagging in
patients undergoing dental
procedures.
Because Actimin contains pseudoephedrine urinary retention may
occasionally occur in male subjects where prostatic enlargement is
present.
Fixed drug eruption
due to pseudoephedrine, taking the form of erythematous nummular
patches, and lichenoid skin eruption due to triprolidine have been
reported but both these reactions should be regarded as rare events.
Rarely, sleep disturbances and hallucinations have been reported.
RECOMMENDED DOSAGE:
ADULTS AND CHILDREN OVER 12 YEARS: One tablet, 3 – 4 times as
needed.
CHILDREN 6 – 12 YEARS: ½ tablet 3 – 4 times a day as needed.
ROUTE OF ADMINISTRATION: Oral
CONTRAINDICATIONS: Actimin is contraindicated in individuals, who have
previously exhibited intolerance to it or to pse