Axcel Iridin Plus Linctus

Country: Malaysia

Language: English

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

Active ingredient:

PHOLCODINE; TRIPROLIDINE HYDROCHLORIDE

Available from:

KOTRA PHARMA (M) SDN. BHD.

INN (International Name):

PHOLCODINE; TRIPROLIDINE HYDROCHLORIDE

Units in package:

60ml mL; 90ml mL

Manufactured by:

KOTRA PHARMA (M) SDN. BHD.

Patient Information leaflet

AXCEL IRIDIN PLUS LINCTUS
Pholcodine/Triprolidine HCl (5mg/1.25mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Axcel Iridin Plus Linctus
is used for.
2.
How Axcel Iridin Plus Linctus
works.
3.
Before you use Axcel Iridin Plus
Linctus.
4.
How to take Axcel Iridin Plus
Linctus.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Iridin Plus Linctus.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT AXCEL IRIDIN PLUS LINCTUS IS
USED FOR
Axcel Iridin Plus Linctus is used for
the relief of unproductive or irritating
coughs associated with common cold
and flu-like symptoms such as runny
nose, sneezing and watery eye.
HOW
AXCEL
IRIDIN
PLUS
LINCTUS
WORKS
Pholcodine is cough suppressant and
has
a
mild
sedative
effect
which
relieves
local
irritation
of
the
respiratory tract over 8 to 10 hours.
Triprolidine
is
a
competitive
histamine H1-receptor antagonist. It
blocks
the
effects
of
the
naturally
occurring chemical histamine in your
body.
BEFORE YOU USE AXCEL IRIDIN PLUS
LINCTUS
_-When you must not use it _
Do not take Axcel Iridin Plus Linctus
if:
•
You
are
allergic
or
hypersensitive
pholcodine
or
triprolidine
or
any
other
component of Axcel Iridin Plus
Linctus.
•
Do
not
use
this
medicine
in
children under 2 years of age.
_-Before you start to use it _
Tell your doctor if:
•
You have respiratory problems.
•
You
have
liver
and
renal
impairment.
•
You are pregnant or lactating.
_ _
_ _
_-Taking other medicines _
You should tell your doctor if you are
taking the following medicine as it
may interact with your Axcel Iridin
Plus Linctus:
•
Alcohol
•
Medicines
used
to
treat
depression
•
Opioid analgesics
•
Antimuscarinic drugs
Taking
Axcel
Iridin
Plus
Linctus
with
a
benzodiazepine
(medicine
used as sedatives or to treat anxiety)
can
depress
your
central
nervous
system. Inform your doctor if you are
currently taking any benzodiazepine.
Seek medical attention immediately
if
you
or
the
person
taking
t

Summary of Product characteristics

concomitant use, but may occur later than that. Discontinue Axcel
Iridin
Plus
Linctus
if
serotonin
syndrome
is
suspected.
Adrenal Insufficiency:
Cases of adrenal insufficiency have been reported with opioid use,
more often following greater than one month of use. Presentation of
adrenal insufficiency may include non-specific symptoms and signs
including nausea, vomiting, decreased appetite, fatigue, weakness,
dizziness,
and
low
blood
pressure.
If
adrenal
insufficiency
is
suspected, confirm the diagnosis with diagnostic testing as soon as
possible. If adrenal insufficiency is diagnosed, treat with
physiologic
replacement dosing of corticosteroids. Wean the patient off of the
opioid
to
allow
adrenal
function
to
recover
and
continue
corticosteroid
treatment
until
adrenal
function
recovers.
Other
opioids may be tried as some cases reported use of a different
opioid without recurrence of adrenal insufficiency. The information
available does not identify any particular opioids as being more
likely to be associated with adrenal insufficiency.
Sexual Function / Reproduction:
Long term use of opioids may be associated with decreased sex
hormone
levels
and
symptoms
such
as
low
libido,
erectile
dysfunction, or infertility (See Postmarketing Experience).
Pregnancy & lactation:
No specific data on the use of triprolidine and pholcodine during
pregnancy and lactation. Hence it is not recommended for pregnant
women and nursing mothers unless the expected benefit to the
mother outweighs any potential risks to the fetus or infant.
SIDE EFFECTS:
Nausea and vomiting, drowsiness, skin rashes, with or without
irritation, have occasionally been reported. Dryness of mouth, nose
and throat may occur. After large doses, restlessness, excitement,
ataxia and respiratory depression may occur.
Postmarketing Experience:
Serotonin syndrome (See Warnings and Precautions)
Adrenal insufficiency (See Warnings & Precautions)
Androgen deficiency:
Cases of androgen deficiency have occurred with chronic use of
opioids. Chronic use of opioids may influ