PEACE SYRUP

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Disponibil de la:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (nume internaţional):

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Unități în pachet:

60mlUnits mL; 100mlUnits mL; 120 ml Units mL; 60 ml mL; 100 ml mL; 4000 ml Units mL; 120 ml Units mL; 100 ml Units mL; 60 ml Units mL

Produs de:

Y.S.P. INDUSTRIES (M) SDN BHD

Prospect

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1 |
PEACE SYRUP
Triprolidine hydrochloride/Pseudoephedrine hydrochloride (1.25mg/5mL /
30mg/5mL)
WHAT IS IN THIS LEAFLET
1.
What PEACE SYRUP is used for
2.
How PEACE SYRUP works
3.
Before you use PEACE SYRUP
4.
How to use PEACE SYRUP
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
PEACE
SYRUP
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT PEACE SYRUP IS USED FOR
PEACE SYRUP is used for symptomatic relief
of sneezing, stuffy nose and runny nose caused
by
seasonal
allergic
and
other
unknown
causes.
HOW PEACE SYRUP WORKS
Triprolidine belongs to a class of medications
known as antihistamine. It works by blocking
the action of histamines, biological substances
in
the
body
that
produces
symptoms
of
sneezing, itching, watery eyes and runny nose.
Pseudoephedrine is a sympathomimetic agent
that
works
by
constricting
blood
vessels,
leading to a reduction in mucosal swelling and
nasal congestion.
BEFORE YOU USE PEACE SYRUP
_-When you must not use it _
You must not take PEACE SYRUP if you
have disease relating to heart or blood vessels,
endocrine
disorder
(hormone)
or
sensitive
towards this preparation of medication. People
on
monoamine
oxidase
inhibitor
(MAO)
treatment or within 2 weeks of stopping it
should avoid this medication.
_-Before you start to use it _
Consult your doctor and pharmacist regarding
the consumption of PEACE SYRUP if you are
pregnant or breastfeeding. Tell your doctor or
pharmacist if you are allergic to any other
medicines or you have any other health related
problems such as:
- narrow-angle glaucoma (angle closure eye
disease due to increased pressure inside eyes)
- pyloroduodenal obstruction (gastric outflow
obstruction)
-
prostatic
hypertrophy
(enlargement
of
prostate gland)
- diabetes (high blood glucose in blood)
- ischemic heart disease
-hyperthyroidism
(overactive
thyroid
hormone)
-
severe
impairment
of
kidney
or
liver
function.
_-Taking other medicines _
Tell your doctor if

Caracteristicilor produsului

ATTACHMENT 1
PEACE
SYRUP
Peace
Syrup
contains
the
antihistamine
triprolidine
hydrochloride,
and
the
potent
decongestant
pseudoephedrine
hydrochloride.
Peace
Syrup
provides
prompt
relief
of
nasal
congestion due to cold and allergy.
INGREDIENT(S)
Each 5ml contains:
Pseudoephedrine
HCl
......................................................
30mg
Triprolidine
HCl
............................................................
.25mg
1
Preservatives:
Sodium
Benzoate
............................................................
25mg
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMICS
AND
PHARMACOKINETICS):
1.
Triprolidine is a competitive histamine H
1
-receptor antagonist. In
the
guinea
pig
ileum,
triprolidine
is
twice
as
active
as
chlorpheniramine.
Triprolidine
is
five
times
more
active
than
mepyramine
in
protecting
against
histamine
induced
bronchospasm.
2.
Being an alkylamine H
1
-receptor antagonist, triprolidine has less
anticholinergic and sedative activity than the phenothiazines.
3.
Pseudoephedrine is a sympathomimetic agent with direct and
indirect effects on adrenergic receptors. It has agonist activity at
both
β
1
and
β
2
-adrenoreceptors, leading to increased cardiac
output and to relaxation of bronchial smooth muscle. Its action
on
α
-adrenoreceptors
in
the
mucosa
of
the
respiratory
tract
produce a degree of vasoconstriction which leads to a reduction
in mucosal edema.
4.
Triprolidine
is
promptly
absorbed
and
rapidly
reaches
a
therapeutic
level.
After
oral
administration,
peak
plasma
concentrations are attained after 1.9 ± 0.6 hours. It is widely
distributed
throughout
the
body
with
an
apparent
volume
of
distribution of 8.7 ± 7.8L/kg. Triprolidine is highly (90%) bound
to plasma proteins; its mean half life is 3.0 hours.
5.
Pseudoephedrine is rapidly and completely absorbed from the
gastrointestinal
tract
following
oral
administration,
with
no
presystemic metabolism. It acheives peak plasma concentration
between 1 and 3 hours. It is eliminated largely unchanged in the
urine (55~90%) in 24 hours, and has plasma half