PROLIDIN SYRUP

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

Unit dalam pakej:

60 ml

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
PROLIDIN SYRUP
Triprolidine Hydrochloride/Pseudoephedrine Hydrochloride (1.25mg/30mg
per 5ml)
1
What is in this leaflet
1.
What PROLIDIN SYRUP is used
for
2.
How PROLIDIN SYRUP works
3.
Before you use PROLIDIN
SYRUP
4.
How to use PROLIDIN SYRUP
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
PROLIDIN SYRUP
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
What PROLIDIN SYRUP is used
for
PROLIDIN SYRUP is used for the
temporary relief of nasal and sinus
congestion, sneezing and runny nose
associated with the common cold and
allergic rhinitis (inflammation of the
mucous membrane inside the nose).
How PROLIDIN SYRUP works
Triprolidine Hydrochloride is an
antihistamine which works by
blocking a certain natural substance
(histamine) that your body makes
during an allergic reaction. The
antimuscarinic action provides a
drying effect on the lining of nasal
cavity.
Pseudoephedrine Hydrochloride is a
decongestant. It works by narrowing
the blood vessels to decrease swelling
and congestion.
Before you use PROLIDIN SYRUP
- When you must not use it
Do not use PROLIDIN SYRUP if:
 You are allergic or hypersensitive to
any ingredients in this product.
 You are being treated with
monoamine oxidase inhibitors
(MAOIs) for depression.
 Use of antihistamines in new-born or
premature infants as they have
higher risk to antimuscarinic effects,
such as Central Nervous System
excitation and convulsion.
 You have blood clot inside a blood
vessel of the heart.
 You have excessive amount of
thyroid hormones.
Pregnancy and lactation
Tell your doctor or pharmacist if you
are pregnant, planning to get pregnant
or breastfeeding. Use is not
recommended during breastfeeding
due to the risk of excitement or
irritability in infants. Antihistamines
may block the milk production. Ask
your doctor for advice before using
any medicines.
- Before you start to use it
Tell your doctor or pharmacist before
using this medicine if you

Ciri produk

PROLIDIN SYRUP
MAL19910177AZ
DESCRIPTION:
SYRUP
Colour
:
Red
Flavour
:
Cherry
CONTENT:
Each 5 ml Contains:
Triprolidine HCl ..................... 1.25 mg
Pseudoephedrine HCl ................. 30 mg
Preservatives: Sodium Benzoate 0.1% w/v & Methyl Paraben 0.1% w/v &
Propyl Paraben 0.01% w/v.
PHARMACODYNAMICS:
Triprolidine HCl
It is an antihistamine which acts by competing with histamine for
Hi-receptor, but do not reverse responses mediated
by histamine alone. The antimuscarinic action provides a drying effect
on the nasal mucosa.
Pseudoephedrine HCl
It is a sympathomimetic amine with direct and indirect effects on
adrenoreceptors. It constricts the peripheral vessels,
thus raising the blood pressure. It relaxes the bronchioles and
decreases the tone and peristaltic movements of the
intestine but contracts the uterus.
PHARMACOKINETICS:
Triprolidine HCl is absorbed after oral administration and distributes
throughout the body. It is metabolised in the liver
and excreted in the urine.
Pseudoephedrine HCl is rapidly and completely absorbed after oral
administration. After an oral dose of 180 mg, peak
plasma conc. of 500 to 900 ng/ml are attained in 1 to 3 hours. Plasma
half-life after an oral dose is 5 to 8 hours which
may be increased in subjects with alkaline urine and decreased in
subjects with acid urine. The volume of distribution
is 2 to 3 litres/kg body-weight. It is metabolised by N-demethylation
to a small extent. About 70% of a dose is excreted
in the urine in 36 hours with less than 1% as norpseudoephedrine and
the remainder as unchanged drug.
INDICATIONS:
For the temporary relief of nasal and sinus congestion, sneezing and
rhinorrhoea associated with the common cold and
allergic rhinitis.
RECOMMENDED DOSAGE:
Adults and children over 12 years
:
2 teaspoonfuls (10 ml).
Children 7 - 12 years
:
1 teaspoonful (5 ml).
Children 2 - 6 years
:
½ teaspoonful (2.5 ml).
All to be taken 4 to 6 hourly.
WARNING (When Used For Treatment of Cough and Cold):
1.
Not to be used in children less than 2 years of age.
2.
To be