FEDAC TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

PSEUDOEPHEDRINE HYDROCHLORIDE; Tripolidine Hydrochloride

Boleh didapati daripada:

DCH AURIGA (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

PSEUDOEPHEDRINE HYDROCHLORIDE; Tripolidine Hydrochloride

Unit dalam pakej:

10x10x10 Tablets

Dikeluarkan oleh:

PT Actavis Indonesia

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
FEDAC TABLET
_ _
Triprolidine HCl, Pseudoephedrine HCl (2.5mg, 60mg)
1
‘’WHAT IS IN THIS LEAFLET
1.
What Fedac is used for
2.
How Fedac work
3.
Before you use Fedac
4.
How to take Fedac
5.
While you are using Fedac
6.
Side effects
7.
Storage
and
disposal
of
Fedac
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
FEDAC IS USED FOR
Fedac
is
used
to
relieve
the
symptoms
of
colds,
flu
and
allergies including runny nose,
watery
eyes,
nasal
congestion
and blocked sinuses.
HOW
FEDAC WORK
Fedac contains 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.
BEFORE YOU USE FEDAC
_-When you must not use it _
Do not take Fedac if:
•
You
are
allergic
(hypersensitive)
to
pseudoephedrine hydrochloride,
triprolidine
hydrochloride
or
any of the other ingredients
•
you
have
very
high
blood
pressure or severe heart disease.
•
you
are
taking
drugs
for
depression
known
as
Monoamine Oxidase Inhibitors
(MAOIs)
within
the
last
two
weeks.
•
you
have overactive thyroid
(thyroid
producing
too
much
thyroid hormone)
• You are pregnant, likely to get
pregnant, or are breast-feeding
• You are consuming alcohol
_-Before you start to take it _
You
should
check
with
your
doctor
or
pharmacist
before
taking Fedac if:
•
you
are
pregnant
or
breastfeeding
If you are not sure if any of the
above apply to you, talk to your
doctor
or
pharmacist
before
taking Fedac.
Children
• Not to be used in children less
than 2 years of age.
• To be used with caution and
on
doctor’s
or
pharmacist’s
advice in children 2 to 6 years
of age.
_-Taking other medicines_
Please
tell
your
doctor
or
pharmacist if you are taking or
have
recently
taken
any
other
medicines, including medicines
obtained without a prescription,
including the following:
•Sedatives (drugs used to treat
anxiety and tension).
•

Ciri produk

AAAN8686 - Fedac All strengths -, PIL, Malaysia
03
28.01.2022
DD
09.06.2022
DD
120 x 208 mm
Actavis Jakarta
6 pt
Profile
Black
FEDAC
PRODUCT DESCRIPTION:
Tablets
: Light pink, round and flat tablets, 8 mm diameter with score line
and “DHA” logo.
Syrup
: Clear mixture, yellow in colour, sweet taste with orange flavour.
COMPOSITION:
1) Tablets :
Triprolidine HCI BP
2.5mg/tablet
Pseudoephedrine HCI BP
60mg/tablet
2) Syrup :
Triprolidine HCI BP
1.25mg/5ml
Pseudoephedrine HCI BP
30mg/5ml
Preservatives:
Methyl hydroxybenzoate
0.15% w/v
Propyl hydroxybenzoate
0.015% w/v
PHARMACOLOGY:
Triprolidine is an antihistamine which competes with histamine for
H1-receptor sites on effector cells. It
prevents but does not reverse responses mediated by histamine alone.
Its anti-cholinergic actions provide
a drying effect on the nasal mucosa. Pseudoephedrine acts on
alpha-adrenergic receptors in the mucosa of
the respiratory tract, producing vasoconstriction. It shrinks swollen
nasal mucous membrane, reduces tissue
hyperemia, oedema and nasal congestion, and increases nasal airway
patency. Also drainage of sinus
secretions may be increased and obstructed eustachian ostia may be
opened.
INDICATIONS:
Symptomatic treatment of nasal and respiratory congestion, common
cold, acute sinusitis, allergic rhinitis.
RECOMMENDED DOSAGE:
Tablet :
Adults :
1 tablet 3 times a day
Syrup :
Adults and children over 12 years: 2 teaspoonfuls 3 times a day.
Children :
6 - 12 years: 1 teaspoonful,
2 - 5 years: ½ teaspoon.
Doses to be taken 3 times a day.
Note: 1 teaspoonful is equal to 5ml.
Route of administration : Oral
WARNING:
When Fedac Syrup is used for treatment of cough and cold:
Not to be used in children less than 2 years of age.
To be used with caution and on doctor’s or pharmacist’s advice in
children 2 to 6 years of age.
ADVERSE EFFECTS:
Drowsiness, dryness of mouth, nervousness, restlessness, trouble in
sleeping.
PRECAUTIONS:
Patients sensitive to one antihistamine or sympathomimetic may be
sensitive to others. Triprolidine may
cause