Simtec Tablet 10mg

Երկիր: Մալայզիա

Լեզու: անգլերեն

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

Ակտիվ բաղադրիչ:

CETIRIZINE HYDROCHLORIDE

Հասանելի է:

Duopharma Marketing Sdn. Bhd.

INN (Միջազգային անվանումը):

CETIRIZINE HYDROCHLORIDE

Միավորները փաթեթում:

500Tablet Tablets; 100 Tablet Tablets; 30 Tablet Tablets

Պատրաստված է:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Տեղեկատվական թերթիկ

_Consumer Medication Information Leaflet (RiMUP) _
1
SIMTEC TABLET
Cetirizine hydrochloride (10mg)
________________________________________________________________________________________________________
WHAT IS IN THIS LEAFLET
1.
What Simtec is used for
2.
How Simtec works
3.
Before you use Simtec
4.
How to use Simtec
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Simtec
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT SIMTEC IS USED FOR
Simtec relieves symptoms associated
with seasonal rhinitis (hay fever)
and
perennial
rhinitis
(occurs
throughout
the year) such as sneezing, irritated,
runny and blocked up nose, itchy, red
and watering eyes.
Simtec
is
also
used
to
relieve
symptoms
associated
with
a
skin
condition
called
urticaria;
these
symptoms
include
swelling,
redness
and itchiness of the skin.
HOW SIMTEC WORKS
Simtec belongs to a class of medicines
known
as
antihistamines.
Antihistamines
help
reduce
allergic
symptoms by preventing the effects of
a substance called histamine, which is
produced
by
the
body
during
an
allergic reaction.
Your
doctor
may
have
prescribed
Simtec for another reason. Ask your
doctor if you have any questions about
why Simtec has been prescribed for
you.
BEFORE YOU USE SIMTEC
-
_When you must not use it _
Do not take Simtec if you are allergic
to cetirizine hydrochloride or any of
the tablet ingredients listed at the end
of this leaflet.
_Pregnancy and breastfeeding _
The
safe
use
of
cetirizine
during
pregnancy has not been established. As
a
precaution,
Simtec
should
not
be
used
during
the
first
3
months
of
pregnancy. Do not use Simtec if you
are breastfeeding.
Do not use Simtec in children less than
3 years old.
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 you are not sure whether you should
start taking Simtec, talk to your doctor
or pharmacist.
_ _
-
_Before you start to use it _
Tell your doctor or pharmacist if you:
•
are aller

Ապրանքի հատկությունները

The safety and effectiveness of cetirizine in pediatric patients under
the age
of 2 years have not yet been established.
CONTRAINDICATIONS
Patients who have shown hypersensitivity to any of the constituents of
Simtec. Simtec is also contraindicated during lactation.
DRUG INTERACTIONS
There are no reports of hazardous interactions with other drugs to
date.
Nevertheless, Simtec should be used with caution if sedatives are also
being taken. Concomitant administration of Cetirizine with alcohol
does not
impair
psychomotor
performance
any
more
than
the
impairment
of
performance produced by alcohol alone.
RECOMMENDED DOSAGE, DOSAGE SCHEDULE AND ROUTE OF
ADMINISTRATION
_Adults:_ 10mg once daily.
_Children ≥ 6 years:_ 10 mg daily, either 5mg twice daily or 10mg
once daily.
_Children between 3 and 6 years:_ 5mg daily, either 2.5mg twice daily
or 5mg
once daily.
For patients with renal impairment, dosage should be reduced to 5mg
once
daily.
For patients with hepatic impairment, a dose of 5mg once a day is
recommended.
It is advisable to take the drug with a little liquid during the
evening meal
since the symptoms for which the product is given usually appear
during the
night. In patient affected by side effects, the dose may be taken as
5mg in
the morning and 5mg in the evening.
SYMPTOMS AND TREATMENT FOR OVERDOSAGE AND
ANTIDOTE(S)
Drowsiness can be a symptom of overdosage. There is no specific
antidote
for overdosage. Treatment should be symptomatic and supportive. This
may include induction of emesis, gastric lavage to decrease absorption
and
the use of saline cathartics to enhance elimination.
PHARMACEUTICAL INFORMATION
STORAGE CONDITIONS
Store below 30°C in a cool dry place.
Protect from excessive moisture.
Keep out of reach of children.
Jauhi daripada kanak-kanak.
SHELF LIFE
Please refer to outer package.
PACK SIZE/PACKAGE
Blister packs of 30's, 100's and 500's
Not all pack sizes available locally.
ROUTE OF ADMINISTRATION: ORAL.
PRODUCT REGISTRATION HOLDER:
DUOPHARMA MARKETING SDN. BHD.
Lot No. 2, 4, 6, 8 & 10, Jal