ROTIFAR TABLET 10MG

Country: Malaysia

Language: English

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

Active ingredient:

LORATADINE

Available from:

DUOPHARMA (M) SDN. BHD.

INN (International Name):

LORATADINE

Units in package:

250Tablet Tablets; 50Tablet Tablets; 20Tablet Tablets; 100Tablet Tablets; 30Tablet Tablets; 500Tablet Tablets

Manufactured by:

DUOPHARMA (M) SDN. BHD.

Patient Information leaflet

_Consumer Medication Information Leaflet (RiMUP)_
1
ROTIFAR TABLET 10 MG
Loratadine (10mg)
WHAT IS IN THIS LEAFLET
1.
What Rotifar is used for
2.
How Rotifar works
3.
Before you use Rotifar
4.
How to use Rotifar
5.
While you are using it
6.
Side Effect
7.
Storage and disposal of Rotifar
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT ROTIFAR IS USED FOR
Rotifar
relieves
symptoms
associated
with
allergic
rhinitis
(allergic
inflammation
of
the
nasal
airways),
such as sneezing, runny or itchy nose,
and burning or itchy eyes.
Rotifar
can
also
be
used
to
relieve
symptoms
associated
with
a
skin
condition
called
urticaria;
these
symptoms include itching, redness and
lumps on the skin called hives.
HOW ROTIFAR WORKS
Rotifar 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.
Your
doctor
may
have
prescribed
Rotifar for another reason. Ask your
doctor if you have any questions about
why
Rotifar has
been
prescribed for
you.
BEFORE YOU USE ROTIFAR
_- When you must not use it_
_ _
Do not take Rotifar if you are allergic
to
loratadine
or
any
of
the
tablet
ingredients
listed
at
the
end
of
this
leaflet. If you have an allergic reaction,
you may get a skin rash, or experience
difficulty in breathing or faintness.
Do not use Rotifar if you are pregnant
or breastfeeding unless you and your
doctor or pharmacists have discussed
the risks and benefits involved.
Do not use Rotifar in children less than
2 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 Rotifar, talk to your doctor
or pharmacist.
-
_Before you start to use it_
_ _
Tell your doctor or pharmacist if you
have allergies to:
•
Any other medicines
•
Any other substances, such as
foods, preservatives or dyes.
Inform your doctor if you have liver
disea

Summary of Product characteristics

Page 1 of 2
[REVISION DATE: 14.05.2019
[DUOPHARMA (M) SDN BHD]
ROTIFAR TABLET 10MG
DESCRIPTION:
7.5mm in length, oval, scored on one side and marked 'RT' on the other
side, white to off-white tablet.
COMPOSITION:
Each tablet contains Loratadine 10 mg.
PHARMACODYNAMICS:
Loratadine is a potent, long-acting antihistamine with relative
selectivity for peripheral H1-receptors. It exhibits greater affinity
for peripheral H1-
receptors than for central H1-receptors. These properties account for
the observed lack of sedation. The incidence of sedation with
loratadine is
comparable to that of placebo. Antihistamines antagonize, in varying
degrees, most of the pharmacological effects histamines, including
urticaria
and pruritus. Also, the anticholinergic actions of most antihistamines
provide a drying effect on the nasal mucosa.
PHARMACOKINETICS:
ABSORPTION:
Onset of action: 1 hour.
Time to peak concentration: 1 to 21 hours; Descarboethoxyloratadine
(active metabolite) – 3 to 4 hours.
Time to peak effect: 4 to 6 hours.
Duration of action: At least 24 hours. The pharmacokinetics of
loratadine and descarboethoxyloratadine are independent of dose over
the dose
range of 10 to 40mg and are not altered by the duration of treatment.
In a single dose study, food increased the systemic bioavailability
(AUC) of
loratadine and descarboethoxyloratadine by approximately 40% and 15%,
respectively. The time to peak plasma concentration (T
max
) of loratadine
and descarboethoxyloratadine was delayed by 1 hour. Peak plasma
concentrations (C
max
) were not affected by food.
Geriatric: In a study involving twelve healthy geriatric subjects (66
to 78 years old), the AUC and peak plasma levels (C
max
) of both loratadine and
descarboethoxyloratadine were approximately 50% greater than those
observed in studies of younger subjects.
Chronic Renal Impairment: In a study involving 12 subjects with
chronic renal impairment (creatinine clearance ≤30mL/min) both AUC
and C
max
increased by approximately 73% for loratadine and by 120% for
descarboe