TIRLOR 10MG TABLET

Страна: Малайзия

Език: английски

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

Активна съставка:

LORATADINE

Предлага се от:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Международно Name):

LORATADINE

Броя в опаковка:

20 Tablet Tablets; 10 Tablet Tablets; 100 Tablet Tablets; 30 Tablet Tablets

Произведено от:

NOVARTIS BANGLADESH LTD

Листовка

TIRLOR
® 10 MG TABLETS
Loratadine 10 mg Tablets
_Consumer Medication Information Leaflet (RiMUP) _
WHAT IS IN THIS LEAFLET:
1.
What is TIRLOR used for
2.
How TIRLOR works
3.
Before you use TIRLOR
4.
How to use TIRLOR
5.
While you are using it
6.
Side effects
7.
Storage and disposal of TIRLOR
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IS TIRLOR USED FOR?
This medicine is prescribed to relieve
symptoms associated with allergic
rhinitis such as sneezing, runny or itchy
nose and itchy, red or teary eyes.
It is also used to relieve symptoms
such as itching and hives.
HOW TIRLOR WORKS?
TIRLOR is an anti-allergy medicine. It
helps to control your allergic reaction
and its symptoms.
BEFORE YOU USE TIRLOR
_WHEN YOU MUST NOT USE IT _
-
if you are allergic (hypersensitive)
to loratadine or to any of the other
excipients of TIRLOR.
PREGNANCY AND
LACTATION
Tell your doctor or pharmacist if you
are pregnant, or are planning to become
pregnant or if you are breast-feeding
before taking any medicine. You
should not use this medicine during
pregnancy and when you are breast-
feeding unless your doctor has
specifically recommended it.
_BEFORE YOU START USE IT _
Tell your doctor if you have any of the
following illnesses before taking this
medicine:
-
Severe liver disease
-
If you have to undergo any skin
tests, it may be necessary to
stop taking this medicine at
least 2 days before the test to
make sure the result of test is
correct.
_TAKING OTHER _
_MEDICINES_
_ _
Please tell your doctor or
pharmacist if you are taking, or
have recently taken, any other
medicine.
This includes medicines
that can be bought without a
prescription and herbal medicines.
Potential interaction may occur
with some medicines that make
some liver enzymes less active
resulting in elevated levels of
loratadine, which may cause an
increase in adverse events.
HOW TO USE TIRLOR
?
_- HOW MUCH TO USE _
The doctor will prescribe the
individual dose which is
appropriate for you. It is important
that you take y

Данни за продукта

TIRLOR
® 10 MG TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Tirlor
®
10 mg Tablet.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg loratadine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, uncoated round convex tablet.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Loratadine is indicated for the relief of symptoms associated with
allergic rhinitis, urticaria and
other allergic dermatological condition.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, including th
e elderly, and children over 12 years of age
10 mg once daily
Children 6 - 12 years of age
Body weight > 30 kg:
10 mg once daily
Efficacy and safety of_ _loratadine in children under 2 years has not
been established.
Patients with hepatic impairment
Patients with severe liver impairment should be administered a lower
initial dose because they
may have reduced clearance of loratadine. An initial dose of 10 mg
every other day is
recommended for adults and children weighing more than 30 kg.
Patients with renal impairment
No dose adjustments are required in patients with renal insufficiency.
Elderly
No dose adjustments are required in the elderly.
Method of administration
For oral use.
It may be taken without regard to mealtime.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Loratadine should be administered with caution in patients with severe
liver impairment.
The administration of loratadine should be discontinued at least 48
hours before skin tests since
antihistamines may prevent or reduce otherwise positive reactions to
dermal reactivity index.
TIRLOR
® 10 MG TABLETS
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
When
administered
concomitantly
with
alcohol,
loratadine
has
no
potentiating
effects
as
measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of CYP3A4 or
CYP2D6 resulting in
elevated levels of loratadine (s