Rupatal

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Rupatadine fumarate 12.8mg Equivalent to 10 mg rupatadine free base

Sẵn có từ:

iNova Pharmaceuticals (New Zealand) Limited

INN (Tên quốc tế):

Rupatadine fumarate 12.8 mg (Equivalent to 10 mg rupatadine free base)

Liều dùng:

10 mg

Dạng dược phẩm:

Tablet

Thành phần:

Active: Rupatadine fumarate 12.8mg Equivalent to 10 mg rupatadine free base Excipient: Iron oxide red Iron oxide yellow Lactose Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch

Các đơn vị trong gói:

Blister pack, PVC/PVDC//Alu, 3 tablets (sample pack), 3 tablets

Lớp học:

Prescription

Loại thuốc theo toa:

Prescription

Sản xuất bởi:

Urquima SA

Chỉ dẫn điều trị:

RUPATAL tablets are indicated for symptomatic treatment of seasonal allergic rhinitis (SAR) in adults and adolescents (over 12 years of age).

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC//Alu, 3 tablets (sample pack) - 3 tablets - 3 years from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/PVDC//Alu, 20 tablets - 20 tablets - 3 years from date of manufacture stored at or below 25°C protect from light

Ngày ủy quyền:

2009-10-30

Tờ rơi thông tin

RUPATAL
®
 10 MG TABLETS 

Rupatadine (as fumarate) 10 mg 

CONSUMER 
MEDICINE 
INFORMATION      _ _

WHAT IS IN THIS LEAFLET 

This leaflet answers some common 
questions about RUPATAL tablets. 

It does not contain all the available 
information. 

It does not take the place of talking 
to your doctor or pharmacist. 

All medicines have risks and 
benefits.  Your doctor or pharmacist 
has weighed the risks of you taking 
RUPATAL against the benefits they 
expect it will have for you. 

IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST. 

KEEP THIS LEAFLET WITH THE 
MEDICINE. 
You may need to read it again. 

WHAT RUPATAL IS  
USED FOR 

RUPATAL is an antihistamine. 

RUPATAL_ _relieves symptoms of 
allergic rhinitis such as sneezing, 
runny nose, itching in the eyes and 
nose. 

RUPATAL is also used to relieve 
symptoms associated with chronic 
idiopathic urticaria (an allergic skin 
rash) such as itching and hives 
(localised skin redness and 
swelling). 

THIS MEDICINE IS AVAILABLE ONLY 
WITH A DOCTOR’S PRESCRIPTION. 

Your doctor, however, may 
prescribe RUPATAL_ _for another 
purpose. 

Ask your doctor if you have any 
questions about why RUPATAL 
has been prescribed for you. 

BEFORE YOU TAKE/GIVE 
RUPATAL_ _
_ _
_WHEN YOU MUST NOT _
_TAKE/GIVE IT _

DO NOT TAKE RUPATAL IF YOU 
HAVE AN TO RUPATADINE OR ANY OF 
THE INGREDIENTS LISTED AT THE END 
OF THIS LEAFLET. 
Some of the symptoms of an 
allergic reaction may include skin 
rash, difficulty in breathing or 
faintness. 

DO NOT TAKE RUPATAL IF YOU 
HAVE, OR HAVE HAD LIVER OR KIDNEY 
DISEASE. 

DO NOT TAKE RUPATAL WITH 
GRAPEFRUIT JUICE, AS THIS MAY 
INCREASE THE LEVEL OF RUPATAL IN 
YOUR BODY. 

THERE IS CURRENTLY NOT ENOUGH 
INFORMATION AVAILABLE TO 
RECOMMEND RUPATAL_ _FOR USE IN 
CHILDREN UNDER 12 YEARS OF AGE. 

DO NOT TAKE RUPATAL_ _AFTER THE 
EXPIRY DATE (EXP) PRINTED ON

Đặc tính sản phẩm

DATA SHEET 
RUPATAL
®
_ _
_RUPATADINE (AS FUMARATE) 10 MG TABLETS _
PRESENTATION 
RUPATAL tablets are round, light salmon pink in colour and with no
markings. 
Each tablet contains 10 mg of rupatadine (as fumarate). 

USES 
_ACTIONS _
Rupatadine is a non-sedating antiallergic compound which displays
strong 
antagonist activity towards both histamine H1 receptors and Platelet-
Activating Factor (PAF) receptors. PAF and histamine are known to 
complement and promote secretion of each other. PAF induces
vasodilatation 
and an increase in vascular permeability, which may be responsible
for the 
appearance of rhinorrhoea and nasal congestion. PAF may have a major
role 
in the late phase allergic reaction. Rupatadine’s PAF antagonistic
activity 
represents the likely mechanism behind the inhibition of eosinophil
migration 
which has been suggested to be beneficial in the treatment of
chronic 
urticaria.  

In addition, rupatadine is an antiallergic drug with other benefits
such as 
inhibition of mast cell degranulation, neutrophil and
eosinophil migration and 
cytokine release. 

Rupatadine shows high H1 receptor affinity and little or no activity
on other 
CNS receptors. Rupatadine also has a very long side chain and
little 
liposolubility, therefore, there is little or no crossing of the
blood-brain barrier. 
These properties account for the observed lack of sedation. 

_PHARMACOKINETICS _
ABSORPTION AND BIOAVAILABILITY 
Rupatadine is rapidly absorbed after oral administration, with a t
max
 of 
approximately 0.75 hours after intake. The mean C
max
 was 2.6 ng/mL after a 
single oral dose of 10 mg and 4.6 ng/mL after a single oral
dose of 20 mg. 
Pharmacokinetics of rupatadine was linear for a dose between 10 and
40 mg. 
After a dose of 10 mg/day for 7 days, the mean C
max
 was 3.8 ng/mL. The 
plasma concentration followed a bi-exponential drop-off with a mean 
Rupatal-DS-NZ-S4-05Aug11D_25°C  
1 
elimination half-life of 5.9 hours. The binding