PARIET 10 rabeprazole sodium 10 mg enteric-coated tablet blister pack

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

rabeprazole sodium, Quantity: 10 mg

থেকে পাওয়া:

Janssen-Cilag Pty Ltd

INN (আন্তর্জাতিক নাম):

Rabeprazole sodium

ফার্মাসিউটিকাল ফর্ম:

Tablet, enteric coated

রচনা:

Excipient Ingredients: iron oxide red; hypromellose phthalate; magnesium stearate; diacetylated monoglycerides; magnesium oxide; purified talc; mannitol; titanium dioxide; Carnauba Wax; ethylcellulose; hyprolose; butan-1-ol; Shellac; ethanol absolute; iron oxide black

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

7, 14

প্রেসক্রিপশন টাইপ:

(S2) Pharmacy Medicine, (S3) Pharmacist Only Medicine

থেরাপিউটিক ইঙ্গিত:

Symptomatic relief of heartburn and other symptoms of gastro-oesophageal reflux disease.

পণ্য সারাংশ:

Visual Identification: Pink, biconvex tablets, marked with "E241" in black ink on one side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2010-04-08

তথ্য লিফলেট

PARIET® 10 (221207) ACMI
1
PARIET
® 10 TABLETS
_Rabeprazole sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PARIET 10 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
PARIET 10 against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING PARIET 10 ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PARIET 10 IS
USED FOR
The name of your medicine is
PARIET 10. It contains the active
ingredient rabeprazole sodium.
PARIET 10 is used for symptomatic
relief of heartburn and stomach acid
complaints due to gastro-oesophageal
reflux caused by "washing back" of
food and acid from the stomach into
the food pipe, also known as the
oesophagus.
Reflux can cause a burning sensation
in the chest, rising up to the throat,
also known as heartburn. Frequent
heartburn is when you have
heartburn for two or more days a
week. Heartburn that occurs
frequently is a typical symptom of
gastro-oesophageal reflux disease
(GORD).
PARIET 10 belongs to a group of
medicines called proton pump
inhibitors (PPIs). PARIET 10 works
by decreasing the amount of acid the
stomach makes to give relief from
the symptoms. Your food will still be
digested in the same way.
PARIET 10 will start to suppress
acid within a few hours; however it
will not give instant symptom relief.
You may need to take PARIET 10
for a few days before experiencing
the full effect.
There is no evidence that PARIET 10
is addictive.
PARIET 10 is only available from
your pharmacist or doctor.
BEFORE YOU TAKE
PARIET 10
_WHEN YOU MUST NOT TAKE IT: _
DO NOT TAKE PARIET 10 IF YOU
HAVE AN ALLERGY TO:
•
rabeprazole sodium
•
any of the ingredients listed at the
end of this leaflet.
•
other proton pump inhibitors
(omeprazole, esomeprazole,
lansoprazole,

পণ্য বৈশিষ্ট্য

1.180622 Page 1 of 13
PARIET10(221207)API
PARIET 10
®
R
ABEPRAZOLE SODIUM
A
USTRALIAN
P
RODUCT
I
NFORMATION
1
NAME OF THE MEDICINE
Rabeprazole sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PARIET 10 is available as enteric coated tablets containing 10 mg
rabeprazole sodium
(equivalent to 9.42 mg rabeprazole).
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PARIET 10 tablets are pink, biconvex tablets, marked with “
ε
241” in black ink on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
PARIET 10 is indicated for:
•
Symptomatic relief of heartburn and other symptoms of
gastro-oesophageal reflux
disease
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
ADULTS 18 YEARS OF AGE AND OVER:
The recommended dose is one tablet per day to be taken at the same
time each day (to
facilitate treatment compliance) for at least 7 days and up to 14
days. If symptom control has
not been achieved after two weeks of continuous treatment with PARIET
10, patients should
be referred to their doctor. PARIET 10 tablets should not be chewed or
crushed, but should
be swallowed
whole
.
PARIET 10 tablets were taken with or without food in the pivotal
clinical
trials.
USE IN CHILDREN UNDER 18 YEARS OF AGE
PARIET 10 is not recommended for use in children as there is no
experience of its use in this
group.
Product Information - Australia
1.180622 Page 2 of 13
PARIET10(221207)API
USE IN ELDERLY PATIENTS
No dosage adjustment is necessary in elderly patients.
USE IN PATIENTS WITH RENAL IMPAIRMENT
No dosage adjustment is necessary for patients with renal impairment.
There are no data on the use of rabeprazole in combination with
antibiotic regimens in
patients with renal impairment.
USE IN PATIENTS WITH HEPATIC IMPAIRMENT
Patients with mild to moderate hepatic impairment experience higher
exposure to rabeprazole
sodium at a given dose than do healthy patients. Caution should be
exercised in patients with
severe hepatic impairment (see 4.4 SPECIAL WARNINGS AND PRECAUTIONS
FOR USE).
There are no data on th