PARIET rabeprazole sodium 10mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

rabeprazole sodium, Quantity: 10 mg

제공처:

Janssen-Cilag Pty Ltd

약제 형태:

Tablet, enteric coated

구성:

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

관리 경로:

Oral

패키지 단위:

30 tablets, 7 tablets (starter pack only), 28 tablets

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Pariet is indicated for treatment and prevention of relapse of gastro-oesophageal reflux disease; symptomatic treatment gastro-oesophageal reflux disease; treatment of duodenal ulcers; treatment of gastric ulcers. Patients whose gastric and duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDS) usually require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence. Pariet is also indicated, in combination with clarithromycin and amoxycillin, for eradication of Helicobacter pylori in patients with peptic ulcer disease or chronic gastritis; and healing of peptic ulcers in patients with Helicobacter pylori associated ulcers.

제품 요약:

Visual Identification: Pink film coated biconvex tablets marked "E241".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2000-10-31

환자 정보 전단

PARIET
®
(190617) ACMI
1
PARIET
® TABLETS
_Rabeprazole sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PARIET 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 has weighed
the risks of you taking PARIET
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING PARIET ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT PARIET IS USED
FOR
The name of your medicine is
PARIET. It contains the active
ingredient rabeprazole sodium.
PARIET belongs to a group of
medicines called proton pump
inhibitors (PPIs). PARIET works by
decreasing the amount of acid the
stomach makes, to give relief from
the symptoms and allow healing to
take place. Your food will still be
digested in the same way.
GASTRO-OESOPHAGEAL REFLUX DISEASE:
PARIET is used to treat gastro-
oesophageal reflux disease (GORD),
commonly known as 'reflux'. This
can be caused by food and acid from
the stomach flowing the wrong way
(reflux) back up 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. PARIET is
also used to help stop gastro-
oesophageal reflux disease from
coming back or relapsing.
PEPTIC ULCERS:
PARIET is used to treat peptic
ulcers. Depending on the position of
the ulcer it is called a gastric or
duodenal ulcer. A gastric ulcer
occurs in the stomach. A duodenal
ulcer occurs in the duodenum, which
is the tube leading out of the
stomach.
These ulcers can be caused by too
much acid being made in the
stomach.
Most people who have a peptic ulcer
also have bacteria called
Helicobacter pylori in their stomach.
Your doctor may also prescribe a
course of antibiotics (clarithromycin
and amoxycillin) for you. When
PARIET is taken with antibiotics, the
combination therapy will kill t

제품 특성 요약

CCDS 180622
Page 1 of 16
PARIET (200622) API
PARIET
®
R
ABEPRAZOLE SODIUM
A
USTRALIAN
P
RODUCT
I
NFORMATION
1
NAME OF THE MEDICINE
Rabeprazole sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PARIET is available as enteric coated tablets containing 10 mg
rabeprazole sodium
(equivalent to 9.42 mg rabeprazole) or 20 mg rabeprazole sodium
(equivalent to 18.85 mg
rabeprazole).
For the full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
PARIET 10 mg are pink, biconvex tablets, marked with “ε 241” in
black ink on one side
presented in blister packs of 7 (starter pack only), 28 and 30
tablets.
PARIET 20 mg are light yellow, biconvex tablets, marked with “ε
243” in red ink on one side
presented in blister packs of 7, 28 and 30 tablets.
Not all pack sizes may be supplied.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
PARIET is indicated for:
•
Treatment and prevention of relapse of gastro-oesophageal reflux
disease
•
Symptomatic treatment of gastro-oesophageal reflux disease
•
Treatment of duodenal ulcers
•
Treatment of gastric ulcers.
Patients whose gastric and duodenal ulceration is not associated with
ingestion of non-
steroidal anti-inflammatory drugs (NSAIDs) usually require treatment
with antimicrobial agents
in addition to antisecretory drugs whether on first presentation or on
recurrence.
PARIET is also indicated, in combination with clarithromycin and
amoxycillin, for:
•
Eradication of _Helicobacter pylori_ in patients with peptic ulcer
disease or chronic
gastritis
•
Healing of peptic ulcers in patients with _Helicobacter pylori_
associated ulcers.
Product Information - Australia
CCDS 180622
Page 2 of 16
PARIET (200622) API
4.2
DOSE
AND
METHOD
OF
ADMINSTRATION
PARIET tablets should not be chewed or crushed, but should be
swallowed whole. PARIET
tablets should be taken at the same time each day to facilitate
treatment compliance. PARIET
was taken with or without food in the pivotal clinical trials.
ADULTS
_Treatment of active Gastro-Oesophageal Reflux Disease (GO