RABEPRAZOLE MYLAN rabeprazole sodium 20mg enteric coated tablet blister pack

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

rabeprazole sodium, Quantity: 20 mg

Saadav alates:

Arrotex Pharmaceuticals Pty Ltd

INN (Rahvusvaheline Nimetus):

Rabeprazole sodium

Ravimvorm:

Tablet, enteric coated

Koostis:

Excipient Ingredients: mannitol; magnesium stearate; diethyl phthalate; ethylcellulose; hypromellose phthalate; purified talc; iron oxide yellow; light magnesium oxide; povidone; sodium starch glycollate type A; titanium dioxide

Manustamisviis:

Oral

Ühikuid pakis:

30

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

Rabeprazole 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. Rabeprazole 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.

Toote kokkuvõte:

Visual Identification: Yellow coloured, round, biconvex, delayed release tablet, plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Volitamisolek:

Registered

Loa andmise kuupäev:

2012-07-09

Infovoldik

RABEPRAZOLE MYLAN TABLETS
_Rabeprazole-Sodium _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
RABEPRAZOLE MYLAN
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 RABEPRAZOLE MYLAN
against the benefits this
medicine is expected to have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING RABEPRAZOLE
MYLAN ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. You may need to
read it again.
WHAT RABEPRAZOLE
MYLAN IS USED FOR
The name of your medicine is
RABEPRAZOLE MYLAN. It
contains the active
ingredient rabeprazole
sodium.
RABEPRAZOLE MYLAN
belongs to a group of
medicines called proton
pump inhibitors (PPIs).
RABEPRAZOLE MYLAN 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:
RABEPRAZOLE MYLAN 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.
RABEPRAZOLE MYLAN is also
used to help stop gastro-
oesophageal reflux disease
from coming back or
relapsing.
PEPTIC ULCERS:
RABEPRAZOLE MYLAN 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 a
bacteria called Helicobacter
pylori in their stomach. Your
doctor may also prescribe a
course of antibiotics
(clarithromycin and

Toote omadused

AUSTRALIAN PRODUCT INFORMATION – RABEPRAZOLE MYLAN
(RABEPRAZOLE SODIUM) ENTERIC COATED TABLETS
1
NAME OF THE MEDICINE
Rabeprazole sodium
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each enteric coated (EC) tablet contains 10 mg rabeprazole sodium
(equivalent to 9.42 mg
rabeprazole) or 20 mg rabeprazole sodium (equivalent to 18.85 mg
rabeprazole), as the active
ingredient.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
RABEPRAZOLE MYLAN 10mg are pink, round, biconvex delayed release
tablets plain on both sides.
RABEPRAZOLE MYLAN 20mg are yellow, round, biconvex delayed release
tablets, plain on both sides.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
RABEPRAZOLE MYLAN 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.
RABEPRAZOLE MYLAN is also indicated, in combination with
clarithromycin and amoxicillin, 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
RABEPRAZOLE MYLAN tablets are intended for oral administration.
RABEPRAZOLE MYLAN tablets should not be chewed or crushed, but should
be swallowed whole.
RABEPRAZOLE MYLAN tablets should be taken at the same time each day to
facilitate treatment
compliance. Rabeprazole was taken with or without food in the pivotal
clinical trials.
ADULTS
_Treatment of active Gastro-Oesophageal Reflux Disease (GORD):_ The
recommended oral dose for
this condition is one 20 mg tablet to be taken once daily for four to
eight w