RABEPRAZOLE SANDOZ rabeprazole sodium 10 mg enteric coated tablet blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

rabeprazole sodium, Quantity: 10 mg

Предлага се от:

Sandoz Pty Ltd

INN (Международно Name):

Rabeprazole sodium

Лекарствена форма:

Tablet, enteric coated

Композиция:

Excipient Ingredients: sodium stearylfumarate; purified talc; hyprolose; hypromellose; iron oxide yellow; mannitol; iron oxide red; dibutyl sebacate; hypromellose phthalate; titanium dioxide; calcium hydroxide

Начин на приложение:

Oral

Броя в опаковка:

28

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Rabeprazole Sandoz 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 Sandoz 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.

Каталог на резюме:

Visual Identification: pink, round, biconvex coated tablet; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2012-03-08

Листовка

RABEPRAZOLE SANDOZ
®
VERSION 02
1
RABEPRAZOLE SANDOZ
®
_Rabeprazole (as sodium) enteric coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Rabeprazole Sandoz.
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 this medicine
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
RABEPRAZOLE
SANDOZ IS USED
FOR
This medicine contains the active
ingredient rabeprazole sodium.
Rabeprazole belongs to a group of
medicines called proton pump
inhibitors (PPIs). It 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 normal way.
GASTRO-OESOPHAGEAL REFLUX DISEASE
(GORD)
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 sodium is also used to
help stop reflux oesophagitis from
coming back or relapsing.
GASTRIC AND DUODENAL 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 amoxycillin) for you. When this
medicine is taken with antibiotics,
the combination therapy will kill the
Helicobacter pylori and let your ulcer
heal.
CHRONIC GASTRITIS
The

Данни за продукта

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Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
RABEPRAZOLE SANDOZ
® (RABEPRZOLE SODIUM) ENTERIC-COATED
TABLETS
1.
NAME OF THE MEDICINE
Rabeprazole sodium
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Rabeprazole Sandoz
®
10 mg enteric-coated tablet contains 10 mg rabeprazole sodium,
equivalent to 9.42 mg rabeprazole.
Each Rabeprazole Sandoz
®
20 mg enteric-coated tablet contains 20 mg rabeprazole sodium
equivalent to 18.85 mg rabeprazole.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Rabeprazole Sandoz
®
10 mg – pink, round, biconvex enteric-coated tablet.
Rabeprazole Sandoz
®
20 mg – yellow, round, biconvex enteric-coated tablet.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Rabeprazole Sandoz 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 Sandoz 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.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_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 weeks.
190724-Rabeprazole Sandoz-pi
Page 2 of 16
_PREVENTION OF RELAPSE OF GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD):_
The recommended
oral dose for preventing relapse of GORD, once healing is achieved, is
one 10 mg tablet to be
taken once daily.
If need