CHEMMART RABEPRAZOLE rabeprazole sodium 10mg enteric coated tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

rabeprazole sodium, Quantity: 10 mg

Saatavilla:

Arrotex Pharmaceuticals Pty Ltd

INN (Kansainvälinen yleisnimi):

Rabeprazole sodium

Lääkemuoto:

Tablet, enteric coated

Koostumus:

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

Antoreitti:

Oral

Kpl paketissa:

28

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

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.

Tuoteyhteenveto:

Visual Identification: Pink 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

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2016-01-06

Pakkausseloste

CHEMMART RABEPRAZOLE
TABLETS
_Rabeprazole sodium_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about rabeprazole. 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 using 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Rabeprazole is used to treat reflux
oesophagitis, peptic ulcers and
chronic gastritis. It belongs to a
group of medicines called proton
pump inhibitors (PPIs).
REFLUX OESOPHAGITIS
This can be caused by food and acid
from the stomach flowing the wrong
way (reflux) back up the food pipe
(oesophagus). Reflux can cause a
burning sensation in the chest rising
up to the throat (heartburn).
Rabeprazole also helps to stop reflux
oesophagitis from coming back.
PEPTIC ULCERS
This can be caused by the stomach
making too much acid. It is called a
gastric (stomach) or duodenal ulcer
depending on the position of the
ulcer. People who have a peptic ulcer
may also have bacteria called
Helicobacter pylori in their stomach.
Taking antibiotics will kill
Helicobacter pylori and allow the
ulcer to heal.
CHRONIC GASTRITIS
Helicobacter pylori may inflame the
stomach, resulting in pain, nausea
and vomiting. Taking antibiotics will
kill Helicobacter pylori and allow the
stomach to heal.
_HOW IT WORKS_
Rabeprazole works by decreasing the
amount of acid the stomach makes,
to give relief from the symptoms and
allow healing to take place. Your
food is still digested in the same way.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is not addictive.
The

Valmisteyhteenveto

1
AUSTRALIAN PRODUCT INFORMATION
CHEMMART RABEPRAZOLE (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
CHEMMART RABEPRAZOLE ENTERIC COATED TABLETS
10 MG ENTERIC COATED TABLETS:
Pink coloured, round, biconvex tablets, plain on both sides.
20 MG ENTERIC COATED TABLETS:
Yellow coloured, round, biconvex, plain on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rabeprazole EC tablet 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 EC tablet 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.
2
4.2
DOSE AND METHOD OF ADMINISTRATION
CHEMMART Rabeprazole enteric-coated tablets are intended for oral
administration.
DOSAGE
Rabeprazole EC tablets should not be chewed or crushed, but should be
swallowed whole and
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