PANTOPRAZOLE GENERICHEALTH pantoprazole (as sodium sesquihydrate) 20 mg enteric-coated tablet blister pack.

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate, Quantity: 22.7 mg (Equivalent: pantoprazole, Qty 20 mg)

Available from:

Generic Health Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: mannitol; sodium carbonate; sodium starch glycollate; crospovidone; colloidal anhydrous silica; calcium stearate; hypromellose; macrogol 6000; sodium hydroxide; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin

Administration route:

Oral

Units in package:

100, 14, 56, 28, 5, 50, 60, 140, 30, 15

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults 1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: ? Duodenal ulcer ? Gastric ulcer ? Gastro-oesophageal reflux disease (GORD): - Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD - Reflux oesophagitis ? Gastrointestinal lesions refractory to H2 blockers ? Zollinger-Ellison Syndrome Patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.,2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis. 3. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: ? Clarithromycin and amoxicillin or ? Clarithromycin and metronidazole or ? Amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see Section 4.2 Dose and Method of Administration).,4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism.,5. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.,Children aged from 5 to 17 years Gastro-oesophageal reflux disease (GORD) ? Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD ? Reflux oesophagitis The treatment duration should not exceed 8 weeks.

Product summary:

Visual Identification: Yellow to pale yellow, oval shaped, biconvex enteric-coated tablets plain on both the sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-03-21

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
PANTOPRAZOLE GENERICHEALTH
(PANTOPRAZOLE SODIUM SESQUIHYDRATE) ENTERIC-COATED TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Pantoprazole generichealth.
It does not contain all the
available information. It does
not take the place of talking to
your doctor or pharmacist.
The information in this leaflet
was last updated on the date
listed on the final page. More
recent information on the
medicine may be available. You
should ensure that you speak to
your pharmacist or doctor to
obtain the most up to date
information on this medicine.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Pantoprazole generichealth
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 PANTOPRAZOLE
GENERICHEALTH IS USED FOR
_ULCERS _
Pantoprazole generichealth is
used to treat and help heal
duodenal and gastric 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.
There can be caused in part 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. When Pantoprazole
generichealth is taken with
antibiotics the combination
therapy will kill the Helicobacter
pylori and let your ulcer heal.
Pantoprazole generichealth may
also be used to prevent ulcers
associated with the use of non-
steroidal anti-inflammatory drugs
(NSAIDs). These are medicines
used to relieve pain, swelling
and other symptoms of
inflammation, including arthritis
(inflammation of the joints).
_REFLUX DISEASE _
Pantoprazole generichealth is
also used to treat reflux
oesophagitis or reflux disease.
This can be caused by "washing
back" (reflux) of food and acid
from the stomach i

Summary of Product characteristics

Pantoprazole generichealth v5.0
Page 1 of 22
(pantoprazole sodium sesquihydrate) enteric-coated tablets
AUSTRALIAN PRODUCT INFORMATION –
PANTOPRAZOLE GENERICHEALTH
(PANTOPRAZOLE SODIUM SESQUIHYDRATE) ENTERIC-COATED TABLETS
1
NAME OF THE MEDICINE
Pantoprazole (as sodium sesquihydrate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Pantoprazole generichealth 20 mg enteric-coated tablet contains
22.7 mg pantoprazole sodium
sesquihydrate equivalent to 20 mg of pantoprazole.
Each Pantoprazole generichealth 40 mg enteric-coated tablet contains
45.4 mg of pantoprazole sodium
sesquihydrate equivalent to 40 mg of pantoprazole.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Pantoprazole generichealth 20 mg: yellow to pale yellow, oval shaped,
biconvex, enteric-coated tablets,
plain on both sides; and
Pantoprazole generichealth 40 mg: yellow to pale yellow, oval shaped,
biconvex, enteric-coated tablets
plain on both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ADULTS
1.
Symptomatic improvement and healing of gastrointestinal diseases which
require a reduction in acid
secretion:
•
Duodenal ulcer
•
Gastric ulcer
•
Gastro-oesophageal reflux disease (GORD):
-
Symptomatic GORD. The treatment of heartburn and other symptoms
associated with GORD
-
Reflux oesophagitis
•
Gastrointestinal lesions refractory to H
2
blockers
•
Zollinger-Ellison Syndrome
Patients whose gastric or duodenal ulceration is not associated with
ingestion of non-steroidal
anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial
agents in addition to
antisecretory drugs whether on first presentation or on recurrence.
Pantoprazole generichealth v5.0
Page 2 of 22
(pantoprazole sodium sesquihydrate) enteric-coated tablets
2.
Maintenance of healed reflux oesophagitis in patients previously
treated for moderate to severe
reflux oesophagitis.
3.
For eradication of _ Helicobacter pylori_, treatment with pantoprazole
and one of the following
combinations of antibiotics:
•
Clarithromyc