PANTOPRAZOLE MYL 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: 22.56 mg (Equivalent: pantoprazole, Qty 20 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

Pantoprazole sodium sesquihydrate

Pharmaceutical form:

Tablet, enteric coated

Composition:

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

Administration route:

Oral

Units in package:

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

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:,i) Duodenal ulcer ii) Gastric ulcer iii) Gastro-oesophageal reflux disease (GORD): - Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD - Reflux oesophagitis iv) Gastrointestinal lesions refractory H2 blockers v) 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:,i) Clarithromycin and amoxicillin or ii) Clarithromycin and metronidazole or iii) Amoxicillin and metronidazole,is recommended in cases

Product summary:

Visual Identification: Yellow to light yellow, oval, biconvex enteric-coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2010-02-17

Patient Information leaflet

PANTOPRAZOLE MYL
_pantoprazole_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PANTOPRAZOLE
MYL. 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
PANTOPRAZOLE MYL 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 MYL
IS USED FOR
The name of your medicine is
PANTOPRAZOLE MYL. It contains
the active ingredient pantoprazole.
ULCERS
PANTOPRAZOLE MYL 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.
These 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 MYL is
taken with antibiotics, the
combination therapy will kill the
Helicobacter pylori and let your ulcer
heal.
PANTOPRAZOLE MYL may 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 MYL is used to
treat reflux oesophagitis or reflux
disease. This can be caused by
"washing back" (reflux) of food and
acid from the stomach into 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.
PANTOPRAZOLE MYL is also
used to prevent reflux oesophagitis
from coming back.
ZOLLINGER-ELLISON SYNDROME
PANTOPRAZOLE MYL is used to
treat a rare condition called

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
PANTOPRAZOLE MYL
_pantoprazole (as sodium sesquihydrate) _
1
NAME OF THE MEDICINE
Pantoprazole (as sodium sesquihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PANTOPRAZOLE MYL 20mg enteric coated tablet contains 22.56 mg
pantoprazole sodium sesquihydrate
equivalent to 20mg of pantoprazole.
Each
PANTOPRAZOLE
MYL
40mg
enteric
coated
tablet
contains
45.12
mg
of
pantoprazole
sodium
sesquihydrate equivalent to 40mg of pantoprazole.
EXCIPIENTS WITH KNOWN EFFECT
PANTOPRAZOLE MYL also contains traces of soya bean products.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
PANTOPRAZOLE MYL 20 mg enteric-coated tablets are yellow to light
yellow,
_oval _
shaped, biconvex enteric
coated tablets plain on both sides.
PANTOPRAZOLE MYL 40 mg enteric-coated tablets are yellow to light
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):
i. symptomatic GORD. The treatment of heartburn and other symptoms
associated with GORD
ii. 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.
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:
PANTOPRAZOLE MYL – PRODUCT INFORMATION
2
•
clarithromycin and amoxicillin or
•
clarithromycin and metronidazole or
•
amoxicillin and metronidazo