SOMAC Pantoprazole 40 mg (as sodium sesquihydrate) enteric-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole sodium sesquihydrate, Quantity: 45.1 mg (Equivalent: pantoprazole, Qty 40 mg)

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

Pharmaceutical form:

Tablet, enteric coated

Composition:

Excipient Ingredients: sodium carbonate; iron oxide yellow; titanium dioxide; polysorbate 80; sodium lauryl sulfate; mannitol; methacrylic acid copolymer; povidone; hypromellose; triethyl citrate; propylene glycol; calcium stearate; crospovidone; butan-1-ol; isopropyl alcohol; iron oxide red; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

60 tablets, 100 tablets, 140 tablets, 15 tablets, 5 TABLETS, as both trade and starter packs, 56 tablets, 28 tablets, 50 tablets, 30 tablets, 14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Adults: 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 to 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: - 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 Dosage & 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 oval biconvex enteric-coated tablets with white to off-white cores. The tab are marked with letter "P40" on one side and blank on reverse. Tab dimensions height 4mm Length 12mm width 6mm; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-07-08

Patient Information leaflet

SOMAC
® TABLETS AND
GRANULES
_pantoprazole sodium sesquihydrate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Somac.
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 Somac 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 SOMAC IS USED
FOR
ULCERS
Somac 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 Somac is taken with
antibiotics the combination therapy
will kill the Helicobacter pylori and
let your ulcer heal.
Somac 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
Somac 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 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.
Somac is also us

Summary of Product characteristics

SOMAC TABLETS AND GRANULES V14.0 (CCDS
V9.0) _ _
_ _
_ _
_Page 1 _
AUSTRALIAN PRODUCT INFORMATION
SOMAC
® (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
TABLETS AND
GRANULES
1
NAME OF THE MEDICINE
Pantoprazole (as sodium sesquihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOMAC
20
mg
enteric
coated
tablets,
each
tablet
contains
22.6 mg
pantoprazole
sodium
sesquihydrate equivalent to 20 mg pantoprazole.
SOMAC
40
mg
enteric
coated
tablets,
each
tablet
contains
45.1 mg
pantoprazole
sodium
sesquihydrate equivalent to 40 mg pantoprazole.
SOMAC 40 mg enteric coated granules, each sachet contains 45.1 mg
pantoprazole sodium
sesquihydrate equivalent to 40 mg pantoprazole.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
20 mg enteric coated tablets are yellow and oval shaped, marked with
the letter "P20" on one side.
40 mg enteric coated tablets are yellow and oval shaped, marked with
the letter "P40" on one side.
40 mg granules are pale yellowish to dark brownish in colour
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)
o
Symptomatic GORD. The treatment of heartburn and other symptoms
associated with
GORD
o
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
SOMAC TABLETS AND GRANULES V14.0 (CCDS
V9.0) _ _
_ _
_ _
_Page 2 _
3.
For eradication of _ Helicobacter pylori_, treatment with pantoprazole
and one of the following
combinations of antibiotics:
•
Clarit