SOMAC HEARTBURN RELIEF pantoprazole (as sodium sesquihydrate) 20mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

pantoprazole, Quantity: 22.57 mg (Equivalent: pantoprazole, Qty 20 mg)

Available from:

Takeda Pharmaceuticals Australia Pty Ltd

INN (International Name):

Pantoprazole

Pharmaceutical form:

Tablet, enteric coated

Composition:

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

Administration route:

Oral

Units in package:

7 tablets, 2 tablets, 14 tablets

Prescription type:

(S3) Pharmacist Only Medicine

Therapeutic indications:

Somac Heartburn Relief is indicated for symptomatic relief of heartburn, acid regurgitation and other symptoms associated with gastro-oesophageal reflux disease (GORD).

Product summary:

Visual Identification: Yellow, oval, biconvex enteric-coated tablets with white to off-white cores. 'P20' printed on one side in brown ink.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-08-01

Patient Information leaflet

SOMAC
® HEARTBURN
RELIEF TABLETS
_pantoprazole sodium sesquihydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Somac Heartburn
Relief.
It does not contain all the available
information. It does not take the
place of talking to your pharmacist or
doctor.
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.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT SOMAC
HEARTBURN RELIEF IS
USED FOR
Somac Heartburn Relief is used for
lasting symptomatic relief of frequent
heartburn and stomach acid
complaints due to gastro-oesophageal
reflux disease (GORD).
These symptoms 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.
Frequent heartburn is when you have
heartburn for two or more days a
week. Heartburn that occurs
frequently is a typical symptom of
GORD.
Somac Heartburn Relief is not the
right medicine for you if you suffer
heartburn only occasionally (one
episode of heartburn a week or less),
or if you want immediate relief of
heartburn.
SOMAC HEARTBURN RELIEF WILL START
TO SUPPRESS ACID WITHIN A FEW
HOURS, HOWEVER IT IS NOT INTENDED TO
PROVIDE INSTANT SYMPTOM RELIEF.
FOR EFFECTIVE, LASTING RELIEF, YOU
SHOULD TAKE A FULL COURSE OF SOMAC
HEARTBURN RELIEF (SEE 'HOW TO TAKE
SOMAC HEARTBURN RELIEF' BELOW).
Somac Heartburn Relief belongs to a
group of medicines called proton
pump inhibitors (PPIs). This
medicine works by decreasing the
amount of acid the stomach makes

Summary of Product characteristics

SOMAC HEARTBURN RELIEF V14 (CCDS V9.0)
_ _
_Page 1 _
AUSTRALIAN PRODUCT INFORMATION
SOMAC
® HEARTBURN RELIEF (PANTOPRAZOLE SODIUM
SESQUIHYDRATE)
1
NAME OF THE MEDICINE
Pantoprazole (as pantoprazole sodium sesquihydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOMAC Heartburn Relief enteric coated tablets, each tablet contains
22.6 mg pantoprazole sodium
sesquihydrate, equivalent to 20 mg pantoprazole
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
SOMAC Heartburn Relief enteric coated tablets are yellow and oval
shaped, marked with the letter
"P20" on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SOMAC Heartburn Relief is indicated for symptomatic relief of
heartburn, acid regurgitation and other
symptoms associated with gastro-oesophageal reflux disease (GORD).
4.2
DOSE AND METHOD OF ADMINISTRATION
SOMAC Heartburn Relief is indicated for use in adults 18 years of age
and over. SOMAC Heartburn
Relief tablets should not be chewed or crushed but swallowed whole
with a little water.
SYMPTOMATIC GORD
The recommended dosage is one SOMAC Heartburn Relief 20 mg tablet per
day for at least 7 days,
and up to 14 days. If symptom control has not been achieved after two
weeks of continuous
treatment with SOMAC Heartburn Relief 20 mg tablet per day, patients
should be referred to their
doctor.
USE IN CHILDREN
There are limited data currently available on the use of pantoprazole
in children. SOMAC Heartburn
Relief is not recommended for use in children and adolescents under 18
years of age.
USE IN THE ELDERLY
No dose adjustment is necessary in elderly patients.
IMPAIRED RENAL FUNCTION
No dose adjustment is required when pantoprazole is administered to
patients with impaired renal
function.
SOMAC HEARTBURN RELIEF V14 (CCDS V9.0)
_ _
_Page 2 _
IMPAIRED HEPATIC FUNCTION
Pantoprazole
is
contraindicated
in
patients
with
cirrhosis
or
severe
liver
disease
(see
Contraindications). No dose adjustment is required when pantoprazole
is administered to patients
with milder forms