SALPRAZ HEARTBURN RELIEF pantoprazole (as sodium sesquihydrate) 20 mg enteric-coated tablet blister pack (reformulation 2)

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

pantoprazole sodium sesquihydrate, Quantity: 22.56 mg

Tilgængelig fra:

Alphapharm Pty Ltd

Lægemiddelform:

Tablet, enteric coated

Sammensætning:

Excipient Ingredients: Carnauba Wax; triethyl citrate; calcium stearate; mannitol; purified water; sodium carbonate; povidone; macrogol 6000; purified talc; crospovidone; hypromellose; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; iron oxide yellow; xanthan gum; polyvinyl alcohol; lecithin

Indgivelsesvej:

Oral

Enheder i pakken:

7, 14

Recept type:

(S2) Pharmacy Medicine, (S3) Pharmacist Only Medicine

Terapeutiske indikationer:

Symptomatic relief of heartburn, acid regurgitation and other symptoms associated with gastroesophageal reflux disease (GORD).

Produkt oversigt:

Visual Identification: 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; Container Closure: Child resistant closure

Autorisation status:

Registered

Autorisation dato:

2020-11-12

Indlægsseddel

SALPRAZ HEARTBURN
RELIEF
_Pantoprazole (as sodium sesquihydrate) enteric coated tablets
(Reformulation 2)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SALPRAZ
HEARTBURN RELIEF.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
Use SALPRAZ HEARTBURN
RELIEF as directed and follow the
advice given in this leaflet.
All medicines have risks and
benefits. Your doctor or pharmacist
has weighed the risks of you taking
SALPRAZ HEARTBURN RELIEF
against the benefits of this medicine
is expected to 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 SALPRAZ
HEARTBURN RELIEF
IS USED FOR
The name of your medicine is
SALPRAZ HEARTBURN RELIEF.
It contains the active ingredient
called pantoprazole.
HEARTBURN AND GASTRO-
OESOPHAGEAL REFLUX DISEASE
SALPRAZ HEARTBURN RELIEF
is used for the relief of symptoms of
frequent heartburn, acid regurgitation
and stomach acid complaints due to
gastro-oesophageal reflux disease
(GORD). 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.
Frequent heartburn is when you have
heartburn for two or more days a
week. Heartburn that occurs
frequently is a typical symptom of
gastro-oesophageal reflux disease
(GORD). SALPRAZ HEARTBURN
RELIEF is recommended for adults
over 18 years of age suffering from
heartburn at least 2 times a week.
SALPRAZ 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.
HOW SALPRAZ
HEARTBURN RELIEF
WORKS
SALPRAZ HEARTBURN RELIEF
belongs to a group of medicines
called proton pump inhibitors (PPls).
SALPRAZ HEARTBURN RELIEF
works by de

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
SALPRAZ HEARTBURN RELIEF
_Pantoprazole (as sodium sesquihydrate) tablets (reformulation 2) _
1 NAME OF THE MEDICINE
Pantoprazole (as pantoprazole sodium sesquihydrate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each SALPRAZ HEARTBURN RELIEF enteric coated tablet contains 22.6 mg
pantoprazole sodium
sesquihydrate equivalent to 20 mg of pantoprazole.
Excipients with known effects: SALPRAZ HEARTBURN RELIEF also contains
traces of soya bean
products.
For the full list of excipients, see Section 6.1
LIST OF EXCIPIENTS
.
3 PHARMACEUTICAL FORM
SALPRAZ HEARTBURN RELIEF is available as 20 mg (yellow, oval shaped,
plain on both sides)
biconvex, enteric-coated tablets. SALPRAZ HEARTBURN RELIEF is
available in blister packs of 7 & 14
tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HEARTBURN AND GASTRO-OESOPHAGEAL REFLUX DISEASE
SALPRAZ HEARTBURN RELIEF is used for the relief of symptoms of
heartburn, acid regurgitation and
other symptoms associated with gastro-oesophageal reflux disease
(GORD).
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS:
SALPRAZ HEARTBURN RELIEF is indicated for use in adults 18 years of
age and over.
The
recommended dosage is one SALPRAZ HEARTBURN RELIEF tablet per day for
at least 7 days, and up
to 14 days. If symptoms relief has not been achieved after two weeks
of continuous treatment with one
SALPRAZ HEARTBURN RELIEF tablet per day, patients should be referred
to their doctor. SALPRAZ
HEARTBURN RELIEF tablets should not be chewed or crushed but swallowed
whole with a little water.
CHILDREN AND ADOLESCENTS < 18 YEARS:
There are no data currently available on the use of pantoprazole in
children. SALPRAZ HEARTBURN
RELIEF is not recommended for use in children and adolescents under 18
years of age.
SALPRAZ HEARTBURN RELIEF
– AUSTRALIAN PRODUCT INFORMATION
2
USE IN HEPATIC IMPAIRMENT:
Pantoprazole is contraindicated in patients with cirrhosis or severe
liver disease (see Section 4.3
CONTRAINDICATIONS
). No dose adjustment is required when pantoprazole is adminis