NOUMED PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 40mg enteric coated tablet blister pack

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

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

Saatavilla:

AVALLON PHARMACEUTICALS PTY LTD

Lääkemuoto:

Tablet, enteric coated

Koostumus:

Excipient Ingredients: hyprolose; calcium stearate; triethyl citrate; crospovidone; sodium carbonate; colloidal anhydrous silica; microcrystalline cellulose; titanium dioxide; hypromellose; iron oxide yellow; quinoline yellow aluminium lake; macrogol 400; brilliant scarlet 4R aluminium lake; polysorbate 80; purified water; methacrylic acid copolymer; sodium lauryl sulfate

Antoreitti:

Oral

Kpl paketissa:

30 tablets, 5 tablets

Prescription tyyppi:

(S4) Prescription Only Medicine

Käyttöaiheet:

1. For 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 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 micro-organism. 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.

Tuoteyhteenveto:

Visual Identification: Yellow, oval coated tablet.; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2018-02-26

Pakkausseloste

NOUMED PANTOPRAZOLE
1
NOUMED PANTOPRAZOLE
_pantoprazole (as sodium sesquihydrate) enteric coated tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Noumed
Pantoprazole. 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 this medicine
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 THIS MEDICINE IS
USED FOR
This medicine contains the active
ingredient pantoprazole. It belongs to
a group of medicines called proton
pump inhibitors (PPIs).
It works by decreasing the amount of
acid the stomach makes to give relief
from the symptoms and allow
healing to take place.
ULCERS
Noumed Pantoprazole 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.
Ulcers 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 Noumed Pantoprazole is taken
with antibiotics the combination
therapy will kill the Helicobacter
pylori and let your ulcer heal.
This medicine 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
Noumed Pantoprazole 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

Valmisteyhteenveto

Product Information - Australia
Page 1 of 18
AUSTRALIAN PRODUCT INFORMATION – NOUMED
PANTOPRAZOLE ENTERIC-COATED TABLETS
(PANTOPRAZOLE)
1. NAME OF THE MEDICINE
Pantoprazole (as sodium sesquihydrate)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each NOUMED PANTOPRAZOLE 40 mg enteric coated tablet contains 45.10 mg
of pantoprazole sodium
sesquihydrate equivalent to 40 mg of pantoprazole.
Each NOUMED PANTOPRAZOLE 20 mg enteric coated tablet contains 22.55 mg
pantoprazole sodium
sesquihydrate equivalent to 20 mg of pantoprazole.
For the full list of excipients, see _section 6.1 List of excipients_.
3. PHARMACEUTICAL FORM
NOUMED PANTOPRAZOLE 40 mg - yellow and oval shaped enteric coated
tablets containing 40 mg pantoprazole
(as sodium sesquihydrate).
NOUMED PANTOPRAZOLE 20 mg - yellow and oval shaped enteric coated
tablets containing 20 mg pantoprazole
(as sodium sesquihydrate).
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1.
For symptomatic improvement and healing of the following
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:
•
clarithromycin and amoxicillin or
•
clarithromycin and metronidazole or
•
amoxicillin and metronidazole
is recommended in cases of duodenal ulcer and gastric ulcer with the
objective