IPCA PANTOPRAZOLE pantoprazole (as sodium sesquihydrate) 20 mg enteric-coated tablet blister pack.

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

pantoprazole sodium sesquihydrate, Quantity: 22.7 mg (Equivalent: pantoprazole, Qty 20 mg)

Mevcut itibaren:

Ipca Pharma (Australia) Pty Ltd

INN (International Adı):

Pantoprazole sodium sesquihydrate

Farmasötik formu:

Tablet, enteric coated

Kompozisyon:

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

Uygulama yolu:

Oral

Paketteki üniteler:

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

Reçete türü:

(S4) Prescription Only Medicine

Terapötik endikasyonlar:

1. For 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. 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.

Ürün özeti:

Visual Identification: Yellow to pale yellow, oval shaped, biconvex enteric-coated tablets plain on both the sides.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Yetkilendirme durumu:

Licence status A

Yetkilendirme tarihi:

2010-02-17

Bilgilendirme broşürü

IPCA PANTOPRAZOLE
Consumer Medicine Information
Pantoprazole (as sodium sesquilhydrate) delayed release tablets
_ _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about IPCA 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 IPCA PANTOPRAZOLE against the benefits this medicine is
expected to have
for you.
Use IPCA PANTOPRAZOLE as directed and follow the advice given in this
leaflet.
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 IS IPCA PANTOPRAZOLE USED FOR
The
name
of
your
medicine
is
IPCA
PANTOPRAZOLE.
It
contains
the
active
ingredient called pantoprazole.
_ULCERS _
IPCA 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.
IPCA PANTOPRAZOLE 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 _
IPCA 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 a
burning sensation
in the chest rising up to the throat, also known as heartburn.
IPCA PANTOPRAZOLE is also used to prevent reflux oesophagitis from
coming
back.
Ipca Pantoprazole CMI V1 100210
- 1 -
_ _
_ZOLLINGER-ELLISON SYNDROME _
IPCA PANTOPRAZOLE is used to treat a rare condition called
Zollinger-Ellison
syndrome, where the stomach produces very large amounts