Panzop Relief

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pantoprazole sodium sesquihydrate 22.55mg equivalent to 20 mg Pantoprazole;  ;  

Available from:

Viatris Limited

INN (International Name):

Pantoprazole sodium sesquihydrate 22.55 mg (equivalent to 20 mg Pantoprazole)

Dosage:

20 mg

Pharmaceutical form:

Enteric coated tablet

Composition:

Active: Pantoprazole sodium sesquihydrate 22.55mg equivalent to 20 mg Pantoprazole     Excipient: Calcium stearate Crospovidone Mannitol Methacrylic acid copolymer Opadry yellow OY-52945 Povidone Purified water   Sodium carbonate Triethyl citrate

Units in package:

Blister pack, Dessicant PE/aluminium, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Mylan Laboratories Limited

Therapeutic indications:

1. For the symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion: - Duodenal ulcer

Product summary:

Package - Contents - Shelf Life: Blister pack, Polyamide/PVC/aluminium or Dessicant PE/aluminium - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, Polyamide/PVC/aluminium or Dessicant PE/aluminium - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with 2 in 1 desiccant - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE with 2 in 1 desiccant - 90 tablets - 36 months from date of manufacture stored at or below 25°C 100 days opened stored at or below 25°C - Bottle, plastic, HDPE with 2 in 1 desiccant - 100 tablets - 36 months from date of manufacture stored at or below 25°C 100 days opened stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 25°C 100 days opened stored at or below 25°C

Authorization date:

2010-01-14

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
PANZOP RELIEF
_PANTOPRAZOLE ENTERIC-COATED TABLETS 20 MG & 40 MG_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Panzop Relief.
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 Panzop
Relief 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 PANZOP RELIEF
IS USED FOR
Panzop Relief contains the active
ingredient pantoprazole. It belongs
to a group of medicines called
Proton Pump Inhibitors or PPIs.
ULCERS
Panzop Relief is used to treat or
help heal peptic ulcers of the
stomach and duodenum. These can
be caused in part by too much acid
being made in the stomach. Panzop
Relief is also used to help stop
duodenal ulcers re-occurring.
REFLUX OESOPHAGITIS
Panzop Relief is used to treat reflux
oesophagitis or reflux disease. This
is 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.
HELICOBACTER PYLORI
Panzop Relief can also be used in
combination with certain antibiotics
to help eliminate _H. pylori _infections
in certain people with ulcers or
chronic gastritis. _H. pylori _is a
bacteria which is associated with
the development of ulcers.
ZOLLINGER-ELLISON SYNDROME
Panzop Relief is also used to treat a
rare condition called Zollinger-
Ellision syndrome, where the
stomach produces large amounts of
acid, much more than in ulcers or
reflux disease.
Panzop Relief works by decreasing
the amount of acid the stomach
makes to give relief from the
symptoms and allow healing to take
place.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED F

Summary of Product characteristics

Page 1 of 22
NEW ZEALAND DATA SHEET
PANZOP RELIEF
1. PRODUCT NAME
Panzop Relief, 20 mg and 40 mg, gastro-resistant tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Panzop Relief 20 mg tablets contain pantoprazole sodium sesquihydrate
22.55 mg, equivalent to
pantoprazole 20 mg.
Panzop Relief 40 mg tablets contain pantoprazole sodium sesquihydrate
45.100 mg, equivalent to
pantoprazole 40 mg.
Excipient(s) with known effect: mannitol, povidone, sodium carbonate,
triethyl citrate.
Allergen declaration: sulfites and gluten from wheat.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Panzop Relief 20 mg tablets are dark yellow, oval, biconvex, enteric
coated tablets, plain on both
sides and approximately 4.3 mm x 8.4 mm.
Panzop Relief 40 mg tablets are dark yellow, oval, biconvex, enteric
coated tablets, plain on both
sides and approximately 5.7 mm x 11.6 mm.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
1.
For the symptomatic improvement and healing of gastrointestinal
diseases which require a
reduction in acid secretion:
•
Duodenal ulcer
•
Gastric ulcer
•
Gastro-oesophageal reflux disease (GORD)
•
For the treatment of mild reflux disease and associated symptoms (e.g.
heartburn, acid
regurgitation, pain on swallowing)
•
Reflux oesophagitis
•
Zollinger-Ellison Syndrome
2.
Eradication of Helicobacter pylori (hereinafter referred to as H.
pylori) in combination with
•
clarithromycin and amoxycillin or
•
clarithromycin and metronidazole or
•
amoxycillin and metronidazole
(see section 4.2) in cases of duodenal ulcer and gastric ulcer with
the objective of reducing
the recurrence of duodenal and gastric ulcers caused by this
microorganism.
Page 2 of 22
The NIH have recommended that regimens to eradicate H. pylori in
patients with PUD should
contain both anti-secretory agents and anti-microbial agents (to which
H. pylori has been
demonstrated to be sensitive _ in vivo_). A trial by Bardhan in
patients with gastritis, florid
duodenal ulcer or history of duodenal ulcer has