TAZAC PULVULES nizatidine 300mg capsule

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

nizatidine, Quantity: 300 mg

Доступно од:

Arrow Pharma Pty Ltd

Фармацеутски облик:

Capsule, hard

Састав:

Excipient Ingredients: dimeticone 350; purified talc; pregelatinised maize starch; povidone; maize starch; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; ethanol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; iron oxide yellow; iron oxide red; Gelatin

Пут администрације:

Oral

Јединице у пакету:

30, 7 capsules, 4 capsules, 100

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

TAZAC is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. TAZAC is also indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of active duodenal ulcer. Continuous therapy with nizatidine for longer than 1 year has not been studied. TAZAC is indicated for up to 8 weeks for the treatment of benign gastric ulcer. TAZAC is indicated for up to 12 weeks for the treatment of oesophagitis, including erosive and ulcerative oesophagitis and associated heartburn due to reflux.

Резиме производа:

Visual Identification: Size 1 capsule consisting of a brown cap and a pale yellow body, printed with "N300" .; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Статус ауторизације:

Registered

Датум одобрења:

1994-06-29

Информативни летак

TAZAC
®
1
TAZAC
®
_nizatidine _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet is designed to provide
you with answers to some common
questions about this medicine. It
does not contain all the available
information that is known about
Tazac.
It does not take the place of talking
with your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Tazac 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 THIS
MEDICINE.
You may need to read it again.
WHAT TAZAC IS USED
FOR
Tazac contains an active ingredient
called nizatidine. It belongs to a class
of medicines called H2-antagonists
or H2-blockers.
Tazac is used to treat the following
conditions:
REFLUX OESOPHAGITIS
This can be caused by reflux or
"washing back" of food and acid
from the stomach into the food pipe.
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
ULCERS
Depending on the position of the
ulcer it is either 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. Tazac is also
used to stop duodenal ulcers from
coming back.
Tazac works by reducing the amount
of acid in your stomach. This helps
reduce the pain and allows the ulcer
and reflux disease to heal in most
people.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
THIS MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is only available with
a doctor's prescription.
There is no evidence that it is
addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TAZAC IF YOU HAVE EVER
HAD AN ALLERGIC REACTION TO:
•
nizatidine or other histamine H2-
receptor antagonists (e.g.
cimetidine, ranitidine,
famotidine)
•
any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic r

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION – TAZAC (NIZATIDINE)
CAPSULES
1
NAME OF THE MEDICINE
Nizatidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAZAC (nizatidine) is a histamine H2-receptor antagonist.
Each capsule contains for oral administration either 150 mg or 300 mg
of nizatidine as the active
ingredient.
3
PHARMACEUTICAL FORM
150 mg: Size 2 capsule consisting of a dark yellow cap and a pale
yellow body, printed with "N150".
300 mg: Size 1 capsule consisting of a brown cap and a pale yellow
body, printed with "N300".
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
TAZAC is indicated for up to 8 weeks for the treatment of active
duodenal ulcer. In most patients,
the ulcer will heal within 4 weeks.
TAZAC is also indicated for maintenance therapy for duodenal ulcer
patients, at a reduced dosage of
150 mg h.s. after healing of an active duodenal ulcer. Continuous
therapy with nizatidine for longer
than 1 year has not been studied.
TAZAC is indicated for up to 8 weeks for the treatment of benign
gastric ulcer.
TAZAC is indicated for up to 12 weeks for the treatment of
oesophagitis, including erosive and
ulcerative oesophagitis and associated heartburn due to reflux.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Active Duodenal Ulcer--The recommended oral dosage for adults is 150
mg twice daily or 300 mg
once daily in the evening.
2
Benign Gastric Ulcer--The recommended daily dose is 150 mg twice daily
or 300 mg once daily in the
evening. Prior to treatment with nizatidine, care should be taken to
exclude the possibility of gastric
cancer.
Maintenance
Therapy--The
recommended
oral
dosage
for
adults
with
duodenal
ulcer
is
150 mg once daily in the evening for a period not exceeding 12 months.
Gastroesophageal Reflux Disease--The recommended oral dosage in adults
for the treatment of
erosions, ulcerations, and associated heartburn is 150 mg twice daily.
Dosage Adjustment for Patients with Moderate to Severe Renal
Insufficiency--The dose for patients
with renal dysfunction should be reduced as follows
CREATINE CLEARANCE
DO