TACIDINE nizatidine 150mg capsule blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

nizatidine, Quantity: 150 mg

Доступно од:

Alphapharm Pty Ltd

Фармацеутски облик:

Capsule

Састав:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; Gelatin; allura red AC; pregelatinised maize starch; colloidal anhydrous silica; quinoline yellow; titanium dioxide; sodium lauryl sulfate; iron oxide yellow; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Пут администрације:

Oral

Јединице у пакету:

60 capsules, 30 capsules

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

TACIDINE is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks. TACIDINE is also indicated for the maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150mg at bedtime, after healing of the active duodenal ulcer. Continuous therapy with nizatidine for longer than 1 year has not been studied. TACIDINE is indicated for up to 8 weeks for the treatment of benign gastric ulcer. TACIDINE 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: Capsule with a pale yellow body and a dark yellow cap. The body is printed with "NZ 150" and the cap with G" in black ink.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2003-04-29

Информативни летак

TACIDINE
®
_nizatidine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TACIDINE. 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 TACIDINE
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 TACIDINE IS
USED FOR
TACIDINE contains the active
ingredient nizatidine.
Nizatidine belongs to a group of
medicines called histamine (H2)
antagonist or histamine (H2)
blockers. These medicines work by
reducing the amount of stomach acid
produced which in turn reduces the
pain and allows the ulcers and/or
reflux disease to heal in most people.
ULCERS
TACIDINE is used to treat both
gastric ulcers and duodenal ulcers. A
gastric ulcer occurs in the stomach. A
duodenal ulcer occurs in the
duodenum (which is part of your
small intestine). The ulcers can be
caused in part by too much acid
being made in the stomach.
TACIDINE is also used to help stop
duodenal ulcers from coming back.
REFLUX DISEASE
TACIDINE is also 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 causes burning sensation in
the chest rising up to the throat
(heartburn) and most often occurs
after eating or at night.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
TACIDINE is not recommended for
use in children, as the safety and
effectiveness have not been
established.
This medicine is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
TACIDINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TACIDINE IF YOU HAVE
AN ALLERGY TO:
•

Карактеристике производа

AUSTRALIAN PRODUCT INFORMATION
TACIDINE
®
_nizatidine capsule _
1
NAME OF THE MEDICINE
Nizatidine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TACIDINE capsules contain 150 mg or 300 mg of nizatidine as the active
ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TACIDINE 150 capsules – hard gelatin capsule with a pale yellow body
and dark yellow cap. The body has
“NZ 150” and the cap has “G” printed in black.
TACIDINE 300 capsules – hard gelatin capsule with a light brown body
and cap. The body has “NZ 300” and
the cap has “G” printed in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TACIDINE is indicated for up to 8 weeks for the treatment of active
duodenal ulcer. In most patients, the ulcer
will heal within 4 weeks.
TACIDINE is also indicated for maintenance therapy for duodenal ulcer
patients, at a reduced dosage of 150
mg at bedtime, after healing of the active duodenal ulcer. Continuous
therapy with nizatidine for longer than
1 year has not been studied.
TACIDINE is indicated for up to 8 weeks for the treatment of benign
gastric ulcer.
TACIDINE 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
DOSE 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 (for up to
8 weeks). In most cases, the ulcer will heal within 4 weeks.
BENIGN GASTRIC ULCER
The recommended daily dose is 150 mg twice daily or 300 mg once daily
in the evening (for up to 8 weeks).
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. Continuous therapy with nizatidine for longer
than 12 months has not been studied.
GASTRO-OESOPHAGEAL REFLUX DISEASE
The recommended