ZANTAC 150mg tablet

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

ranitidine hydrochloride, Quantity: 168 mg

Dostupné z:

Aspen Pharmacare Australia Pty Ltd

Forma lieku:

Tablet, film coated

Zloženie:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; triacetin

Spôsob podávania:

Oral

Počet v balení:

90 tablets (E), 2 tablets (starter pack), 60 tablets, 6 tablets

Typ predpisu:

Not scheduled. Not considered by committee, (S4) Prescription Only Medicine

Terapeutické indikácie:

1. Short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage. 2. Maintenance treatment to reduce the risk of relapse in duodenal ulcer. 3. Maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer. 4. Treatment of gastrinoma (Zollinger-Ellison syndrome). 5. Short-term symptomatic treatment of reflux oesophagitis unresponsive to conservative anti-reflux measures and simple drug therapies such as antacids. 6. Maintenance treatment to reduce the risk of relapse of reflux oesophagitis. 7. Treatment of scleroderma oesophagitis. The intravenous injection is indicated where oral treatment is inappropriate

Prehľad produktov:

Visual Identification: White, film-coated biconvex tablets, engraved on one side with "RAN 150" and plain on the other; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Stav Autorizácia:

Licence status A

Dátum Autorizácia:

1995-11-20

Príbalový leták

ZANTAC
®
TABLETS
1
ZANTAC
® TABLETS
_Ranitidine hydrochloride _
CONSUMER MEDICINE INFORMATION
ABOUT YOUR ZANTAC
TABLETS
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU TAKE YOUR MEDICINE.
This leaflet does not have the
complete information available about
your medicine. If you have any
questions about your medicine, you
should ask your doctor or pharmacist
(also known as chemist).
All medicines have some risks.
Sometimes new risks are found even
when a medicine has been used for
many years.
If there is anything you do not
understand, ask your doctor or
pharmacist. If you want more
information, ask your doctor or
pharmacist.
WHAT IS IN MY ZANTAC?
The medicine in your Zantac tablets
is called ranitidine (as
hydrochloride). This belongs to a
group of medicines called H2-
antagonists.
WHAT DOES MY ZANTAC
DO?
Zantac is mostly used to:
•
treat stomach and duodenal ulcer
disease (also known as peptic
ulcer),
•
stop these ulcers from coming
back,
•
treat reflux oesophagitis (also
known as reflux).
These problems are caused, in part,
by too much acid in the stomach.
This can lead to pain such as
heartburn. Zantac works by reducing
the amount of acid in the stomach.
This reduces the pain and also allows
the ulcer and reflux to heal.
Zantac is also used to treat:
•
Zollinger-Ellison disease,
•
scleroderma oesophagitis.
BEFORE YOU TAKE IT
_DO NOT TAKE IF: _
You must not take Zantac if:
•
you have ever had an allergic
(hypersensitive) reaction to
ranitidine or any of the
ingredients listed towards the end
of this leaflet.
•
the expiry date (EXP) printed on
the pack has passed
•
the packaging is torn or shows
signs of tampering
_TELL YOUR DOCTOR IF: _
You must tell your doctor if:
•
you are allergic to foods, dyes,
preservatives or any other
medicines
•
you have ever had an allergic
(hypersensitive) reaction to
ranitidine or any of the
ingredients listed towards the end
of this leaflet.
•
you are allergic to any medicine,
•
you have stomach cancer,
•
you have kidney disease,
•
you have had stomach u

Súhrn charakteristických

Zantac ranitidine (as hydrochloride) PI
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION
ZANTAC
RANITIDINE (AS HYDROCHLORIDE)
TABLETS, DISPERSIBLE TABLETS, EFFERVESCENT TABLETS, ORAL LIQUID AND
INJECTION
1.
NAME OF THE MEDICINE:
Ranitidine hydrochloride.
2. AND 3. QUALITATIVE AND QUANTITATIVE COMPOSITION AND PHARMACEUTICAL
FORM
Zantac 150 mg tablets are white film-coated tablets engraved “RAN
150” on one face and plain on the other.
The tablets contain 150 mg ranitidine (as hydrochloride).
Zantac 300 mg tablets are white capsule-shaped, film-coated tablets
engraved “RAN 300” on one face and
plain on the other. The tablets contain 300 mg ranitidine (as
hydrochloride).
Zantac 150 mg dispersible tablets are white, capsule-shaped,
film-coated tablets with a breakline on one
face. The tablets contain 150 mg ranitidine (as hydrochloride). These
tablets also contain saccharin sodium
as an excipient.
Zantac 150 mg effervescent tablets are white to pale yellow, round,
bevelled tablets debossed “GS LHK” on
one side and flat on the other. The tablets contain 150 mg of
ranitidine (as hydrochloride). Each 150 mg
tablet contains 328 mg (14.3 mEq) sodium, as well as aspartame and
sodium benzoate as excipients.
Zantac 300 mg effervescent tablets are white to pale yellow, round,
bevelled tablets debossed “GS MJG” on
one side and flat on the other. The tablets contain 300 mg of
ranitidine (as hydrochloride). Each 300 mg
tablet contains 479 mg (20.8 mEq) sodium, as well as aspartame and
sodium benzoate as excipients.
Zantac oral liquid is a clear pale yellow liquid containing 150 mg
ranitidine (as hydrochloride) in each 10 mL.
It
also
contains
butyl
hydrozybenzoate,
propyl
hydroxybenzoate,
ethanol
and
saccharin
sodium
as
excipients.
Zantac injection is a clear colourless to pale yellow liquid,
practically free from visible particles containing
50 mg ranitidine (as hydrochloride) in 2 mL ampoules.
For the full list of excipients, see Section 6.1 List of excipients.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Sh