ZANTAC 150mg/10mL

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

ranitidine hydrochloride, Quantity: 16.8 mg/mL (Equivalent: ranitidine, Qty 15 mg/mL)

Boleh didapati daripada:

Aspen Pharmacare Australia Pty Ltd

Borang farmaseutikal:

Oral Liquid

Komposisi:

Excipient Ingredients: hypromellose; ethanol; sorbitol solution (70 per cent) (non-crystallising); butyl hydroxybenzoate; saccharin sodium; propyl hydroxybenzoate; sodium chloride; dibasic sodium phosphate; monobasic potassium phosphate; purified water; Flavour

Laluan pentadbiran:

Oral

Unit dalam pakej:

300mL

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

Short-term treatment of proven duodenal ulcer and gastric ulcer, including intravenous use for prophylaxis against recurrent haemorrhage: maintenance treatment to reduce the risk of relapse in duodenal ulcer: maintenance treatment for periods up to one year to reduce the risk of relapse in patients with documented healing of benign gastric ulcer: treatment of gastrinoma (Zollinger-Ellison syndrome): short-term treatment of severe reflux oesophagitis: treatment of scleroderma oesophagitis. The intravenous injection is indicated where oral treatment is inappropriate. NEW INDICATIONS AS AT 2 NOVEMBER 1993: 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 syndrom

Ringkasan produk:

Visual Identification: Clear pale yellow liquid in the above container.; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

1994-03-08

Risalah maklumat

Zantac oral liquid - CMI
1
ZANTAC ORAL LIQUID
_ranitidine (as hydrochloride) oral solution _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zantac oral liquid. It
does not contain all of 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 Zantac Oral
liquid against the benefits this
medicine is expected to 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 ZANTAC ORAL
LIQUID IS USED FOR
Zantac oral liquid belongs to a group
of medicines called H2-antagonists.
It 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 or heartburn).
Zantac oral liquid is also used to
treat:
•
Zollinger-Ellison disease,
•
scleroderma oesophagitis.
These problems are improved by
reducing the amount of acid in the
stomach. Zantac oral liquid reduces
stomach acid to decrease pain and
allow the ulcer and reflux to heal.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ZANTAC ORAL
LIQUID HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is not addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE _
_ZANTAC ORAL LIQUID _
DO NOT TAKE ZANTAC ORAL LIQUID IF
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO RANITIDINE OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Symptoms of an allergic reaction
may be mild or severe. They usually
include some or all of the following:
wheezing, swelling of the lips/mouth,
difficulty in breathing, hayfever,
lumpy rash ("hives") or fainting.
DO NOT TAKE ZANTAC ORAL LIQUID IF
YOU ARE PREGNANT, TRYING TO BECOME
PREGNANT OR BREASTFEEDING, UNLESS
YOUR DOCTOR SAYS YOU SHOULD.
Your doctor will discuss the risks a

Ciri produk

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