Zantac

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Ranitidine hydrochloride 16.8 mg/mL equivalent to Ranitidine 15 mg/mL;  

זמין מ:

GlaxoSmithKline NZ Limited

INN (שם בינלאומי):

Ranitidine hydrochloride 16.8 mg/mL (=Ranitidine 15 mg/mL)

כמות:

150mg/10mL

טופס פרצבטיות:

Syrup

הרכב:

Active: Ranitidine hydrochloride 16.8 mg/mL equivalent to Ranitidine 15 mg/mL   Excipient: Butyl hydroxybenzoate Dibasic sodium phosphate Ethanol Hypromellose Mint flavour 17.42.3632 Monobasic potassium phosphate Propyl hydroxybenzoate Saccharin sodium Sodium chloride Sorbitol Water

יחידות באריזה:

Bottle, glass, 300 mL

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Glaxo Wellcome Manufacturing Pte Ltd

סממני תרפויטית:

-The treatment of duodenal ulcer, and benign gastric ulcer, including that associated with non-steroidal anti- inflammatory agents. - The prevention of non-steroidal anti-inflammatory agent (including aspirin) associated duodenal ulcers in patients with a history of duodenal ulceration proven by endoscopy. - The treatment of post-operative ulcer - The treatment of oesophageal reflux disease - Symptom relief in gastro-oesophageal reflux disease - The treatment of Zollinger-Ellison syndrome - The treatment of chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but not associated with the above conditions. ZANTAC Syrup is also indicated for the following conditions where reduction of gastric secretion and acid output is desirable: - The prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients. - The prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers. - Before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's syndrome), particularly obstetric patients during labour.

leaflet_short:

Package - Contents - Shelf Life: Bottle, glass, - 300 mL - 24 months from date of manufacture stored at or below 25°C

תאריך אישור:

1987-08-20

עלון מידע

 
1 
ZANTAC
®
 SYRUP 
RANITIDINE HYDROCHLORIDE, 150MG/10ML SYRUP 
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS 
LEAFLET? 
Please read this leaflet 
carefully before you start 
taking Zantac syrup. 
This leaflet does not have 
all information available 
about your medicine. If you 
have any questions about 
your medicine, you should 
ask your doctor or 
pharmacist. 
All medicines have some 
risks. Your doctor has 
weighed the risks of you 
taking Zantac syrup against 
the benefits he/she expects 
it will have for you. 
If there is anything you do 
not understand, ask your 
doctor or pharmacist. If you 
want more information, ask 
your doctor or pharmacist. 
WHAT ZANTAC IS 
USED FOR 
The medicine in your 
Zantac syrup is called 
ranitidine (as 
hydrochloride). This 
belongs to a group of 
medicines called H
2
-
antagonists. 
Zantac is mostly used to:  
  relieve and treat the 
symptoms of reflux 
oesophagitis (also 
known as reflux)  
  treat stomach and 
duodenal ulcer disease 
(also known as peptic 
ulcer), including when 
they are caused by 
taking anti-
inflammatory tablets.  
  stop these ulcers from 
coming back  
  treat chronic dyspepsia 
(indigestion)  
  treat duodenal ulcers 
associated with 
Helicobacter _pylori _
infection, in 
combination with 
amoxicillin (antibiotic) 
and metronidazole 
(antibacterial agent)  

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 – where the 
stomach produces very 
large amounts of acid, 
much more than in 
ulcers and reflux 
dise

מאפייני מוצר

_The medicine is not currently marketed in New Zealand _
1 
NEW ZEALAND DATA SHEET 
ZANTAC
®
 SYRUP 
_RANITIDINE HYDROCHLORIDE SYRUP _
_ _
QUALITATIVE AND QUANTITATIVE COMPOSITION  
ZANTAC Syrup: Each 10mL contains ranitidine 150mg (as the
hydrochloride). 
PHARMACEUTICAL FORM  
Syrup. 
CLINICAL PARTICULARS  
_THERAPEUTIC INDICATIONS  _
ZANTAC Syrup is indicated for: 
- 
the treatment of duodenal ulcer, and benign gastric ulcer, including
that 
associated with non-steroidal anti- inflammatory agents. 
- 
the prevention of non-steroidal anti-inflammatory agent (including 
aspirin) associated duodenal ulcers in patients with a history of 
duodenal ulceration proven by endoscopy. 
- 
the treatment of post-operative ulcer 
- 
the treatment of oesophageal reflux disease 
- 
symptom relief in gastro-oesophageal reflux disease 
- 
the treatment of Zollinger-Ellison syndrome 
- 
the treatment of chronic episodic dyspepsia, characterised by pain 
(epigastric or retrosternal) which is related to meals or disturbs
sleep 
but not associated with the above conditions. 
ZANTAC Syrup is also indicated for the following conditions where
reduction 
of gastric secretion and acid output is desirable: 
- 
the prophylaxis of upper gastrointestinal haemorrhage from stress 
ulceration in seriously ill patients. 
_The medicine is not currently marketed in New Zealand _
2 
- 
the prophylaxis of recurrent haemorrhage in patients with bleeding 
peptic ulcers. 
- 
before general anaesthesia in patients considered to be at risk of
acid 
aspiration (Mendelson's syndrome), particularly obstetric patients 
during labour. 
For appropriate cases ZANTAC Injection is also available (see ZANTAC 
Injection Data Sheet). 
_POSOLOGY AND METHOD OF ADMINISTRATION  _
Zantac Syrup contains approximately 7.5% w/v ethanol (alcohol), i.e.
up to 
405 mg per 5 mL spoonful (approximately a teaspoonful) which is
equivalent 
to about 11 mL of beer or 5 mL of wine. 
ADULTS 
Duodenal Ulcer and Benign Ga