Zantac 150mg/10ml syrup

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Ranitidine hydrochloride

זמין מ:

GlaxoSmithKline UK Ltd

קוד ATC:

A02BA02

INN (שם בינלאומי):

Ranitidine hydrochloride

כמות:

15mg/1ml

טופס פרצבטיות:

Oral solution

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 01030100; GTIN: 5000123101757

עלון מידע

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC
®
SYRUP
RANITIDINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor, pharmacist or nurse.
This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Zantac is and what it is used for
2
What you need to know before you take Zantac
3
How to take Zantac Syrup
4
Possible side effects
5
How to store Zantac
6
Contents of the pack and other information
1
WHAT ZANTAC IS AND WHAT IT IS USED FOR
Zantac contains a medicine called ranitidine. This belongs to a group
of medicines
called H
2
-receptor antagonists. It lowers the amount of acid in your stomach.
For adults (including the elderly) Zantac is used to:

heal and stop ulcers in the stomach, or the part of the gut it empties
into (the
duodenum)

help clear up infection in your stomach, when taken with antibiotic
medicines
(medicines taken to treat germs)

stop stomach ulcers when they are a side effect of some medicines

stop ulcers from bleeding

improve problems caused by acid in the food pipe (oesophagus) or too
much acid
in the stomach. Both of these can cause pain or discomfort sometimes
known as
‘indigestion’, ‘dyspepsia’ or ‘heartburn’

stop acid coming up from the stomach while under anaesthetic during an
operation.
For children (3 to 18 years) Zantac is used to:

heal ulcers in the stomach, of the part of the gut it empties into
(the duodenum)

heal and stop problems caused by acid in the food pipe (oesophagus) or
too
much acid in the stomach. Both of these can cause pain or discomfort
sometimes
known as

מאפייני מוצר

OBJECT 1
ZANTAC SYRUP
Summary of Product Characteristics Updated 26-Oct-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Zantac Syrup
2. Qualitative and quantitative composition
Each 10 ml of syrup contains Ranitidine Hydrochloride 168.0 mg
(Equivalent to Ranitidine 150.0 mg)
Each 10 ml of syrup also contains the following excipients:
- 800 mg ethanol
- 1.5 mg propyl hydroxybenzoate
- 0.75 mg butyl hydroxybenzoate
- 700 mg sorbitol
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Syrup
4. Clinical particulars
4.1 Therapeutic indications
Adults
Zantac syrup is indicated for the treatment of duodenal ulcer and
benign gastric ulcer, including that
associated with non-steroidal anti-inflammatory agents. In addition,
Zantac syrup is indicated for the
prevention of NSAID associated duodenal ulcers. Zantac syrup is also
indicated for the treatment of post-
operative ulcer, Zollinger-Ellison Syndrome and oesophageal reflux
disease including long term
management of healed oesophagitis. Other patients with chronic
episodic dyspepsia, characterised by pain
(epigastric or retrosternal) which is related to meals or disturbs
sleep but is not associated with the
preceding conditions may benefit from ranitidine treatment. Zantac
syrup is indicated for the following
conditions where reduction of gastric secretion and acid output is
desirable; the prophylaxis of gastro-
intestinal haemorrhage from stress ulceration in seriously ill
patients, the prophylaxis of recurrent
haemorrhage in patients with bleeding peptic ulcers and 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 separate
SPC).
Children (3 to 18 years):
Short term treatment of peptic ulcer. Treatment of gastro-oesophageal
reflux, including reflux
oesophagitis and symptomatic relief of gastro-oesophageal reflux
disease.
See section 4.4 Special warnings and precautions for use