Tagamet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Cimetidine

Available from:

GlaxoSmithKline Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

TAGAMET
1
TAGAMET
_Cimetidine_
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about
TAGAMET.  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 possible risks of taking
TAGAMET against the expected
benefits.
If you have any concerns about
taking this medicine talk to your
doctor or pharmacist.
Keep this leaflet with this medicine.
You may need to read it again.
WHAT TAGAMET IS
USED FOR
TAGAMET contains cimetidine as
the active ingredient.
TAGAMET helps heal peptic ulcers
and relieves the pain and discomfort
they cause.  Peptic ulcers can also be
called gastric ulcers or duodenal
ulcers depending on where they
occur.  A gastric ulcer occurs in the
stomach.  A duodenal ulcer occurs in
the duodenum which is the tube
leading out of the stomach.  These
can be caused in part by the acid
made in the stomach.
TAGAMET is also used to treat
reflux oesophagitis or reflux disease.
This can be caused when food and
acid from the stomach washes back
into the food pipe (oesophagus).
This can cause a burning feeling in
the chest known as heartburn.
Heartburn usually occurs after eating
or at night.  TAGAMET relieves
these symptoms and helps heal any
damage to the food pipe.
TAGAMET is also used to treat a
rare condition called
Zollinger-Ellison syndrome.  In this
condition the stomach produces very
large amounts of acid.
TAGAMET belongs to a class of
medicines called H2 antagonists or
H2 blockers.  It works by reducing
the amount of acid produced by your
stomach.  This helps to reduce pain
and allows any damage to heal.
Your doctor may have prescribed
TAGAMET for another reason.  Ask
your doctor if you have any
questions about why TAGAMET has
been prescribed for you.
There is no evidence 

Summary of Product characteristics

1 
TAGAMET® PRODUCT INFORMATION 
(CIMETIDINE) 

DESCRIPTION 

TAGAMET (cimetidine) is a histamine
H2-receptor antagonist.  Chemically it is: 2-cyano-1-methyl-
3-{2-(5-methylimidazol-4-yl-methylthio)ethyl} guanidine. 

HN
N
H
3
C
S
N
H
N
H
N
CN
CH
3

Cimetidine is an odourless white to off-white powder, slightly soluble
in water. 

PHARMACOLOGY 

TAGAMET is a histamine H2-receptor antagonist and represents a new
class of pharmacological 
agents.  It was the first available agent that blocked the action
of histamine at the histamine H2-
receptor site of the parietal cells and does so by competitive
inhibition. 

Pharmacologically, TAGAMET does not exhibit classical anticholinergic
effects.  Studies have 
shown that TAGAMET inhibits both daytime and nocturnal basal
gastric acid secretion.  TAGAMET 
also inhibits gastric acid secretion stimulated by food, histamine,
pentagastrin, caffeine and insulin. 

TAGAMET has been shown by _in vitro_ studies to be
a specific competitive H2-receptor antagonist 
without significant interaction at catecholamine, 
β-receptors, histamine H1-receptors or muscarinic 
receptors. 

Its potency in terms of administered dose and, more meaningfully, in
terms of blood concentrations 
achieved, is very similar in man and in experimental animals.
 Thus, in all species studied a blood 
concentration of about 2
μmol/L is associated with 50% inhibition of maximal acid output. 

In chronic toxicity studies in dogs, some animals administered
504mg/kg showed evidence of liver 
and kidney damage. 

The kinetics of TAGAMET and its absorption, metabolism and
excretion are essentially similar in 
man, rat and dog. 

2 
HUMAN PHARMACOLOGY: 
Pharmacokinetic studies carried out in humans have demonstrated
that cimetidine is well absorbed 
orally.  Oral absorption studies carried out using a 200mg dose have
resulted in blood levels 
averaging 2.8
μmol/L (0.7mg/L) occurring at times ranging from 45 - 75
minu