Vallergan

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Trimeprazine tartrate

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Listed (Export Only)

Patient Information leaflet

VALLERGAN
®
 AND
VALLERGAN FORTE

_Trimeprazine tartrate_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vallergan.
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 or pharmacist
has weighed the risks of you taking
Vallergan against the benefits they
expect it will 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 VALLERGAN IS
USED FOR
Vallergan can be taken to treat hives
or pinkish itchy swellings on the
skin. This condition is called
urticaria.
Vallergan can also be taken to relieve
itching due to sunburn,
photosensitivity, measles and chicken
pox.
Your doctor may have prescribed
Vallergan for another reason. Ask
your doctor if you have any questions
about why Vallergan has been
prescribed for you.
Vallergan should not be used in
children under 2 years of age because
safety of such use had not been
established.
BEFORE YOU TAKE
VALLERGAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE VALLERGAN IF YOU HAVE
AN ALLERGY TO VALLERGAN OR ANY OF
THE INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction to
Vallergan may include swelling of
the face, lips, tongue or other parts of
the body, shortness of breath,
wheezing or trouble breathing
DO NOT TAKE VALLERGAN IF YOU HAVE,
OR HAVE HAD, ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
asthma
•
severe liver or kidney disease
•
closed-angle glaucoma
•
unusual heart beats
•
prostate problems
•
difficulty passing urine
•
a narrowing or blockage between
the stomach and small intestine
which causes vomiting of
undigested food
DO NOT GIVE VALLERGAN TO A CHILD
UNDER 2 YEARS.
The safety of Vallergan in children
under 2 years) has not been
established.
DO NOT TAKE VALLERGAN AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
DO NOT TAKE VALLERGAN IF TH

Summary of Product characteristics

Vallergan PI 
#689v6.0 
Page 1 of 6  
PRODUCT INFORMATION 
VALLERGAN
® 
NAME OF THE MEDICINE 
NON-PROPRIETARY NAME 
Trimeprazine tartrate 
CHEMICAL STRUCTURE 

CAS NUMBER 
4330-99-8 
DESCRIPTION 
Trimeprazine  tartrate  is  (_RS_)-dimethyl  (2-methyl  -3-phenothiazin-10-ylpropyl)  amine 
(2_R_,3_R_)-tartrate.  It  contains  not  less  than  99%  and  not  more  than  101%  of 
(C
18
H
22
N
2
S)
2
,C
4
H
6
O
6
, calculated with reference to the dried substance. Trimeprazine tartrate 
is a white or slightly cream powder which darkens on exposure to light. It is freely soluble in 
water and sparingly soluble in ethanol (96%). 
Vallergan Syrup contains 7.5 mg trimeprazine tartrate in 5 mL. The inactive ingredients are 
68%  w/v  of  sucrose,  ethanol,  sodium  citrate,  sodium  sulfite  anhydrous,  sodium 
metabisulfite,  sodium  benzoate,  anhydrous  citric  acid,  ascorbic  acid,  caramel  and  apricot 
flavour 91.  
Vallergan  Forte  Syrup  contains  30  mg  trimeprazine  tartrate  in  5  mL.    The  inactive 
ingredients  are  68%  w/v  of  sucrose,  ethanol,  sodium  citrate,  sodium  sulfite  anhydrous, 
sodium  metabisulfite,  sodium  benzoate,  anhydrous  citric  acid,  ascorbic  acid,  and  apricot 
flavour 91.  
Vallergan  Tablets  contain  10 mg trimeprazine tartrate. The inactive ingredients are acacia, 
brilliant  blue  FCF,  erythrosine,  magnesium  stearate,  polyvinyl  acetate,  colloidal  anhydrous 
silica, wheat starch and sucrose. 
PHARMACOLOGY 
PHARMACOKINETIC PROPERTIES 
There is little information about blood levels, distribution and excretion in humans. The rate 
of metabolism and excretion of phenothiazines decreases in old
age. 
PHARMACODYNAMIC PROPERTIES 
Trimeprazine has a central sedative effect,�