Vallergan Forte Syrup 30mg/5ml bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

alimemazine (trimeprazine) tartrate

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

alimemazine (trimeprazine) tartrate

Class:

Medicine Registered

Authorization status:

Registered

Patient Information leaflet

VALLERGAN
® AND
VALLERGAN FORTE
_Alimemazine (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
•
epilepsy
•
Parkinson's disease
•
hypothyroidism (underactive
thyroid gland)
•
myasthenia gravis (disease
causing muscle weakness)
•
pheochromocytoma (tumour of
adrenal glands)
•
agranulocytosis (lack of white
blood cells)
•
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
u

Summary of Product characteristics

vallergan-ccdsv1-piv9-26jul17
Page 1 of 6
PRODUCT INFORMATION
VALLERGAN
®
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Alimemazine (trimeprazine) tartrate
CHEMICAL STRUCTURE
CAS NUMBER
4330-99-8
DESCRIPTION
Alimemazine (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.
Alimemazine
(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 alimemazine (trimeprazine) tartrate in
5 mL. The inactive
ingredients are 68% w/v of sucrose, ethanol, sodium citrate dihydrate,
sodium sulfite,
sodium metabisulfite, sodium benzoate, citric acid, ascorbic acid,
caramel and apricot
flavour 91.
Vallergan Forte Syrup contains 30 mg alimemazine (trimeprazine)
tartrate in 5 mL. The
inactive ingredients are 68% w/v of sucrose, ethanol, sodium citrate
dihydrate, sodium
sulfite, sodium metabisulfite, sodium benzoate, citric acid, ascorbic
acid, and apricot flavour
91.
Vallergan
Tablets
contain
10
mg
alimemazine
(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
Alimemazine (trimeprazine) tartrate has a central sedative effect,
comparable to that of
chlorpromazine, but largely devoid of the latter’s anti-adrenaline
action.
It has powerful antihistaminic, anti-emetic, antipruritic and sedative
actions.
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INDICATIONS
URTICARIA
Vallergan is used for the oral treatment of pruritus irrespective of
the cause. T