Vallergan Forte

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alimemazine tartrate 0.6%{relative};  ; Alimemazine tartrate 0.6%{relative}

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Alimemazine tartrate 0.6% w/v

Dosage:

30 mg/5mL

Pharmaceutical form:

Syrup

Composition:

Active: Alimemazine tartrate 0.6%{relative}   Excipient: Ascorbic acid Citric acid as monohydrate Ethanol Prunus armeniaca Purified water Sodium benzoate Sodium citrate dihydrate Sodium metabisulfite Sodium sulfite Sucrose Active: Alimemazine tartrate 0.6%{relative} Excipient: Ascorbic acid Citric acid monohydrate Ethanol Prunus armeniaca Purified water Sodium benzoate Sodium citrate dihydrate Sodium metabisulfite Sodium sulfite Sucrose

Units in package:

Bottle, glass, 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sanofi Chimie

Therapeutic indications:

· Urticaria

Product summary:

Package - Contents - Shelf Life: Bottle, glass, - 100 mL - 36 months from date of manufacture stored at or below 25°C protect from light 1 months opened stored at or below 25°C protect from light

Authorization date:

1969-12-31

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

New Zealand Data Sheet
June 2017
Vallergan Forte
vallergan-forte-ccdsv1-dsv5-16jun17
Page 1
DATA SHEET
1
VALLERGAN FORTE
® 30MG/5ML SYRUP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5mL of syrup contains alimemazine tartrate 30mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vallergan Forte syrup is a clear, colourless to pale yellow coloured,
apricot flavoured liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vallergan Forte is used in:
1.
Urticaria and pruritus.
2.
Premedication for anaesthesia.
4.2
DOSE AND METHOD OF ADMINISTRATION
Vallergan is contraindicated for use in children less than 2 years of
age due to the risk of marked
sedation and respiratory depression.
Urticaria and Pruritus
_Adults _
10 mg two or three times daily. Up to 100 mg per day has been used in
intractable cases.
New Zealand Data Sheet
June 2017
Vallergan Forte
vallergan-forte-ccdsv1-dsv5-16jun17
Page 2
_Elderly _
Dosage should be reduced to 10 mg once or twice daily.
_Children _
2.5 to 5 mg three or four times daily.
Pre-anaesthetic Medication
_Children (2 to 7 years of age) _
The maximum dosage of Vallergan Forte syrup recommended for this
indication is 2 mg/kg
bodyweight.
For instructions on dilution of medicine before administration see
section 6.6.
4.3
CONTRAINDICATION
_ _
Vallergan Forte should be avoided in patients with liver or renal
dysfunction, epilepsy,
Parkinson's disease, hypothyroidism, phaeochromocytoma, myasthenia
gravis, and prostate
hypertrophy.
It should be avoided in patients known to be hypersensitive to
phenothiazines or any of the
excipients or with a history of narrow angle glaucoma or a history of
agranulocytosis.
Vallergan is contraindicated for use in children less than 2 years of
age due to the risk of marked
sedation and respiratory depression.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
QT interval prolongation has been reported with phenothiazines.
Alimemazine should be used with caution in:
•
elderly or volume depleted patients who are more susceptible to
orthos