TELFAST fexofenadine hydrochloride 180mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fexofenadine hydrochloride, Quantity: 180 mg

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; titanium dioxide; macrogol 400; povidone; magnesium stearate; microcrystalline cellulose; hypromellose; colloidal anhydrous silica; pregelatinised maize starch; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

30 BCF Promo Pack, 100, 90, 2 Starter Pack - NOT FOR SALE, 10 BCF Promo Pack, 70, 20, 30, 50, 80, 60, 10

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

Relief of symptoms associated with seasonal allergic rhinitis or urticaria for adults and children aged 12 years and over.

Product summary:

Visual Identification: Peach, oblong, double convex, tablets debossed with '018' (underlined) on one side and a scripted 'e' on the other.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-03-30

Patient Information leaflet

TELFAST
®
(tell-fast)
T
E
L
F
A
S
T
®
ACTIVE INGREDIENT(S): _Fexofenadine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Telfast. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR OR
PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF YOU
HAVE ANY CONCERNS OR QUESTIONS ABOUT USING TELFAST.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Telfast?
2. What should I know before I use Telfast?
3. What if I am taking other medicines?
4. How do I use Telfast?
5. What should I know while using Telfast?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING TELFAST?
TELFAST CONTAINS THE ACTIVE INGREDIENT FEXOFENADINE
HYDROCHLORIDE. Telfast is one of a group of medicines called
antihistamines.
Antihistamines help reduce allergic symptoms by preventing
the effects of a substance called histamine, which your body
produces when exposed to certain substances.
Telfast is a non-sedating antihistamine which means it has
been shown not to cause drowsiness.
TELFAST 60MG TABLETS ARE USED TO RELIEVE THE SYMPTOMS
OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS (INCLUDING
HAYFEVER) IN ADULTS AND CHILDREN AGED 12 YEARS OR OLDER.
TELFAST 120MG TABLETS ARE USED TO RELIEVE THE SYMPTOMS
OF HAYFEVER (SEASONAL ALLERGIC RHINITIS (INCLUDING
HAYFEVER) SUCH AS SNEEZING, ITCHY, WATERY OR RED EYES AND
ITCHY, BLOCKED OR RUNNY NOSE IN ADULTS AND CHILDREN AGED
12 YEARS OR OLDER.
TELFAST 180MG TABLETS ARE USED TO RELIEVE THE SYMPTOMS
OF HAYFEVER (SEASONAL ALLERGIC RHINITIS) SUCH AS SNEEZING,
ITCHY, WATERY OR RED EYES AND ITCHY, BLOCKED OR RUNNY
NOSE AS WELL AS THE SYMPTOMS OF URTICARIA OTHERWISE
KNOWN AS HIVES OR ITCHY RASH IN ADULTS AND CHILDREN AGED
12 YEARS OR OLDER.
2.
WHAT SHOULD I KNOW BEFORE I USE TELFAST?
WARNINGS
DO NOT USE TELFAST IF:
•
you are pregnant, intend to become pregnant, or if you
are breastfeeding, unless advised to do so by a Doctor or
Pharmacist.
•
you are allergic to ingredient fexofenadine hydrochloride,
or any of the ingredients listed at the end of

Summary of Product characteristics

telfast-ccdsv5-piv18-06jul21
Page 1
AUSTRALIAN PRODUCT INFORMATION – TELFAST (FEXOFENADINE)
1
NAME OF THE MEDICINE
Fexofenadine (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TELFAST 6 – 11 YEARS TABLETS
*
Each tablet contains fexofenadine HCl 30 mg equivalent to 28 mg
fexofenadine.
TELFAST 60 MG TABLETS
Each tablet contains fexofenadine HCl 60 mg equivalent to 56 mg
fexofenadine.
TELFAST 120 MG TABLETS
Each tablet contains fexofenadine HCl 120 mg equivalent to 112 mg
fexofenadine.
TELFAST 180 MG TABLETS
Each tablet contains fexofenadine HCl 180 mg equivalent to 168 mg
fexofenadine.
TELFAST ORAL LIQUID
Each mL of oral liquid contains fexofenadine HCl 6 mg (30 mg/ 5mL)
equivalent to 5.6 mg
fexofenadine.
Excipients with known effect in Telfast Oral Liquid: propyl
hydroxybenzoate, butyl
hydroxybenzoate and sucrose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TELFAST 6 – 11 YEARS TABLETS
*
Peach, round, standard convex film-coated tablets engraved with
‘03’ on one side and a scripted
‘
_e_
’ on the other.
TELFAST 60MG TABLETS
Peach, oval, double convex, tablets, debossed with ‘06’ on one
side and a scripted ‘e’ on the other.
TELFAST 120 MG TABLETS
Peach, oblong, double convex, tablets debossed with ‘012’
(underlined) on one side and a scripted
“e” on the other.
telfast-ccdsv5-piv18-06jul21
Page 2
TELFAST 180 MG TABLETS
Peach oblong, double convex tablets, debossed with ‘018’
(underlined) on one side and a scripted
“e” on the other.
TELFAST ORAL LIQUID
White uniform aqueous suspension, with a raspberry cream flavour.
_ _
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ORAL LIQUID
Relief of symptoms associated with urticaria from 6 months of age.
Relief of symptoms
associated with seasonal allergic rhinitis from 2 years of age.
6 – 11 YEARS TABLETS
*
Relief of symptoms associated with seasonal allergic rhinitis,
allergic rhinitis or urticaria in
children aged 6 to 11 years.
60 MG TABLETS
Relief of symptoms associate