TELFAST 6-11 YEARS fexofenadine hydrochloride 30mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fexofenadine hydrochloride, Quantity: 30 mg

Available from:

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

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

2, 20

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

Relief of symptoms associated with seasonal allergic rhinitis, allergic rhinitis or urticaria in adults and children from 6 years of age.

Product summary:

Visual Identification: Peach, round, standard convex film-coated tablets engraved with ?03? on one side and a scripted ?e? on the other.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-07-10

Patient Information leaflet

TELFAST
® ORAL LIQUID AND 6-11 YEARS TABLETS
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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 is my child using Telfast?
2. What should I know before my child uses Telfast?
3. What if my child is taking other medicines?
4. How do I give Telfast to my child?
5. What should I know while my child is taking Telfast?
6. Are there any side effects?
7. Product details
1.
WHY IS MY CHILD USING TELFAST?
TELFAST CONTAINS THE ACTIVE INGREDIENT FEXOFENADINE
HYDROCHLORIDE. Fexofenadine hydrochloride 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 to not cause drowsiness.
TELFAST IS USED TO RELIEVE THE SYMPTOMS OF:
•
HAYFEVER (SEASONAL ALLERGIC RHINITIS) AND YEAR ROUND
ALLERGIES (PERENNIAL ALLERGIC RHINITIS). SYMPTOMS
INCLUDE RUNNY, ITCHY, BLOCKED NOSE, SNEEZING AND
ITCHY, WATERY, RED EYES.
•
HIVES OR NETTLE RASH (CHRONIC IDIOPATHIC URTICARIA).
SYMPTOMS INCLUDE PINK TO RED, ITCHY SWELLINGS ON THE
SKIN.
Your pharmacist or doctor may have recommended this
medicine for another reason.
2.
WHAT SHOULD I KNOW BEFORE MY CHILD USES
TELFAST?
WARNINGS
DO NOT GIVE TELFAST TO YOUR CHILD IF:
•
YOUR CHILD HAS HAD AN ALLERGIC REACTION TO
FEXOFENADINE, TERFENADINE (TELDANE®) OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
Always check the ingredients to make sure your child can
use this medicine.
•
YOUR CHILD IS UNDER 2 YEARS OF AGE FOR ALLERGIES
(ALLERGIC RHINITIS) OR 6 MONTHS OF AGE FOR HIVES
(CHRONIC IDIOPATH

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