Telfast

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fexofenadine hydrochloride 60mg;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Fexofenadine hydrochloride 60 mg

Dosage:

60 mg

Pharmaceutical form:

Tablet

Composition:

Active: Fexofenadine hydrochloride 60mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Ferric oxide, pink Hypromellose E-15 Hypromellose E-5 Iron oxide yellow Macrogol 400 Magnesium stearate Microcrystalline cellulose Povidone Pregelatinised maize starch Titanium dioxide

Units in package:

Blister pack, Blister pack PVC/PE/PVDC -Al, 10 tablets

Class:

General sale

Prescription type:

General sale

Manufactured by:

Sanofi-Aventis Deutschland GmbH

Therapeutic indications:

The treatment of seasonal allergic rhinitis in adults and children 12 years of age

Product summary:

Package - Contents - Shelf Life: Blister pack, Blister pack PVC/PE/PVDC -Al - 10 tablets - 60 months from date of manufacture stored at or below 25°C. Manufactured at sanofi-aventis us llc, Missouri, USA 36 months from date of manufacture stored at or below 30°C. Manufactured at Sanofi Winthrop Industrie, Tours - Blister pack, Blister pack PVC/PE/PVDC -Al - 20 tablets - 60 months from date of manufacture stored at or below 25°C. Manufactured at sanofi-aventis us llc, Missouri, USA 36 months from date of manufacture stored at or below 30°C. Manufactured at Sanofi Winthrop Industrie, Tours

Authorization date:

2010-05-05

Patient Information leaflet

Telfast
©®
*
1
TELFAST®
(tell-fast)
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 IS USED TO RELIEVE THE SYMPTOMS OF HAYFEVER
(SEASONAL ALLERGIC RHINITIS) IN ADULTS AND CHILDREN AGED 12
YEARS OR OLDER.
SYMPTOMS OF HAYFEVER INCLUDE RUNNY OR ITCHY NOSE,
SNEEZING, AND ITCHY, WATERY, RED EYES.
HAYFEVER IS USUALLY CAUSED BY ALLERGY TO VARIOUS TYPES OF
POLLEN FROM GRASSES, WEEDS OR TREES.
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 this leaflet.
•
Always check the ingredients to make sure you can
use this medicine.
•
you are under 12 years of age
•
the expiry date (EXP) printed on the pack has passed
or if the packaging is damaged or shows signs of
tampering.
If you take it after the expiry date has passed, it may not
work as well.
CHECK WITH YOUR DOCTOR IF YOU:
•
blocked nose without any other symptoms
•

Summary of Product characteristics

telfast-ccdsv7-dsv19-22feb24
Page 1
Internal
NEW ZEALAND DATASHEET
1 PRODUCT NAME
Telfast® 6 – 11 years 30mg film coated tablets#
Telfast® 60mg film coated tablets
Telfast® 120mg film coated tablets
Telfast® 180mg film coated tablets
Telfast® Oral Liquid, 6mg/mL, suspension
Telfast® Oral Liquid, Re-formulation 6mg/mL, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
6 – 11 years 30mg film coated tablets#: Each tablet contains 30mg of
fexofenadine hydrochloride
equivalent to 28mg of fexofenadine.
60mg film coated tablets: Each tablet contains 60mg of fexofenadine
hydrochloride equivalent to
56mg of fexofenadine.
120mg film coated tablets: Each tablet contains 120mg of fexofenadine
hydrochloride equivalent
to 112mg of fexofenadine.
180mg film coated tablets: Each tablet contains 180mg of fexofenadine
hydrochloride equivalent
to 168mg of fexofenadine.
Oral liquid, 6mg/mL: Each mL of liquid contains 6mg (30mg/5mL) of
fexofenadine
hydrochloride equivalent to 5.6mg of fexofenadine.
Oral liquid re-formulation, 6mg/mL: Each mL of liquid contains 6mg
(30mg/5mL) of
fexofenadine hydrochloride equivalent to 5.6mg of fexofenadine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
6 – 11 years 30mg film coated tablets#: peach, round, standard
convex.
60mg film coated tablets: peach, oval, double convex.
telfast-ccdsv7-dsv19-22feb24
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Internal
120mg film coated tablets: peach, modified capsule shaped (6.1mm x
15.8mm).
180mg film coated tablets: peach, capsule shaped (7.6mm x 17.3mm).
Oral liquid: white uniform aqueous suspension, with a raspberry cream
flavour.
Oral liquid re-formulation: white uniform aqueous suspension, with a
raspberry cream flavour
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHARMACY ONLY MEDICINE
Relief of symptoms associated with seasonal allergic rhinitis and
allergic rhinitis in adults and
children from 2 years of age.
Relief of symptoms of urticaria in adults and children from 6 months
of age.
Telfast 6 – 11 years 30mg film coated tablets#: 20 tablet