Telfast

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Fexofenadine hydrochloride 120mg;  ;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Fexofenadine hydrochloride 120 mg

Dosage:

120 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Fexofenadine hydrochloride 120mg     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, PVC/PE/PVDC/Al, 2 tablets

Class:

Pharmacy only

Prescription type:

Pharmacy only

Manufactured by:

Hoechst Marion Roussel Inc. located at Dow Chemical Company

Therapeutic indications:

Relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.

Product summary:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC/Al - 2 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 Insutrie, Tours - 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, 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 - Blister pack, PVC/PE/PVDC/Al - 30 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:

1997-06-02

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 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 this

Summary of Product characteristics

telfast-gsl-ccdsv6-dsv17-19jun23
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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-gsl-ccdsv6-dsv17-19jun23
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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#: 2