Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
fexofenadine hydrochloride, Quantity: 60 mg
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Tablet, film coated
Excipient Ingredients: macrogol 400; titanium dioxide; hypromellose; povidone; pregelatinised maize starch; magnesium stearate; croscarmellose sodium; microcrystalline cellulose; colloidal anhydrous silica; iron oxide yellow; iron oxide red
Oral
2, 20
(S2) Pharmacy Medicine
Relief of symptoms associated with allergic rhinitis in adults and children aged 12 years and older.
Visual Identification: Peach, oval, double convex, tablets, debossed with ?06? 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
Registered
1999-09-07
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 Read the complete document
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 Read the complete document