Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
fexofenadine hydrochloride, Quantity: 30 mg
Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare
Tablet, film coated
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
Oral
2, 20
(S2) Pharmacy Medicine
Relief of symptoms associated with seasonal allergic rhinitis, allergic rhinitis or urticaria in adults and children from 6 years of age.
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
Licence status A
2000-07-10
TELFAST ® ORAL LIQUID AND 6-11 YEARS TABLETS T E L F A S T ® O R A L L I Q U I D A N D 6 - 1 1 Y E A R S T A B L E T S 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 Lees het volledige 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 Lees het volledige document