Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Fexofenadine hydrochloride 60mg; ;
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Fexofenadine hydrochloride 60 mg
60 mg
Film coated tablet
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
Blister pack, sample pack, 2 tablets
Pharmacy only
Pharmacy only
Hoechst Marion Roussel Inc. located at Dow Chemical Company
Relief of symptoms associated with seasonal allergic rhinitis and allergic rhinitis in adults and children from 2 years of age.
Package - Contents - Shelf Life: Blister pack, sample pack - 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 Industrie, Tours - Blister pack, - 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
1999-01-27
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 Read the complete document
telfast-gsl-ccdsv6-dsv17-19jun23 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-gsl-ccdsv6-dsv17-19jun23 Page 2 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#: 2 Read the complete document