Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
loratadine, Quantity: 10 mg
Alphapharm Pty Ltd
Loratadine
Tablet, film coated
Excipient Ingredients: Carnauba Wax; lactose monohydrate; magnesium stearate; microcrystalline cellulose; pregelatinised maize starch; maize starch; purified talc; silicon dioxide; hypromellose; PEG-150 distearate; lauromacrogol 400
Oral
50 tablets, 70 tablets, 90 tablets, 30 tablets, 10 tablets
Medicine Registered
(S2) Pharmacy Medicine
In adults and children 12 years and older: treatment of seasonal and perennial allergic rhinitis; relief of symptoms and signs of chronic urticaria.
Visual Identification: White, circular, biconvex tablets, scored on one side and marked with "LR" over "10" on the other. Diameter 7.5mm and thickness 3.2mm.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-03-15
ALLEREZE ® ACTIVE INGREDIENT(S): _Loratadine_ CONSUMER MEDICINE INFORMATION (CMI) This leaflet provides important information about using ALLEREZE. 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 ALLEREZE. WHERE TO FIND INFORMATION IN THIS LEAFLET: 1. Why am I using ALLEREZE? 2. What should I know before I use ALLEREZE? 3. What if I am taking other medicines? 4. How do I use ALLEREZE? 5. What should I know while using ALLEREZE? 6. Are there any side effects? 7. Product details 1. WHY AM I USING ALLEREZE ALLEREZE CONTAINS THE ACTIVE INGREDIENT LORATADINE. ALLEREZE is a non-sedating antihistamine. ALLEREZE IS USED TO RELIEVE THE SYMPTOMS OF SNEEZING; RUNNY NOSE; WATERY, ITCHY OR RED EYES IN THE FOLLOWING ALLERGIC CONDITIONS: • HAYFEVER (ALSO KNOWN AS SEASONAL ALLERGIC RHINITIS), WHICH USUALLY OCCURS DURING THE WARMER SEASONS • PERENNIAL ALLERGIC RHINITIS, WHICH MAY OCCUR THROUGHOUT THE YEAR. ALLEREZE CAN ALSO BE USED TO RELIEVE THE SYMPTOMS OF HIVES OR NETTLE RASH (ALSO KNOWN AS CHRONIC URTICARIA), WHICH APPEARS AS A PINKISH SKIN RASH WITH ITCHY, SWOLLEN LUMPS. The body releases histamine in response to substances it recognises as 'foreign', such as pollen, dust and dyes. This can cause the symptoms mentioned above. Antihistamines can relieve allergic symptoms by blocking the effects of histamine. The severity of your condition will depend how sensitive you are to 'foreign substances'. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY ALLEREZE HAS BEEN RECOMMENDED. They may have recommended ALLEREZE for another reason. There is no evidence that ALLEREZE is addictive. 2. WHAT SHOULD I KNOW BEFORE I USE ALLEREZE? WARNINGS DO NOT USE ALLEREZE IF: • you are allergic to any other medicines containing: o loratadine (e.g. Claratyne, Clarinase, Lorastyne) o desloratadine (e.g. Claramax) o or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this m Læs hele dokumentet
AUSTRALIAN PRODUCT INFORMATION ALLEREZE ® _Loratadine tablets _ 1 NAME OF THE MEDICINE Loratadine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of loratadine as the active ingredient. Excipients with known effect: lactose and gluten For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Loratadine 10 mg film-coated tablets: white, round, biconvex, scored on one side and marked “LR” over “10” on the reverse 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In adults and children 12 years +and older, ALLEREZE tablets are indicated for the: • treatment of seasonal and perennial allergic rhinitis • relief of symptoms and signs of chronic urticaria. 4.2 DOSE AND METHOD OF ADMINISTRATION Adults and children 12 years of age and over. 10 mg (one tablet) daily. For patients with severe hepatic impairment a lower initial dose (5 mg daily) is recommended. 4.3 CONTRAINDICATIONS ALLEREZE tablets are contraindicated in patients who have shown hypersensitivity or idiosyncrasy to loratadine, desloratadine or any of the excipients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Immune system In a 17-month study in monkeys, loratadine demonstrated no functional impairment of the immune system as indicated by mortality, peripheral leucocyte count or incidences of inflammatory reactions, autoimmune disease and malignancy. Specific studies investigating the effect of loratadine on immune function in man have not been performed. Hepatic As with all drugs metabolised by the liver, loratadine should be used with caution in patients with severe liver dysfunction. USE IN THE ELDERLY No data available. ALLEREZE ® – PRODUCT INFORMATION 2 PAEDIATRIC USE No data available. EFFECTS ON LABORATORY TESTS ALLEREZE should be discontinued approximately 48 hours prior to skin testing procedures since antihistamines may prevent or diminish otherwise positive reactions to dermal reactivity indicators. 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS Various Læs hele dokumentet