দেশ: দক্ষিণ আফ্রিকা
ভাষা: ইংরেজি
সূত্র: South African Health Products Regulatory Authority (SAHPRA)
Biotech Laboratories (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS LORATADINE 10,0 mg
Registered
2003-03-11
Biotech Laboratories (Pty) Ltd_ _ 10 mg Loratadine Tablets 1.3.2 – Approved PIL Page 1 of 7 CLEAN PROPOSED PATIENT INFORMATION LEAFLET FOR LORDYNO PATIENT INFORMATION LEAFLET SCHEDULING STATUS S2 LORDYNO, 10 MG, TABLETS LORATADINE CONTAINS SUGAR (69,175 MG LACTOSE MONOHYDRATE PER TABLET) READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU LORDYNO is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to take LORDYNO carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Do not share LORDYNO with any other person. • Ask your health care provider or pharmacist if you need more information or advice. • You must see a doctor if your symptoms worsen or do not improve. WHAT IS IN THIS LEAFLET 1. What LORDYNO is and what it is used for 2. What you need to know before you take LORDYNO 3. How to take LORDYNO 4. Possible side effects 5. How to store LORDYNO 6. Contents of the pack and other information. Biotech Laboratories (Pty) Ltd_ _ 10 mg Loratadine Tablets 1.3.2 – Approved PIL Page 2 of 7 1. WHAT LORDYNO IS AND WHAT IT IS USED FOR LORDYNO contains loratadine which belongs to a class of medicines called antihistamines. LORDYNO is indicated for the relief of the symptoms of • perennial (symptoms are present throughout the year) and/or seasonal (symptoms are present during the spring and summer months) allergic rhinitis (inflammation of the nose), such as sneezing, runny or itchy nose and burning or itchy eyes • chronic urticaria, such as itchy, raised, red or skin-coloured welts on your skin • allergic skin disorders, such as itching, redness and swelling of areas on your skin. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORDYNO DO NOT TAKE LORDYNO: If you are hypersensitive (allergic) to loratadine or any of the other ingredients of LORDYNO (listed in section 6). WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH LORDYNO: • if you are elderly, as the safety of LORDYNO in elderl সম্পূর্ণ নথি পড়ুন
Biotech Laboratories (Pty) Ltd_ _ 10 mg Loratadine Tablets _ _ 1.3.1.1 Approved PI Page 1 of 9 CLEAN AMENDED PROPOSED PROFESSIONAL INFORMATION FOR LORDYNO SCHEDULING STATUS 1. NAME OF THE MEDICINE LORDYNO tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg loratadine. Excipient with known effect: Contains sugar (69,175 mg lactose monohydrate per tablet). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM_ _ Tablets. White, oval tablets, notched and coded LT/10 on one side (length: 7,5 to 7,9 mm and width: 4,9 to 5,3 mm). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LORDYNO is indicated for the relief of the symptoms associated with perennial and/or seasonal allergic rhinitis, chronic urticaria and other allergic skin disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY S2 Biotech Laboratories (Pty) Ltd_ _ 10 mg Loratadine Tablets _ _ 1.3.1.1 Approved PI Page 2 of 9 Take one tablet once daily. METHOD OF ADMINISTRATION Oral administration. LORDYNO can be taken with or without food. 4.3 CONTRAINDICATIONS • LORDYNO is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to loratadine or to any of the excipients listed in section 6.1. • Safety of LORDYNO in the elderly has not been established. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine, the active ingredient in LORDYNO; an initial dose of 5 mg once daily or 10 mg every second day is recommended. Increase in body mass has been reported with the use of LORDYNO (see section 4.8). LORDYNO contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take LORDYNO. 4.5 INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION When administered concomitantly with alcohol, LORDYNO has no potentiating effects as measured by psychomotor perfo সম্পূর্ণ নথি পড়ুন