国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Loratadine
Accord Healthcare Ireland Ltd.
R06AX13
Loratadine
Tablet
loratadine
Not marketed
2022-10-21
PACKAGE LEAFLET: INFORMATION FOR THE USER LORATADINE ACCORD 10 MG TABLETS loratadine FOR MEDICINES AVAILABLE ONLY ON PRESCRIPTION: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. FOR MEDICINES AVAILABLE WITHOUT A PRESCRIPTION: READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or, pharmacist, has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse or if your symptoms change. See section 4. WHAT IS IN THIS LEAFLET : 1. What Loratadine Accord is and what it is used for 2. What you need to know before you take Loratadine Accord 3. How to take Loratadine Accord 4. Possible side effects 5. How to store Loratadine Accord 6. Contents of the pack and other information 1. WHAT LORATADINE ACCORD IS AND WHAT IT IS USED FOR The full name of your medicine is Loratadine Accord tablets. WHAT LORATADINE ACCORD IS Loratadine Accord tablets contain the active substance loratadine which belongs to a class of medicines called “antihistamines”. HOW LORATADINE ACCORD WORKS Loratadine Accord helps to reduce your allergy symptoms by stopping the effects of a substance called “histamine”, which is produc 阅读完整的文件
Health Products Regulatory Authority 24 October 2022 CRN009SLT Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Loratadine Accord 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg loratadine. Excipient with known effect: Each tablet contains 67.55 mg lactose (as monohydrate). For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White or almost white, 8 mm round, flat uncoated tablets debossed with "KH" on one side and a score line on the reverse. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Loratadine Accord are indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ One tablet once daily. _Paediatric population _ Children 6 years of age and older with a body weight greater than 30 kg: One tablet once daily For appropriate dosing in children younger than 6 years or with body weight of 30 kg or less, there are other formulations more suitable. Children under 2 years of age: Safety and efficacy of loratadine have not been established. No data are available. _Patients with hepatic impairment_ Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg. _Patients with renal impairment_ No dosage adjustments are required in patients with renal insufficiency. _Elderly _ No dosage adjustments are required in the elderly. Method of administration Oral use. The tablet may be taken without regard to mealtime. Health Products Regulatory Authority 24 October 2022 CRN009SLT Page 2 of 6 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Loratadine 阅读完整的文件