Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LORATADINE
Merck Sharp & Dohme Ireland (Human Health) Limited
LORATADINE
10 Milligram
Oral Lyophilisate
Product not subject to medical prescription
Authorised
0000-00-00
Clarityn - BE/H/xxxx/WS/002 September 2013 1 PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITYN RAPIDE ALLERGY 10 MG ORAL LYOPHILISATES Loratadine 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, pharmacist, or nurse 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. - You must talk to a doctor if you do not feel better or if you feel worse. See section 4. 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Clarityn Rapide Allergy is and what it is used for 2. What you need to know before you take Clarityn Rapide Allergy 3. How to take Clarityn Rapide Allergy 4. Possible side effects 5. How to store Clarityn Rapide Allergy 6. Contents of the pack and other information 1. WHAT CLARITYN RAPIDE ALLERGY IS AND WHAT IT IS USED FOR The full name of your medicine is Clarityn Rapide Allergy. Clarityn Rapide Allergy are “oral lyophil Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarityn Rapide Allergy 10 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each oral lyophilisate contains 10 mg loratadine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral lyophilisate White, round, tablet - shaped unit debossed with 'C10'. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarityn Rapide Allergy is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years with a body weight more than 30 kg_._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 12 years of age: 10 mg once daily (one oral lyophilisate once daily). _Paediatric population_ Children 2 to 12 years of age are dosed by weight: Body weight more than 30 kg: 10 mg once daily (one oral lyophilisate once daily). Body weight 30 kg or less: The 10 mg strength oral lyophilisate is not appropriate in children with a body weight less than 30 kg. There are other formulations more suitable for children 2 to 12 years old with body weight 30 kg or less. The safety and efficacy of Clarityn Rapide Allergy in children under 2 years of age 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 oral lyophilisate may be taken wi Read the complete document