Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LORATADINE
Merck Sharp & Dohme Ireland (Human Health) Limited
LORATADINE
5 MG/5ml
Syrup
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER CLARITYN 1 MG/ML SYRUP 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 is and what it is used for 2. What you need to know before you take Clarityn 3. How to take Clarityn 4. Possible side effects 5 How to store Clarityn 6. Contents of the pack and other information 1. WHAT CLARITYN IS AND WHAT IT IS USED FOR The full name of your medicine is Clarityn syrup. WHAT CLARITYN IS Clarityn syrup contains the active substance loratadine which belongs to a class of medicines called “antihistamines”. HOW CLARITYN WORKS Clarityn helps to re Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Clarityn 1mg/1ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml of syrup contains 1mg of loratadine. Excipients with known effect: The quantity of sucrose in the loratadine syrup composition is 600mg/ml. The amount of sucrose per 5ml (5mg) dose is 3 grams. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup Clear, colourless to light yellow syrup. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clarityn is indicated for the symptomatic treatment of allergic rhinitis and chronic idiopathic urticaria in adults and children over the age of 2 years_._ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and children over 12 years of age: 10 ml (10 mg) of the syrup once daily. _Paediatric population_ Children 2 to 12 years of age are dosed by weight: Body weight more than 30 kg: 10 ml (10 mg) of the syrup once daily. Body weight 30 kg or less: 5 ml (5 mg) of the syrup once daily. The safety and efficacy of Clarityn 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, and for children weighing 30 kg or less, 5 ml (5 mg) every other day is recommended. _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 syrup may be taken without regard to mealtime. HEALTH PRODUCTS REGULATORY AUTHORITY _______________________ Read the complete document