Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Paracetamol
Reckitt Benckiser Ireland Ltd
N02BE; N02BE01
Paracetamol
500 milligram(s)
Powder for oral solution
Product not subject to medical prescription
Anilides; paracetamol
Marketed
1978-04-01
PACKAGE LEAFLET: INFORMATION FOR THE USER LEMSIP COLD & FLU Hot Lemon 500mg Powder for Oral solution Paracetamol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to take Lemsip Cold & Flu Hot Lemon carefully to get the best results from it. Always use 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. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET: 1. What Lemsip Cold & Flu Hot Lemon is and what it is used for 2. What you need to know before you take Lemsip Cold & Flu Hot Lemon 3. How to take Lemsip Cold & Flu Hot Lemon 4. Possible side effects 5. How to store Lemsip Cold & Flu Hot Lemon 6. Contents of the pack and other information 1. WHAT LEMSIP COLD & FLU HOT LEMON IS AND WHAT IT IS USED FOR Each sachet of Lemsip Cold & Flu Hot Lemon 500mg Powder for Oral Solution contains 500mg paracetamol. Paracetamol has pain killing (analgesic) and fever reduction (antipyretic) properties. Lemsip Cold & Flu Hot Lemon can be used to relieve the symptoms of common cold or influenza such as headache, sore throat, fever, body aches and pains. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEMSIP COLD & FLU HOT LEMON DO NOT TAKE LEMSIP COLD & FLU HOT LEMON If you are allergic (hypersensitive) to paracetamol or any of the other ingredients listed in section 6 If you are taking any other paracetamol containing products If you are less than 12 years of age TAKE SPECIAL CARE WITH LEMSIP COLD & FLU HOT LEMON If you have been told by your doctor that you have an intolerance to some sugars, Lugege kogu dokumenti
Health Products Regulatory Authority 12 January 2024 CRN00F208 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lemsip Cold & Flu Hot Lemon 500 mg Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENTS MG/SACHET Paracetamol 500.0 Excipients with known effects: Aspartame - 22.5 mg/sachet Sodium - 93.77 mg (4 mmol)/sachet Sucrose - 3.04 g/sachet Lactose* - 9.72 mg per sachet * Present in curcumin powder For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution. Pale cream coloured homogenous powder with an odour and taste of lemon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of the symptoms associated with the common cold or influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Paracetamol should be used at the lowest effective dose for the shortest possible time. The maximum daily dose must not be exceeded. POSOLOGY Adults, the elderly and adolescents aged 16 years and over: 1 sachet every 4 hours as required. Do not take more than 6 sachets in 24 hours. In all patients over 16 years of age, the maximum daily dose of paracetamol should not exceed 60 mg/kg/day (up to a maximum of 2 g per day) in the following situations, unless directed by a physician: (see section 4.4) Weight less than 50kg Dehydration Malnutrition Chronic alcoholism Renal impairment Paracetamol should be used with caution in patients with renal impairment as a reduced dose and/or prolonged dosing interval may be necessary (see section 4.4). Hepatic impairment Paracetamol should be used with caution in patients with hepatic impairment as a reduced dose or prolonged dosing interval may be necessary (see section 4.4). Health Products Regulatory Authority 12 January 2024 CRN00F208 Page 2 of 6 The elderly Experience has indicated that normal adult dosage of paracetamol is usually appropriate. However, in frail, immobile elderly subjects or in elderly patients with renal or hepatic impairment, a reduc Lugege kogu dokumenti