Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Paracetamol; Ascorbic acid
Haleon Ireland Limited
N02BE; N02BE01
Paracetamol; Ascorbic acid
600 mg/40 milligram(s)
Powder for oral solution
Product not subject to medical prescription
Anilides; paracetamol
Not marketed
2006-10-20
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PANADOL HEAD COLD POWDER FOR ORAL SOLUTION PARACETAMOL 600MG, ASCORBIC ACID 40MG READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine as described in this leaflet or as your healthcare professional 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 after three days. WHAT IS IN THIS LEAFLET: 1) What Panadol Head Cold is and what it is used for 2) What you need to know before you take Panadol Head Cold 3) How to take Panadol Head Cold 4) Possible side effects 5) How to store and dispose of Panadol Head Cold 6) Contents of the pack and other information 1) WHAT PANADOL HEAD COLD IS AND WHAT IT IS USED FOR Panadol Head Cold contains paracetamol and ascorbic acid (Vitamin C). Paracetamol is a pain killing drug that also helps to reduce your temperature when you have a fever. The Vitamin C supplements your natural Vitamin C levels which may drop when you have a viral infection like a cold. Panadol Head Cold provides relief from the symptoms of flu, fever, chills and feverish colds including headache, aches and pains. 2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE PANADOL HEAD COLD DO NOT TAKE PANADOL HEAD COLD IF YOU: ‐are allergic to paracetamol, ascorbic acid (Vitamin C) or any of the other ingredients listed in section 6 ‐are taking any other paracetamol containing products -suffer from severe liver or kidney problems WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Panadol Head Cold: • If you suffer from liver or kidney problems. • If you have a severe infection, are severely malnourished, have low body weight (less than 50 kg) or are a chronic heavy alcohol user as this may increase t Прочетете целия документ
Health Products Regulatory Authority 26 June 2023 CRN00DLHM Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Panadol Head Cold Powder for Oral SolutionParacetamol 600 mg Ascorbic Acid 40 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE CONSTITUENTS MG / 6 G POWDER SACHET Paracetemol 600.00 Ascorbic Acid 40.0 For excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution Sachets containing an off white free flowing powder with an odour of lemon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The relief of symptoms of influenza and feverish colds including headache, and aches and pains. Also effective in the relief of menstrual pain, toothache and musculoskeletal disorders. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Directions for use Empty contents of sachet into mug. Half fill with very hot water. Stir well. Add cold water as necessary and sugar if desired. RECOMMENDED DOSE AND DOSAGE SCHEDULE Adults (including elderly) and children aged 16 years and over: One sachet to be taken every four hours, if necessary, up to a maximum of six sachets in any 24 hours. Not to be given to children under 16 years of age except on medical advice. Do not take more often than every 4 hours. Do not take more than 6 sachets in any 24 hours. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. 4.3 CONTRAINDICATIONS This product is contraindicated in patients with hypersensitivity to paracetamol, ascorbic acid or to any of the excipients listed in section 6.1 and in patients with severe hepatic or renal impairment. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contains paracetamol. Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Cases of paracetamol induced hepatotoxicity, including fatal cases, have been reported in patients taking paracetam Прочетете целия документ