Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Paracetamol
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
N02BE; N02BE01
Paracetamol
500 milligram(s)
Film-coated tablet
Anilides; paracetamol
Marketed
1989-03-02
28.3401 203534 Interleaved 2 of 5 Barcode Type Barcode Number: Magnification: BARCODE INFO BWR: 0 Micrometre 28.3401 203534 Interleaved 2 of 5 Barcode Type Barcode Number: Magnification: BARCODE INFO BWR: 0 Micrometre 70% 50% 1. 20% BLACK Aprilia Ireland ANADIN PARACETAMOL TD: WYA0061 - SC: 0032 Offset N/A 62000000203534 N/A Leaflet N/A N/A N/A TR2795658/A 0000015699 AIP_CHAMPS_2022_HALEON_Version 1 16 - Mar - 2023 V1 STUDIO LOCATION: NON PRODUCTION D2A AWP NO: Artwork Information Panel CHAMPS NO: MANUFACTURING SITE: SITE COMPONENT NO: SITE CHANGE CONTROL NO: APPROVING MARKET: PRODUCT MARKET TRADE NAME: MATERIAL SPEC NO: PRINT PROCESS: TECHNICAL DRAWING NO: BARCODE NO: BAR WIDTH REDUCTION: PHARMA CODE NO: TOTAL NUMBER OF COLOURS INCLUDING VARNISH & FOILS: TOTAL SPECIAL FINISHES: X No MICRO TEXT: 6.0pt 6.0pt 6.0pt 100% BODY TEXT SIZE: N/A FORMULATION CODE SMALLEST TEXT SIZE: LEADING: HORIZONTAL SCALE: PRODUCTION COMPONENT TYPE: 0 1 EUROPE The full name of this medicine as listed above has been abbreviated throughout the leaflet for ease of reference to ‘paracetamol tablets’ or ‘paracetamol’. PACKAGE LEAFLET: INFORMATION FOR THE USER. 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 the leaflet or as your doctor or pharmacist 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 SEE A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE AFTER 3 DAYS. IN THIS LEAFLET: 1. WHAT PARACETAMOL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL TABLETS 3. HOW TO TAKE PARACETAMOL TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PARACETAMOL TABLETS 6. CONTENT OF THE PACK AND OTHER INFORMATION 1.WHAT PARACETAMOL IS AND WHAT IT IS USED FOR Each Fi read_full_document
Health Products Regulatory Authority 15 May 2023 CRN00DKCP Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500 mg Film Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Paracetamol 500 mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated Tablet. White capsule shaped film coated tablets embossed on one face with "P-500" and with a break bar on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Paracetamol is a mild analgesic and anti-pyretic.The tablets are recommended for use in the short-term management of headaches including migraine and tension headaches, backache, rheumatic, muscle pain, period pains, nerve pains, toothache and for relieving fever, aches and pains of colds and flu. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS: 1-2 tablets 3-4 times daily. A maximum of 8 tablets should not be exceeded in any 24-hour period. Paediatric Population Alternative liquid paracetamol formulations are available which may be more appropriate, especially for younger children. CHILDREN UNDER 6 YEARS: This medicine is not appropriate for children under 6 years of age. FOR CHILDREN 6 TO 9 YEARS OF AGE: Give ½ a tablet with a drink of water, every 4 to 6 hours as required. FOR CHILDREN 10 TO 11 YEARS OF AGE: Give 1 tablet with a drink of water, every 4 to 6 hours as required. FOR ADOLESCENTS 12 TO 15 YEARS OF AGE: Give 1 to 1 ½ a tablet with a drink of water, every 4 to 6 hours as required. A maximum of 4 doses should not be exceeded in any 24 hour period. Method of Administration: Oral 4.3 CONTRAINDICATIONS Hypersensitivity to Paracetamol or any of the constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 15 May 2023 CRN00DKCP Page 2 of 5 Paracetamol should be administered with caution under the following circumstances (see section 4.2 where relevant): Hepatic impairment Chronic alcoholism. The hazards of overdose are greater in those with non read_full_document