Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Caffeine; Aspirin
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
N02BA; N02BA51
Caffeine; Aspirin
500 mg/32 milligram(s)
Capsule, hard
Salicylic acid and derivatives; acetylsalicylic acid, combinations excl. psycholeptics
Marketed
1984-01-27
28.3401 202548 Interleaved 2 of 5 Barcode Type Barcode Number: Magnification: BARCODE INFO BWR: 0 Micrometre 70% 50% 1. 20% BLACK Aprilia Ireland ANADIN EXTRA WYA0062 - SC: 0032 Offset N/A 62000000202548 N/A Leaflet N/A N/A N/A TR2755396/A 0000015152 AIP_CHAMPS_2022_HALEON_Version 1 07 - Feb - 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: 5.5pt 5.5pt 6.0pt 94% BODY TEXT SIZE: N/A FORMULATION CODE SMALLEST TEXT SIZE: LEADING: HORIZONTAL SCALE: PRODUCTION COMPONENT TYPE: 0 1 EUROPE 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 IN MORE THAN 3 DAYS. IN THIS LEAFLET: 1. What your medicine is and what it is used for 2. What you need to know before you take your medicine 3. How to take your medicine 4. Possible side effects 5. How to store your medicine 6. Content of the pack and other information 1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR Each hard capsule of Anadin Maximum Strength contains Aspirin (Acetylsalicyclic acid) 500mg and Caffeine 32mg. Aspirin works by relieving pain and reducing high temperature and fever. Aspirin belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and has anti-inflammatory properties. In addition, the capsule Lestu allt skjalið
Health Products Regulatory Authority 15 May 2023 CRN00DKCP Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Anadin Maximum Strength Hard Capsules Aspirin 500mg, caffeine 32mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: Aspirin (Acetylsalicylic Acid) 500.0 mg Caffeine Anhydrous 32.0 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsules, hard. Size 0 hard gelatin capsules with green caps and yellow bodies, containing a white powder/granule mixture. ‘Anadin 500’ is printed longitudinally in black on each half. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of headaches, neuralgia, rheumatic, period and dental pain, and the symptoms of colds and flu. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS AND CHILDREN OVER 16 YEARS: 1 capsule every three to four hours Do not exceed 8 capsules in 24 hours Do not give to children and adolescents aged under 16 years, except on medical advice, where the benefit outweighs the risk. ELDERLY: Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed. See also Section 4.4. Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs. Method of Administration: Oral. 4.3 CONTRAINDICATIONS • Use in patients hypersensitive (e.g. bronchospasm, rhinitis, urticaria) to the active ingredients or any other constituents. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Use in patients with bleeding disorders. • Use in patients with severe heart failure. • Use in patients who are breast feeding or in the last 3 months of pregnancy. • Use in children under 16 years. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR Lestu allt skjalið