Kraj: Malta
Język: angielski
Źródło: Medicines Authority
PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
GlaxoSmithKline Export Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
N02BE01
PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
TABLET
PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 30 mg
OTC
ANALGESICS
Withdrawn
2007-02-09
CLIENT: GLAXOSMITHKLINE DESCRIPTION: PANADOL SINUS MALTA LEAFSERT LEAFLET CODE: P2581P SIZE: 118.5 X 234.95MM FOLDED SIZE: 104.5 X 39.16MM COLOUR: ■ ■ BLACK ■ (NOTE: DIE LINE DOES NOT PRINT) ■ (NOTE: REPRESENTS COPY FREE AREA) ■ (NOTE: REPRESENTS GLUE SPOT) DATE: 7.7.2009 WT: A66952 PHARMACODE: 2581 CHANGES MADE TO ORIGINAL FILE: 22.06.09 - USING P83856 AS BASE ART • UPDATE CODE NUMBER AND INSERT REVISION DATE AS PER CLIENT MARKED UP PROOF. • UPDATE CLIENT PHARMACODE. 7.7.2009 • INSERT DOUBLE TAB TEMPLATE AS PER CLIENT REQUEST IN EMAIL DATED 3.7.2009. • INSERT PRODUCT CODE AND PHARMACODE ONTO BACK OF LEAFLET. • CONDENSE TEXT TO SUIT COPY FREE AREA. P2581P Revision date: 02/2007 P2581P Przeczytaj cały dokument
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT PANADOL Actifast Tablets 500mg. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains paracetamol 500 mg Excipients: Contains 173mg (7.5mmol) sodium per tablet. For a full list of excipients see Section 6.1 3. FOR A FULL LIST OF EXCIPIENTS SEE SECTION 6.1 PHARMACEUTICAL FORM Film-coated tablets White film-coated capsule shaped tablets with flat edges, debossed with the letter ‘P’. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A mild analgesic and antipyretic recommended in the short-term management of the symptoms of headaches, musculoskeletal disorders, menstrual pains, toothache and for relieving fever, aches and pains of common colds and flu. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults (including the elderly): 500 to 1000 mg (1-2 tablets) every 4 to 6 hours as required. Children: Not recommended for children under 12 years of age. Do not exceed the stated dose. Should not be used with other paracetamol containing products. Minimum dosing interval: 4 hours. Maximum daily dose: 4000 mg (8 tablets). Page 2 of 6 4.3 CONTRAINDICATIONS PANADOL Actifast is contraindicated in patients with a previous history of hypersensitivity to paracetamol or any of the other ingredients. Use in children under 6 years of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Each PANADOL Actifast tablet contains 173 mg of sodium (346 mg sodium per 2 tablet dose) and should only be used with caution in patients with hypertension, oedema or renal insufficiency because of the sodium content. If you have been diagnosed with liver or kidney impairment, seek medical advice before ta Przeczytaj cały dokument