Transcription of AUSTRALIAN PRODUCT INFORMATION PANADOL ... - …
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1 AUSTRALIAN PRODUCT INFORMATION PANADOL OSTEO (PARACETAMOL) TABLETS 1 NAME OF THE medicine Paracetamol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Paracetamol 665 mg/tablet Excipients: For the full list of excipients, see section List of Excipients. 3 PHARMACEUTICAL FORM White to off-white film coated capsule shaped tablets with flat edges. Embossed with the logo 8 on the front face and plain on the back face. 4 CLINICAL PARTICULARS THERAPEUTIC INDICATIONS PANADOL OSTEO provides effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscular aches and pains such as backache. Provides effective temporary relief of pain and discomfort associated with: headache, tension headache, cold and flu, period pain, toothache and pain after dental procedures. Reduces fever. DOSE AND METHOD OF ADMINISTRATION Adults and children aged 12 years and over: 2 caplets swallowed whole three times a day every 6 to 8 hours.
3 Paediatric use Not recommended for children under 12 years of age. Effects on laboratory tests No data available. 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS The following interactions with paracetamol have been noted:
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DEVELOPMENT OF PAEDIATRIC MEDICINES:, DEVELOPMENT OF PAEDIATRIC MEDICINES: PHARMACEUTICAL DEVELOPMENT. POINTS, PHARMACEUTICAL, DEVELOPMENT OF PAEDIATRIC MEDICINES: POINTS, Development of paediatric medicines: points to consider in pharmaceutical development, Paediatric, Medicines, Position Paediatric Age Categories to, Of paediatric development, EU regulatory framework and the role, 2. qualitative and quantitative composition