País: República de Sud-àfrica
Idioma: anglès
Font: South African Health Products Regulatory Authority (SAHPRA)
GlaxoSmithKline Consumer Healthcare SA (Pty) Ltd
See ingredients
TABLET
EACH TABLET COPNTAINS PARACETAMOL 500,0 mg
Registered
2018-11-11
GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG) APPROVED PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S0 for packs containing 6, 10, 12, 16 or 24 film-coated tablets S1 for packs containing 48, 96 or 100 film-coated tablets PROPRIETARY NAME AND DOSAGE FORM: CALPOL TABLETS READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. CALPOL TABLETS is available without a doctor’s prescription, for you to treat a mild illness. Nevertheless, you still need to use CALPOL TABLETS carefully to get the best results from it. Keep this leaflet. You may need to read it again. Do not share CALPOL TABLETS with any other person. Ask your pharmacist if you need more information or advice. You must see a doctor if your symptoms worsen or do not improve after 10 days. COMPOSITION: WHAT CALPOL TABLETS CONTAIN: Each film-coated tablet contains 500 mg paracetamol. GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG) APPROVED PATIENT INFORMATION LEAFLET The other ingredients are: maize starch, calcium carbonate, alginic acid, crospovidone, povidone (K-25), magnesium stearate, colloidal anhydrous silica, titanium dioxide, hypromellose 3cP, hypromellose 6cP, macrogol, polysorbate 80, carnauba wax. Sugar Free. APPROVED INDICATIONS AND USE WHAT CALPOL TABLETS IS USED FOR: CALPOL TABLETS is fast absorbed and is indicated for the symptomatic relief of mild to moderate pain and fever such as headache, migraine, backache, muscle pains, sore throat, toothache, pain and fever associated with colds and flu. INSTRUCTIONS BEFORE TAKING CALPOL TABLETS. DO NOT TAKE CALPOL TABLETS: If you are allergic to paracetamol or any of the ingredients in the tablet. If you have severe liver problems. TAKE SPECIAL CARE WITH CALPOL TABLETS: DO NOT EXCEED THE RECOMMENDED DAILY DOSE, AS IT MAY CAUSE SERIOUS HARM TO YOUR LIVER. Do not use Calpol tablets if you are taking any other p Llegiu el document complet
GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG) APPROVED PROFESSIONAL INFORMATION Page 1 of 11 GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG) APPROVED PROFESSIONAL INFORMATION Page 2 of 11 SCHEDULING STATUS: S0 for packs containing 6, 10, 12, 16 or 24 film-coated tablets S1 for packs containing 48, 96 or 100 film-coated tablets PROPRIETARY NAME AND DOSAGE FORM: CALPOL TABLETS (film-coated tablet) COMPOSITION: Each film-coated tablet contains 500 mg paracetamol. Excipients: As preservative: Nipasept sodium 0,199 % m/m (containing sodium methyl parahydroxybenzoate, sodium ethyl parahydroxybenzoate; sodium propyl parahydroxybenzoate) The other ingredients are: maize starch, calcium carbonate, alginic acid, crospovidone, povidone (K-25), magnesium stearate, colloidal anhydrous silica, titanium dioxide, hypromellose 3cP, hypromellose 6cP, macrogol, polysorbate 80, carnauba wax. Sugar Free. PHARMACOLOGICAL CLASSIFICATION: A 2.7. Antipyretic or Antipyretic and anti-inflammatory analgesics PHARMACOLOGICAL ACTION: PHARMACODYNAMIC PROPERTIES Paracetamol is an antipyretic and analgesic. GLAXOSMITHKLINE CONSUMER HEALTHCARE SOUTH AFRICA (PTY) LTD CALPOL TABLETS REG. NO. 44/2.7/0321 (PARACETAMOL 500 MG) APPROVED PROFESSIONAL INFORMATION Page 3 of 11 Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system_. _ _ _ _ _ Clinical Efficacy The perception of analgesia occurred from a median time of 15 minutes post dosing in adult patients after surgical removal of third molars with a Calpol dose of 1 gram. The 1 gram dose demonstrated superior analgesia compared to the Calpol 500mg dose and placebo. Both Calpol doses provided analgesia superior to placebo. PHARMACOKINETIC PROPERTIES Paracetamol tablets contain disintegrant excipient(s) which accelerates/improves the rate of disintegration/dissolution and absorption from the ga Llegiu el document complet