Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Paracetamol; Caffeine
Haleon Ireland Limited
N02BE; N02BE51
Paracetamol; Caffeine
500 mg/65 milligram(s)
Effervescent tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
2001-11-02
1 PATIENT INFORMATION LEAFLET PANADOL EXTRA 500MG/65MG SOLUBLE EFFERVESCENT TABLETS 500mg Paracetamol 65mg Caffeine PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Panadol Extra Soluble tablets carefully to get the best results from them. • Keep this leaflet, you may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve. • If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Panadol Extra Soluble tablets do 2. Check before you take Panadol Extra Soluble tablets 3. How to take Panadol Extra Soluble tablets 4. Possible side effects 5. How to store Panadol Extra Soluble tablets 6. Further information 1. WHAT PANADOL EXTRA SOLUBLE TABLETS DO PANADOL EXTRA SOLUBLE TABLETS ARE USED FOR THE RELIEF OF HEADACHE, BACKACHE, RHEUMATIC PAIN, MUSCLE PAIN, NEURALGIA, TOOTHACHE AND PERIOD PAIN . They also relieve discomfort in colds, flu and sore throat and help reduce temperature. The tablets contain two active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol. 2. CHECK BEFORE YOU TAKE PANADOL EXTRA SOLUBLE TABLETS _ _ DO NOT TAKE PANADOL EXTRA TABLETS: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, caffeine or to any of the other ingredients (listed in Section 6). • If you are taking any OTHER MEDICINES CONTAINING PARACETAMOL . • If you are under 12 YEARS OF AGE . CHECK WITH YOUR DOCTOR BEFORE USE IF: • have LIVER or KIDNEY problems, including ALCOHOLIC LIVER DISEASE • are UNDERWEIGHT (<50KG) or malnourished • REGULARLY DRINK ALCOHOL •suffer from severe DEHYDRATION • are taking medicines that affect your LIVER • have a SEVERE INFECTION as this may increase the risk of Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 14 November 2023 CRN00DSJR Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Panadol Extra 500mg/65mg Soluble Effervescent Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500.0 mg and Caffeine 65 mg. _Excipients: _Also contains 425mg sodium per tablet. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Soluble Effervescent tablets. Flat, white tablets with beveled edges, plain on one side, breakline on the other. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The tablets are recommended for use as an analgesic in the relief of mild to moderate pain such as is associated with rheumatism, neuralgia, musculoskeletal disorders, headache and of discomfort associated with influenza, feverishness and feverish colds, toothache and dysmenorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Panadol Extra Soluble should be dissolved in at least half a tumbler full of water. Adults (including the elderly) and children aged 16 years and over: 2 tablets up to four times daily. Do not exceed 8 tablets in 24 hours. Children aged 12 – 15 years: 1 tablet up to four times daily. Do not exceed 4 tablets in 24 hours. Not recommended for children under 12 years of age. Minimum dosing interval: 4 hours. The lowest dose necessary to achieve efficacy should be used. Do not exceed the stated dose. Should not be used with other paracetamol-containing products. RENAL IMPAIRMENT Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol and caffeine products in patients with renal impairment are primarily a consequence of the paracetamol content of the drug. Health Products Regulatory Authority 14 November 2023 CRN00DSJR Page 2 of 6 HEPATIC IMPAIRMENT Patients who have been diagnosed with liver or kidney impairment must seek medical advi Olvassa el a teljes dokumentumot