Please consult the summary of product characteristics for full product information.
Panadol Extra Film-coated Tablets (paracetamol 500mg, caffeine 65mg). Indications: Mild to moderate pain including rheumatism, neuralgia, musculoskeletal disorders, headache, toothache, menstrual pain, discomfort of flu, fever and feverish colds. Dosage: Adults and children 16 years and over: 2 tablets up to 4 times a day. Do not exceed 8 tablets in 24 hours. May need a lower dose if underweight (<50kg), malnourished, dehydrated or have alcohol problems. Children aged 12- 15 years: 1 tablet up to four times daily. Do not exceed 4 tablets in 24 hours. Do not give to children under 12 years. Minimum dosage interval: 4 hours. The lowest dose necessary to achieve efficacy should be used. Contraindications: Hypersensitivity to paracetamol, caffeine or any of the other ingredients. Precautions: Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Use with caution in patients on concomitant treatment with drugs that induce hepatic enzymes and in patients with risk factors for hepatotoxicity (see SPC for further details). Patients diagnosed with liver or kidney impairment must seek medical advice before use. Caution, regarding paracetamol, if used at therapeutic doses for a prolonged period or administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism). If suspected, discontinue use promptly and monitor closely, including measurement of urinary 5-oxoproline. Do not exceed the stated dose. Prolonged use except under medical supervision may be harmful. If high fever, or signs of secondary infection occur of if symptoms persist for longer than 3 days, consult your doctor. Contains parahydroxybenzoates, which may cause allergic reactions (possibly delayed). Avoid excessive concurrent caffeine intake. Side effects: Very rare cases of serious skin reactions have been reported. (paracetamol) Very rare: Hypersensitivity reactions including anaphylaxis and skin rash, thrombocytopenia, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, bronchospasm, hepatic dysfunction. Unknown: High anion gap metabolic acidosis. (caffeine) Frequency unknown: Nervousness, dizziness. insomnia, restlessness, anxiety, irritability, gastrointestinal disturbances and palpitations. MA Holder: Haleon Ireland Limited, Clocherane, Youghal Road, Dungarvan, Co. Waterford, X35 Y983, Ireland MA Number: PA 678/27/1. Legal Category: 12 Tablets GSL; 24 Tablets Pharmacy Only. Text revised: Jan 2026. Further information available on request.
