Please consult the summary of product characteristics for full product information.
Panadol 500mg Film Coated Tablets (paracetamol). Indications: Short-term management of headaches, musculoskeletal disorders, menstrual pains, toothache, symptoms of colds and flu, mild to moderate pain associated with diagnosed osteoarthritis. Dosage: Adults (including the elderly) and children 16 years and over: 1-2 tablets, up to 4 times daily, as required. Children aged 10-15 years of age: 1 tablet, up to 4 times daily as required. Max 4 doses in 24 hours. Do not give to children for more than 3 days without consulting a doctor. Do not give to children under 10 years. Minimum dosage interval is 4 hours. Contraindications: Hypersensitivity to paracetamol or any of the other ingredients. Precautions: Do not use with any other paracetamol-containing products. Use with caution in patients with depleted glutathione levels / glutathione depleted states. Those 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. Side effects: Very rare: Hypersensitivity reactions including anaphylaxis and skin rash, thrombocytopenia, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, serious skin reactions, bronchospasm, hepatic dysfunction. Not known: High anion gap metabolic acidosis. Legal Category: 12 Tablets GSL; 24 Tablets Pharmacy Only. MA Number: PA 678/107/1. MA Holder: Haleon Ireland Limited, Clocherane, Youghal Road, Dungarvan, Co. Waterford, X35 Y983, Ireland. Text prepared: June 2025. Further information available on request.
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. Patients on concomitant treatment with drugs that induce hepatic enzymes. Patients with depleted glutathione levels / glutathione depleted states, such as sepsis. Patients diagnosed with liver or kidney impairment. 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: June 2025. Further information available on request.
Panadol ActiFast Tablets 500mg (paracetamol) Indications: Short-term management of symptoms of headaches, musculoskeletal disorders, menstrual pains, toothache, colds and flu. Dosage: Adults (including the elderly) and children 16 years and over: 1-2 tablets up to 4 times daily, as required. Children aged 12-15 years: 1 tablet up to 4 times daily, as required. Max 4 doses in 24 hours. Do not give to children for more than 3 days without consulting a doctor. Do not give to children under 12 years. Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol or any of the other ingredients. Precautions: Do not use with any other paracetamol-containing products. Use with caution in patients with depleted glutathione levels / glutathione depleted states. Patients with liver or kidney impairment should 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. Contains 352 mg sodium per 2 tablet dose, use with caution in those on a low sodium diet. Prolonged use, except under medical supervision, may be harmful. Side effects: Very rare: Hypersensitivity reactions including anaphylaxis and skin rash, thrombocytopenia, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, serious skin reactions, bronchospasm, hepatic dysfunction. Not known: High anion gap metabolic acidosis. MA Number: PA 678/39/12. Legal Category: 10 Tablets GSL;20 Tablets Pharmacy Only. MA Holder: Haleon Ireland Limited, Clocherane, Youghal Road, Dungarvan, Co. Waterford, X35 Y983, Ireland. Text revised: June 2025. Further information available on request.
Panadol Actifast Lemon 500 mg Soluble Tablets, Panadol ActiFast 500mg Soluble Tablets (paracetamol) Indications: Short-term management of symptoms of headaches, musculoskeletal disorders, menstrual pain, toothache, colds and flu, as well as symptomatic relief of mild to moderate pain associated with doctor-diagnosed osteoarthritis. Dosage: Adults (including the elderly) and children 16 years and over: 1-2 tablets up to 4 times daily, as required. Children aged 10-15 years: 1 tablet up to 4 times daily, as required. Max 4 doses in 24 hours. Do not give to children for more than 3 days without consulting a doctor. Do not give to children under 10 years. Minimum dosing interval: 4 hours. Contraindications: Hypersensitivity to paracetamol or any of the other ingredients. Precautions: Do not use with any other paracetamol-containing products. Use with caution in patients with glutathione depleted states, those with risk factors for hepatotoxicity (see SPC for list). 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. Contains: 427 mg sodium per tablet, use with caution in those on a low sodium diet. 50 mg sorbitol per tablet Patients with hereditary fructose intolerance should not take this medicinal product. Side effects: Very rare: Thrombocytopaenia, hypersensitivity reactions including anaphylaxis, skin rash, angioedema, Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, serious skin reactions, bronchospasm, hepatic dysfunction. Not known: High anion gap metabolic acidosis. MA Holder: Haleon Ireland Limited, Clocherane, Youghal Road, Dungarvan, Co. Waterford, X35 Y983, Ireland. MA Number: Actifast Lemon Soluble: PA 678/39/17. Actifast Soluble: PA 678/39/14 Legal Category: Pharmacy Only. Text revised: June 2025. Further information available on request.
Panadol Night Film-coated Tablets (paracetamol, diphenhydramine hydrochloride). Indications: Short-term treatment of bedtime symptoms of cold and flu pain, rheumatic and muscle pain, backache, toothache, headache, menstrual pain. Dosage: Adults and children 16 years and over: 2 tablets, 20 minutes before bed. Children aged 12-15 years: 1 tablet, 20 minutes before bed. Minimum dosing interval between this and any other paracetamol containing product: 4 hours. Other products containing paracetamol may be taken during the day, but the total daily dose of paracetamol must not exceed 4000mg for adults and 2000mg for children aged 12-15 years. Do not give to children under 12 years except on medical advice. Do not use for more than 7 days without medical advice. Contraindications: Hypersensitivity to paracetamol or any of the other ingredients. Closed angle glaucoma, porphyria. Precautions: Hepatic or renal dysfunction/failure. Patients with depleted glutathione levels (e.g. eating disorders) or chronic alcoholism or sepsis. Avoid use with alcohol. Caution in elderly patients and avoid use in elderly patients with confusion. Avoid concurrent use with sedatives (including hypnotics and anxiolytics), antimuscarinics and other antihistamines. Caution in those with epilepsy or seizure disorders, myasthenia gravis, narrow angle glaucoma, prostatic hypertrophy, urinary retention, asthma, bronchitis, COPD or with any form of glucose-galactose malabsorption or lactase deficiency. Avoid use of MAOIs within 2 weeks. 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. Side effects: See SPC for full details. Common (diphenhydramine): fatigue, sedation, attention disturbance, dizziness, unsteadiness, dry mouth. Legal Category: Pharmacy only. MA Number: PA 678/39/8. MA Holder: Haleon Ireland Limited, Clocherane, Youghal Road, Dungarvan, Co. Waterford, X35 Y983, Ireland. Text prepared: June 2025. Further information available on request.
