Paracetamol 120mg/5ml and 250mg/5ml Oral Suspension
Abbreviated Prescribing Information. Paracetamol 120mg/5ml and Paracetamol 250mg/5ml Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: Oral, off-white cream suspensions. Each 5 ml containing 120 mg and 250 mg of Paracetamol, respectively. Therapeutic Indications: For the treatment of mild to moderate pain, including headache, migraine, neuralgia, toothache, sore throat, period pains, and aches and pains and for the reduction of fever and to be used as an adjunctive treatment to relieve symptoms of cold and flu. Posology and method of administration: For oral administration only. For 120mg/5ml: For the relief of fever after vaccinations at 2, 3 and 4 months: One 2.5ml spoonful (small end). This dose may be given up to 4 times a day starting at the time of vaccination. Leave at least 4 hours between doses. Age: 2 – 3 months (weighs over 4 kg and was born after 37 weeks): For pain and other causes of fever: 2.5 mL to 5 mL as required. Do not give to babies less than 2 months of age. 3 – 6 months: one 2.5 mL spoonful 4 times a day, 6-24 months: one 5 mL spoonful 4 times a day, 2-4 years: one 5 mL spoonful and one 2.5 mL spoonful 4 times a day, 4 – 8 years: two 5 mL spoonful 4 times a day, 8 -10 years: three 5 mL spoonful 4 times a day, and 8 – 10 years: four 5 mL spoonful 4 times a day. For 250mg/5ml- Children aged 6 – 8 years old one 5ml spoonful 4 times a day, 8 – 10 years: one 5.0ml spoonful and one 2.5ml spoonful 4 times a day, and 10 – 12 years: two 5ml 4 times a day, 12 – 16 years: two to three 5 mL spoonful 4 times a day, and Adults and children over 16 years: two to four 5 mL spoonful 4 times a day. Do not give this medicine to children for more than 3 days without consulting healthcare. Contra-indications: Hypersensitivity to paracetamol and/or other constituents. Patients with severe hepatic dysfunction. Special Warnings and Precautions for use: Care in patients with severe renal or hepatic impairment. Hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA). Patients should be informed about the signs of serious skin reactions and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Do not give with any other paracetamol-containing products. Immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed serious liver damage. If symptoms persist the doctor should be consulted. Keep out of the reach and sight of children. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not relevant. Legal Category: Pharmacy. The reported adverse reactions: Not known: Blood disorder (including thrombocytopenia and agranulocytosis), Liver injury, Fixed eruption, Rash pruritic, Urticaria, Renal papillary necrosis, and Transaminases increased. Very rare: Anaphylactic reaction, Hypersensitivity, and Rash. Uncommon: Nephropathy toxic. Pack and NHS price: 250mg/5ml: 100 ml – £3.77 and 500 ml – £18.65. 120mg/5ml: 100 ML – £3.69. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd., Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Marketing Authorisation Number: PL 00427/0077 (120mg/5ml) and PL 00427/0078 (250mg/5ml). Date of Preparation: January 2023.
Paracetamol Adult 500mg/5ml Oral Suspension
Abbreviated Prescribing Information: Paracetamol Adult 500mg/5ml Oral Suspension. Consult Summary of Product Characteristics before prescribing. Presentation: An opaque, pink/brown suspension oral suspension containing 500mg of paracetamol per 5ml. Therapeutic Indications: For the treatment of mild to moderate pain in patients who are unable to receive other paracetamol formulations such as lower strength liquid preparations, effervescent tablets or tablets. Posology and method of administration: For oral administration only. Adults and adolescents over 16 years: 500mg (5ml) or 1000mg (10ml) up to three to four times a day, as required. Maximum daily dose should not exceed 4g (40ml). Patients with renal impairment, it is recommended to reduce the dose and increase the minimum interval between each administration to 6-8 hours depending on the glomerular filtration rate unless directed otherwise by a physician. In patients with hepatic impairment or Gilbert’s Syndrome, the daily dose should not exceed 2g/day unless directed by a physician. In frail, immobile, elderly subjects or in elderly patients with renal or hepatic impairment, a reduction in the amount or frequency of dosing may be appropriate. Paediatric population: Not applicable. Contra-indications: Hypersensitivity to paracetamol or to any of the excipients listed. Patients with severe hepatic dysfunction. Do not use this medicine in children and adolescents under 16 years. Special Warnings and Precautions for use: Care should be exercised in patients with Hepatic impairment, Chronic alcoholism, Renal impairment (GFR≤50ml/min), Gilbert’s Syndrome (familial non-haemolytic jaundice), Concomitant treatment with medicinal products affecting hepatic function, Glucose-6-phosphate dehydrogenase deficiency, Haemolytic anaemia, Glutathione deficiency, Dehydration, Chronic malnutrition, Weight less than 50kg, and Elderly. Medicinal products containing paracetamol should be taken for only a few days without the advice of a physician or dentist and not at high doses. Prolonged or frequent use is discouraged and patients should be advised not to take other paracetamol containing products concurrently. Overdose of paracetamol can severely damage the liver, immediate medical advice should be sought due to the risk of delayed serious or irreversible liver damage. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA). If skin reactions occur, treatment should be discontinued and medical advice should be sought immediately. Any warning from the MC, CHM CSM or MHRA. No. Black Triangle notice: Not applicable. Legal Category: POM. The reported side effects are: hypersensitivity including skin rash, blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia and agranulocytosis, skin reactions, pancreatitis, allergic reactions, and nephrotoxic effects after prolonged administration. Pack Size and NHS Price: 150ml – £29.72. Marketing Authorisation Number: PL 00427/0160 Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [January-2023]