Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Paracetamol
Azure Pharmaceuticals Ltd
N02BE01
Paracetamol
Capsule, hard
paracetamol
Not marketed
2022-06-03
Package leaflet: Information for the patient PARACETAMOL 500 MG CAPSULES, HARD paracetamol 3. HOW TO TAKE PARACETAMOL CAPSULES ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 16 YEARS AND OVER: Take 1-2 capsules every 4 to 6 hours as required. Do not take more than eight capsules in any 24 hours. Do not take more than four capsules a day (2 g/day) in the following situations, unless directed by your doctor: - Weight less than 50 kg - Use of large quantities of alcohol regularly (alcoholism) - Dehydration - Malnutrition. CHILDREN AGED 10-15 YEARS: Give 1 capsule every 4 to 6 hours as required. Do not take more than 4 capsules in any 24 hours. Do not give to children for more than 3 days without consulting a doctor. CHILDREN UNDER 10 YEARS: Do not give to children under 10 years of age. Use in kidney or liver impairment: If you have been diagnosed with kidney or liver problems, please consult your doctor or pharmacist. You may need to take a lower dose or increase the length of time between doses. • CONTAINS PARACETAMOL. • DO NOT TAKE MORE THAN THE RECOMMENDED DOSE. • DO NOT TAKE MORE FREQUENTLY THAN EVERY 4 HOURS. • DO NOT TAKE MORE THAN 4 DOSES IN 24 HOURS. • IF SYMPTOMS PERSIST CONSULT YOUR DOCTOR. • PROLONGED USE EXCEPT UNDER MEDICAL SUPERVISION MAY BE HARMFUL. • ALWAYS USE THE LOWEST EFFECTIVE DOSE TO RELIEVE YOUR SYMPTOMS. IF YOU TAKE TOO MANY CAPSULES IMMEDIATE MEDICAL ADVICE should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. 4. POSSIBLE SIDE EFFECTS Like all medicines Paracetamol capsules can have side effects, but not everybody gets them. Very rare cases of serious skin reactions have been reported. STOP TAKING THIS MEDICINE AND TELL YOUR DOCTOR IMMEDIATELY IF: • you experience serious skin reactions, very rare cases of which have been reported. • you experience allergic reactions such as skin rash or itching, sometimes with breathing problems or swelling of the lips, tongue, throat or face. • you experience a seve Izlasiet visu dokumentu
Health Products Regulatory Authority 03 June 2022 CRN00C3F6 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol 500 mg Capsules, hard 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 500 mg paracetamol. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM CAPSULE, HARD (Capsules) White to off-white crystalline powder filled in size '0' capsules with ivory colour body and ivory colour cap, having a nominal lock length of 21.4 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in the short-term management of mild pain and fever and for symptoms of common colds and flu in adults, the elderly and children aged over 10 years. Paracetamol may also be used in the symptomatic relief of mild to moderate pain associated with osteoarthritis in adults and the elderly, as diagnosed by a doctor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS (INCLUDING THE ELDERLY) AND CHILDREN AGED 16 YEARS AND OVER: One or two capsules up to four times daily as required. Renal impairment Paracetamol should be used with caution in patients with renal impairment as a reduced dose and/or prolonged dosing interval may be necessary (see section 4.4). Hepatic impairment Paracetamol should be used with caution in patients with hepatic impairment as a reduced dose or prolonged dosing interval may be necessary (see section 4.4). The elderly Experience has indicated that normal adult dosage of paracetamol is usually appropriate. However, 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 (see section 4.4). In all patients over 16 years of age, the maximum daily dose of paracetamol should not exceed 60 mg/kg/day (up to a maximum of 2 g per day) in the following situations, unless directed by a physician: (see section 4.4) • Weight less than 50kg • Dehydration • Malnutrition • Chronic alcoholism CHILDREN AGED 10-15 YEARS: One capsule up to four times Izlasiet visu dokumentu