מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
Bristol Laboratories Ltd
N02BE01
Paracetamol
500mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5060013941504 5060013941511 5060013943911
SAME SIZE ARTWORK 435 x 130 mm Front 29mm 435 mm 130 mm IXXXXXX Package leaflet: Information for the user PARACETAMOL 500MG CAPSULES Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after three days. What is in this leaflet 1. What Paracetamol Capsules are and what they are used for 2. What you need to know before you take Paracetamol Capsules 3. How to take Paracetamol Capsules 4. Possible side effects 5. How to Store Paracetamol Capsules 6. Contents of the pack and other information 1. What Paracetamol Capsules are and what they are used for Paracetamol capsules are used for the relief of headache, tension headache, migraine, backache, rheumatic and muscle pain, toothache and period pain. They also relieve sore throat and the fever, aches and pains of colds and flu. The active ingredient is paracetamol which is a painkiller and also reduces your temperature when you have a fever. 2. What you need to know before you take Paracetamol Capsules Do not take this medicine if you: • are allergic to paracetamol or any other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if you: • are suffering from liver problems including liver problems due to excessive alcohol consumption • if you suffer from mild arthritis • have a severe infection as this may increase the risk of metabolic acidosis. Signs of metabolic acidosis include - deep, rapid, difficult breathing - feeling sick(nausea), being sick (vomiting) קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT PARACETAMOL 500mg CAPSULES 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 500mg of paracetamol. Excipients with known effect: Also contains Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate (E216). For the full list of excipients, see section6.1. 3 PHARMACEUTICAL FORM HARD GELATIN CAPSULES Red cap, white body, hard gelatin capsule, containing a white free flowing powder. _ _ 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For relief of mild to moderate pain including headaches, migraine, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, muscular and back pain, neuralgia, toothache, sore throat and period pain and to relieve the symptoms of feverishness and colds and flu. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: Unless otherwise directed by a doctor ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER: 2 capsules up to 4 times a day, as required. Do not take more frequently than every 4 hours and not more than 8 capsules in any 24 hour period. CHILDREN AGED 12 TO 15 YEARS: One capsule every 4 – 6 hours when necessary to a maximum of 4 doses in 24 hours Do not take more than 4 capsules in any 24 hour period CHILDREN UNDER 12: Not recommended for children under 12 years of age. Method of administration: For oral administration Intake of paracetamol with food and drink does not affect the efficacy of the medicinal product. _ _ 4.3. CONTRAINDICATIONS Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged or frequent use is discouraged. Patients should be advised not to take other Paracetamol containing products concurrently. Taking multiple daily doses in one administration can severely damage the liver; in such case unconsciousness does not occur. However, medical assistance should be sought immediately. Prolonged use except under medical supervision may be harmful. In adolescents treated קרא את המסמך השלם