Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
PARACETAMOL; Anhydrous caffeine
Brillpharma (Ireland) Limited
N02BE; N02BE51
PARACETAMOL; Anhydrous caffeine
500/65 mg/mg
Tablet
Anilides; paracetamol, combinations excl. psycholeptics
Not marketed
2014-12-12
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT PARACETAMOL/CAFFEINE 500 MG/65 MG TABLETS (Paracetamol & Caffeine) 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 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 all the possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if your symptoms worsen or do not improve within 3 days for fever and 5 days for pain. WHAT IS IN THIS LEAFLET 1. What Paracetamol/Caffeine 500 mg/65 mg Tablets are and what they are used for 2. What do you need to know before you take Paracetamol/Caffeine 500 mg/65 mg Tablets 3. How to take Paracetamol/Caffeine 500 mg/65 mg Tablets 4. Possible side effects 5. How to store Paracetamol/Caffeine 500 mg/65 mg Tablets 6. Contents of the pack and other information 1. WHAT PARACETAMOL/CAFFEINE 500 MG/65 MG TABLETS ARE AND WHAT ARE THEY USED FOR The name of your medicine is Paracetamol/Caffeine 500 mg/65 mg Tablets. It is a combination of two medicines called caffeine and paracetamol. The tablets contain two active ingredients. Paracetamol is a pain reliever (analgesic) and helps to reduce your temperature when you have a fever. Caffeine helps to increase the pain relief from paracetamol and makes you more alert. This medicine is for symptomatic treatment of mild to moderate pain and fever in conditions such as headache, toothache and period pains. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL/ CAFFEINE 500 MG/65 MG TABLETS IMPORTANT THINGS YOU SHOULD KNOW ABOUT PARACETAMOL/CAFFEINE 500 MG/65 MG TABLETS • Do not take this medicine with other paracetamol containing medicines. • Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this p Belgenin tamamını okuyun
Health Products Regulatory Authority 22 July 2022 CRN00CXZD Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol / Caffeine 500mg/65mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500mg and Caffeine 65mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Capsule shaped tablets White to off white, capsule shaped, biconvex tablets plain on both sides approximately 17.46mm x 7.14mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of mild to moderate pain and/or fever in adults and children aged 16 years or over. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology ADULTS (16 YEARS AND OVER): Two tablets up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 tablets in 24 hours. ELDERLY: As for adults. Not recommended for children under 16 years. _ _ The lowest dose necessary to achieve efficacy should be used. Should not be used with other paracetamol-containing products. _ _ Renal Impairment: Patients who have been diagnosed with renal impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol and caffeine products in patients with renal impairment are primarily a consequence of the paracetamol content of the drug. _ _ In case of renal insufficiency dose adjustment is necessary: Hepatic Impairment: Patients who have been diagnosed with liver impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol and caffeine products in patients with hepatic impairment are primarily a consequence of the paracetamol content of the drug. In patients with impaired hepatic function or Gilbert's syndrome, the dose must be reduced or the dosing interval prolonged. The daily effective dose of paracetamol should not exceed 60 mg/kg/day (up to maximum 2 g paracetamol /day) in the following situations: Adults or adolescents weighing less than 50 kg Belgenin tamamını okuyun