Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
PARACETAMOL; DIPHENHYDRAMINE HYDROCHLORIDE
Chanelle Medical
N02BE; N02BE01; R06AA; R06AA02
PARACETAMOL; DIPHENHYDRAMINE HYDROCHLORIDE
500 mg/25 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Anilides; paracetamol; Aminoalkyl ethers; diphenhydramine
Not marketed
2017-01-06
ID: PL186M (DCP) IE Version: 03 Revision Date: 15/05/2019 IE/H/0462/001/DC PACKAGE LEAFLET: INFORMATION FOR THE USER PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 500MG/25MG FILM-COATED TABLETS PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 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, pharmacist or nurse have 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, pharmacist or nurse. 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 7 days. THE NAME OF THIS MEDICINE IS PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 500MG/25MG FILM-COATED TABLETS. _In the rest of this leaflet Paracetamol/Diphenhydramine Hydrochloride 500mg/25mg Film-_ _coated Tablets is called Paracetamol/Diphenhydramine Hydrochloride._ WHAT IS IN THIS LEAFLET: 1. What Paracetamol/Diphenhydramine Hydrochloride is and what it is used for 2. What you need to know before you take Paracetamol/Diphenhydramine Hydrochloride 3. How to take Paracetamol/Diphenhydramine Hydrochloride 4. Possible side effects 5. How to store Paracetamol/Diphenhydramine Hydrochloride 6. Contents of the pack and other information 1. WHAT PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR Paracetamol/Diphenhydramine Hydrochloride contains paracetamol which is an analgesic (a pain killer which relieves aches and shivers) and antipyretic (it reduces body temperature when you have a fever) and diphenhydramine hydrochloride, an antihistamine that causes sleepiness or drowsiness making it useful when pain is keeping you awake. Paracetamol/Diphenhydramine Hydrochloride is used for fast and effective relief of, aches and pains associated with colds and flu, headaches, backache, rheuma Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 10 October 2019 CRN0093KG Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol/Diphenhydramine Hydrochloride 500 mg/25 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains paracetamol 500.0mg and diphenhydramine hydrochloride 25.0mg. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablet Blue/light blue film coated capsule shaped tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the short term treatment of bedtime symptoms of pain, for example arising from colds and flu, rheumatic and muscle pain, backache, toothache, headache and period pain which is causing difficulty in getting to sleep. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration only. ADULTS (INCLUDING THE ELDERLY) AND ADOLESCENTS 16 YEARS AND OVER: 2 tablets to be taken 20 minutes before bedtime. Other products containing paracetamol may be taken during the day but the total daily dose of paracetamol must not exceed 4000 mg (including this product) in any 24 hour period. Allow at least four hours between taking any paracetamol-containing product and this product. MAXIMUM DAILY DOSE OF PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 500 MG/25 MG FILM-COATED TABLETS: Two tablets (1000mg paracetamol, 50mg diphenhydramine) in 24 hours. ADOLESCENTS 12 TO 15 YEARS: 1 tablet to be taken 20 minutes before bedtime. Other products containing paracetamol may be taken during the day but the total daily dose of paracetamol must not exceed 3000 mg (including this product) in any 24 hour period. Allow at least four to six hours between taking any paracetamol-containing product and this product. MAXIMUM DAILY DOSE OF PARACETAMOL/DIPHENHYDRAMINE HYDROCHLORIDE 500 MG/25 MG FILM-COATED TABLETS: ONE TABLET (500 MG PARACETAMOL, 25 MG DIPHENHYDRAMINE) IN 24 HOURS. The maximum daily dose of paracetamol should not exceed 2000 mg in the following situations, unless directed by a physician: Adults or adolescents w Olvassa el a teljes dokumentumot