Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Diphenhydramine hydrochloride
Ennogen Healthcare Ltd
R06AA02
Diphenhydramine hydrochloride
25mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03040100
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Paracetamol and diphenhydramine hydrochloride 500 mg/25 mg Film-coated Tablets 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 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 7 days. WHAT IS IN THIS LEAFLET 1. WHAT PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE 3. HOW TO TAKE USE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE IS AND WHAT IT IS USED FOR Paracetamol and diphenhydramine hydrochloride is used to provide fast and effective relief of the fever, aches and pains associated with colds and flu, headaches, backache, rheumatic and muscle pains, period pains and toothache which is causing difficulty in getting to sleep. The active ingredients are paracetamol and diphenhydramine hydrochloride. Paracetamol is a painkiller and diphenhydramine hydrochloride is an antihistamine that causes sleepiness or drowsiness making it useful when pain is keeping you awake. You must talk to a doctor if you do not feel better or if you feel worse after 7 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE DO NOT TAKE PARACETAMOL AND DIPHENHYDRAMINE HYDROCHLORIDE IF YOU: are allergic to paracetamol or diphenhydramine or any of the other ingredients of this me Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Paracetamol and diphenhydramine hydrochloride 500mg/25mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains Paracetamol 500 mg and Diphenhydramine hydrochloride 25 mg Excipients with known effect: Each tablet contains: 0.0426 mg of Brilliant blue FCF (E133) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Blue, capsule shaped, biconvex, film coated tablet, 17.6 mm x 7.5 mm, engraved with “A163” on one side. 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 Posology Do not exceed the stated dose or frequency of dosing Children: Not recommended for children under 12 years of age except on medical advice. 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 AND DIPHENHYDRAMINE HYDROCHLORIDE 500 MG/25MG 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 AND DIPHENHYDRAMINE HYDROCHLORIDE 500 MG/25MG FILM-COATED TABLETS: One t Lugege kogu dokumenti