Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acetylcysteine
Alliance Healthcare (Distribution) Ltd
R05CB01
Acetylcysteine
600mg
Oral tablet
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 270516/2 Ennogen EP_Mucolight 600mg Leaflet UK English 180 x 270 mm 9 pt 1 of 1 4 01-12-18 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production Colours Used Black Keyline Mucolight 600mg Tablets (ACETYLCYSTEINE) PACKAGE LEAFLET: INFORMATION FOR THE USER READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. ! Keep this leaflet. You may need to read it again. ! If you have any further questions, ask your doctor, pharmacist or nurse. ! This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. ! 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. WHAT IS IN THIS LEAFLET: 1. WHAT MUCOLIGHT TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOLIGHT TABLETS 3. HOW TO TAKE MUCOLIGHT TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MUCOLIGHT TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT MUCOLIGHT TABLETS ARE AND WHAT THEY ARE USED FOR Mucolight 600mg Tablets contain a medicine called Acetylcysteine. This belongs to a group of medicines called mucolytics. It works by making the mucus (phlegm) less sticky which makes the mucus easier to cough up. Acetylcysteine is used for problems with the breathing passages (respiratory tract). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOLIGHT TABLETS DO NOT TAKE MUCOLIGHT TABLETS IF YOU: ! ARE ALLERGIC (HYPERSENSITIVE) TO ACETYLCYSTEINE or any of the other ingredients of this medicine (listed in section 6) ! Are under 14 years of age. WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before taking Mucolight Tablets: ! If you have asthma ! If you have a history of stomach ulcers ! If you are allergic to histamines ! If you have l Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mucolight 600mg Tablets Acetylcysteine 600mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg acetylcysteine. Excipient with known effect Sodium (less than 23mg per tablet) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White, round convex tablets 13mm in diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolight 600 mg tablet is a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterised by excessive, viscous mucus, including chronic obstructive airways disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION In general the usual recommended dosage is: Adults including elderly and adolescents 14 years and older: 600 mg (1 tablet) once daily. Duration of therapy: The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor. Hepatic and Renal Impairment: In patients with impaired kidney or liver impairment there is insufficient data on whether dosage adjustments are required. Hepatic and renal impairment can reduce clearance which may result in an increase in adverse drug reactions due to drug accumulation. For oral use. Swallow the tablet with a drink of water. The tablet should be taken after food. 4.3 CONTRAINDICATIONS Hypersensitivity to acetylcysteine or to any of the excipients listed in section 6.1. These tablets should not be used in children under 14 years of age. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Serious skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome have been reported whilst taking acetylcysteine, but these occur rarely. For this reason, medical advice should be sought immediately and the patient should stop taking acetylcysteine in the event of new-onset changes to the skin and mucous membranes. See also section 4.8. There are no studies on the efficacy and safety of once daily acetylcysteine 600 mg effervescent tablet in the adolescent population. However, m Przeczytaj cały dokument