Country: Միացյալ Թագավորություն
language: անգլերեն
source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Acetylcysteine
Special Order
R05CB01
Acetylcysteine
600mg
Oral capsule
No Controlled Drug Status
Valid as a prescribable product
BNF: 03070000
LAETUS CODE LAETUS CODE 280 MM 160 MM 260 MM 140 MM 10 10 10 280 MM 160 MM 260 MM 140 MM 10 10 10 10 10 Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 021219/3 Ennogen Mucolight 600mg Capsules Leaflet UK English 160 x 280 mm 9 pt 1 of 1 1 02-12-19 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : prasad.pdp@gmail.com Ph : +91-09845156610 Colours Used Black Keyline Talk to your doctor, pharmacist or nurse before taking Mucolight Capsules: Mucolight Capsules 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). ! If you have asthma 3. HOW TO TAKE MUCOLIGHT CAPSULES WARNINGS AND PRECAUTIONS ! If you have a history of stomach ulcers ! Are under 14 years of age ! ARE ALLERGIC TO ACETYLCYSTEINE or any of the other ingredients of this medicine (listed in section 6) 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE MUCOLIGHT CAPSULES Serious skin rashes (Steven-Johnson syndrome and Lyell's syndrome) have rarely been reported with the use of acetylcysteine. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MUCOLIGHT CAPSULES 1. WHAT MUCOLIGHT CAPSULES ARE AND WHAT THEY ARE USED FOR 6. CONTENTS OF THE PACK AND OTHER INFORMATION DO NOT TAKE MUCOLIGHT CAPSULES IF YOU: ! If you are allergic to histamine. If you are not able to tolerate food and drinks that contain large amounts of histamine such as wine, tomatoes or processed food, then Mucolight Capsules are not suitable for you because acetylcysteine affects how histamine is broken down in the body. The most common symptoms of histamine intolerance are migraine headaches, flushing, hives and rhinitis (stuffy, runny nose) and itching. ! If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet read_full_document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Mucolight 600mg Capsules Acetylcysteine 600mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 600 mg acetylcysteine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Almost white, crystalline powder, filled in white hard gelatin 00 Capsule size. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolight 600mg Capsules are a mucolytic agent for the adjunctive therapy of respiratory tract disorders characterized 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 capsule) 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. For oral use. Swallow the capsule with a drink of water. The capsule should be taken after food. Hepatic and Renal Impairment In patients with impaired kidney or liver function 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. 4.3 CONTRAINDICATIONS Hypersensitivity to acetylcysteine or to any of the excipients listed in section 6.1. This medicine 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 capsule in the adolescent population. However, mild, moderate or severe adverse react read_full_document