Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Carbocisteine
Phoenix Labs
R05CB; R05CB03
Carbocisteine
250 mg/5ml
Oral solution
Product not subject to medical prescription
Mucolytics; carbocisteine
Marketed
1985-12-20
PATIENT INFORMATION LEAFLET (Carbocisteine) Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1. What Exputex Oral Solution is and what it is used for 2. Before you take Exputex Oral Solution 3. How to take Exputex Oral Solution 4. Possible side effects 5. How to store Exputex Oral Solution 6. Further information 1. WHAT EXPUTEX ORAL SOLUTION IS AND WHAT IT IS USED FOR Exputex Oral Solution contains the active ingredient carbocisteine, which liquefies viscous mucus and assists in the clearance of phlegm. 2. BEFORE YOU TAKE EXPUTEX ORAL SOLUTION Do NOT take the solution if you: • are allergic (hypersensitive) to carbocisteine or any of the other ingredients in the solution _(see Section 6 and end of Section 2)_ • suffer from peptic ulcers (stomach ulcers) Take special care Talk to your doctor before taking the solution if you have: • a history of peptic ulcers (stomach ulcers) Taking other medicines Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription. Taking Exputex Oral Solution with food and drink. You can take the solution with or without food. Pregnancy and breast-feeding Tell your doctor if you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breast-feeding. Exputex Oral Solution should not be taken by pregnant or breast-feeding women unless advised to by a doctor. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy, or if you are breast-feeding. Driving and using machinery Exputex Oral Solution should not have any e Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Exputex 250mg / 5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml of liquid contains 250 mg of Carbocisteine. Excipients: Contains sunset yellow (E110), parahydroxybenzoates (E215, E217, E219), ethanol, and salts containing sodium. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral Solution. A viscous, orange coloured liquid with an odour of condensed milk and orange. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS As a mucolytic adjunct for respiratory tract disorders characterised by excessive or viscous mucous. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration Adults The usual dose is three 5 ml spoonfuls three times daily initially, reducing to two 5 ml spoonfuls three times daily when a satisfactory response has been obtained. Children 6-12 years: The usual dose is one 5ml spoonful (250 mg) two to three times daily. 2-5 years: The usual dose is half a 5ml spoonful (125 mg) two to three times daily. Under 2 years: Not recommended. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to carbocisteine or to any of the excipients in Exputex. Use in patients with known active peptic ulceration. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Because of the possible effects on the mucous glands of the stomach, this product should be used with caution in patients with a history of peptic ulceration and avoided in patients with active ulceration. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D Lees het volledige document