Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
SODIUM CITRATE SODIUM LAURYL SULFOACETATE
E.C. De Witt & Company Limited
SODIUM CITRATE SODIUM LAURYL SULFOACETATE
5 Milligram
Rectal Solution
Withdrawn
2008-12-12
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fleet Micro-enema Rectal Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml dose contains: For excipients, see 6.1. 3 PHARMACEUTICAL FORM Rectal solution Slight opaque solution with no particulate matter or turbidity. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of occasional constipation in bedridden patients and geriatrics. Use in paediatrics and obstetrics should only be under medical supervision. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children aged 3 years and older: Administer the contents of one Fleet Micro-enema rectally 15 minutes before effect is wanted. Lie on left side with both knees bent, arms at rest. Remove orange protective shield. With steady pressure, gently insert enema full length into the rectum with tip pointing towards navel. Squeeze tube until contents are expelled. Discontinue use if resistance is encountered. Forcing an enema can result in injury. 4.3 CONTRAINDICATIONS It is advisable to avoid the use of Fleet Micro-enema in cases of haemorrhoid eruptions and in patients with inflammatory bowel diseases or any acute gastrointestinal conditions. Do not use when there is a hypersensitivity to the active ingredients or any of the excipients. Do not administer to children under 3 years of age. Sodium Citrate 450 mg Sodium Lauryl Sulphoacetate 45 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/10/2006_ _CRN 2029443_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Excessive use may cause diarrhoea and fluid loss which should be treated symptomatically. Frequent or prolonged use of a laxative for more than one week may result in depend Przeczytaj cały dokument