País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
SODIUM CITRATE, SODIUM LAURYL SULFOACETATE
McNeil Healthcare (Ireland) Ltd
A06AG11
SODIUM CITRATE, SODIUM LAURYL SULFOACETATE
450 & 45 MG/5ml
Rectal Solution
Product not subject to medical prescription
LAURILSULFATE, INCL COMBINATIONS
Transfer Pending
2005-04-29
Rectal Solution Sodium Citrate 450 mg / 5 ml Sodium Lauryl Sulphoacetate 45 mg / 5 ml READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • This medicine is available without prescription. • However you still need to take Microlax carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen. • If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please talk to your doctor or pharmacist. IN THIS LEAFLET 1. What Microlax is and what it is used for. 2. Before you use Microlax 3. How to use Microlax 4. Possible side effects 5. How to store Microlax 6. Further information 1. WHAT MICROLAX IS AND WHAT IT IS USED FOR Microlax enema is a laxative used to empty the large bowel in constipation, or prior to surgical and diagnostic procedures or in obstetrics prior to delivery. The enema acts as a laxative by softening the stools and by its lubricating properties. This medicine is for use in adults and children. 2. BEFORE YOU USE MICROLAX This medicine is suitable for most children and adults but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE… If you have ever had a hypersensitivity reaction (e.g. rash, swelling of the face and throat, difficulty breathing) to any of the ingredients. See Section 6. TAKE SPECIAL CARE WITH MICROLAX... If you have ulcers or inflammation of your large bowel or any other part of your intestine. Prolonged use may lead to irritation of the anal canal. The nozzle should only be inserted to half its length when used in children under 3 years old. Seek medical advice if symptoms persist and avoid prolonged use. Speak to your doctor or pharmacist before using Microlax if you are taking sodium polystyrene sulphonate (a medicin Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Microlax Rectal Solution Sodium Citrate 450mg/5ml Sodium Lauryl Sulphoacetate 45mg/5ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml unit dose contains sodium citrate 450mg and sodium lauryl sulphoacetate 45mg. Excipient: Contains Sorbic acid (E200) 5mg/5ml unit dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Rectal solution (enema) A colourless, viscous liquid, containing small air bubbles, supplied in disposable 5 ml white low density capped polyethylene microenema tubes with elongated nozzles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The Microlax enema acts as a laxative through its faecal softening and lubricant properties. For evacuation of the colon in constipation, or prior to surgical and diagnostic procedures or in obstetrics prior to delivery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Rectal. Recommended dosage schedules. Adults - One Microenema administered as necessary. Children - As adults unless below the age of 3, when the nozzle should be inserted only half its length. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or any of the excipients listed in section 6.1 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged usage of the microenema may lead to irritation of the anal canal. When used in children under 3 years old, the nozzle should be inserted only to half its length. When used in patients with inflammatory or ulcerative conditions of the large bowel, or with acute gastrointestinal conditions, extreme caution should be exercised. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 13/04/2016_ _CRN 2174835_ _page number: 1_ Lubricate the nozzl Llegiu el document complet