Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
STERCULIA
Norgine Limited
A06AC03
STERCULIA
62 %w/w
Granules
Product not subject to medical prescription
Bulk-forming laxatives
Authorised
1984-09-25
1 NORMACOL ® 62% W/W GRANULES STERCULIA 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. This medicine is available without prescription but you still need to take NORMACOL 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. • If you get side effects , talk to your doctor or pharmacist . This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse after 4 days. IN THIS LEAFLET 1. What NORMACOL is and what it is used for 2. What you need to know before you take NORMACOL 3. How to take NORMACOL 4. Possible side effects 5. How to store NORMACOL 6. Contents of the pack and other information 1. WHAT NORMACOL IS AND WHAT IT IS USED FOR NORMACOL granules contain 62% w/w sterculia. Sterculia is a vegetable gum from the karaya tree. It is this natural dietary fibre in NORMACOL which helps to relieve constipation and help keep you regular. It is also used by people: • with colostomies or ileostomies • who need a high fibre diet, for example in diverticular disease of the colon • who have had rectal or anal surgery • who have swallowed something sharp, to reduce the chance of damage to the intestine (gut). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NORMACOL _ _ DO NOT TAKE NORMACOL IF: • your doctor has told you that you have a blockage in your intestine (gut) • your doctor has told you that you have total loss of muscle tone in the colon • your doctor has told yo Leggi il documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Normacol 62% w/w Granules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of NORMACOL Granules contains 0.62g of sterculia BP (62% w/w). Each sachet contains 4.34g of sterculia BP. Excipient: Contains sucrose 24.593% w/w and sodium hydrogen carbonate 1.5% w/w. For a full list of excipients, see 6.1 3 PHARMACEUTICAL FORM Granules White irregular shaped granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The treatment of constipation (including pregnancy and lactation). Management of colostomies and ileostomies. The 'High Residue Diet' management of diverticular disease of the colon and other conditions requiring a high fibre regimen. The initiation and maintenance of bowel action after rectal and anal surgery. Administration after ingestion of sharp foreign bodies to provide a coating and reduce the possibility of intestinal damage during transit. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS: _1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals. _OLDER PEOPLE:_ As adult dose. Paediatric population _CHILDREN (6-12 YEARS): _one half the above amount or as directed by the physician. NORMACOL® is not recommended for children under 6 years of age. The granules should be placed dry on the tongue and without chewing or crushing, swallowed immediately with plenty of water or a cool drink. Prior to drinking they may also be sprinkled onto and taken with soft food such as yoghurt. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 25/11/2015_ _CRN 2169992_ _page number: 1_ 4.3 CONTRAINDICATIONS Intestinal obstruction, faecal impaction, and colonic atony. Patients with rare hereditary probl Leggi il documento completo