Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
LACTULOSE
Abbott Healthcare Products Ltd
LACTULOSE
3.335 g/5ml
Oral Solution
Product not subject to medical prescription
Authorised
0000-00-00
1 PACKAGE LEAFLET: INFORMATION FOR THE USER LACTECON, 3.335G/5 ML ORAL SOLUTION Lactulose READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You must talk to a doctor if you do not feel better or if you feel worse after several days. WHAT IS IN THIS LEAFLET: 1. What LACTECON is and what it is used for 2. What you need to know before you take LACTECON 3. How to take LACTECON 4. Possible side effects 5. How to store LACTECON 6. Contents of the pack and other information 1. WHAT LACTECON IS AND WHAT IT IS USED FOR WHAT LACTECON IS LACTECON contains a laxative called lactulose. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body. WHAT LACTECON IS USED FOR • LACTECON is used to treat constipation (infrequent bowel movements, hard and dry stools). LACTECON is used to treat hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness including coma). 2 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTECON DO NOT TAKE LACTECON − if you are allergic (hypersensitive) to − lactulose − any of the other ingredients of LACTECON (listed in section 6) − if you suffer from − galactosaemia (a severe genetic disorder where you cannot digest galactose) Przeczytaj cały dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lactecon 3.335g/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Liquid lactulose containing 3.335g of lactulose per 5ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution A clear, viscous liquid, colourless to brownish yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (1) In the symptomatic treatment of constipation. (2) In the treatment of hepatic encephalopathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The lactulose solution may be administered diluted or undiluted. A single dose of lactulose should be swallowed in one and should not be kept in the mouth for an extended period of time. The posology should be adjusted according to the individual needs of the patient. In case of single daily dose, this should be taken at the same time, e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids during the day. For Lactecon in bottles the measuring cup may be used. Dosing in constipation Lactulose may be given as a single daily dose or in two divided doses, using the measuring cup. After a few days the starting dosage may be adjusted to the maintenance dose based upon treatment response. Several days (2-3 days) of treatment may be needed before treatment effect occurs. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 17/09/2014_ _CRN 2150717_ _page number: 1_ Dosing in hepatic encephalopathv - for adults only: Starting dose: 3 to 4 times daily 30 - 45 ml. This dose may be adjusted to the maintenance dose to achieve 2 to 3 soft stools per day. Paediatric population The safety and efficacy in c Przeczytaj cały dokument