Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
LACTULOSE
Abbott Healthcare Products Ltd
LACTULOSE
3.335 MG/5ml
Oral Solution
Product not subject to medical prescription
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER DUPHALAC® 3.335 g / 5 ml Oral Solution LACTULOSE 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 further question, ask your doctor or pharmacist. 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Duphalac is and what it is used for 2. Before you take Duphalac 3. How to take Duphalac 4. Possible side effects 5. How to store Duphalac 6. Further information 1. WHAT DUPHALAC IS Duphalac 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 DUPHALAC IS USED FOR Duphalac is used to treat constipation (infrequent bowel movements, hard and dry stools) to produce a soft stool. Duphalac is used to treat hepatic encephalopathy, also called portal systemic encephalopathy (a liver disease causing difficulty thinking, tremor, decreased level of consciousness including coma) 2. BEFORE YOU TAKE DUPHALAC DO NOT TAKE DUPHALAC: if you are allergic (hypersensitive) to lactulose or any of the other ingredients of Duphalac (listed in Section 6). If you suffer from - galactosaemia (a sever genetic disorder where you cannot digest galactose) - blockage in your bowel (apart from normal constipation) v This information is confidential Lactulose SOLID 1000555108 1.0 If you are not sure, talk to your doctor or pharmacist before taking Duphalac. TAKE SPECIAL CARE WITH DUPHALAC Please consult your doctor before taking Duphalac if you suffer from any medical conditions or illnesses, in particular: – if you are unable to digest milk sugar (lactose) You should not take Duphalac if you suff Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duphalac 3.335g/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lactulose solution containing 3.335 g of lactulose per 5 ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, colourless to pale brownish – yellow viscous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (1) In the 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 a 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 (1.5 – 2 litres, equal to 6-8 glasses) during the day. DOSING IN CONSTIPATION Lactulose may be given as a single daily dose or in two divided doses; for Duphalac in bottles the measuring cup should be used. Several days (2-3 days) of treatment may be needed before treatment effect occurs. DOSING IN HEPATIC ENCEPHALOPATHY Initially 30 – 50 ml three times daily; dosage should be adjusted to produce 2 to 3 soft stools daily. Adults 15ml twice daily Children 5-10 years 10ml twice daily Children 2-5 years 5ml twice daily Infants 1- 2 years 2.5 - 5ml twice daily Infants 1month – 1 year 2.5ml twice daily HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 15/07/2014_ _CRN 2149609_ _page number: 1_ 4.3 CONTRAIN Preberite celoten dokument