Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Lactulose
Fresenius Kabi Austria GmbH
A06AD; A06AD11
Lactulose
670 milligram(s)/millilitre
Oral solution
Product not subject to medical prescription
Osmotically acting laxatives; lactulose
Marketed
2010-11-26
PACKAGE LEAFLET: INFORMATION FOR THE USER LACTULOSE FRESENIUS 670 MG/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 has 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. See section 4. - You must talk to a doctor if you do not feel better or if you feel worse after 3 days. _ _ _ _ WHAT IS IN THIS LEAFLET 1. What Lactulose Fresenius is and what it is used for 2. What you need to know before you take Lactulose Fresenius 3. How to take Lactulose Fresenius 4. Possible side effects 5. How to store Lactulose Fresenius _ _ 6. Contents of the pack and other information_ _ 1. WHAT LACTULOSE FRESENIUS IS AND WHAT IT IS USED FOR Lactulose Fresenius 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. Lactulose Fresenius is used to: - treat the symptoms of constipation - treat a special liver disease (portal systemic encephalopathy) You must talk to a doctor if you do not feel better or if you feel worse after 3 days. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LACTULOSE FRESENIUS DO NOT TAKE LACTULOSE FRESENIUS - if you are allergic to lactulose or any of the other ingredients of this medicine (listed in section 6). - if you suffer from - galactosaemia (a severe genetic disorder where you cannot digest galactose) - acute inflammatory bowel disease (like Crohn's disease or ulcerative colitis) blockage in your bowel (apart from normal constipation), digestive perforation or risk of digestive perforation, abdominal pain of undetermined cause WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Lactulose Fresenius. Прочитајте комплетан документ
Health Products Regulatory Authority 15 June 2022 CRN00CY48 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lactulose Fresenius 670mg/ml oral solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 670 mg Lactulose (as lactulose liquid). 3 PHARMACEUTICAL FORM Oral solution Clear colourless to pale brownish yellow, viscous solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Symptomatic treatment of Constipation • Treatment of portal systemic encephalopathy Lactulose Fresenius is indicated in adults and for constipation only in children and adolescents aged 1 month to 18 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The posology should be adjusted according to the individual needs of the patient. The starting dose can be adjusted after adequate treatment effect individually (maintenance dose). Several days (2-3 days) of treatment may be needed in some patients before adequate treatment effect occurs. In case of single daily dose, this should be taken at the same time of the day, e.g. during breakfast. During the therapy with laxatives it is recommended to drink sufficient amounts of fluids (1.5-2 l/day, equal to 6-8 glasses). CONSTIPATION Starting dose Maintenance dose Adults 15 - 45 ml corresponding to 10 - 30 g lactulose 15 - 30 ml corresponding to 10 - 20 g lactulose PAEDIATRIC POPULATION Starting dose Maintenance dose Adolescents over 14 years 15 - 45 ml corresponding to 10 - 30 g lactulose 15 - 30 ml corresponding to 10 - 20 g lactulose Children (7-14 years) 15 ml corresponding to 10 g lactulose 10 - 15 ml corresponding to 7 - 10 g lactulose Children (1-6 years) 5 - 10 ml corresponding to 3 - 7 g lactulose Babies up to 5 ml corresponding to up to 3 g Health Products Regulatory Authority 15 June 2022 CRN00CY48 Page 2 of 5 lactulose If diarrhoea occurs, the dosing regimen should be reduced. TREATMENT OF PORTAL SYSTEMIC ENCEPHALOPATHY - FOR ADULTS ONLY: Beginning with 30 - 50 ml 3times daily (corresponding to 60 - 100 g Lactulose daily). The dosag Прочитајте комплетан документ