Country: Malta
Language: English
Source: Medicines Authority
LACTULOSE
Mylan IRE Healthcare Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
A06AD11
LACTULOSE 3.335 g/5ml
ORAL SOLUTION
LACTULOSE 3.335 g/5ml
OTC
DRUGS FOR CONSTIPATION
Authorised
2006-01-19
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 BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse 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, pharmacist or nurse. 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 several days. WHAT IS IN THIS LEAFLET: 1. What Duphalac is and what it is used for 2. What you need to know before you take Duphalac 3. How to take Duphalac 4. Possible side effects 5. How to store Duphalac 6. Contents of the pack and other information 1. WHAT DUPHALAC IS AND WHAT IT IS USED FOR 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). Duphalac is used to treat or prevent hepatic encephalopathy (a liver disease causing confusion, tremor, decreased level of consciousness including coma). This is also known as a ‘hepatic coma’. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DUPHALAC DO NOT TAKE DUPHALAC: • if you are allergic (hypersensitive) to – lactulose or – any of the other ingredients of Duphalac (see sections 2 and 6). • if you suffer from – galactosaemia (a severe genetic disorder where you cannot digest galactose) – blockage in your gastrointestinal tract (apart from normal constipation) – gastrointestinal perforation or risk of gastrointestinal perforation (damage/puncture to the gastric and/or intestinal wall) If you are not sure, talk to your doctor or pharmacist before tak Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Duphalac 3.335 g / 5 ml Oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lactulose 3.335 g per 5 ml oral solution (as Lactulose, liquid 667 g/l) For a full list of excipients, see section 6.1 Duphalac contains residues from the route of production with known effect, see section 4.4. 3. PHARMACEUTICAL FORM Oral solution. Clear, colourless to pale brownish – yellow viscous liquid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Constipation. Hepatic encephalopathy (HE): treatment and prevention of hepatic coma or precoma. 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. 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. Starting dose daily Maintenance dose daily Adults and adolescents 15 - 45 ml 15 – 30 ml Children (7-14 years) 15 ml 10 – 15 ml Children (1-6 years) 5 - 10 ml 5 – 10 ml Infants under 1 year Up to 5 ml Up to 5 ml Method of Administration Oral use. For Duphalac in bottles the measuring cup may be used to administer the appropriate dose. DOSING IN HEPATIC ENCEPHALOPATHY (HE) Adults: For oral administration Starting Dose Maintenance Dose 3 to 4 times daily 30-45 ml Starting dose may be adjusted to the maintenance dose to achieve 2 – 3 soft stools per day SPECIAL POPULATIONS Paediatric populati Read the complete document