Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
LACTULOSE
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
A06AD11
LACTULOSE 3.35 g/5ml
ORAL SOLUTION
LACTULOSE 3.35 g/5ml
OTC
DRUGS FOR CONSTIPATION
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-12-01
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER LACTULOSE CRESCENT 3.35G/ 5ML SOLUTION 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 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, 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 Lactulose Solution is and what it is used for 2. What you need to know before you take Lactulose Solution 3. How to take Lactulose Solution 4. Possible side effects 5. How to store Lactulose Solution 6. Contents of the pack and other information 1. WHAT LACTULOSE SOLUTION IS AND WHAT IT IS USED FOR Lactulose is a laxative. It makes the stool softer and easier to pass, by drawing water into the bowel. It is not absorbed into your body. It is used to treat: • constipation (infrequent bowel movements, hard and dry stools) • 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 LACTULOSE SOLUTION DO NOT TAKE LACTULOSE SOLUTION IF: • you are allergic (hypersensitive) to lactulose or any of the other ingredients (listed in Section 6) • you have a rare problem called 'galactosaemia' • you have a blockage caused by anything else but normal constipation, digestive perforation or risk of digestive perforation. Do not take Lactulose Solution if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist BEFORE taking Lactulose Solution. Page 2 of 6 WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Lactulo Baca dokumen lengkap
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lactulose Crescent 3.35 g/5 ml Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lactulose 3.35 g/5 ml. For excipients, see 6.1 3. PHARMACEUTICAL FORM Oral Solution. A clear or not more than slightly opalescent, viscous liquid, colourless to brownish yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of constipation. For the treatment of hepatic encephalopathy (HE); hepatic coma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Posology. _ The lactulose solution may be administered diluted or undiluted. Each dose may if necessary be taken with water or fruit juices, etc. Each 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 (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 lactulose in bottles the measuring cup may be used. 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 Dosing in HE (for adults only): _Starting dose_ : 3 to 4 times daily 30-45 ml (6-9 x 5 ml spoonfuls). This dose may be adjusted to the maintenance dose to achieve two or three soft stools each day. Paediatric population: The safety and efficacy in children (newborn to 18 years of age) with hepatic encephalopathy (HE) have not been established. No data are available. Elderly patients and pati Baca dokumen lengkap