Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Macrogol 4000
Casen-Recordati S.L.
A06AD; A06AD15
Macrogol 4000
10 gram(s)
Powder for oral solution
Oral use
pack sizes of 10, 20, 50 and 100 sachets
Product subject to prescription which may be renewed (B)
Drugs for constipation. Osmotically acting laxatives
Osmotically acting laxatives; macrogol
Symptomatic treatment of constipation in adults and children aged 8 years and above
Not marketed
2013-06-28
PACKAGE LEAFLET: INFORMATION FOR THE USER PEGLAX 10G POWDER FOR ORAL SOLUTION IN SACHET MACROGOL 4000 READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Peglax is and what it is used for 2. What you need to know before you take Peglax 3. How to take Peglax 4. Possible side effects 5. How to store Peglax 6. Contents of the pack and other information 1. WHAT PEGLAX IS AND WHAT IT IS USED FOR The name of this medicine is Peglax 10g powder for oral solution in sachet. Peglax is considered as osmotic laxative. Peglax is used for the symptomatic treatment of constipation in adults and children 8 years old and over. It should be used with appropriate changes to lifestyle and diet (see section 2). You must talk to a doctor if you do not feel better or if you feel worse. This medicine contains Macrogol (P.E.G. = polyethylene glycol). In the case of constipation, the maximum treatment period in children is 3 months. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEGLAX OCCASIONAL CONSTIPATION: Occasional constipation may be related to a recent change in your lifestyle. There are medicines that can be used for short term treatment. Ask the opinion of your doctor in the case of recent constipation which cannot be explained by changes in your lifestyle, or in the case of constipation associated with pain, fever or abdominal swelling. CHRONIC CONSTIPATION (LONG TERM CONSTIPATION): Chronic constipation may be caused by: Intestinal disease that requires a physician’s advice. Intestinal dysfu Baca dokumen lengkapnya
Health Products Regulatory Authority 30 November 2020 CRN00C23W Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Peglax 10 g powder for oral solution in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains 10 g of macrogol 4000. Excipient(s) with known effect: 0.0000018 mg of sulphur dioxide (E-220) per sachet and less than 1 mmol of sodium per sachet. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Powder for oral solution in sachet. Almost white powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of constipation in adults and children aged 8 years and above. An organic disorder should have been ruled out before initiation of treatment. Peglax should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-months treatment course in children. If symptoms persist despite associated dietary measures, an underlying cause should be suspected and treated 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral use Posology 1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125 ml of liquids (e.g. water) after each dose. The effect of Peglax becomes apparent within 24 to 48 hours after its administration. The daily dose should be adapted according to the clinical effects and may range from one sachet every other day (especially in children) up to 2 sachets a day. Treatment should be stopped gradually and resumed if constipation recurs. _Paedriatic population_ 1 to 2 sachets per day, preferably taken as a single dose in the morning. It is recommended to drink 125 ml of liquids (e.g. water) after each dose. In children, treatment should not exceed 3 months due to a lack of clinical data for treatment lasting longer than 3 months. Treatment-induced restoration of bowel movements will be maintained by lifestyle and dietary measures. Method of administration Each sachet should be dissolved in a glass of water (125 ml approxi Baca dokumen lengkapnya