Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Macrogol 4000
IPSEN Consumer HealthCare
A06AD; A06AD15
Macrogol 4000
10 gram(s)
Powder for oral solution in sachet
Osmotically acting laxatives; macrogol
Not marketed
2002-02-22
__________________________________________________________________________________________________________ Document name: 23_IDR_IE Reason for change: Type IB Variation to update the product information according to CCDS V2.0 Document replaced: 20.1_IDR_IE Preparation date: 17/01/2022 Page 1 of 5 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IDROLAX 10 G, 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. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. You must consult your doctor if your symptoms worsen or do not improve. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET 1. What Idrolax is and what it is used for 2. What you need to know before you take Idrolax 3. How to take Idrolax 4. Possible side effects 5. How to store Idrolax 6. Contents of the pack and other information 1. WHAT IDROLAX IS AND WHAT IT IS USED FOR Idrolax contains the active substance Macrogol 4000 and belongs to a group of medicines called osmotic laxatives. It works by adding water to the stools, which helps to overcome problems caused by very slow bowel movements. Idrolax is not absorbed into the bloodstream or broken down in the body. Idrolax is used for the treatment of constipation in adults and children aged 8 years and above. This medicine is a powder that you dissolve in a glass of water (at least 50ml) and drink. It usually takes 24 to 48 hours to work. The treatment of constipation with any medicine should only be in addition to a healthy lifestyle and diet. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IDROLAX DO NOT TAKE IDROLAX: if you are allergic (hypersensitive) to macrogol ( Lestu allt skjalið
Health Products Regulatory Authority 20 January 2022 CRN00CNQH Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Idrolax 10g, powder for oral solution in a sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Macrogol 4000 ………………………………………………………10.00g per sachet Excipients with known effect: Sorbitol (E420) ………………………………………………………1.7 mg per sachet. Sulphur dioxide (E220) ………………………………………………0.12* 10 -2 mg per sachet For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution in sachet. Almost white powder with an odour and taste of orange-grapefruit. 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. IDROLAX 10 g should remain a temporary adjuvant treatment to appropriate lifestyle and dietary management of constipation, with a maximum 3-month 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 (10-20 g) per day, preferably taken as a single dose in the morning. The daily dose should be adjusted according to the clinical response and may range from one sachet every other day (especially in children) up to 2 sachets a day. The effect of IDROLAX becomes apparent within 24 to 48 hours after its administration. Paediatric population 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 The content of each sachet should be dissolved in about 50 ml of water just before use and taken in the morning. The resultant solution will be Lestu allt skjalið