Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Sodium picosulphate; Magnesium oxide, light ; Citric acid, anhydrous
Ferring Ireland Ltd
A06AB; A06AB58
Sodium picosulphate; Magnesium oxide, light ; Citric acid, anhydrous
10 mg/3.5 g/12 gram(s)
Powder for oral solution
Product subject to prescription which may be renewed (B)
Contact laxatives; sodium picosulfate, combinations
Marketed
1983-02-24
PACKAGE LEAFLET: INFORMATION FOR THE USER PICOLAX ® 10 MG/ 3.5 G/ 12 G POWDER FOR ORAL SOLUTION Sodium Picosulfate, Magnesium Oxide, Citric Acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 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. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET 1. What Picolax is and what it is used for 2. What you need to know before you take Picolax 3. How to take Picolax 4. Possible side effects 5. How to store Picolax 6. Contents of the pack and other information 1. WHAT PICOLAX IS AND WHAT IT IS USED FOR Picolax is a powder that contains sodium picosulfate, a laxative that works by increasing the activity of the intestine. Picolax also contains magnesium citrate, another type of laxative that works by holding back fluid in the bowel to provide a wash-out effect. Picolax is used for clearance of the bowel prior to examination by radiography, endoscopy or surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PICOLAX DO NOT TAKE PICOLAX IF YOU: - are allergic (hypersensitive) to sodium picosulfate or any of the other ingredients of this medicine (listed in section 6) - have reduced ability of the stomach to empty (gastric retention) - have stomach or intestinal ulcers - have severe problems with your kidneys - have a blockage or perforation of your bowel - are currently suffering from feeling or being sick - have a condition requiring abdominal surgery such as appendicitis - have been told by a doctor that you have congestive cardiac failure (the heart is unable to pump blood efficiently around the body). - have an active inflammatory bowel disease such as Crohn read_full_document
Health Products Regulatory Authority 09 March 2021 CRN009W3S Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Picolax 10mg / 3.5g / 12 g Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains: Sodium Picosulfate 10.0 mg Magnesium Oxide 3.5 g Citric Acid (anhydrous) 12.0 g Each sachet also contains: Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg) potassium] Lactose (60 mg flavour contains 7.5% lactose which equals 4.5 mg per dosage form) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution White crystalline powder 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For evacuation of the bowel prior to radiological, endoscopic or surgical procedures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION METHOD OF ADMINISTRATION Route of administration: Oral. A low residue diet is recommended on the day prior to the procedure. A clear liquid diet is recommended on the day of the procedure. To avoid dehydration it is important to follow the liquid intake recommendation as advocated together with the Picolax dosing while the effects of Picolax persist (see section 4.2, Posology). Apart from the liquid intake together with the treatment regimen (Picolax + additional liquids), a normal, thirst driven intake of clear liquids is recommended. Clear liquids should include a variety of fruit juice without pulp, soft drinks, clear soup, tea, coffee (without milk, soy or cream) and water. Liquid intake should not be restricted to only drinking water. POSOLOGY _DIRECTIONS FOR RECONSTITUTION: _ Reconstitute the contents of one sachet in a cup of water (approximately 150ml). Stir for 2-3 minutes. The solution should now become an off-white, cloudy liquid with a faint odour of orange. Drink the solution. If it becomes warm wait until it cools sufficiently to drink. _ _ _ _ _ADULTS (INCLUDING ELDERLY)_: The first Picolax sachet is taken before 8 am the day before the procedure and the second is taken 6 to 8 hours later. O read_full_document