Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Magnesium oxide; Citric acid anhydrous; Sodium picosulfate
Ferring Pharmaceuticals Ltd
n/a
Magnesium oxide; Citric acid anhydrous; Sodium picosulfate
3.5gram ; 12gram ; 10mg
Powder for oral solution
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 01060500; GTIN: 5015919705590 5015919577418
Package leaflet: Information for the patient PICOLAX ® Powder for oral solution Sodium Picosulfate / Magnesium Oxide / Citric Acid • if you are younger than 18 years, elderly or physically weak. You should make sure to drink a sufficient amount of fluid and electrolytes during the course of the treatment • if you are taking Picolax ® prior to surgery involving the bowel If you have an early time of the day procedure, you might need to take the second dose during night and possible sleep disturbance may occur. OTHER MEDICINES AND PICOLAX ® Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is especially important to tell your doctor if you are taking: • bulk forming laxatives e.g. bran • prescribed oral medication, especially if it is regularly prescribed as their effects may be modified e.g. contraceptives, antibiotics, anti- diabetics, iron, penicillamine or anti- epileptics. These medicines should be taken at least 2 hours before and not less than 6 hours after administration of Picolax ® • prescribed medication that may affect water and/or electrolyte balance e.g. water tablets, steroids, lithium, digoxin, antidepressants, carbamazepine or anti-psychotics PREGNANCY, BREAST-FEEDING AND FERTILITY If you are pregnant or breast-feeding, think you may be pregnant or are trying to have a baby, ask your doctor or pharmacist for advice before taking this medicine. DRIVING AND USING MACHINES Picolax ® has no effect on the ability to drive and use machines. However, you should make sure that you have access to a toilet at all times following each dose, until the effect wears off. PICOLAX ® CONTAINS POTASSIUM AND LACTOSE Each sachet contains 5 mmol (or 195 mg) potassium. You should discuss this with your doctor if you have kidney problems or you have been put on a controlled potassium diet. This medicine also contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this med Læs hele dokumentet
OBJECT 1 PICOLAX Summary of Product Characteristics Updated 28-Jul-2016 | Ferring Pharmaceuticals Ltd 1. Name of the medicinal product PICOLAX powder for oral solution 2. Qualitative and quantitative composition Each sachet contains the following active ingredients: Sodium picosulfate 10.0mg Magnesium oxide, light 3.5g Citric acid, anhydrous 12.0g - Each sachet also contains: Potassium hydrogen carbonate 0.5g [equivalent to 5 mmol (195 mg) potassium] Lactose (as a component of the flavour) 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 PICOLAX is indicated in adults, adolescents and children from the age of 1 year: - To clean the bowel prior to X-ray examination or endoscopy. - To clean the bowel prior to surgery when judged clinically necessary (see section 4.4 regarding open colorectal surgery). 4.2 Posology and method of administration Posology _Adults (including the elderly):_ The two PICOLAX sachets are taken dependent on the planned time of the procedure: • The first reconstituted sachet is taken 10 to 18 hours before the procedure, followed by at least five 250 ml drinks of clear liquids, spread over several hours • The second reconstituted sachet is taken 4 to 6 hours before the procedure, followed by at least three 250 ml drinks of clear liquids, spread over several hours • Clear liquids may be consumed until 2 hours before the time of the procedure _Special populations_ Limited data is available for treatment of patients with low body weight (BMI less than 18). The rehydration regimen above has not been tested in such individuals and therefore monitoring of their hydration status is required and the regimen may need to be altered appropriately (see section 4.4). _Paediatric population:_ A measuring spoon is provided with the product. It is recommended that a narrow flat edge, for example the back of a knife blade, is drawn across the top of a heaped measuring spoon to o Læs hele dokumentet