País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
sodium bicarbonate, Quantity: 178.5 mg; potassium chloride, Quantity: 46.6 mg; sodium chloride, Quantity: 350.7 mg; macrogol 3350, Quantity: 13.125 g
Viatris Pty Ltd
macrogol 3350,potassium chloride,sodium bicarbonate,sodium chloride
Solution, powder for
Excipient Ingredients: acesulfame potassium; Flavour
Oral
10, 20, 8, 6, 2, 30
Not scheduled. Not considered by committee
For effective relief from constipation, treatment of chronic constipation. Molaxole is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of the abdomen and rectum.
Visual Identification: White crystalline powder; Container Type: Sachet; Container Material: Al laminated with LDPE/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2013-08-08
MOLAXOLE ® POWDER FOR ORAL SOLUTION _macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about MOLAXOLE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT MOLAXOLE IS USED FOR MOLAXOLE helps you to have a comfortable bowel movement even if you have been constipated for a long time. MOLAXOLE also works in very bad constipation (called faecal impaction), as determined by your doctor. Macrogol 3350 increases the volume of faeces by binding water leading to a normalisation of motility in the colon. The physiological consequences are an increased movement of the softened stools and easing of defaecation. The salts in the formulation help maintain the body's normal salt and water balance. This medicine is available without a doctor’s prescription. However, you still need to take MOLAXOLE carefully to get the best results from it. BEFORE YOU TAKE MOLAXOLE _WHEN YOU MUST NOT TAKE IT_ Do not take MOLAXOLE if you have an allergy to any of the ingredients listed at the end of this leaflet. Do not give this medicine to a child under the age of 12 years. Do not take MOLAXOLE if your doctor has told you that you have: • An obstruction in your intestine (gut) • A perforated gut wall • Severe inflammatory bowel disease like ulcerative colitis, Crohn's disease or toxic megacolon • Paralysis of the bowel Do not take MOLAXOLE after the expiry date printed on the pack. If you use this medicine after the expiry date has passed, Leia o documento completo
AUSTRALIAN PRODUCT INFORMATION MOLAXOLE ® _macrogol 3350/sodium chloride/sodium bicarbonate/potassium chloride _ _powder for oral solution _ 1 NAME OF THE MEDICINE macrogol 3350, sodium chloride, sodium bicarbonate and potassium chloride _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 13.8 g sachet of MOLAXOLE contains: Macrogol 3350 13.125 g Sodium chloride 350.7 mg Sodium bicarbonate 178.5 mg Potassium chloride 46.6 mg When it is made into a drink with 125 mL water, each sachet provides: Sodium 65 mmol/L Chloride 53 mmol/L Bicarbonate 17 mmol/L Potassium 5.4 mmol/L Excipients with known effect: Each sachet contains 26 mg of potassium and 187 mg of sodium. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM White crystalline powder for oral solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For effective relief from constipation, treatment of chronic constipation and treatment of faecal impaction defined as refractory constipation with faecal loading of the rectum and/or colon confirmed by physical examination of abdomen and rectum. 4.2 DOSE AND METHOD OF ADMINISTRATION Dosage in adults and children over 12 years: CONSTIPATION: The dose is 1 sachet daily. This may be increased up to 3 sachets daily, if required. FAECAL IMPACTION AS DIAGNOSED BY A DOCTOR: 8 sachets daily, consumed within 6 hours. A course of treatment for faecal impaction does not normally exceed 3 days. PATIENTS WITH IMPAIRED CARDIOVASCULAR FUNCTION: For the treatment of faecal impaction the dose should be divided so that no more than two sachets are taken in any one hour. PATIENTS WITH RENAL INSUFFICIENCY: No dosage change is necessary for treatment of either constipation or faecal impaction. Administration: MOLAXOLE ® – PRODUCT INFORMATION 2 For oral administration. Each sachet should be dissolved in 125 mL water. For faecal impaction, 8 sachets may be dissolved in 1 litre of water and stored well covered in the fridge for up to 6 hours (see Section 6.4 SPECIAL PRECAUTIONS FOR STORAGE). Leia o documento completo