Riik: Malta
keel: inglise
Allikas: Medicines Authority
MACROGOL, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, POTASSIUM CHLORIDE
Rowex Ltd Newtown Bantry, Co. Cork, , Ireland
A06AD65
MACROGOL 3350 13.125 g SODIUM CHLORIDE 0.3507 g SODIUM HYDROGEN CARBONATE 0.1785 g POTASSIUM CHLORIDE 0.0466 g
POWDER FOR ORAL SOLUTION
MACROGOL 3350 13.125 g SODIUM CHLORIDE 0.3507 g SODIUM HYDROGEN CARBONATE 0.1785 g POTASSIUM CHLORIDE 0.0466 g
OTC
DRUGS FOR CONSTIPATION
Licence number in the source country: NOT APPLICAPABLE
Authorised
2019-11-26
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MACROLIEF 13.8G SACHET, POWDER FOR ORAL SOLUTION macrogol 3350 / sodium chloride / sodium hydrogen carbonate / potassium chloride _ _ 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 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 Macrolief is and what it is used for 2. What you need to know before you take Macrolief 3. How to take Macrolief 4. Possible side effects 5. How to store Macrolief 6. Contents of the pack and other information 1. WHAT MACROLIEF IS AND WHAT IT IS USED FOR _ _ Macrolief is a laxative used for the treatment of constipation (especially if constipation lasts a long time) in adults, adolescents and elderly. It is not recommended for children below 12 years of age. It is also used to treat a build up of hard faeces in your bowel which may be a result of long-term constipation (this is known as faecal impaction). Macrogol 3350 makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes (salts) help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MACROLIEF DO NOT TAKE MACROLIEF - if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in _ _ this medicine (listed in section 6) - if you have a perforated gut (bowel) wall - if you have a blockage in your intestine (gut obstruction, ileus) - if you have severe inflammatory bowel disease such as ulcerative coliti Lugege kogu dokumenti
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Macrolief 13.8g sachet, powder for oral solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each sachet contains the following quantitative composition of active ingredients: Macrogol 3350 13.125 g Sodium chloride 0.3507 g Sodium hydrogen carbonate 0.1785 g Potassium chloride 0.0466 g The content of electrolyte ions per sachet following reconstitution in 125 ml of water is equivalent to: Sodium 65 mmol/l Chloride 53 mmol/l Hydrogen carbonate (bicarbonate) 17 mmol/l Potassium 5 mmol/l Excipient(s) with known effect Each sachet contains 0.8 mg sorbitol (E 420), 8.2 mmol (188 mg) sodium and 0.6 mmol (24.4 mg) potassium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for oral solution. Single-dose sachet containing a white crystalline powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of chronic constipation. Macrolief is also effective in resolving faecal impaction, defined as refractory constipation with faecal loading of the rectum and/or colon. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Chronic constipation:_ _ _ A course of treatment for chronic constipation with _ _ Macrolief does not normally exceed 2 weeks, although this can be repeated if required. As for all laxatives, prolonged use is not usually recommended. Extended use may be necessary in the care of patients with severe chronic or resistant constipation, secondary to multiple sclerosis or Parkinson's disease, or induced by regular constipating medicinal product in particular opioids and antimuscarinics. Page 2 of 6 Adults, adolescents and the elderly: 1-3 sachets daily in divided doses, according to individual response. For extended use, the dose can be adjusted down to 1 or 2 sachets daily. Children below 12 years old: Not recommended. _Faecal impaction_ : A course of treatment for faecal impaction with Macrolief does not normally exceed 3 days. Adults, adolescents and the elderly: 8 sachets daily, all o Lugege kogu dokumenti