Država: Švedska
Jezik: švedščina
Source: Läkemedelsverket (Medical Products Agency)
kaliumklorid; makrogol; natriumklorid; natriumvätekarbonat
Norgine Healthcare B.V.
A06AD65
potassium chloride (potash); macrogol; sodium chloride; sodium bicarbonate
Oral lösning i dospåse
makrogol 13,125 g Aktiv substans; kaliumklorid 0,05 g Aktiv substans; natriumklorid 0,351 g Aktiv substans; natriumvätekarbonat 0,179 g Aktiv substans
Receptfritt
Förpacknings: Dospåse, 10 st; Dospåse, 20 st; Dospåse, 30 st; Dospåse, 50 st
Godkänd
2016-06-02
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MOVICOL ORAL SOLUTION IN SACHET Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride [For medicines available on prescription] 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, pharmacist or nurse. • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. [For medicines available without a prescription] READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better within 2 weeks or if you feel worse. WHAT IS IN THIS LEAFLET: 1. What Movicol is and what it is used for 2. What you need to know before you take Movicol 3. How to take Movicol 4. Possible side effects 5. How to store Movicol 6. Contents of the pack and other information 1. WHAT MOVICOL IS AND WHAT IT IS USED FOR The name of this medicine is Movicol oral solution in sachet. It is a laxative for the treatment of constipation in adolescents, adults and older people. It is not recommended for children below 12 years of age. Movicol helps you to have a comfortable bowel movement even if you have been constipated for a long time. Movicol also works in very bad Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Movicol oral solution in sachet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 25 mL sachet of Movicol contains the following active substances: Macrogol 3350 13.125 g Sodium chloride 0.3508 g Sodium hydrogen carbonate 0.1786 g Potassium chloride 0.0502 g The concentration of electrolyte ions present in each 25 mL sachet is as follows: Sodium 325 mmol/L Chloride 267 mmol/L Potassium 27 mmol/L Hydrogen carbonate 85 mmol/L This corresponds to the following amount of each electrolyte in each 25 mL dose: Sodium 8.125 mmol Chloride 6.675 mmol Potassium 0.675 mmol Hydrogen carbonate 2.125 mmol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution in sachet Clear, colourless to light yellow, free flowing liquid 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of constipation in adults and adolescents (12 years and above). Movicol 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 Movicol should be used directly from the sachet. This product does not need to be diluted with water. CHRONIC CONSTIPATION A course of treatment for constipation with Movicol 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 medication in particular opioids and antimuscarinics. ADULTS, ADOLESCENTS AND OLDER PEOPLE: 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. Alternative Movicol products are available for children. PATIENTS WITH RENAL INSUFFICIENCY: No dosage change is necessary for Preberite celoten dokument