Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Docusate sodium
Sanofi Consumer Healthcare
A06AA02
Docusate sodium
100mg
Oral capsule
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01060200; GTIN: 5012917077032 5000283661825
Package Leaflet: Information for the user 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 or pharmacist has 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 • You must talk to a doctor or pharmacist if you do not feel better or you feel worse • The full name of your medicine is DulcoEase 100 mg Capsules. In this leaflet the shorter name DulcoEase is used What is in this leaflet: 1. What DulcoEase Capsules is and what it is used for 2. What you need to know before you take DulcoEase Capsules 3. How to take DulcoEase Capsules 4. Possible side effects 5. How to store DulcoEase Capsules 6. Contents of the pack and other information 1. What DulcoEase Capsules is and what it is used for What DulcoEase is DulcoEase contains the active substance docusate sodium. This medicine is a laxative. It belongs to a group of medicines called ‘stool softeners’. • DulcoEase is used to treat constipation in adults and children 12 years and over How DulcoEase works DulcoEase softens the stools (faeces). • It does this by increasing the amount of water within the stools (faeces) • This makes your bowel movements easier It helps you when: • You are constipated • You have piles • You have a tear in the lining of your anus (anal fissure) What is constipation? Normal and regular bowel movement is important for most people. However, what is ‘normal and regular’ varies from person to person. Some may have a bowel movement every day, others less often. Whatever it is like for you, it is best that your bowel movement has a regular pattern. • Constipation is an occasional problem for some people - for others, it may happen more often • Cons Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dulcoease 100 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Docusate sodium 100 mg. Excipients of known effect Sorbitol Sunset yellow (E110) 3 PHARMACEUTICAL FORM Capsule, soft A two colour (opaque white and opaque yellow) soft, oval, gelatin capsule with a clear, colourless liquid fill. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of chronic constipation. Prevention of hard, dry stools and reduction of straining at stools in the presence of conditions like haemorrhoids or anal fissures. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children 12 years and above: Up to maximum of 500 mg should be taken daily in divided doses. Treatment should be commenced with large doses such as 100 mg three times daily, which should be adapted to the treatment response. Dulcoease is not recommended for use in children under the age of 12 years. DURATION OF TREATMENT The patient should be advised to consult a physician when constipation persists or worsens during treatment or when laxatives are needed for a long period of time. METHOD OF ADMINISTRATION Oral use. The capsules should be swallowed whole with a glass of water. SPECIAL POPULATIONS No specific dose adjustment is necessary for elderly patients. 4.3 CONTRAINDICATIONS Dulcoease is contraindicated in patients with: - hypersensitivity to docusate or to any of the excipients - abdominal pain if not constipation-related - nausea and vomiting - intestinal obstruction 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Organic disorders should be excluded prior to the administration of any laxative. Each 100 mg capsule contains approximately 19.3 mg of sorbitol, resulting in 96.5 mg sorbitol per maximum recommended daily dose for adults. Patients with hereditary fructose intolerance (HFI) should not take this medicine. Dulcoease 100 mg Capsules contain E110 sunset yellow which may cause allergic reactions. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INT Prečítajte si celý dokument