Страна: Швеція
мова: шведська
Джерело: Läkemedelsverket (Medical Products Agency)
domperidon
NordicInfu Care AB
A03FA03
domperidone
20 mg
Filmdragerad tablett
natriumlaurilsulfat Hjälpämne; laktosmonohydrat Hjälpämne; domperidon 20 mg Aktiv substans
Receptbelagt
Domperidon
Avregistrerad
2013-05-16
1. NAME OF THE MEDICINAL PRODUCT Dompicare 20 mg, film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20 mg domperidone. Excipient with known effect: Contains 116 mg of lactose. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. The film-coated tablets are white, oblong and biconvex with a score line on one face and of about 11.2 mm long and 3.9 mm thick. The tablets can be divided into two equal doses. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Adults The relief of the symptoms of nausea and vomiting, epigastric sense of fullness, upper abdominal discomfort and regurgitation of gastric contents. Adolescents (over 12 years and weighing 35 kg or more) The relief of the symptoms of nausea and vomiting. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION It is recommended to take this medicine before meals. If taken after meals, absorption of the drug is somewhat delayed. _Adults and adolescents (over 12 years and weighing 35 kg or more)_ The initial duration of treatment is four weeks. Patients should be re-evaluated after four weeks and the need for continued treatment re-assessed. 10 mg (1/2 tablet) to 20mg (1 tablet) three to four times per day with a maximum daily dose of 80 mg. _Paediatric population_ Dompicare tablets _ _ are unsuitable for use in children under 12 years of age and weighing less than 35 kg. _Use in patients with hepatic impairment_ No data is available in patients with hepatic impairment. Since domperidone is highly metabolised in the liver, this medicinal product should not be used in patients with hepatic impairment, see section 4.4. _Use in patients with renal impairment_ Since very little unchanged drug is excreted via the kidneys, it is unlikely that the dose of a single administration needs to be adjusted in patients with renal insufficiency. However, on repeated administration, the dosing frequency should be reduced to once or twice daily depending on the severity of the impairment, and the dose may n Прочитайте повний документ