Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
DOMPERIDONE
PIERRE FABRE Ltd
10 Milligram
Orodispersible Tablet
2008-09-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Domperidone Pierre Fabre 10mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One orodispersible tablet contains domperidone 10 mg. Excipient : sulphur dioxide. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. Uniformly white or almost white, biconvex, round orodispersible tablet with a characteristic odor of mint. 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. The initial duration of treatment is four weeks. Patients should be re-evaluated after four weeks and the need for continued treatment re-assessed. _ADULTS AND ADOLESCENTS (OVER 12 YEARS AND WEIGHING 35 KG OR MORE)_ 1 to 2 of the 10 mg tablets three to four times per day with a maximum daily dose of 80 mg. The orodispersible tablet is a tablet which dissolves rapidly in the mouth with the help of the saliva. Place the tablet on the tongue and let it dissolve in the mouth before swallowing. Drink a glass of water after the tablet intake . PAEDIATRIC POPULATION Orodispersible tablets are unsuitable for use in children under 12 years of age and weighing less than 35 kg. For children weighing less than 35 kg, other domperidone containing products are available. IRISH MEDICINES BOARD _________________________________________________________________________________________________ read_full_document