Šalis: Malta
kalba: anglų
Šaltinis: Medicines Authority
DIMETICONE
OM PHARMA S.A. R. da Industria, 2, 2610-088 Amadora, Lisboa, Portugal
A02AF02
DIMETICONE 40 mg
TABLET
DIMETICONE 40 mg
OTC
DRUGS FOR ACID RELATED DISORDERS
Withdrawn
2006-11-21
PROVA Nº 2 ORDEM DE FABRICO: 05-112597 ESPECIFICAÇÃO N.º: 1244L-3 FIBRA: 148 OPERADOR: RM DATA: 12/05/10 DIMENSÕES: 105 X 148 GRAMAGEM: 60G/M 2 CLIENTE: OM PHARMA S.A. CÓD. 2055405056 DESIGNAÇÃO: LIT AERO OM INGLÊS CÓD. LECTUS 319 CORES: PRETO Dimeticone Tablets / oral drops (emulsion) COMPOSITION: Tablets: Each tablet contains 40 mg of activated dimethylpolysiloxane. Oral Drops (emulsion): 100 ml drops contains 10 g of activated dimethylpolysiloxane. PRESENTATION: Tablets: Packs of 20, 60 and 100 units. Oral drops (emulsion): Bottle of 25 ml. PHARMACOTHERAPEUTIC CATEGORY: Group VII - 6 - d, antiflatulent. MARKETING AUTHORIZATION HOLDER/MANUFACTURER: OM PHARMA, S.A. R. da Indústria, 2 – Quinta Grande 2610-088 – Amadora – Lisboa – Portugal INDICATIONS: Aerophagy and meteorism with ali their manifestations: abdominal distension, subcostal, epigastric and hypochondriac pain. Dyspnea an palpitation (espe- cially in cardiac and asthmatic patients) due to the raising of the diaphragm. In abdominal kidney and bone radiology. In paediatrics: difficulty in burping and food regurgitation when burping, in infants, abdominal distension in children, flatulent colic. CONTRA-INDICATIONS AND ADVERSE EFFECTS: No known contra-indications or adverse effects. INTERACTIONS: No known interactions. SPECIAL PRECAUTIONS: Tablets should be chewed and not swailowed whole. Diabetic patients or patients with low sugar diet have to be informed that AERO-OM contains saccharose (435 mg per tablet or 18 mg per drop). EFFECTS ON PREGNANT WOMEN, INFANTS, CHILDREN, OLDER PEOPLE AND PATIENTS WITH SPECIAL ILLNESS: No known contra-indications. EFFECTS ON DRIVING ABILITY AND MACHINE OPERATIONS: Non existent. EXCIPIENTS: Tablets: saccharose, povidone, colloidal anhydrous silica, magnesium stearate, vanillin. Oral drops (emulsion): saccharose, amaranth (E123), strawberry oil, potassium sorbate, purified water. POSOLOGY: a) Tablets: Adult: two tablets or more after each meal. b) Drops: Infants: 10 drops, 3 or 4 times a Perskaitykite visą dokumentą
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aero-OM , dimethicone 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aero-OM - tablets : each tablet contains 40 mg of dimeticone Aero-OM - Oral emulsion : each millilitre contains 100 mg of dimeticone 3. PHARMACEUTICAL FORM Tablet and Oral emulsion 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Aerophagia and meteorism with all manifestations forms, namely distension and abdominal pain. Preparation for abdominal, renal and bone radiology. In pediatrics : Symptoms cause by the swallowing of gas and Adjuvant in the management of recurrent abdominal pain or infant colic. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS : 2 tablets 4 times daily after meals_ _ CHILDREN UNDER 12 MONTHS : 5 to 10 drops 3 or 4 daily CHILDREN WITH 12 MONTHS AND OLDER : 10 drops or one tablet 3 or 4 times daily The tablets must be chewed and not swallowed entire. 4.3. CONTRAINDICATIONS Contra-indications are unknown for dimethicone. 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE The tablets have to be chewed and not swallowed entire. 4.5. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Unknown. 4.6 PREGNANCY AND LACTATION Contra-indications are unknown in Aero-OM administration during pregnancy and lactation. 4.7. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Unknown. 4.8. UNDESIREABLE EFFECTS Unkown. Page 2 of 3 4.9. OVERDOSE Cases of overdose are unknown. 5. PHARMACOLOGICAL PROPERTIES 5.1. PHARMACODYNAMIC PROPERTIES Aero-OM belongs to pharmacotherapeutic group VII-6.d : antiflatulents. Whatever their origin, Perskaitykite visą dokumentą