Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium alginate; Calcium carbonate; Sodium bicarbonate
Teva UK Ltd
A02BX13
Sodium alginate; Calcium carbonate; Sodium bicarbonate
50mg/1ml ; 16mg/1ml ; 26.7mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010201; GTIN: 5023497334316
LABELLING TEXT FOR ACIDEX LIQUID PEPPERMINT FLAVOUR PL04917/0027. ACIDEX ORAL SUSPENSION 500ML & 150ML PEPTAC PEPPERMINT LIQUID (TEVA) 500ML BOOTS HEARTBURN RELIEF PEPPERMINT FLAVOUR 150ML & 500ML HEALTHPOINT HEARTBURN AND INDIGESTION ORAL SUSPENSION 250ML RENNIE LIQUID HEARTBURN RELIEF ORAL SUSPENSION 150ML & 250ML WELL PHARMACEUTICALS HEARTBURN & INDIGESTION PEPPERMINT FLAVOUR ORAL SUSPENSION LLOYDSPHARMACY HEARTBURN AND INDIGESTION LIQUID PEPPERMINT FLAVOURED (150ML AND 500ML) CARE HEARTBURN RELIEF ORAL SUSPENSION (500ML) PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING LABEL/LEAFLET PINEWOOD-500ML 1. NAME OF THE MEDICINAL PRODUCT _ACIDEX ORAL SUSPENSION_ _SODIUM BICARBONATE,_ _SODIUM ALGINATE,_ _CALCIUM CARBONATE_ _PEPPERMINT FLAVOUR _ _SUGAR FREE _ _FAST EFFECTIVE RELIEF FROM THE PAIN OF HEARTBURN AND ACID INDIGESTION _ 2. STATEMENT OF ACTIVE SUBSTANCE(S) EACH 5 ML OF THIS MEDICINE CONTAINS: 133.5 mg Sodium Bicarbonate, 250 mg Sodium Alginate, 80 mg Calcium Carbonate. 3. LIST OF EXCIPIENTS It also contains carbomer, sodium hydroxide, saccharin sodium, ethyl parahydroxybenzoate (E214) , propyl parahydroxybenzoate (E216) , butyl parahydroxybenzate, isopropyl alcohol, peppermint oil, purified water. Contains sodium. See leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS 100 ml oral suspension 150 ml oral suspension 200 ml oral suspension 250 ml oral suspension 300 ml oral suspension 500 ml oral suspension 5. METHOD AND ROUTE(S) OF ADMINISTRATION DOSAGE: For oral use. Shake well before use. ADULTS AND CHILDREN OVER 12 YEARS: Take 10-20 ml (two to four 5 ml spoonfuls) after meals and at bedtime, up to four times a day. CHILDREN UNDER 12 YEARS: Should be given only on medical advice. SEE THE LEAFLET FOR FURTHER INFORMATION. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. 7. OTHER SPECIAL WARNING(S), IF NECESSARY Not applicable. 8. EXPIRY DA Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Acidex Oral Suspension LloydsPharmacy Heartburn and Indigestion Liquid Peppermint Flavoured Boots Heartburn Relief Peppermint Flavour Peptac Peppermint Liquid Tesco Heartburn & Indigestion relief Heartburn and Indigestion Oral Suspension Peppermint Flavour Healthpoint Heartburn and Indigestion Oral Suspension Rennie Liquid Heartburn Relief Oral Suspension Well Pharmaceuticals Heartburn & Indigestion Peppermint Flavour Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5ml contains: Sodium Bicarbonate PhEur - 133.5mg Sodium Alginate PhEur - 250mg Calcium Carbonate PhEur - 80mg 3 PHARMACEUTICAL FORM Oral Suspension Peppermint Flavoured White Suspension Gluten and Sugar free 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acidex alleviates the painful conditions resulting from the reflux of gastric acid and bile into the oesophagus by suppressing the reflux itself. It is indicated in heartburn, including heartburn of pregnancy, dyspepsia associated with gastric reflux, hiatus hernia, reflux oesophagitis, regurgitation and all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use Adults and children over 12 years: Two to four 5ml spoonfuls Children 6 -12 years: One to two 5ml spoonfuls Not recommended in children under six years of age. Doses should be taken after meals and at bedtime. 4.3 CONTRAINDICATIONS This medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients listed in section 6.1, including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms do not improve after seven days, the clinical situation should be reviewed. Each 10 ml dose of Acidex contains about 6 mmoles of sodium and therefore care should be exercised in patients on a sodium restricted diet. Ea Přečtěte si celý dokument