Riik: Suurbritannia
keel: inglise
Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium alginate; Calcium carbonate; Sodium bicarbonate
Reckitt Benckiser Healthcare (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: 5000158065376 5000158064591 5000158065581 5000158065093
TR1565541 H 10 mm 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 CUSTOMER INFO: Minimum Point Size = (FRONT LABEL ONLY) LEAFLET MEASURES AT 9PT 7.00pt G av i s co n Pe p p e r m i nt L i q u i d R e l i e f T B R 2 6 4 6 - D 8 3 4 6 1 4 2 – E n g l i s h PATIENT INFORMATION LEAFLET GAVISCON PEPPERMINT LIQUID RELIEF Sodium alginate, Sodium bicarbonate, Calcium carbonate Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmacist or doctor. WHAT IS GAVISCON PEPPERMINT LIQUID RELIEF AND WHAT IS IT USED FOR? Gaviscon Peppermint Liquid Relief belongs to a group of medicines called ‘reflux suppressants’, which form a protective layer on top of the stomach contents to prevent stomach acid escaping from the stomach where it works into the food pipe causing pain and discomfort. Gaviscon Peppermint Liquid Relief is used for the treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, which may occur, for example, following meals or during pregnancy. BEFORE USING GAVISCON PEPPERMINT LIQUID RELIEF DO NOT TAKE THIS PRODUCT IF: • You know you are allergic to any of the ingredients as very rarely difficulty in breathing and skin rashes have occured (see further information for full ingredients list). TAKE SPECIAL CARE BEFORE TREATMENT WITH GAVISCON PEPPERMINT LIQUID RELIEF : This medicine contains 285.2 mg (12.4 mmol) of sodium per 20 ml dose. If you have been advised to follow a low sodium (salt) diet ask your doctor before taking this product. The maximum recommended daily dose of this medicinal product contains 1140.8 mg sodium (found in table salt). This is equivalent to 57 % of the adult recommended maximum daily dietary intake for sodium. Talk to your doctor or pharmacist if you need this product on a daily basis for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet. This product contains methyl (E218) and propyl (E216) parah Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Peppermint Liquid Relief. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gaviscon Peppermint Liquid Relief contains 250mg sodium alginate, 133.5mg sodium bicarbonate and 80mg calcium carbonate per 5ml. Excipient(s) with known effect: Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216 Sodium For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. An opaque, off-white to cream suspension with the odour and flavour of peppermint. 4 CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults and children over 12 years: 10-20ml after meals and at bedtime. Children under 12 years: Should be given only on medical advice. Elderly: No dosage modification is required in this age group. Hepatic Impairment: No dose modification necessary. Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4). 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 7 days, the clinical situation should be reviewed. This medicinal product contains 285.2 mg (12.4 mmol) sodium per 20 ml dose, equivalent to 14.26 % of the WHO recommended maximum daily intake for sodium. The maximum daily dose of this product is equivalent to 57 % of the WHO recommended maximum daily intake for sodium. This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and Lugege kogu dokumenti