Land: Storbritannia
Språk: engelsk
Kilde: 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: 5000158065352 5000158064584 5000158065574 5000158065086
_RELIEF_ _HEARTBURN & INDIGESTION_ _HEARTBURN & INDIGESTION_ _SODIUM ALGINATE_ _SODIUM BICARBONATE_ _CALCIUM CARBONATE_ _SODIUM ALGINATE_ _SODIUM BICARBONATE_ _CALCIUM CARBONATE_ _ORAL SUSPENSION_ WHAT IS THIS PRODUCT? Each 10ml of oral suspension contains 500mg sodium alginate, 267mg sodium bicarbonate and 160mg calcium carbonate as the active ingredients. PATIENT INFORMATION LEAFLET GAVISCON ORIGINALANISEED 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 ORIGINAL ANISEED RELIEF AND WHAT IS IT USED FOR? Gaviscon Original Aniseed 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 in the food pipe causing pain and discomfort. Gaviscon Original Aniseed 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 ORIGINAL ANISEED 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 occur (see further information for a full list of ingredients) TAKE SPECIAL CARE BEFORE TREATMENT WITH GAVISCON ORIGINAL ANISEED RELIEF : This medicine contains 142.6 mg sodium (main component of cooking/table salt) in each 10 ml. This is equivalent to 7.1 % of the recommended maximum daily dietary intake of sodium for an adult. 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 produc Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Original Aniseed Relief. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gaviscon Original Aniseed Relief contains 250 mg sodium alginate, 133.5 mg sodium bicarbonate and 80 mg calcium carbonate per 5 ml. Excipient(s) with known effect: Methyl parahydroxybenzoate E218: 40 mg/ 10ml Propyl parahydroxybenzoate E216: 6 mg/10ml Benzyl alcohol* (1.1 mg/10ml) Sodium 142.6 mg (6.2 mmol)/ 10ml *present in fennel flavour For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. An opaque, pink suspension with the odour and flavour of fennel. 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 142.6 mg sodium per 10 ml, equivalent to 7.1 % 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 Les hele dokumentet