국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium alginate; Sodium bicarbonate; Calcium carbonate
Reckitt Benckiser Healthcare (UK) Ltd
Sodium alginate; Sodium bicarbonate; Calcium carbonate
50mg/1ml ; 26.7mg/1ml ; 16mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF:
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (LABEL) 1. NAME OF THE MEDICINAL PRODUCT Gaviscon Cool Liquid 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each chewable 10 ml of oral suspension contains 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg calcium carbonate as the active ingredients. 3. LIST OF EXCIPIENTS This product is sugar free and gluten free. Contains sodium, methyl (E218) and propyl (E2016) parahydroxybenzoates. High in sodium – see leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Oral suspension. 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. Adults and children 12 years an over: Take 10-20 ml (two to four 5 ml spoonfuls) after meals and at bedtime. Children under 12 years: Should be given only on medical advice. 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN Keep out of the reach and sight of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY You can take this product if you are pregnant or breast feeding. Gaviscon Cool Liquid brings up to 4 hours relief from the pain and discomfort of heartburn and acid indigestion. 8. EXPIRY DATE Do not use this product after the expiry date (EXP: month/year shown). 9. SPECIAL STORAGE CONDITIONS Do not store above 30°C. Do not refrigerate or freeze. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Reckitt Benckiser Healthcare (UK) Ltd.,103-105 Bath Road, Slough, SL1 3UH, United Kingdom 12. MARKETING AUTHORISATION NUMBER(S) PL 00063/0739 13. BATCH NUMBER Batch: BN 14. GENERAL CLASSIFICATION FOR SUPPLY GSL 15. INSTRUCTIONS ON USE Shake well before use. • Heartburn & Indigestion • Cool mint flavour PATIENT INFORMATION LEAFLET GAVISCON COOL LIQUID Sodium alginate, Sodium hydrogen carbonate, Calcium carbonate Please read this leaflet carefully before you take this medicine. If you are not sure about anything ask your pharmaci 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Cool Liquid 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Gaviscon Cool Liquid contains 250mg sodium alginate, 133.5 mg sodium bicarbonate and 80 mg calcium carbonate per 5 ml. Excipient(s) with known effect: Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216 Sodium For excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Gastric reflux, hearburn, 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: 10-20 ml after meals and at bedtime. Children under 12 years: Should be given only on medical advice. Elderly: No dose 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). If symptoms persist consult your doctor. 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) of 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 renal impairment). Each 10 ml dose contains 160 mg (1.6 mmol) of calcium 전체 문서 읽기