Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sodium alginate; Potassium bicarbonate
Reckitt Benckiser Healthcare (UK) Ltd
Sodium alginate; Potassium bicarbonate
100mg/1ml ; 20mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01010201; GTIN: 5000158064515 5000158065109 5000158065635
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING (TUBE) 1. NAME OF THE MEDICINAL PRODUCT Gaviscon Advance Peppermint Flavour Oral Suspension 2. STATEMENT OF ACTIVE SUBSTANCE(S) Each 10 ml contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 3. LIST OF EXCIPIENTS Contains sodium, potassium, calcium, methyl (E218) and propyl (E216) para- hydroxybenzoates. High in sodium - see leaflet for further information. 4. PHARMACEUTICAL FORM AND CONTENTS Oral suspension 300 ml 5. METHOD AND ROUTE(S) OF ADMINISTRATION For oral use. Adults, including elderly and children 12 years and over: Take 5-10 ml (one to two 5 ml spoonfuls) after meals and at bedtime. Children under 12 years: Should only be taken 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 sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY If symptoms persist after 7 days consult your doctor. 8. EXPIRY DATE Do not use this product after the expiry date (EXP: month/year shown). 9. SPECIAL STORAGE CONDITIONS Do not refrigerate. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Reckitt Benckiser 0000 Gaviscon UK RTQ Round 1 1.3.2 Mock-up Label Clean Gaviscon Advance National Peppermint Flavour - UK BROMI Copy eCTD Page 1 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Reckitt Benckiser Healthcare (UK) Ltd., Hull, HU8 7DS 12. MARKETING AUTHORISATION NUMBER(S) PL 00063/0748 13. BATCH NUMBER Batch: BN 14. GENERAL CLASSIFICATION FOR SUPPLY GSL 15. INSTRUCTIONS ON USE Check that the cap seal is unbroken before first using this product. Shake well before use. • Heartburn & Indigestion • Extra Strength Formula Reckitt Benckiser 0000 Gaviscon UK RTQ Round 1 1.3.2 Mock-up Label Clean Gaviscon Advance National Peppermint Flavour - UK BROMI Copy eCTD Page 2 Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Gaviscon Advance Peppermint Flavour Oral Suspension. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20.0 mg. Each 10 ml dose is equivalent to two 5 ml measuring spoons. Excipient(s) with known effect: Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216 Sodium For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension. Off-white viscous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of symptoms resulting from the reflux of acid, bile and pepsin into the oesophagus such as acid regurgitation, heartburn, indigestion (occurring due to the reflux of stomach contents), for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy, accompanying reflux oesophagitis, including symptoms of laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux during concomitant treatment with or following withdrawal of acid suppressing therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults and children 12 years and over: 5-10 ml after meals and at bedtime (one to two 5 ml measuring spoons). Children under 12 years: Should be given only on medical advice. Elderly: No dose modification is required for 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 CONTRINDICATIONS The 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 d Izlasiet visu dokumentu