1. Product Name Gaviscon, drinkable solution sachets 2. Ingredients Per sachet: Active IngredientsSodium alginate: 500 mg Sodium bicarbonate: 267 mg Contains 145 mg (63 milli-equivalents) of sodium per sachet. Excipients with known effect: methylparaben, propylparaben, sodium For a full list of excipients, see section 6.1. 3. Dosage Form Sachet-doses for drinkable solution 4. Product Information 4.1. Therapeutic IndicationsSymptomatic treatment of gastro-oesophageal reflux. 4.2. Directions for Use and DosageDrink dissolved powder of 1 sachet 3 times per day (one after each main meal). Can also be drunk in the evening, just before bed. In case of severe reflux or oesophageal inflammation, this dose can be doubled. 4.3. Contra-indicationsDo NOT use if you are allergic or hypersensitive to any of this medicine's ingredients or excipients. 4.4. Precautions and Warnings– Contains sodium (145 mg per sachet). Use with caution if you are on a strict low-sodium diet. – Contains methylparaben and propylparaben. May cause allergic reaction (which may be delayed). 4.5. Interactions with Other MedicinesAntacids such as Gaviscon should not be taken at the same time as certain other orally-administered medicines. Interactions for which precautions should be taken: If taken simultaneously, medicines are less easily absorbed by the digestive system. Do not take doses of Gaviscon within 2 hours of: – antibiotic tuberculosis treatments (e.g. ethambutol, isoniazid); – tetracycline antibiotics; – lincosamides; – H2-antagonist antihistamines; – atenolol, metoprolol or propranolol; – chloroquine; – diflunisal; – digoxin; – bisphosphonates; – sodium fluoride; – glucocorticoids (e.g. prednisolone, dexamethasone); – indometacin; – kayexalate; – ketoconazole; – lansoprazole; – phenothiazine antipsychotics; – penicillamine; – iron salts; or – sparfloxacin. Do not take doses of Gaviscon within 4 hours of: – fluoroquinolone antibiotics. Interactions to take into consideration: – salicylates: increased renal excretion of salicylates via urine alkalinisation. 4.6. Use by Women who are Pregnant or Breast-FeedingNo reliable data exists regarding the possibility of teratogenesis in animals due to consumption of Gaviscon. Extensive clinical testing has indicated no particular malformative or foetotoxic effects in humans; however, epidemiological studies would be required to confirm these findings. Based on the above, Gaviscon may be prescribed, if necessary, to women who are pregnant or breast-feeding. 4.7. Possible Side EffectsAssociated with calcium carbonate: – constipation (very rare, due to this medicine's alginate content); – hypercalcaemia with risk of kidney stones and kidney failure (if used for an extensive period); and – allergic reactions such as hives, bronchial spasm, and anaphylactic or anaphylactoid reactions. 4.8. Excessive DoseNo cases of excessive dose have been reported. However, excessive dose can amplify potential undesirable side effects. 5. Pharmacological Properties 5.1. Pharmacodynamic PropertiesOther medicines for peptic ulcer and gastro-oesophageal reflux ATC Code: A02BX The physicochemical properties of Gaviscon, a gel formed on contact with gastric acid, give it 3 properties: – Its lightness allows it to rise above the gastric juices around the cardia. – Its viscosity and consistency form a physical barrier to reduce the number of regurgitations. In cases of severe reflux, the gel initially regurgitates into the oesophagus and settles between the oesophageal wall and the irritating gastric juices. – Its alkaline pH neutralises the acidic pH of regurgitated gastric juices. Gastric pH readings indicate that Gaviscon increases pH around the cardia by 2 units while leaving the pH of the rest of the stomach unchanged. Gaviscon's pharmacological effectiveness has been confirmed by oesophageal pH readings, which indicate that it significantly reduces the length of time during which the contents of the oesophagus remain acidic (i.e. with a pH below 4), as well as the number and average length of reflux episodes. Gaviscon's effectiveness in treating symptoms of reflux is clearly established in the case of patients who had previously suffered from stage I or II oesophagitis. 5.2. Pharmacokinetic PropertiesOn contact with stomach acid, Gaviscon transforms into a light, frothy, viscous gel (which releases bubbles of carbon dioxide and has a near-neutral pH). It remains in the upper part of the stomach for 2 to 4 hours and is slowly evacuated by the stomach's natural self-emptying mechanism. Gaviscon does not interfere with the digestive process. The alginates (non-absorbable polysaccharides) contained in the gel are completely eliminated via the digestion . 6. Pharmaceutical Information 6.1. ExcipientsCalcium carbonate, carbomer (974P), sodium saccharin, natural mint flavour, sodium hydroxide, methylparaben (E218), propylparaben (E216), purified water. 6.2. Shelf Life2 years 6.3. Storage InstructionsStore below 25 °C. 6.4. PackagingSachet-doses (aluminium/PE) of 10 ml in packs of 20, 24 or 48. 7. Marketing Authorisation Holder RECKITT BENCKISER HEALTHCARE, Dansom Lane, Hull HU8 7DS, United Kingdom 8. Marketing Authorisation No. – 369 162-5: Sachet-doses (aluminium/PE) of 10 ml; packs of 20. – 330 952-5: Sachet-doses (aluminium/PE) of 10 ml; packs of 24. – 369 163-1: Sachet-doses (aluminium/PE) of 10 ml; packs of 48. 9. Prescription and Delivery Conditions Non-prescription medicine Our resident doctor of pharmacy, Marie Louvegnies, has uploaded a presentation on gastro-oesophageal reflux to the health advice section of our website. Please do not hesitate to contact us if you have any questions about this product. Self-medicate responsibly. If this product does not have the desired effect, or your condition does not improve after a few days, consult your doctor.