- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Gaviscon Advance Peppermint FlavourOral 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.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.
The medicinal product is contraindicated in patients with known or suspected hypersensitivity to the active substances or to any of the excipients.
4.4 Special warnings and precautions for use
Each 10 ml dose has a sodium content of 106 mg (4.6 mmol) and a potassium content of 78 mg (2.0 mmol). This should be taken into account when a highly restricted salt diet is recommended, e.g. in some cases of congestive cardiac failure and renal impairment or when taking drugs which can increase plasma potassium levels.Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.There is a possibility of reduced efficacy in patients with very low levels of gastric acid.Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.If symptoms do not improve after seven days, the clinical situation should be reviewed.This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
An open, uncontrolled study in 146 pregnant women did not demonstrate any significant undesirable effects of Gaviscon Advance on the course of the pregnancy or on the health of the foetus/new-born child. Based on this and previous experience, Gaviscon Advance - Peppermint Flavour may be used during pregnancy and lactation. Nevertheless, taking into account the presence of calcium carbonate it is recommended to limit the treatment duration as much as possible.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
In the event of overdose, symptomatic treatment should be given. The patient may notice abdominal distension.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD).ATC code: A02BX.On ingestion the suspension reacts with gastric acid to rapidly form a raft of alginic acid gel having a near-neutral pH which floats on the stomach contents quickly and effectively impeding gastro-oesophageal reflux for up to 4 hours, and protecting the oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed into the oesophagus in preference to the stomach contents and exert a demulcent effect. In addition in vitro evidence has shown that the raft has a secondary action and is able to entrap bile and pepsin within its structure, further protecting the oesophagus from these gastric components.
5.2 Pharmacokinetic properties
The mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3 Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
6. Pharmaceutical particulars
6.1 List of excipients
Calcium carbonateCarbomer 974PMethyl parahydroxybenzoate E218Propyl parahydroxybenzoate E216Saccharin sodiumPeppermint flavourSodium hydroxide for pH adjustmentPurified water
6.3 Shelf life
Shelf life: 2 years.Shelf-life after opening: 6 months.
6.4 Special precautions for storage
Do not refrigerate.
6.5 Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad. The bottles are enclosed in a cardboard outer containing either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations or a clear injection moulded crystal polystyrene measuring spoon with one bowl containing 2.5 ml and 5 ml measure. The pack sizes are 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension. Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, United Kingdom.
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Forum Health Products Limited
Forum Health Products Limited, Betchworth House, 57/65 Station Road, Redhill, Surrey, RH1 1DL
+44 (0) 1737 857701
Customer Care direct line
0500 455 456
+44 (0)1737 857 782
Medical Information Direct Line
0500 455 456