GAVISCON ADVANCE ANISEED SUSPENSION
Active substance(s): POTASSIUM BICARBONATE / SODIUM ALGINATE
NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Aniseed Suspension.
QUALITATIVE AND QUANTITATIVE COMPOSITION
An off-white, viscous suspension.
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. Can also be used to treat the
symptoms of gastro-oesophageal reflux during concomitant treatment with or
following withdrawal of acid suppressing therapy.
Posology and method of administration
Adults and children 12 years and over: 5-10ml after meals and at bedtime
Children under 12 years: Should be given only on medical advice
Elderly: No dose modification is required for this age group.
This medicinal product is contraindicated in patients with known or suspected
hypersensitivity to any of the ingredients, or any of the excipients listed in
section 6.1, including methyl parahydroxybenzoate (E218) and propyl
parahydroxybenzoate (E216) (see section 4.4).
Special warnings and precautions for use
If symptoms do not improve after seven days, the clinical situation should be
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.
parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
Clinical studies in more than 500 pregnant women as well as a large amount of
data from post-marketing experience indicate no malformative nor
foeto/neonatal toxicity of the active substances. Gaviscon can be used during
pregnancy, if clinically needed.
No known effect on breast fed infants. Gaviscon can be used during breast
No known effect on human fertility.
Effects on ability to drive and use machines
Adverse reactions have been ranked under headings of frequency using the
following convention: very common (1/10), common (1/100 and <1/10),
uncommon (1/1000 and <1/100), rare (1/10,000 and <1/1000), very rare (<
1/10,000) and not known (cannot be estimated from the available data).
Anaphylactic and anaphylactoid
reactions. Hypersensitivity reactions
such as urticaria.
Respiratory effects such as
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
In the event of overdosage, symptomatic treatment should be given. The
patient may notice abdominal distension.
Pharmacotherapeutic classification: A02E A01 Anti-regurgitant
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
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
it structure, further protecting the oesophagus from these gastric components.
The mode of action of Gaviscon Advance Aniseed Suspension is physical and
does not depend on absorption into the systemic circulation.
Preclinical safety data
No preclinical findings of relevance to the prescriber have been reported.
List of excipients
Special precautions for storage
Do not refrigerate.
Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip
and lined with an expanded polyethylene wad and containing 80, 100, 125, 140, 150,
180, 200, 250, 300, 500 or 560 ml suspension.
Special precautions for disposal
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
29 April 2002
DATE OF REVISION OF THE TEXT