GAVISCON STRAWBERRY FLAVOUR TABLETS
Active substance(s): CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM HYDROGEN CARBONATE
NAME OF THE MEDICINAL PRODUCT
Gaviscon Strawberry Flavour Tablets.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate
133.5 mg, calcium carbonate 80 mg.
For excipients, see Section 6.1.
Chewable tablet. (Tablet)
Pale pink, circular, flat with bevelled edges with the odour and flavour of
Treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion, for example, following meals
or during pregnancy.
Posology and method of administration
For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at
Children under 12 years: Should be given only on medical advice.
This medicinal product is contraindicated in patients with known or suspected
hypersensitivity to the active substances or to any of the excipients.
Special warnings and precautions for use
If symptoms do not improve after seven days, the clinical situation should be
The sodium content of a four-tablet dose is 246 mg (10.6 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.
Each four-tablet dose contains 320 mg (3.2 mmol) of calcium carbonate. Care needs
to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent
calcium containing renal calculi.
Due to its aspartame content this product should not be given to patients with
Interaction with other medicinal products and other forms of interaction
A time-interval of 2 hours should be considered between Gaviscon intake and
the administration of other medicinal products, especially tetracyclines,
digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid
hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol),
estramustine. See also 4.4.
Fertility, pregnancy and lactation
Clinical studies in more than 500 pregnant women as well as a large amount of data from postmarketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances.
Gaviscon can be used during pregnancy, if clinically needed.
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers.
Gaviscon can be used during breast-feeding.
Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring
fertility or reproduction.
Clinical data do not suggest that Gaviscon has an 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).
System Organ Class
Respiratory, Thoracic and
Anaphylactic and anaphylactoid reactions.
Hypersensitivity reactions such as
Respiratory effects such as bronchospasm.
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: www.mhra.gov.uk/yellowcard.
In the event of overdosage symptomatic treatment should be given. The
patient may notice abdominal distension.
Pharmacotherapeutic classification: A02E A01 Anti-regurgitant.
On ingestion Gaviscon Strawberry 250 mg Tablets react rapidly with gastric acid to
form a raft of alginic acid gel having a near neutral pH and which floats on the
stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up
to 4 hours. In severe cases the raft itself may be refluxed into the oesophagus, in
preference to the stomach contents, and exert a demulcent effect.
The mode of action of Gaviscon Strawberry Flavour Tablets is physical and
does not depend on absorption into the systemic circulation.
Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.
List of excipients
Xylitol and Carmellose sodium
Red iron oxide
Strawberry cream flavour (Strawberry cream PHS-048481)
Ingredients of the strawberry cream flavour:
Modified starch E1450
Propylene glycol E1520
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with
aluminium foil lidding blisters packed into cartons.
Pack sizes: 2, 4, 6, 8,16, 24, 32, 48, 60, 64, 72, 80.
Pack sizes 8, 12, 16, 32.
Not all pack sizes may be marketed.
Special precautions for disposal
No special instructions.
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT