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GAVISCON STRAWBERRY FLAVOUR TABLETS

Active substance(s): CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM HYDROGEN CARBONATE / CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM HYDROGEN CARBONATE / CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM HYDROGEN CARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Strawberry Flavour Tablets.

2

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.

3

PHARMACEUTICAL FORM
Chewable tablet. (Tablet)
Pale pink, circular, flat with bevelled edges with the odour and flavour of
strawberry.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion, for example, following meals
or during pregnancy.

4.2

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
bedtime.
Children under 12 years: Should be given only on medical advice.

Elderly:

4.3

No

dose

modifications

necessary

for

this

age

group.

Contraindications

This 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

If symptoms do not improve after seven days, the clinical situation should be
reviewed.
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
phenylketonuria.
4.5

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),
glucocorticoid,
chloroquine,
biphosphonates
(diphosphonates)
and
estramustine. See also 4.4.

4.6

Fertility, pregnancy and lactation

Pregnancy:
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.
Breast feeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers.
Gaviscon can be used during breast-feeding.

Fertility:
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.

4.7

Effects on ability to drive and use machines
None.

4.8

Undesirable effects

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
Immune System
Disorders

Respiratory, Thoracic and
Mediastinal Disorders

Frequency

Adverse Event

Very rare

Anaphylactic and anaphylactoid reactions.
Hypersensitivity reactions such as
urticaria.

Very rare

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.
4.9

Overdose
In the event of overdosage symptomatic treatment should be given. The
patient may notice abdominal distension.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2

Pharmacokinetic properties
The mode of action of Gaviscon Strawberry Flavour Tablets is physical and
does not depend on absorption into the systemic circulation.

5.3

Preclinical safety data
No pre-clinical findings of any relevance to the prescriber have been reported.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Mannitol
Macrogol 20,000
Aspartame
Magnesium stearate
Xylitol and Carmellose sodium
Red iron oxide
Strawberry cream flavour (Strawberry cream PHS-048481)
Ingredients of the strawberry cream flavour:
Maltodextrin
Modified starch E1450
Vegetable oil
Propylene glycol E1520

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

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.
Polypropylene container.
Pack sizes 8, 12, 16, 32.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special instructions.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom.

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0155.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/12/2009

10

DATE OF REVISION OF THE TEXT
27/11/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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