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GAVISCON EXTRA STRENGTH 500 PEPPERMINT TABLETS

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

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1.

NAME OF THE MEDICINAL PRODUCT
Gaviscon Extra Strength 500 Peppermint Tablets.

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 500mg, sodium bicarbonate 267mg and calcium
carbonate 160mg.
For excipients, see Section 6.1.

3.

PHARMACEUTICAL FORM
Chewable tablet.
An off-white to cream, circular, flat with bevelled edges tablet with the odour and flavour of
peppermint.

4.

CLINICAL PARTICULARS

4.1.

Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn
and acid 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: One to two tablets after meals and at bedtime.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.

4.3

Contraindications

This medicinal product is contraindicated in patients with known or suspected hypersensitivity to
the active substances or to any of the excipients listed in section 6.1.

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 two-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 two-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, fluoroquinolones, iron salts, thyroid hormones,
chloroquine, biphosphonates 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 post-marketing 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

Frequency
Very rare

Adverse Event
Anaphylactic and anaphylactoid reactions.

Hypersensitivity reactions such as urticaria.
Respiratory, Thoracic and
Mediastinal Disorders

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 national reporting system.
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: A02BX 13. Other drugs for peptic ulcer and gastrooesophageal reflux disease.
On ingestion Gaviscon Extra Strength 500 Peppermint 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 effectively impeding gastro-oesophageal reflux. 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 Extra Strength 500 Peppermint Tablets 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
Lemon flavour no. 1

Marcrogol 20,000
Mannitol (E421)
Copovidone
Aspartame (E951)
Acesulfame potassium (E950)
Magnesium stearate

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf life
Two years.

6.4.

Special precautions for storage
Do not store above 30°C. Store in the original package.

6.5.

Nature and contents of container

Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding
blister trays into cartons.
Blister tray containing six or ight individually sealed tablets. Two, four, six or eight blister trays in a
carton.
Not all pack sizes may be marketed

6.6.

Instruction for use and handling (, and disposal)

No special instructions.

No Data Held
7.
MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS
United Kingdom.

8.

MARKETING AUTHORISATION NUMBER
PL 00063/0138

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7 October 2003

10

DATE OF REVISION OF THE TEXT
24/09/2014

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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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