GAVISCON EXTRA STRENGTH 500 PEPPERMINT TABLETS

Active substance: 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
None.

4.4.

Special warnings and precautions for use

The sodium content of two-tablet dose is 246 mg (10.6 mmol). This should be taken into account
when 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.
There is a possibility of reduced efficacy in patients with very low levels of gastric acid.
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Treatment of children younger than 12 years of age is not generally recommended, except on
medical advice.

4.5.

Interactions with other medicinal products and other forms of interaction
None known.

4.6.

Pregnancy and lactation
Open controlled studies in 281 pregnant women did not demonstrate any significant adverse
effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born
child. Based on this and previous experience Gaviscon Extra Strength 500 Peppermint
Tablets may be used during pregnancy and lactation.

4.7.

Effects on ability to drive and use machines
None.

4.8

Undesirable effects
Very rarely (<1/10,000) patients may develop allergic manifestations such as urticaria or
bronchospasm, anaphylactic or anaphylactoid reactions.

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
27/01/2011

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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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