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GAVISCON FRESH MINT FLAVOUR TABLETS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Fresh Mint Flavour Tablets.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg sodium alginate, 133.5mg sodium bicarbonate and 80mg
calcium carbonate.
Excipients: Aspartame (E951)
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 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: 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 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,
estramustine
and
biphosphonates
(diphosphonates). 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
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 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
gastro-oesophageal reflux disease
On ingestion Gaviscon Fresh Mint Flavour 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 Fresh Mint 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
Peppermint flavour (Trusil coolmint flavour 108406)
Polyethylene glycol 20,000
Mannitol
Aspartame (E951)
Magnesium stearate
Xylitol DC
Indigo carmine

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 25°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 blisters packed into cartons.
Blister tray containing two, four, six or eight sealed tablets.
Larger packs (e.g. 16, 24, 32, 48, 60, 64, 72 and 80) will be made up of multiples of
the above units.
Polypropylene container containing 8, 10, 12, 14, 16 or 18 tablets.
Pack sizes 8, 10, 12, 14, 16, 18 tablets.
Larger packs i.e. 20's, 28's and 32's, will be made up of multiples of the above units
and packed into cartons.
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 00063/0678

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

16/12/2011

10

DATE OF REVISION OF THE TEXT
06/11/2014

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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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