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GAVISCON PEPPERMINT FLAVOUR TABLETS

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Peppermint Flavour Tablets.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate
133.5 mg and calcium carbonate 80 mg.
Excipients: Aspartame (E951) 3.75 mg per tablet.
For excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Chewable tablet.
An off-white to cream, slightly mottled tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn and indigestion (related to reflux), for example,
following meals or during pregnancy or in patients with symptoms related to
reflux oesophagitis.

4.2

Posology and method of administration
For oral use, after being thoroughly chewed.
Adults and children 12 years and over: Two to four tablets after meals and at
bedtime.
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.

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 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:
There is a lack of robust pre-clinical data available regarding the effects of alginate on
fertility; limited studies have not reported any negative effects 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
Not relevant.

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
Very rare

Very rare

Adverse Event
Anaphylactic and anaphylactoid reactions.
Hypersensitivity reactions such as urticaria.
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 overdose symptomatic treatment should be given. The patient
may notice abdominal distension.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for peptic ulcer and gastrooesophageal reflux disease (GORD) ATC code: A02BX.
On ingestion the medicinal product reacts 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 mechanism of action of the medicinal product is physical and does not
depend on absorption into the systemic circulation.

5.3

Preclinical Safety Data
Non-clinical data reveal no special hazard for humans.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Peppermint flavour
Macrogol 20,000
Mannitol (E421)
Copovidone
Aspartame (E951)
Acesulfame potassium (E950)
Magnesium stearate

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 years.

6.4

Special precautions for storage
Do not store above 30°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.
Blister pack containing 4, 6 or 8 individually sealed tablets.
Larger packs (16, 24, 32, 48 and 64) will be made up of multiples of the above
units and packed into cartons.

Pack sizes 4, 6, 8, 16, 24, 32, 48 or 64 tablets
Polypropylene container containing 8, 12, 16, 18, 20, 22 or 24 tablets.
Multiple packs (2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24) will be packed into
cartons.
Pack sizes 8, 12, 16, 18, 20, 22, 24, 2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24
tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0627

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/08/2010

10

DATE OF REVISION OF THE TEXT
11/03/2016

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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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