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GAVISCON INSTANTS PEPPERMINT FLAVOUR ORAL POWDER

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Instants Peppermint Flavour
Oral Powder.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains sodium alginate 500 mg, sodium hydrogen carbonate 267 mg
and calcium carbonate 160 mg.
Excipients: Aspartame E951.
For a full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Oral powder in sachet.
Cream coloured powder.

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
Oral administration.

Adults and children 12 years and over: One to two single dose containers after meals
and at bedtime. The product is taken orally without water.
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No modifications necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary.
No data available for children under 12.

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 single dose container is 123 mg (5.3 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 single dose container contains 160 mg (1.6 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
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

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 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 gastro-oesophageal
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
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 mechanism of action of the medicinal product 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
Macrogol 20,000
Macrogol 400
Aspartame (E951)
Citric acid anhydrous
Acesulfame potassium (E950)
Xylitol
Silicon dioxide

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Eighteen months.

6.4

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

6.5

Nature and contents of container
Pack sizes of 4, 6, 12, 16, 20, 24 or 32 unit dose sachets in either a cardboard
box or in a blister pack comprising of a cardboard backing card and a styrene
thermoform front.
The sachets are composed of printed polyester/polyethylene/ aluminium
foil/polyethylene.
Not all pack sizes / types 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 00063/0685

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
26/11/2012

10

DATE OF REVISION OF THE TEXT
27/11/2014

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