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GAVISCON PEPPERMINT LIQUID RELIEF

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 Liquid Relief.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon Peppermint Liquid Relief contains 250mg sodium alginate, 133.5mg sodium
bicarbonate and 80mg calcium carbonate per 5ml.
For excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Oral suspension.
An opaque, off-white to cream suspension with the odour and flavour of peppermint.

4

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all
cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.

4.2.

Posology and Method of Administration
For oral administration.
Adults and children over 12 years: 10-20ml after meals and at bedtime.
Elderly: No dosage modification is required in this age group.
Children 6 to 12 years: 5-10ml after meals and at bedtime.
Children under 6 years: Not recommended.

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, including methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).

4.4

Special warnings and precautions for use

If symptoms do not improve after seven days, the clinical situation should be reviewed.
Each 10 ml dose has a sodium content of 141 mg (6.2 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 10 ml dose 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.
Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may
cause allergic reactions (possibly delayed).

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 and 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
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 Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard

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

On ingestion the 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 gastrooesophageal 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 the product is physical and does not depend on absorption into the
systemic circulation.

5.3.

Preclinical Safety Data
No preclinical findings relevant to the prescriber have been reported.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Carbomer
Methyl parahydroxybenzoate
Propyl parahydroxybenzoate

Saccharin sodium
Peppermint oil
Sodium hydroxide
Water

6.2.

Incompatibilities
Not applicable.

6.3

Shelf life
Three years for 600 ml pack size.
Two years for 100 ml, 150 ml, 200 ml, 250 ml and 300 ml pack sizes.

6.4.

Special Precautions for Storage
Do not store above 30°C. Do not refrigerate or freeze.

6.5

Nature and contents of container
Amber glass Winchester bottle with a polypropylene cap with a polyethylene tamperevident band lined with expanded polyethylene wad containing 100 ml, 150 ml, 200
ml, 250 ml, 300 ml and 600ml.

6.6.

Instruction for Use and Handling
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 00063/0127

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

03/02/2003 / 27/02/2009

10

DATE OF REVISION OF THE TEXT
19/05/2014

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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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