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GAVISCON LIQUID SACHETS MINT FLAVOUR

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Liquid Sachets Mint Flavour

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon contains 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg
calcium carbonate per 10 ml dose.
Excipients:
methyl parahydroxybenzoate (E218) 40 mg/10 ml and propyl
parahydroxybenzoate (E216) 6 mg/10 ml.
For a full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Oral suspension in sachets.
An off-white suspension 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 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 administration.
Adults and children 12 years and over: One to two sachets after meals and at bedtime
(up to four times a day).

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, 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.
Sodium content of a 10 ml, one sachet dose is 141 mg (6.2 mmol). This should be
taken into account when a highly restricted salt diet is required, e.g. in some cases of
congestive cardiac failure and renal impairment.
Each 10 ml, one sachet 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,
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

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 overdosage, symptomatic treatment should be given. The patient may
notice abdominal distension.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic classification: A02BX13. Other drugs for peptic ulcer and
gastro-oesophageal reflux disease.

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 mode 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
Carbomer 974P
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Natural mint flavour
Sodium hydroxide
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 25°C and store in the original package.
refrigerate.

6.5

Do not freeze or

Nature and contents of container
A cardboard outer carton containing unit dose stick pack style sachets.
Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.
Not all pack sizes may be marketed.
The sachets are composed of polyester, aluminium and polyethylene.
Each sachet contains 10 ml of Gaviscon.

6.6

Special precautions for disposal
No special requirement.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0628

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/07/2011

10

DATE OF REVISION OF THE TEXT
19/11/2014

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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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