Skip to Content

GAVISCON DOUBLE ACTION ANISEED

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

View full screen / Print PDF » Download PDF ⇩
Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Double Action Aniseed.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose contains sodium alginate 500 mg, sodium bicarbonate 213 mg and
calcium carbonate 325 mg.
Excipients : Methyl parahydroxybenzoate (E218) and Propyl parahydroxybenzoate
(E216). For a full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Oral suspension.
Opaque, off-white to cream viscous suspension.

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, and for
symptoms of excess stomach acid (hyperacidity).

4.2

Posology and method of administration
For oral administration.
Adults and children 12 years and over: 10-20 ml after meals and at bedtime, up to
four times per day.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.

4.3

Contraindications
Hypersensitivity to any of the ingredients, including the esters of hydroxybenzoates
(parabens).

4.4

Special warnings and precautions for use
Each 20 ml dose has a sodium content of 254.5 mg (11.06 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 20 ml contains 260 mg (6.5 mmol) of calcium. Care needs to be taken in
treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium
containing renal calculi.
Treatment of children younger than 12 years of age is not generally recommended,
except on medical advice.
If symptoms do not improve after seven days, the clinical situation should be
reviewed.

4.5

Interaction with other medicinal products and other forms of interaction
Due to the presence of calcium carbonate which act as an antacid, a timeinterval of 2 hours should be considered between Gaviscon intake an the
administration of other medicinal products, especially H2-antihistaminics
tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics,
thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol),
glucocorticoid, chloroquine, and diphosphonates.

.

4.6

Pregnancy and lactation
Open controlled studies in 281 pregnant women did not demonstrate any significant
adverse effects of Gaviscon on the course of pregnancy or on the health of the
foetus/new-born child. Based on this and previous experience the medicinal product
may be used during pregnancy and lactation.

4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic
manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid
reactions.
Ingestion of large quantities of calcium carbonate may cause alkalosis,
hypercalcaemia, acid rebound, milk alkali syndrome or constipation. These usually
occur following larger than recommended dosages.

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, other drugs for peptic ulcer and gastrooesophageal reflux disease.
The medicinal product is a combination of two antacids (calcium carbonate and
sodium bicarbonate) and an alginate.
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, 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.
Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and
heartburn. This effect is increased by the addition of sodium bicarbonate which also
has a neutralising action. The total neutralising capacity of the product at the lowest
dose of two tablets is approximately 10mEqH+.

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
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Saccharin sodium
Fennel flavour
Sodium hydroxide
Purified water

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two years.
Use within six months of opening.

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 bottles with a polypropylene cap with a polyethylene tamper-evident
band lined with expanded polyethylene wad and containing 150, 200, 300 and 600
ml.
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 00063/0543.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/06/2008

10

DATE OF REVISION OF THE TEXT
28/01/2011

Expand view ⇕

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.

Hide