GAVISCON ADVANCE - PEPPERMINT FLAVOUR

Active substance: SODIUM ALGINATE

View full screen / Print PDF » Download PDF ⇩

Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance - Peppermint Flavour.
Oral Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10ml dose contains sodium alginate 1000.0mg and potassium hydrogen
carbonate 200.0mg. 1ml contains sodium alginate 100.0mg and potassium
hydrogen carbonate 20.0mg.
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Oral suspension.
Off-white viscous suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid
regurgitation, heartburn, indigestion occurring due to the reflux of stomach
contents, for instance, after gastric surgery, as a result of hiatus hernia, during
pregnancy or accompanying reflux oesophagitis.

4.2

Posology and method of administration
Adults and children 12 years and over: 5-10ml after meals and at bedtime (one
to two 5ml measuring spoons).

Children under 12 years: Should be given only on medical advice.
Elderly: No dose modification is required for this age group.

4.3

Contraindications
Hypersensitivity to the active substances or to any of the excipients, including
the esters of hydroxybenzoates (parabens).

4.4

Special warnings and precautions for use
Each 10 ml dose has a sodium content of 106 mg (4.6mmol) and a potassium
content of 78 mg (2.0mmol). 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 or when taking drugs which can increase plasma
potassium levels.
Each 10 ml contains 200 mg (2.0 mmol) of calcium carbonate. Care needs to
be taken in treating patients with hypercalcaemia, nephrocalcinosis and
recurrent calcium containing renal calculi.
There is a possibility of reduced efficacy in patients with very low levels of
gastric acid.
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.
This medicinal product contains Methyl hydroxybenzoate and Propyl
hydroxybenzoate, which may cause allergic reactions (possibly delayed).

4.5

Interaction with other medicinal products and other forms of interaction
None known.

4.6

Pregnancy and lactation
An open, uncontrolled study in 146 pregnant women did not demonstrate any
significant undesirable effects of Gaviscon Advance on the course of the
pregnancy or on the health of the foetus/new-born child. Based on this and
previous experience, Gaviscon Advance - Peppermint Flavour 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 may develop allergic manifestations such as
urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.

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 suspension reacts 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 preclinical findings of relevance to the prescriber have been reported.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Calcium carbonate
Carbomer
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Saccharin sodium
Peppermint flavour
Sodium hydroxide for pH adjustment
Purified water

6.2

Incompatibilities
Not applicable

6.3

Shelf life
Shelf life: 2 years.
Shelf life after opening: 6 months

6.4

Special precautions for storage
Do not refrigerate.

6.5

Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper-evident
strip and lined with an expanded polyethylene wad. The bottles are enclosed
in a cardboard outer containing either a measuring device (natural
polypropylene) containing 5, 10, 15 and 20 ml graduations or a clear injection

moulded crystal polystyrene measuring spoon with one bowl containing 2.5
ml and 5 ml measure. The pack sizes are 80, 100, 125, 140, 150, 180, 200,
250, 300, 400, 500, 560 or 600 ml of suspension.
Not all pack sizes may be marketed. The carton and measuring device or
spoon may not be made available in all markets/pack sizes.

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 00063/0103

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/03/2006

10

DATE OF REVISION OF THE TEXT
04/04/2007

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
(web4)