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GAVISCON ADVANCE PEPPERMINT FLAVOUR ORAL SUSPENSION

Active substance(s): POTASSIUM BICARBONATE / SODIUM ALGINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

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

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 ml dose contains sodium alginate 1000 mg and potassium hydrogen
carbonate 200 mg. 1 ml contains sodium alginate 100 mg and potassium
hydrogen carbonate 20.0 mg.
Each 10 ml dose is equivalent to two 5 ml measuring spoons.
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 resulting from the reflux of acid, bile and pepsin into the
oesophagus 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, accompanying reflux oesophagitis, including symptoms of
laryngopharyngeal reflux such as hoarseness and other voice disorders, sore throats
and cough. It can also be used to treat the symptoms of gastro-oesophageal reflux
during concomitant treatment with or following withdrawal of acid suppressing
therapy.

4.2

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

Contrindications
The 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 106 mg (4.6 mmol) and a potassium
content of 78 mg (2.0 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 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.
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

Fertility, pregnancy and lactation
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of
data from post-marketing experience indicate no malformative nor

foeto/neonatal toxicity of the active substances. Gaviscon can be used during
pregnancy, if clinically needed.
Breast feeding:
No known effect on breast fed infants. Gaviscon can be used during breast
feeding.
Fertility:
No known 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 suspension reacts with gastric acid to rapidly form a raft of alginic
acid gel having a near-neutral pH which floats on the stomach contents quickly and
effectively impeding gastro-oesophageal reflux for up to 4 hours, and protecting the
oesophagus from acid, pepsin and bile. In severe cases the raft itself may be refluxed
into the oesophagus in preference to the stomach contents and exert a demulcent
effect. In addition in vitro evidence has shown that the raft has a secondary action and
is able to entrap bile and pepsin within its structure, further protecting the oesophagus
from these gastric components.

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 974P
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 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 00063/0612.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11/10/2010

10

DATE OF REVISION OF THE TEXT
24/09/2014

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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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