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GAVISCON ADVANCE ANISEED SUSPENSION

Active substance: SODIUM ALGINATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Aniseed Suspension.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances
Sodium alginate

1000.0

Potassium bicarbonate

3

mg/10ml
200.0

PHARMACEUTICAL FORM
Oral suspension.
An 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. 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: 5-10ml after meals and at bedtime
Children under 12 years: Should be given only on medical advice

Elderly: No dose modification is required for this age group.

4.3

Contrindications
This medicinal product is contraindicated in patients with known or suspected
hypersensitivity to any of the ingredients, or 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.
Contains
methyl
parahydroxybenzoate
(E218)
and
propyl
parahydroxybenzoate (E216): 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
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: A02E A01 Anti-regurgitant

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
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
it structure, further protecting the oesophagus from these gastric components.

5.2

Pharmacokinetic properties
The mode of action of Gaviscon Advance Aniseed Suspension 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
Propyl parahydroxybenzoate
Saccharin sodium
Fennel flavour
Sodium hydroxide
Purified water

6.2

Incompatibilities
Not applicable

6.3

Shelf life
Two years

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 and containing 80, 100, 125, 140, 150,
180, 200, 250, 300, 500 or 560 ml suspension.

6.6

Special precautions for disposal
Not applicable.

7

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

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0108

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29 April 2002

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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