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GAVISCON ADVANCE MINT CHEWABLE TABLETS

Active substance: SODIUM ALGINATE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Mint Chewable Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 500 mg and potassium bicarbonate 100
mg.
For excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Chewable tablet.
An off-white to cream, circular, flat with bevelled edges tablet with the odour
and flavour of peppermint. Each tablet is imprinted with a "Sword and Circle"
on one side and "GA500" on the reverse.

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

For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: One to two tablets after meals
and at bedtime.
Children under 12 years: Should be given only on medical advice.
Elderly: No dose modifications necessary for this age group.

4.3

Contrindications
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.

4.4

Special warnings and precautions for use
If symptoms do not improve after seven days, the clinical situation should be
reviewed.
The sodium content of a two-tablet dose is 103 mg (4.5 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 two-tablet dose 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.
Due to its aspartame content this product should not be given to patients with
phenylketonuria.
May cause central nervous system depression in the presence of renal
insufficiency and should not be used in patients with renal failure.

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: A02BX 13. Other drugs for peptic ulcer and
gastro-oesophageal reflux disease.
On ingestion the tablet 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 its structure, further protecting the oesophagus from
these gastric components.

5.2

Pharmacokinetic properties
The mode of action of Gaviscon Advance Tablets 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

Mannitol
Calcium carbonate
Macrogol 20,000
Magnesium stearate
Aspartame
Mint flavour no. 3
Acesulfame potassium
Copovidone

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Two years.

6.4

Special precautions for storage
Do not store above 30°C. Store in the original package.

6.5

Nature and contents of container
White, rigid, injection-moulded, polypropylene cylinder container with snapbead neck finish.
Container containing 20 or 60 tablets. Pack sizes are comprised of either three
20-tablet containers packed into a carton or one 60-tablet container. For some
markets the 60-tablet container will be packed into a carton.
Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with
aluminium foil lidding blisters packed into cartons.

Blister tray containing six individually sealed tablets. Two or four blister trays
in a carton.
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 00063/0613.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/09/2010

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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