Gaviscon Advance Mint Chewable Tablets
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 |
Frequency |
Adverse Event |
|
Immune System Disorders |
Very rare |
Anaphylactic and anaphylactoid reactions. Hypersensitivity reactions such as urticaria. |
|
Respiratory, Thoracic and Mediastinal Disorders |
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.
Overdose
4.9
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 snap-bead 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