Gaviscon Cool Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Cool Tablets.
Gaviscon Cool Mint Tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250mg, sodium bicarbonate 133.5mg and calcium carbonate 80mg.
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.
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example, following meals or during pregnancy.
4.2. Posology and method of administration
For oral administration, after being thoroughly chewed.
Adults and children 12 years and over: Two to four 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 Contraindications
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 four-tablet dose is 246 mg (10.6 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.
Each four-tablet dose contains 320 mg (3.2 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.
4.5 Interaction with other medicinal products and other forms of interaction
A time-interval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroid hormones, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, estramustine and biphosphonates (diphosphonates). See also 4.4.
4.6 Fertility, pregnancy and lactation
Pregnancy:
Clinical studies in more than 500 pregnant women as well as a large amount of data from postmarketing experience indicate no malformative nor feto/ neonatal toxicity of the active substances. Gaviscon can be used during pregnancy, if clinically needed.
Breast feeding:
No effects of the active substances have been shown in breastfed newborns/infants of treated mothers. Gaviscon can be used during breast-feeding.
Fertility:
Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.
Clinical data do not suggest that Gaviscon has an 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 national reporting system.
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 Gaviscon Cool Tablets react rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents, quickly and effectively impeding gastro-oesophageal reflux, for up to 4 hours. 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 mode of action of Gaviscon Cool Tablets is physical and does not depend on absorption into the systemic circulation.
Preclinical safety data
5.3.
No pre-clinical findings of any relevance to the prescriber have been reported.
6. PHARMACEUTICAL PARTICULARS 6.1. List of excipients
Peppermint flavour (Trusil coolmint flavour 108406)
Polyethylene glycol 20,000
Mannitol
Aspartame
Magnesium stearate
Xylitol DC
Indigo carmine
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Two years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Unprinted, glass-clear, thermoformable laminate of uPVC/PE/PVdC with aluminium foil lidding blisters packed into cartons.
Blister tray containing two, four, six or eight sealed tablets.
Larger packs (e.g. 16, 24, 32, 48, 60, 64, 72 and 80) will be made up of multiples of the above units.
Polypropylene container containing 8, 10, 12, 14, 16 or 18 tablets.
Pack sizes 8, 10, 12, 14, 16, 18 tablets.
Larger packs i.e. 20's, 28's and 32's, will be made up of multiples of the above units and packed into cartons.
Not all pack sizes may be marketed.
6.6. Instruction for use and handling
No special instructions.
7. MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS United Kingdom.
8. MARKETING AUTHORISATION NUMBER
PL 00063/0140
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7 October 2003
10 DATE OF REVISION OF THE TEXT
06/11/2014