Gaviscon Peppermint Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Peppermint Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sodium alginate 250 mg, sodium hydrogen carbonate 133.5 mg
and calcium carbonate 80 mg.
Excipients: Aspartame (E951) 3.75 mg per tablet
For excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
An off-white to cream, slightly mottled tablet.
Emboss obverse - sword and circle Emboss reverse - G250
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals or during pregnancy or in patients with symptoms related to reflux oesophagitis.
4.2 Posology and method of administration
Posology
Adults and children 12 years and over: Two to four tablets after meals and at bedtime (up to four times per day).
Children under 12 years: Should be given only on medical advice.
Duration of treatment: If symptoms do not improve after seven days, the clinical situation should be reviewed.
Special patient groups
Elderly: No dose modifications necessary for this age group.
Hepatic Impairment: No modifications necessary.
Renal Insufficiency: Caution if highly restricted salt diet is necessary (see section 4.4).
Method of administration
For oral use, after being thoroughly chewed.
4.3 Contraindications
This medicinal product is contraindicated in patients with known or suspected hypersensitivity to sodium alginate, sodium bicarbonate, and calcium carbonate 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 medicinal product should not be given to patients with phenylketonuria.
For children below 12 years, please see section 4.2.
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 section 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 post-marketing 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:
Clinical experiences have shown that at therapeutic doses no effects on human fertility are anticipated.
4.7 Effects on ability to drive and use machines
Gaviscon has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Adverse reactions have been ranked under headings of frequency using the following convention: Very rare: <1/10,000
|
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: http://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: A02BX13.
On ingestion the medicinal product reacts rapidly with gastric acid to form a raft of alginic acid gel having a near neutral pH and which floats on the stomach contents effectively impeding gastro-oesophageal reflux. 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 mechanism of action of the medicinal product is physical and does not depend on absorption into the systemic circulation.
5.3 Preclinical safety data
There are no non-clinical data of relevance to the prescriber which are additional to those already stated in other sections of the SmPC.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Peppermint flavour Macrogol 20,000 Mannitol (E421)
Aspartame (E951)
Acesulfame potassium (E950)
Magnesium stearate Copovidone
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not store above 30°C
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 pack containing 4, 6 or 8 individually sealed tablets.
Larger packs (16, 24, 32, 48 and 64) will be made up of multiples of the above units and packed into cartons.
Pack sizes 4, 6, 8, 16, 24, 32, 48 or 64 tablets
Polypropylene container containing 8, 12, 16, 18, 20, 22 or 24 tablets.
Multiple packs 32 (2 x 16), 36 (2 x 18), 40 (2 x 20), 44 (2 x 22) or 48 (2 x 24) will be packed into cartons.
Single packs 8, 12, 16, 18, 20, 22 or 24 tablets will be packed into cartons.
Pack sizes 8, 12, 16, 18, 20, 22 24, 2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24 tablets.
Not all pack sizes may be marketed.
6.6. Instruction for use and handling
No special requirements
7. MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU87DS United Kingdom.
8. MARKETING AUTHORISATION NUMBER
PL 00063/0134
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
07/10/2008
10 DATE OF REVISION OF THE TEXT
07/08/2014