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GAVISCON PEPPERMINT FLAVOUR TABLETS

Active substance(s): CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM HYDROGEN CARBONATE / CALCIUM CARBONATE / SODIUM ALGINATE / SODIUM HYDROGEN CARBONATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Gaviscon Peppermint Flavour Tablets.

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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.

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PHARMACEUTICAL FORM
Chewable tablet. An off-white to cream, slightly mottled tablet.

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4.1

CLINICAL PARTICULARS
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 For oral use, after being thoroughly chewed. Adults and children 12 years and over: Two to four tablets after meals and at bedtime. 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. Special warnings and precautions for use 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. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed. Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.

4.4

4.5

Interaction with other medicinal products and other forms of interaction Due to the presence of calcium carbonate which acts as an antacid, a timeinterval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially H2-antihistaminics, tetracyclines, digoxine, fluoroquinolone, iron salt, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine and diphosphonates. Pregnancy and lactation Open controlled studies in 281 pregnant women did not demonstrate any significant adverse effects of Gaviscon on the course of pregnancy or on the health of the foetus/new-born child. Based on this and previous experience the medicinal product may be used during pregnancy and lactation. Nevertheless,

4.6

taking into account the presence of calcium carbonate (see Section 5.3) it is recommended to limit the treatment duration as much as possible. 4.7 Effects on ability to drive and use machines Not relevant. Undesirable effects Very rarely (=1/10,000) patients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic and anaphylactoid reactions. Overdose In the event of overdose symptomatic treatment should be given. The patient may notice abdominal distension.

4.8

4.9

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5.1

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Other drugs for peptic ulcer and gastrooesophageal reflux disease (GORD) ATC code: A02BX. 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, 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 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 is limited evidence in some reports in animals of delay in calcification of foetal skeleton/bone abnormalities relating to calcium carbonate.

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6.1

PHARMACEUTICAL PARTICULARS
List of excipients Peppermint flavour Macrogol 20,000 Mannitol (E421) Copovidone Aspartame (E951) Acesulfame potassium (E950) Magnesium stearate

6.2

Incompatibilities Not applicable.

6.3

Shelf life 2 years.

6.4

Special precautions for storage Do not store above 30C.

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 (2 x 16, 2 x 18, 2 x 20, 2 x 22 or 2 x 24) 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

Special precautions for disposal No special requirements.

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

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MARKETING AUTHORISATION NUMBER(S)
PL 00063/0627

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DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10/08/2010

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DATE OF REVISION OF THE TEXT
20/01/2011

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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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