It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Summary of Product Characteristics last updated on medicines.ie: 26/10/2017

Gaviscon Peppermint Chewable Tablets

1. NAME OF THE MEDICINAL PRODUCT

Gaviscon Peppermint Chewable Tablets

Sodium alginate 250mg

Sodium hydrogen carbonate 133.5mg

Calcium carbonate 80mg

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 a full list of 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 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, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, estramustine and bisphosphonates (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 the 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 raked under headings of frequency using the following convention: Very rare: <1/10,000

System Organ Class

Frequency

Adverse Event

Immune system disorders

Very rare (<1/10,000)

Anaphylactic and anaphylactoid reactions

Hypersensitivity reactions such as urticaria

Respiratory, thoracic and mediastinal disorders

Very rare (<1/10,000)

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 Pharmacovigilance Section, Health Products Regulatory Authority, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie

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 SPC.

6. PHARMACEUTICAL PARTICULARS

6.1 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 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 Special precautions for disposal and other handling

No special requirements.

7. MARKETING AUTHORISATION HOLDER

Reckitt Benckiser Ireland Ltd

7 Riverwalk,

Citywest Business Campus,

Dublin 24

Ireland

.

8. MARKETING AUTHORISATION NUMBER(S)

PA 979/15/4

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 22 December 2004

Date of last renewal: 5 October 2013

10. DATE OF REVISION OF THE TEXT

June 2017

It is recommended that you also refer to http://www.medicines.ie as the Summary of Product Characteristics may have been updated since this copy was printed.