Gaviscon Liquid Sachets

1. Name Of The Medicinal Product

Gaviscon Liquid Sachets.

2. Qualitative And Quantitative Composition

Gaviscon contains 500 mg sodium alginate, 267 mg sodium bicarbonate and 160 mg calcium carbonate per 10 ml dose.

Excipients: methyl parahydroxybenzoate (E218) 40 mg/10 ml and propyl parahydroxybenzoate (E216) 6 mg/10 ml.

For a full list of excipients, see Section 6.1.

3. Pharmaceutical Form

Oral suspension in sachets.

An off-white suspension 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 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 administration.

Adults and children 12 years and over: One to two sachets after meals and at bedtime (up to four times a day).

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.

4.4 Special Warnings And Precautions For Use

Sodium content of a 10 ml, one sachet dose is 141 mg (6.2 mmol). This should be taken into account when a highly restricted salt diet is required, e.g. in some cases of congestive cardiac failure and renal impairment.

Each 10 ml, one sachet dose contains 160 mg (1.6 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.

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.

Contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).

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 time-interval 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.

4.6 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.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Very rarely (

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: A02BX13. Other drugs for peptic ulcer and gastro-oesophageal reflux disease.

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 mode of action of the medicinal product 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

Carbomer 974P

Methyl parahydroxybenzoate (E218)

Propyl parahydroxybenzoate (E216)

Saccharin sodium

Natural mint flavour

Sodium hydroxide

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Two years.

6.4 Special Precautions For Storage

Do not store above 25°C and store in the original package. Do not freeze or refrigerate.

6.5 Nature And Contents Of Container

A cardboard outer carton containing unit dose stick pack style sachets.

Pack sizes: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32 and 36.

Not all pack sizes may be marketed.

The sachets are composed of polyester, aluminium and polyethylene.

Each sachet contains 10 ml of Gaviscon.

6.6 Special Precautions For Disposal And Other Handling

No special requirement.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Limited,

Dansom Lane,

Hull,

HU8 7DS.

United Kingdom.

8. Marketing Authorisation Number(S)

PL 00063/0159.

9. Date Of First Authorisation/Renewal Of The Authorisation

12/11/2007

10. Date Of Revision Of The Text

23/06/2010