Gaviscon Advance Liquid Sachets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Liquid Sachets.
Oral Suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains sodium alginate 500 mg and potassium hydrogen carbonate 100 mg. 1 ml contains sodium alginate 100 mg and potassium hydrogen carbonate 20 mg.
Excipients: methylparahydroxybenzoate (E218) and propylparahydroxybenzoate (E216)
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension.
Off-white viscous suspension in sachets.
4. CLINICAL PARTICULARS
4.1. Therapeutic Indications
Treatment of symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn, indigestion occurring due to the reflux of stomach contents, for instance, after gastric surgery, as a result of hiatus hernia, during pregnancy or accompanying reflux oesophagitis.
4.2 Posology and Method of Administration Posology
Adults and children 12 years and over: 5 - 10 ml after meals and at bedtime.
Children under 12 years: Should only be given 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.
Any unused solution should be discarded.
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 including methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) (see section 4.4).
4.4. Special Warnings and Special Precautions for Use
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Each 5 ml dose has a sodium content of 53 mg (2.3 mmol) and a potassium content of 39 mg (1.0 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 or when taking drugs which can increase plasma potassium levels.
Each 5 ml contains 100 mg (1.0 mmol) of calcium carbonate. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
This medicinal product contains Methyl hydroxybenzoate and Propyl hydroxybenzoate, which may cause allergic reactions (possibly delayed).
For children below 12 years, please see section 4.2.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
None known.
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.
Breastfeeding
No known effect on breastfed infants. Gaviscon can be used during breastfeeding. Fertility:
No known effect on human fertility.
4.7 Effects on ability to drive and use machines
Gaviscon has no or negligible influence on the ability to drive or use machines.
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 yellow card scheme 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: A02BX
On ingestion the suspension reacts 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
No preclinical findings of relevance to the prescriber have been reported.
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Calcium carbonate Carbomer 974P
Methyl parahydroxybenzoate E218 Propyl parahydroxybenzoate E216 Saccharin sodium Peppermint flavour Sodium hydroxide for pH adjustment Purified water
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years.
6.4. Special precautions for storage
Do not refrigerate.
6.5. Nature and contents of container
A cardboard outer carton containing unit dose stick pack style sachets and a clear injection moulded crystal polystyrene measuring spoon with one bowl containing 2.5ml and 5ml measure. The pack sizes are 2, 4, 10, 12, 20, 24 or 48. Not all pack sizes may be marketed. The spoon may not be made available in all market/pack sizes. The sachets are comprised of polyester, aluminium and polyethylene.
A single sachet, or dual sachets, enclosed in an outer cardboard carton, are also available. Each sachet contains either 5 or 10 ml of medicinal product.
6.6. Instructions for use and handling
No special requirements.
7. MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU8 7DS United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00063/0112
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/06/2007
10 DATE OF REVISION OF THE TEXT
06/11/2014