Gaviscon Original Aniseed Relief
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Original Aniseed Relief.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Gaviscon Original Aniseed Relief contains 250mg sodium alginate, 133.5mg sodium bicarbonate and 80mg calcium carbonate per 5ml.
For excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension.
An opaque, pink suspension with the odour and flavour of fennel.
4 Clinical Particulars
4.1. Therapeutic Indications
Gastric reflux, heartburn, flatulence associated with gastric reflux, heartburn of pregnancy, all cases of epigastric and retrosternal distress where the underlying cause is gastric reflux.
4.2. Posology and Method of Administration
For oral administration.
Adults and children over 12 years: 10-20ml after meals and at bedtime.
Elderly: No dosage modification is required in this age group.
Children 6 to 12 years: 5-10ml after meals and at bedtime.
Children under 6 years: Not recommended.
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 precautions for use
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Each 10 ml dose has a sodium content of 141 mg (6.2 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 10 ml 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.
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
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 and biphosphonates (diphosphonates) and estramustine. See also 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 postmarketing 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:
Pre-clinical investigations have revealed alginate has no negative effect on parental or offspring fertility or reproduction.
Clinical data do not suggest that Gaviscon has an effect on human fertility.
4.7. Effects on Ability to Drive and Use Machines
None.
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 at: www.mhra.gov.uk/yellowcard
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
On ingestion the 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 mode of action of the product is physical and does not depend on absorption into the systemic circulation.
5.3. Preclinical Safety Data
No preclinical findings relevant to the prescriber have been reported.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Carbomer
Methyl parahydroxybenzoate Propyl parahydroxybenzoate Saccharin sodium
Fennel flavour Erythrosine Sodium hydroxide Water
6.2. Incompatibilities
Not applicable.
6.3 Shelf life
Three years for 600ml pack size.
Two years for 100ml, 150ml, 200ml, 250ml and 300ml pack sizes.
6.4. Special Precautions for Storage
Do not store above 30°C. Do not refrigerate or freeze.
6.5 Nature and contents of container
Amber glass Winchester bottle with a polypropylene cap with a polyethylene tamper-evident band lined with expanded polyethylene wad containing 100, 150, 200, 250ml, 300 and 600 ml.
6.6. Instruction for Use and Handling
No special instructions.
7. MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited
Dansom Lane
Hull
HU87DS United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
PL 00063/0126
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 27/02/2009
10
DATE OF REVISION OF THE TEXT
19/05/2014