Summary of Product Characteristics (SmPC) - Gaviscon Advance suspension
1 NAME OF THE MEDICINAL PRODUCT
Gaviscon Advance Oral suspension.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml dose contains sodium alginate 500 mg and potassium hydrogen carbonate 10 mg.
Excipients with known effect:
Methylparahydroxybenzoate (E218) (20 mg/ 5 ml)
Propylparahydroxybenzoate (E216) (3 mg/ 5 ml).
Sodium (57.85 mg per 5 ml)
Benzyl alcohol* (0.525 mg/ 5 ml)
*present in the fennel flavour
For a full list of excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
Oral suspension
Off-white, viscous suspension.
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
Posology
Adults and children 12 years and over: 5-10 ml after meals and at bedtime.
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 modification is required 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.
Shake well before use. Check that the cap seal is unbroken before first taking the product.
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 5 ml contains 40 mg (1.0 mmol) of calcium. 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): May cause allergic reactions (possibly delayed).
This medicinal product contains 57.85 mg (2.5 mmol) sodium per 5 ml, equivalent to 2.9 % of the WHO recommended maximum daily intake for sodium.
The maximum daily dose of this product is equivalent to 23.14 % of the WHO recommended maximum daily intake for sodium. This is based on a 10 ml dose taken four times per day.
This product is considered high in sodium. This should be particularly taken into account for those on a low salt diet (e.g. in some cases of congestive heart failure and renal impairment) or when taking drugs which can increase plasma potassium levels.
This medicine contains 1.0 mmol (39.06 mg) potassium in each 5 ml of. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
This medicine contains 0.525 mg benzyl alcohol in each 5 ml. Benzyl alcohol may cause allergic reactions.
Large amounts of Benzyl alcohol can accumulate in the body and cause side effects (called “metabolic acidosis”), which should be considered in pregnant or breast-feeding women, patients with liver or kidney disease.
For children below 12 years, please see section 4.2.
4.5 Interaction with other Medicinal Products and other Forms of Interaction
Due to the presence of calcium and carbonates which act as an antacid, a timeinterval of 2 hours should be considered between Gaviscon intake and the administration of other medicinal products, especially tetracyclines, digoxin, fluoroquinolone, iron salts, thyroid hormones, ketoconazole, neuroleptics, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, estramustine and diphosphonates. See also 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.
This medicine can be used during pregnancy if clinically needed. See also Section 4.4
Breastfeeding
No known effect on breastfed infants. This medicine can be used during breastfeeding. See also Section 4.4
Fertility:
No known effect on human fertility.
4.7 Effects on ability to drive and use machines
This medicine 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 |
| Gastrointestinal Disorders | Uncommon | Diarrhoea, nausea, vomiting |
| 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Symptoms
Some abdominal discomfort may be experienced. The patient may notice abdominal distension.
Management
In the event of overdose, symptomatic treatment should be given.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Pharmacotherapeutic classification: A02 BX, Other drugs for peptic ulcer and gastro-oesophageal reflux disease
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 (up to 4 hours) 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 this product is physical and does not depend on absorption into the systemic circulation.
5.3. Pre-clinical 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
Fennel flavour
Sodium hydroxide (for pH adjustment)
Purified water
Ingredients of fennel flavour:
Fennel anethol
Benzyl alcohol
6.2. Incompatibilities
Not applicable.
6.3. Shelf-life
Shelf life: 2 years.
Shelf life after opening: 6 months.
6.4. Special Precautions for Storage
Do not refrigerate.
6.5. Nature and contents of container
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.
Or
Amber glass bottles with moulded polypropylene cap having a tamper evident strip and lined with an expanded polyethylene wad with either a measuring device (natural polypropylene) containing 5, 10, 15 and 20 ml graduations, or a measuring spoon (crystal polystyrene) containing 2.5 ml and 5 ml measure and containing 80, 100, 125, 140, 150, 180, 200, 250, 300, 400, 500, 560 or 600 ml suspension.
Not all pack sizes may be marketed. The carton and measuring device or spoon may not be made available in all markets/pack sizes.
6.6. Special precautions for disposal
Any unused product or waste material should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull,
HU8 7DS,
United Kingdom
8. MARKETING AUTHORIZATION NUMBER(S)
PL 00063/0097
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/07/2018
10 DATE OF REVISION OF THE TEXT
22/08/2023