1. Name Of The Medicinal Product
Gaviscon Double Action Tablets.
2. Qualitative And Quantitative Composition
Each tablet contains sodium alginate 250 mg, sodium bicarbonate 106.5 mg and calcium carbonate 187.5 mg.
|
|
For a full list of excipients, see Section 6.1.
3. Pharmaceutical Form
Chewable tablet.
A flat, circular, bi-layer tablet with bevelled edges. One layer of the tablet is pink and slightly mottled, and the other white.
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of acid related symptoms of gastro-oesophageal reflux such as acid regurgitation, heartburn and indigestion, for example following meals or during pregnancy.
4.2 Posology And Method Of Administration
For oral administration, after being thoroughly chewed.
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.
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
The sodium content of a two-tablet dose is 110.75 mg (4.82 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 two-tablet dose contains 150 mg (3.75 mmol) of calcium. Care needs to be taken in treating patients with hypercalcaemia, nephrocalcinosis and recurrent calcium containing renal calculi.
Due to its aspartame content this product should not be given to patients with phenylketonuria.
If symptoms do not improve after seven days, the clinical situation should be reviewed.
Prolonged use should be avoided.
As with other antacid products, taking Gaviscon Double Action Tablets can mask the symptoms of other more serious, underlying medical conditions.
Gaviscon Double Action Tablets should not be used in the following cases:
• Patients with server/impaired renal function/-insufficiency
• Patients with hypophosphatemia
There is a possibility of reduced efficacy in patients with very low levels of gastric acid.
There is increased risk for hypernatremia in children with gastroenteritis or suspected renal insufficiency.
Treatment of children younger than 12 years of age is not generally recommended, except on medical advice.
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. Nevertheless, taking into account the presence of calcium carbonate it is recommended to limit the treatment duration as much as possible.
4.7 Effects On Ability To Drive And Use Machines
Not relevant.
4.8 Undesirable Effects
Very rarely (<1/10,000) patients sensitive to the ingredients may develop allergic manifestations such as urticaria or bronchospasm, anaphylactic or anaphylactoid reactions.
Ingestion of large quantities of calcium carbonate may cause alkalosis, hypercalcaemia, acid rebound, milk alkali syndrome or constipation. These usually occur following larger than recommended dosages
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 group: A02BX, Other drugs for peptic ulcer and gastro-oesophageal reflux disease.
The medicinal product is a combination of two antacids (calcium carbonate and sodium bicarbonate) and an alginate.
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.
Calcium carbonate neutralises gastric acid to provide fast relief from indigestion and heartburn. This effect is increased by the addition of sodium bicarbonate which also has a neutralising action. The total neutralising capacity of the product at the lowest dose of two tablets is approximately 10 mEqH+.
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
Macrogol 20,000
Mannitol (E421)
Copovidone
Acesulfame K
Aspartame (E951)
Mint Flavour
Carmoisine Lake (E122)
Magnesium stearate
Xylitol DC (contains carmellose sodium)
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
2 years.
Polypropylene container: Use within 3 months of opening.
6.4 Special Precautions For Storage
Blister trays: Do not store above 30°C. Store in the original package to protect from moisture.
Flip-top lid containers: Do not store above 25°C. Store in the original package to protect from moisture.
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 tray containing 2, 4, 6 or 8 sealed tablets. Pack sizes: 4, 6, 8, 16, 24, 32, 48, 60, 62, 64 and 80 chewable tablets.
Coloured, opaque, injection-moulded, polypropylene flip-top lid containers containing 8, 10, 12 or 16 tablets.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
No special instructions.
7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited,
Dansom Lane,
Hull, HU8 7DS,
United Kingdom.
8. Marketing Authorisation Number(S)
PL 00063/0157
9. Date Of First Authorisation/Renewal Of The Authorisation
27/01/2011
10. Date Of Revision Of The Text
27/01/2011
No comments:
Post a Comment