Fruit Flavoured Antacid Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fruit Flavoured Antacid Tablets - Orange
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
|
INGREDIENT |
QTY |
UNIT |
DOSE |
|
Calcium Carbonate |
500 |
mg |
per tablet |
3. PHARMACEUTICAL FORM
Tablet
4 CLINICAL PARTICULARS
4.1. Therapeutic indications
For relief from indigestion, dyspepsia, heartburn, acidity and flatulence.
4.2. Posology and method of administration
Take one or two tablets, as required, up to a maximum of 16 tablets a day. Suck slowly or chew as preferred.
There is no distinction between adults and the elderly on the pack.
Not recommended for children under 12 years.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
Patients with hypercalcaemia, hyperparathyroidism, hypercalciuria, nephrolithiasis and Zollinger-Ellison syndrome.
Patients on a low phosphate diet.
Patients on cardiac glycosides.
Patients with impaired renal function.
Patients with rare glucose-galactose malabsorption should not take this medicine.
4.4 Special warnings and precautions for use
If symptoms persist consult your doctor.
Keep all medicines out of the sight and reach of children.
The leaflet shall say:
Each orange tablet contains 521 mg of glucose (dextrose) per tablet. This should be taken into account in patients with diabetes mellitus.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
4.5. Interactions with other medicaments and other forms of interaction
The following are noted but are unlikely to apply when the product is used for short-term symptomatic relief, as directed:
Tetracyclines
Bisphosphonates
Thiazide Diuretics
Calcium Carbonate and other antacids may interfere with the absorption of concomitantly administered tetracycline preparations.
Calcium Carbonate and other antacids reduce absorption of bisphosphonates.
Calcium Carbonate may increase the risk of hypercalcaemia.
4.6. Pregnancy and lactation
There are no adequate safety data from the use of Calcium Carbonate in pregnant women.
Calcium Carbonate has been in wide use for many years without ill consequence.
Caution should be exercised when treating pregnant women with Calcium Carbonate, particularly during the first trimester.
No problems are anticipated when using this product during lactation.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Calcium Carbonate can cause constipation and flatulence.
Hypercalcaemia can occur as can alkalosis following the regular use of Calcium Carbonate. The milk-alkali syndrome has occasionally occurred in patients taking large doses. ‘Acid Rebound’ has been reported on cessation of Calcium Carbonate.
4.9. Overdose
Hypercalcaemia - Remove source of calcium. Rehydration may be necessary (if necessary with intravenous 0.9% sodium chloride) and a loop diuretic may be given to increase urinary calcium excretion.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Antacid.
Mechanism of Action/Effect
Calcium Carbonate reacts chemically to neutralise or buffer existing quantities of stomach acid but has no direct effect on its output. This action results in increased pH value of stomach contents, thus providing relief of hyperacidity symptoms. It also reduces acid concentration within the lumen of the oesophagus, thus causing an increase in intra-oesophageal pH and a decrease in pepsin activity, which aids in the control of gastro-oesophageal reflux.
ATC code: A02AC01.
5.2. Pharmacokinetic properties
Not applicable.
5.3. Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Microcrystalline Cellulose Maize Starch Dextrose Monohydrate Sodium Saccharin Magnesium Stearate Sunset Yellow Lake E110 Orange Flavour 9/009175
6.2. Incompatibilities
None known.
6.3. Shelf Life
3 years.
6.4. Special Precautions for Storage
None.
6.5. Nature and Contents of Container
250 micron clear white UPVC/20 micron hard temper, heat seal coated aluminium foil.
24, 48, 72, 96 tablets/carton.
HDPE drum with polyethylene tamper evident caps.
72, 75, 96, 100 tablets/drum.
Roll wrap of 20 tablets in 0.2 gsm Lacquer/0.009 mm soft aluminium foil/7 gsm wax/32 gsm paper.
40, 60, 80, 100, 120 packs will be 2, 3, 4, 5, 6 rolls in a carton.
6.6. Instructions for use, handling and disposal
None.
7 MARKETING AUTHORISATION HOLDER
Wrafton Laboratories Limited
Wrafton
Braunton
North Devon
EX33 2DL
8. MARKETING AUTHORISATION NUMBER
PL 12063/0018
THE
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
First Authorisation: 28th July 1993
10 DATE OF REVISION OF THE TEXT
19/12/2012