Fruit Flavoured Antacid Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fruit Flavoured Antacid Tablets - Blackcurrant
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.
Renal dysfunction
Calcium carbonate tablets should be used with caution in subjects with mild to moderate renal impairment. Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia.
4.3 Contraindications
Hypersensitivity to the active ingredients, excipients, refer to section 6.1
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.
Nephrocalcinosis
Patients with renal calculi, or with a history of renal calculi
Severe renal function impairment (creatinine clearance below 30ml/min)
Hypophosphatemia
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.
This product should be used with caution in renal dysfunction (see Posology and Method of Administration).
Long term uses at high doses can result in undesirable effects such as hypercalcaemia and milk-alkali syndrome, especially in patients with renal insufficiency. Prolonged use possibly enhances the risk for the development of renal calculi.
Calcium carbonate should be used with caution in patients with hypercalciuria.
This product contains dextrose and as such, care is required in patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucraseisomaltase insufficiency should not take this medicine.
The elderly should take care to observe warnings and contraindications, due to increased susceptibility to adverse drug reactions, by means of age-related changes and polypharmacy.
Prolonged use should be avoided. Do not exceed the stated dose and if symptoms persist, despite 7 days of continuous therapy, the clinical situation should be reviewed by a medical professional. Diagnostic measures are recommended in order to rule out a more serious disease.
The leaflet shall say:
Each blackcurrant tablet contains 523 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 medicinal products and other forms of interaction
Changes in gastric acidity, such as that caused by the ingestion of antacids, can affect the rate and degree to which some concurrently administered medicines are absorbed. Due to the presence of calcium carbonate which act as an antacid, a time-interval of 2 hours should be considered between [PRODUCT] intake and the administration of other medicinal products.
The following are noted but are unlikely to apply when the product is used for short-term symptomatic relief, as directed:
Tetracyclines - Calcium Carbonate and other antacids may interfere with the
absorption of concomitantly administered tetracycline preparations.
Bisphosphonates - Calcium Carbonate and other antacids reduce absorption of
bisphosphonates.
Thiazide Diuretics - Calcium Carbonate may increase the risk of hypercalcaemia.
In common with other antacids, calcium carbonate may form complexes with certain drugs e.g., antibiotics (such as tetracyclines and quinolones) and cardiac glycosides (digoxin), H2-antihistaminics, fluoroquinolone, iron containing drugs, ketoconazole, neuroleptics, thyroxine, penicillamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, and diphosphonates leading to their reduced absorption. This should be taken into account when concomitant administration is considered.
Thiazide diuretics reduce the urinary excretion of calcium and increase the serum calcium.
4.6. Fertility, pregnancy and lactation
Pregnancy:
Studies in animals have not been done.
Calcium containing drugs are used widely in pregnancy by way of oral calcium supplements or antacid therapy. No relationship between malformations in general and calcium exposure has been noted. Although a weak association with CNS malformations and exposure in the first 4 months of pregnancy has been detected in one large study
Caution should be exercised when prescribing to pregnant women.
Lactation:
There is no information relating to the excretion of this medicine in breast milk. Calcium carbonate can be used during lactation if taken as instructed. However, no problems would be anticipated from the use of this product during lactation, if taken in accordance with the posology.
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.
Immune System Disorders:
Hypersensitivity, anaphylactic reaction.
Metabolism and Nutrition Disorders:
Hypercalcaemia, alkalosis.
Gastrointestinal Disorders:
Eructation, constipation, nausea, vomiting, abdominal discomfort, diarrhoea.
Musculoskeletal and Connective Tissue Disorders:
Muscular weakness.
Skin and Subcutaneous Disorders:
Rash, urticaria, angioedema.
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
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.
5.1 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 Patent Blue V Lake E131 Ponceau 4R Lake E124 Blackcurrant Flavour 9/696044
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
PL 12063/0015
THE
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
First Authorisation: 28th July 1993
10 DATE OF REVISION OF THE TEXT
04/09/2015