Remegel
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Remegel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Remegel tablet contains 800 mg calcium carbonate.
Also contains glucose syrup, sucrose, glycerol and sorbitol (E420).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Soft, light-green, mint flavoured, chewable square tablet
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Remegel tablets are indicated for the relief of acid indigestion and heartburn, and associated stomach upsets (dyspepsia)
4.2 Posology and method of administration
Posology:
Adults and children 12 years and over: One or two tablets of Remegel to be chewed as a single dose, when symptoms occur.
Repeat as necessary.
Maximum dose: 12 tablets in 24 hours.
Children under 12 years of age: Not recommended.
The Elderly: As for adults, see above.
Hepatic dysfunction: There is no specific information relating to the use of Remegel in hepatic impairment. Normal adult dosage is appropriate.
Renal dysfunction: Remegel should be used with caution in subjects with mild to moderate renal impairment. (see section 4.4). Use in severe renal impairment is contraindicated (see sections 4.3).
Current use of calcium carbonate as a phosphate binder should be taken into account to prevent hypercalcaemia.
Duration of treatment
If symptoms do not improve after 7 days seek medical advice.
Method of Administration:
Oral. Tablets to be chewed and swallowed.
4.3 Contraindications
Hypersensitivity to the active ingredient or any of the excipients, refer to section 6.1
Hypercalcaemia
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
This product should be used with caution in patients with 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 sucrose and glucose syrup and as such, care is required in patients with diabetes mellitus.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase 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.
Keep out of the sight and reach of children.
4.5 Interaction 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. It is recommended that antacids are not taken simultaneously with other medications, but spaced at least 2 hours apart.
In common with other antacids, calcium carbonate may form complexes with certain drugs e.g., antibiotics (such as tetracyclines and quinolones), cardiac glycosides (digoxin), H2-antihistaminics, fluoroquinolone, iron containing drugs, ketoconazole, neuroleptics, thyroxine, penicilamine, beta-blockers (atenolol, metoprolol, propanolol), glucocorticoid, chloroquine, estramustine 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:
No increased risk of congenital defects has been observed after the use of calcium carbonate during pregnancy. Calcium carbonate can be used during pregnancy if taken as instructed, but prolonged intake of high doses should be avoided.
Consult a healthcare professional if you need to take more than recommended levels.
Breast-feeding:
There is no information relating to the excretion of Remegel in breast milk. However, no problems would be anticipated from the use of this product during lactation, if taken in accordance with the posology.
Fertility:
No known effect.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Adverse events which have been associated with calcium carbonate are given below, tabulated by system organ class and frequency. Frequencies are defined as: 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); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
|
System Organ Class |
Frequency |
Adverse Events |
|
Immune System Disorders |
Not known |
Hypersensitivity1, anaphylactic reactiom |
|
Metabolism and Nutrition Disorders |
Not known |
Hypercalcaemia, alkalosis |
|
Gastrointestinal Disorders |
Not known |
Eructation, constipation, nausea, vomiting, abdominal discomfort, diarrhoea. |
Description of adverse events:
'Hypersensitivity reactions: These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity, including asthma, aggravated asthma, bronchospasm, and dyspnoea, or (c) various skin reactions including rash, pruritus, urticaria, purpura or 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: http://www.mhra.gov.uk/yellowcard.
Overdose
4.9
Excessive ingestion of calcium carbonate, especially in patients with impaired renal function can lead to hypercalcaemia, renal insufficiency and alkalosis, characterised by gastro-intestinal symptoms (pain, nausea, vomiting, constipation) and muscular weakness. In these cases, the intake of the product should be stopped and adequate isotonic fluid intake encouraged. In severe cases of overdosage, milk-alkali syndrome may occur.
Treatment should be symptomatic and supportive. Haemodialysis and other therapeutic measures such as saline diuresis have been used to treat successfully the excessive ingestion of calcium carbonate antacid.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic Classification: Antacids
ATC Code: Calcium carbonate, A02AC01
Calcium carbonate is a potent antacid, neutralising gastric acid when taken by the oral route.
Calcium carbonate neutralises gastric acid to provide fast relief for indigestion and heartburn.
5.2 Pharmacokinetic properties Absorption:
Calcium carbonate is converted to calcium chloride by gastric acid (hydrochloric acid) in the stomach, with the resulting formation of carbon dioxide and water. Some of the calcium is absorbed from the intestines but the majority is reconverted into insoluble calcium salts such as carbonate and stearate which is excreted in the faeces.
Distribution, Metabolism and Elimination:
Once absorbed from the stomach, physiological concentrations of calcium are tightly controlled, principally through the effects of parathyroid hormone, vitamin D and its metabolites and calcitonin. These control mechanisms are well documented in standard texts.
5.3 Preclinical safety data
Pre-clinical safety data does not add anything of further significance to the
prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sucrose Glucose syrup Purified water
Hyfoama DS (hydrolysed milk protein)
Gelatin
Comfiour starch Sorbitol (crystalline) (E420)
Glycerol (E422)
Titanium dioxide (E171)
Patent Blue V (E131)
Quinoline yellow (E104)
Paramount C (hydrogenated vegetable fat)
Amerfond Fondant Sugar Peppermint Oil Menthol
Butylated hydroxyanisole (E320)
Talc (used as a processing aid)
6.2 Incompatibilities
None known
6.3 Shelf life
24 months unopened
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Each tablet in stickpacks is wrapped in printed waxed paper and overwrapped in hermetically sealed aluminium foil stickpack.
a) 5 piece stickpack
b) 8 piece stickpack
c) 8 piece stickpack, two stickpacks per clear plastic sleeve
d) 8 piece stickpack, three stickpacks per carton
e) 8 piece stickpack, six stickpacks per carton
f) 8 piece stickpack, five stickpacks per carton
6.6 Special precautions for disposal
None applicable
7 MARKETING AUTHORISATION HOLDER
SSL International plc 103-105 Bath Road Slough SL1 3UH UK
8
MARKETING AUTHORISATION NUMBER(S)
PL 17905/0084
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10
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/7/99
DATE OF REVISION OF THE TEXT
20/07/2015