Calcium Lactate Tablets Bp 300mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calcium Lactate Tablets BP 300 mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Calcium Lactate Pentahydrate 300mg For a full list of excipients, see section 6.1 3. Pharmaceutical Form
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of calcium deficiencies.
4.2. Posology and Method of Administration
For oral administration.
For the correction of calcium deficient diets a dose of 2 tablets daily may be given for all ages (normal human requirements 600 - 700 mg daily. In pregnancy this may rise to 1-2g).
In simple deficiency states doses of up to 15 tablets daily in divided doses may be given.
4.3 Contraindications
Hypersensitivity to calcium lactate or any of the excipients.
Patients with nephrolithiasis.
Conditions associated with hypercalcaemia or hypercalcuria (e.g. hypervitaminosis D, parathyroid disease, milk alkali syndrome, some forms of malignant disease).
4.4. Special warnings and precautions for use
Caution should be shown in patients with impaired renal function, cardiac disease, sarcoidosis, a history of nephrolithiasis.
4.5 Interaction with other medicinal products and other forms of interactions
Calcium lactate inhibits the absorption of tetracyclines, ciprofloxacin, bisphosphonates, fluorides, oral iron, levothyroxine (thyroxine) and zinc. Corticosteroids reduce the absorption of calcium salts.
Increased risk of hypercalcaemia when calcium salts are given with thiazides and related diuretics.
In potassium deficiency with calcium deficiency (hypokalaemia with hypocalcaemia) it is important to treat the calcium deficiency first otherwise correcting the potassium level first may precipitate hypocalcaemic tetany.
The effects of digoxin and other cardiac glycosides may be accentuated by calcium, especially in combination with vitamin D.
Vitamin D increases the gastrointestinal absorption of calcium.
4.6 Pregnancy and Lactation
No adverse effects in normal dosage.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable effects
May cause constipation or other gastrointestinal disturbances, bradycardia or arrhythmias. Prolonged high dose induces hypercalcaemia (these are infrequently seen with calcium lactate tablets).
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
The tablets are unlikely to lead to overdose (hypercalcaemia) unless taken with vitamin D. Symptoms may include anorexia, nausea, abdominal pain, thirst and polyuria. Reduce intake to a minimum and give large amounts of fluid.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Calcium lactate is a source of body calcium, an essential electrolyte involved in maintenance of normal muscle and nerve function and is essential in blood clotting.
5.2. Pharmacokinetic Properties
The normal adult requirement of calcium is about 500 mg/day. It is absorbed from the small intestine. Absorption is increased by vitamin D.
Excretion is via urine, faeces, sweat & saliva.
5.3. Preclinical Safety Data
No data of relevance which is additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Potato Starch Talc
Stearic Acid Magnesium Stearate
6.2. Incompatibilities
None known.
6.3. Shelf Life
5 years.
6.4. Special Precautions for Storage
Do not store above 25°C. Store in the original container. Keep the container tightly closed.
6.5. Nature and Contents of Container
HDPE container with HDPE cap of 84, 100, 250, 500 & 1000 tablets.
6.6. Instruction for Use/Handling Not applicable.
7. MARKETING AUTHORISATION HOLDER
Dalkeith Laboratories Ltd
2 Park Street
Woburn
Bedfordshire
MK17 9PG
8. MARKETING AUTHORISATION NUMBER(S)
PL 17496/0006
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/12/2008
10 DATE OF REVISION OF THE TEXT
15/07/2015