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KALCIPOS-D 500 MG/ 800 IU FILM-COATED TABLETS

Active substance(s): CALCIUM / CHOLECALCIFEROL / COLECALCIFEROL / CALCIUM / CHOLECALCIFEROL / COLECALCIFEROL / CALCIUM / CHOLECALCIFEROL / COLECALCIFEROL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Kalcipos-D 500 mg/ 800 IU film-coated tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains calcium carbonate equivalent to 500 mg
calcium, cholecalciferol (Vitamin D3) 800 IU (20 microgram).
Excipients: sucrose 1.8 mg

3

PHARMACEUTICAL FORM
Film-coated tablet (tablet)
White, oval, engraved R150, 8.5 x 19 mm.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Prevention and treatment of calcium and vitamin D deficiency in the elderly.
Vitamin D and calcium supplement in addition to specific osteoporosis
treatment of patients who are at risk of vitamin D and calcium deficiency.

4.2

Posology and method of administration
Adults and elderly
One film-coated tablet (500 mg/800 IU) daily. To be swallowed with water,
whole, crushed or divided.

The amount of calcium in Kalcipos-D is less than the usually recommended
daily intake.
Kalcipos-D is therefore primarily to be used by patients with need of Dvitamin substitution but with a dietary intake of calcium of 500 mg-1000 mg
per day. The patients dietary intake of calcium should be estimated by the
prescriber.
Dosage in hepatic impairment
No dose adjustment is required
Dosage in renal impairment
Kalcipos-D should not be used in patients with severe renal impairment (see
section 4.3).
There is no relevant indication for use of Kalcipos-D film-coated tablets in
children or adolescents.

4.3

Contraindications









4.4

Hypercalciuria and hypercalcaemia and diseases and/or conditions,
which lead to hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone
metastases,
primary hyperparathyroidism).
Nephrolithiasis.
Nephrocalcinosis
Hypervitaminosis D.
Severe renal impairment and renal failure.
Hypersensitivity to calcium carbonate or cholecalciferol.
Hypersensitivity to any of the excipients.

Special warnings and precautions for use
Kalcipos-D film-coated tablets should be prescribed with caution to patients
suffering from sarcoidosis due to risk of increased metabolism of vitamin D
into its active form. These patients should be monitored with regard to the
calcium content in serum and urine.
During long-term treatment, serum calcium levels should be followed and
renal function should be monitored through measurements of serum creatinine.
Monitoring is especially important in elderly patients on concomitant
treatment with cardiac glycosides or diuretics (see section 4.5) and in patients
with a high tendency to calculus formation. In case of hypercalciuria

(exceeding 300 mg (7.5 mmol)/24 hours) or signs of impaired renal function
the dose should be reduced or the treatment discontinued.
Vitamin D should be used with caution in patients with impairment of renal
function and the effect on calcium and phosphate levels should be monitored.
The risk of soft tissue calcification should be taken into account. In patients
with severe renal insufficiency, vitamin D in the form of cholecalciferol is not
metabolised normally and other forms of vitamin D should be used (see
section 4.3, contraindications).
Kalcipos-D film-coated tablets should be used cautiously in immobilised
patients with osteoporosis due to increased risk of hypercalcaemia.
The content of vitamin D (800 IU) in Kalcipos-D film-coated tablets should be
considered when prescribing other medicinal products containing vitamin D.
Additional doses of calcium or vitamin D should be taken under close medical
supervision. In such cases it is necessary to monitor serum calcium levels and
urinary calcium excretion frequently.
Co-administration with tetracyclines or quinolones is usually not
recommended, or must be done with precaution (see section 4.5).
Kalcipos-D film-coated tablets contains 1.8mg sucrose. Patients with rare
hereditary problems of fructose intolerance, glucose-galactose malabsorption
or sucrase-isomaltase insufficiency should not take this medicine.
Kalcipos-D film-coated tablets are not intended for use in children
4.5

Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased
risk of hypercalcaemia, serum calcium should be regularly monitored during
concomitant use of thiazide diuretics.
Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin
D3 since the metabolism increases.
Systemic corticosteroids reduce calcium absorption. During concomitant use,
it may be necessary to increase the dose of Kalcipos-D.
Hypercalcaemia may increase the toxicity of cardiac glycosides during
treatment with calcium and vitamin D. Patients should be monitored with
regard to electrocardiogram (ECG) and serum calcium levels.
The efficacy of levothyroxine can be reduced by the concurrent use of
calcium, due to decreased levothyroxine absorption. Administration of
calcium and levothyroxine should be separated by at least four hours.

If a bisphosphonate is used concomitantly, this preparation should be
administered at least one hour before the intake of Kalcipos-D since
gastrointestinal absorption may be reduced.
Calcium may also reduce absorption of sodium fluoride and iron salts, and
such preparations should be administered at least three hours before the intake
of Kalcipos-D.
Simultaneous treatment with ion exchange resins such as cholestyramine or
laxatives such as paraffin oil may reduce the gastrointestinal absorption of
vitamin D.
Calcium carbonate may interfere with the absorption of concomitantly
administered tetracycline preparations. For this reason, tetracycline
preparations should be administered at least two hours before or four to six
hours after oral intake of calcium.
The absorption of quinolone antibiotics may be impaired if administered
concomitantly with calcium. Quinolone antibiotics should be taken two hours
before or six hours after intake of calcium.
Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole
cereals) may inhibit calcium absorption through formation of insoluble
compounds with calcium ions. The patient should not take calcium products
within two hours of eating foods high in oxalic acid and phytic acid.

4.6

Fertility, Pregnancy and lactation
Pregnancy
During pregnancy the daily intake should not exceed 1500 mg calcium and
600 IU vitamin D. Recikalc-D forte is not recommended during pregnancy.
Studies in animals have shown reproductive toxicity of high doses of vitamin
D (see 5.3). In pregnant women, overdoses of calcium and vitamin D should
be avoided as permanent hypercalcaemia has been related to adverse effects on
the developing foetus. Kalcipos-D can be used during pregnancy, in case of a
calcium and vitamin D deficiency.
Breast-feeding
Kalcipos-D can be used during breast-feeding. Calcium and vitamin D3 pass
into breast milk. This should be considered when giving additional vitamin D
to the child.
Fertility

Normal endogenous levels of calcium and vitamin D are not expected to have
any adverse effects on fertility.

4.7

Effects on ability to drive and use machines
There are no data about the effect of this product on driving capacity. An
effect is, however, unlikely.

4.8

Undesirable effects
Adverse reactions frequencies are defined as: uncommon (≥1/1,000, <1/100),
rare (>1/10,000, <1/1,000) or not known (cannot be estimated from the
available data
Immune system disorders
Not known (cannot be estimated from the available data): Hypersensitivity
reactions such as angioedema or laryngeal oedema.
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria.
Gastrointestinal disorders
Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.
Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria.

4.9

Overdose
Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of
hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation,
abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia,
polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases,
cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death.
Persistently high calcium levels may lead to irreversible renal damage and soft
tissue calcification.

Treatment of hypercalcaemia: The treatment with calcium and vitamin D must
be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin
D and cardiac glycosides must also be discontinued. Rehydration, and,
according to severity, isolated or combined treatment with loop diuretics,
bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal
function and diuresis must be monitored. In severe cases, ECG and CVP
should be followed.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Calcium, combinations with other drugs.
ATC-code: A12AX
Vitamin D increases the intestinal absorption of calcium.
Administration of calcium and vitamin D3 counteracts the increase of parathyroid
hormone (PTH) which is caused by calcium deficiency and which cause increased
bone resorption.
A clinical study of institutionalised patients suffering from vitamin D deficiency
indicated that a daily intake of 1000 mg calcium and 800 IU vitamin D for six months
normalised the value of the 25-hydroxylated metabolite of vitamin D3 and reduced
secondary hyperparathyroidism and alkaline phosphatases.
An 18 month double-blind, placebo controlled study including 3270 institutionalised
women aged 84 (± 6 years) who received supplementation of vitamin D (800 IU/day)
and calcium phosphate (corresponding to 1200 mg/day of elemental calcium),
showed a significant decrease of PTH secretion. After 18 months, an "intent-to treat"
analysis showed 80 hip fractures in the calcium-vitamin D group and 110 hip
fractures in the placebo group (p=0.004).

5.2

Pharmacokinetic properties
Calcium
Absorption: The amount of calcium absorbed through the gastrointestinal tract
is approximately 30% of the swallowed dose.
Distribution and metabolism: 99% of the calcium in the body is concentrated
in the hard structure of bones and teeth. The remaining 1% is present in the
intra- and extracellular fluids. About 50% of the total blood-calcium content is
in the physiologically active ionised form with approximately 10% being
complexed to citrate, phosphate or other anions, the remaining 40% being
bound to proteins, principally albumin. The bioavailability of calcium can be
slightly increased by concomitant intake of food.

Elimination: Calcium is eliminated through faeces, urine and sweat. Renal
excretion depends on glomerular filtration and calcium tubular reabsorption.
Vitamin D
Absorption: Vitamin D is easily absorbed in the small intestine.
Distribution and metabolism: Cholecalciferol and its metabolites circulate in
the blood bound to a specific globulin. Cholecalciferol is converted in the liver
by hydroxylation to the active form 25-hydroxycholecalciferol. It is then
further converted in the kidneys to 1,25- dihydroxycholecalciferol. 1,25dihydroxycholecalciferol is the metabolite responsible for increasing calcium
absorption. Vitamin D which is not metabolised is stored in adipose and
muscle tissues.
Elimination: Vitamin D is excreted in faeces and urine.

5.3

Preclinical safety data
At vitamin D doses far higher than the human therapeutic range teratogenicity
has been observed in animal studies. There is further no information of
relevance to the safety assessment in addition to what is stated in other parts of
the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Core:
Maltodextrin
Crosscarmellose sodium
Silica, colloidal anhydrous
Magnesium stearate
Cholecalciferol concentrate:
all-rac-alpha-tocopherol
Sucrose
Medium chain triglycerides
Modified food starch
Silicon dioxide
Sodium ascorbate crystalline
Coating:

Hypromellose
Macrogol
Paraffin
6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 years

6.4

Special precautions for storage
Store in the original package, in order to protect from light. Keep the container
tightly closed in order to protect from moisture.

6.5

Nature and contents of container
20, 30,40,50,60, 90, 100 and 180 tablets in plastic containers of HDPE with
screw caps made of HDPE.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 15142/0232

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
30/01/2012

10

DATE OF REVISION OF THE TEXT
18/09/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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