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KALCIPOS-D 500 MG/800 IU CHEWABLE TABLETS

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

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SUMMARY OF PRODUCT CHARACTERISTICS

1

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

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains calcium carbonate equivalent to 500 mg calcium,
cholecalciferol (Vitamin D3) 800 IU (20 microgram).
Excipients: glucose 200 mg and sucrose 1.8 mg
For a full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Chewable tablet
White to off white, round, engraved R152 on one side, diameter 17 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 chewable tablet (500 mg/800 IU) daily. To be chewed or slowly melted
in the mouth.
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 chewable tablets in
children or adolescents.
4.3

Contraindications
• Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria.
• Nephrolithiasis.
• Nephrocalcinosis
• Hypervitaminosis D.
• Renal failure.
• Hypersensitivity to calcium carbonate or cholecalciferol.
• Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1.
Kalcipos-D forte contains partially hydrogenated soya-bean oil and must not
be used by persons allergic to peanuts or soya.

4.4.

Special warnings and precautions for use
Recikalc-D chewable 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).
Recikalc-D forte chewable tablets should be used cautiously in immobilised patients
with osteoporosis due to increased risk of hypercalcaemia.

The content of vitamin D (800 IU) in Recikalc-D forte chewable 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).
Recikalc-D forte chewable tablets contains glucose and 1.8 mg sucrose. Patients with
rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
The content of glucose may be harmful to the teeth.
Recikalc-D forte chewable 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 forte.
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 forte 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.

Administration of strontium and calcium should be separated by at least 2
hours, as calcium may reduce the absorption of strontium.
Simultaneous treatment with orlistat, 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. Kalcipos-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. Tablets 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 to <1/100), rare
(≥1/10,000 to <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 edema.
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.
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
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: Mineral supplements
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 biotransformation:
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 biotransformation:

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 25hydroxycholecalciferol. It is then further converted in the kidneys to 1,25dihydroxycholecalciferol. 1,25-dihydroxycholecalciferol 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 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
Liquid spray dried glucose
Magnesium stearate
Sodium citrate
Xylitol
all-rac-alfa-tocoferol
Acacia
Sodium laurilsulphate
Sucrose
Medium chain triglycerides
Starch sodium octenyl succinate (E1450)
Silicon dioxide
Sodium ascorbate

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
Shelf life: 3 years
Shelf life after first opening container: 6 months

6.4

Special precautions for storage

Store in the original container, in order to protect from light. Keep container tightly
closed in order to protect from moisture.
For storage conditions after first opening of medicinal product, see section 6.3
6.5

Nature and content of container
20, 30,40,50,60, 90, 100 and 180 chewable tablets in plastic containers of
HDPE with screw caps made of HDPE.

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 15142/0056

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
22/12/2014

10

DATE OF REVISION OF THE TEXT
22/12/2014

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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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