Calcemin tablets coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

calcium, vitamin D3, zinc(zinc oxide), copper (copper oxide), manganese (manganese sulfate), boron (sodium borate)

Available from:

Contract Pharmacal Corporation

ATC code:

առկա չէ (A12AX)

INN (International Name):

calcium, vitamin D3, zinc(zinc oxide), copper (copper oxide), manganese (manganese sulfate), boron (sodium borate)

Dosage:

250mg+ 50IU+ 2mg+ 0,5mg+ 0,5mg+ 50mcg

Pharmaceutical form:

tablets coated

Units in package:

(30) in plastic container, (60) in plastic container, (120) in plastic container

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2015-12-02

Patient Information leaflet

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Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CALCEMIN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains:
Calcium citrate and calcium carbonate
250 mg
Vitamin D
3
50 IU
Zinc
2 mg
Copper
0,5 mg
Manganese
0,5 mg
Boron
50 mcg
3.
PHARMACEUTICAL FORM
Coated tablet
4.
CLINICAL PARTICULARS
4.1
Therapeutic Indications
Prophylaxis and treatment of osteopenia and osteoporosis of various
geneses.
Calcium and Vitamin D
3
deficiency in organism during situations and conditions
with poor nutrition or insufficient dietary intake of calcium and
cholecalciferol.
Increased requirement of calcium and Vitamin D
3
during pregnancy and lactation,
and in children above 6 years of age during the period of intensive
growth.
4.2
Posology and Method of Administration
Children 6 to 12 years of age: 1 tablet once a day at mealtime.
Adults and children over 12 years of age: 1 tablet two times daily at
mealtimes.
From week 20 of pregnancy and over the entire lactation period: 1
tablet two times
daily.
Length of treatment
Duration of prophylaxis and treatment in frame of osteoporosis complex
therapy
must be determined individually by physician.
When applying to make up a deficiency of calcium and Vitamin D
3
, an average
duration of treatment has to be not less than 4 to 6 weeks. Quantity
of refresher
courses of treatment within a year to be determined individually.
Patients with liver dysfunction: dose adjustments are not required.
Patients with impaired renal function: do not use Calcemin in case of
severe renal
impairment.
Elderly patients: see dosage for adults. Possible nephratonia must be
taken into
consideration.
4.3
Contraindications
Known hypersensitivity to any ingredient in the drug product;
hypercalcemia and/or
conditions
resulting
in
hypercalcemia
such
as
sarcoidosis,
malignancy,
bone
metastasis and primary hyperthyroidism; severe hypercalciuria;
hypervitaminosis
D
3
; nephrolithiasis; nephrocalcinosis; severe renal impairment; children
below 6
years of age.
4.4
Special Warnings and Precau