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Natekal D3 No. 60

Препарат Натекаль Д3 №60. Italfarmaco (Италфармако) Италия


Producer: Italfarmaco (Italfarmako) Italy

Code of automatic telephone exchange: A12AX

Release form: Firm dosage forms. Chewable tablets.

Indications to use: Deficit of vitamin D. Deficit of calcium. Prevention of osteoporosis.


General characteristics. Structure:

Active agents: calcium a carbonate – 1500 mg (Sa2 + - 600 mg is equivalent), cholecalciferol – 400 ME (it is equivalent dry D3 vitamin * - 4 mg).
Excipients: sorbitol, maltodextrin, croscarmellose sodium, aspartame, sodium saccharinate, lactoses monohydrate, fragrance anisic, fragrance mint, fragrance melassny, magnesium stearate; * - alpha tocopherol acetate, soybeans the oil hydrogenated gelatin, sucrose, starch corn.

Description:
round flat tablets of white or almost white color, with slanted edges and a specific smell, on the one hand tablets marking of "D" is squeezed out.




Pharmacological properties:

The combined drug regulating exchange of calcium and phosphorus in an organism.
Reduces a resorption (rassasyvaniye) and increases density of a bone tissue, compensating for the deficiency of calcium and D3 vitamin of an organism.

Pharmacodynamics. D3 vitamin increases absorption of calcium in digestive tract and its binding in a bone tissue.
Use of calcium and D3 vitamin interferes with increase in production of parathyroid hormone (PTG) which is a stimulator of the raised bone resorption (washing away of calcium from bones).

Pharmacokinetics. D3 vitamin is soaked up in a small intestine. Calcium is soaked up in the ionized form in proximal department of a small intestine by means of active, D-vitamin of the dependent transport mechanism.


Indications to use:

It is applied as treatment-and-prophylactic means:
- for prevention and complex therapy of osteoporosis;
- completions of deficit of calcium and D3 vitamin at elderly people.


Route of administration and doses:

Before use consult with the doctor. Only for adults. The tablet should be rassosat, but not to swallow entirely.
As prophylactic: the adult on 1-2 tablets a day, it is preferential during food.
For therapy of osteoporosis and for completion of deficit of calcium and D3 vitamin at elderly people: a course and a dosage according to recommendations of the doctor.


Features of use:

During treatment by drug it is necessary to control constantly removal of calcium with urine and concentration of calcium and creatinine in a blood plasma. It is necessary to lower a dose or to temporarily stop treatment by drug in case of increase in concentration of calcium or creatinine in blood serum or if calcium level in urine exceeds 7,5 mmol / 24 hour (300 mg / 24 hour).
In order to avoid overdose it is necessary to consider additional intake of D3 vitamin from other sources. Not to apply along with vitamin and mineral complexes, calciferous and D3 vitamin.
At elderly people the need for calcium makes 1,5 g/days, in D3 vitamin – 500 - 1000 ME/days.
For prevention of decrease in absorption of a bisfosfonat or sodium fluoride it is recommended to accept NATEKAL D3 not earlier than in 3 hours after their reception.
Corticosteroids reduce absorbability of calcium therefore treatment by corticosteroids can demand increase in a dose of NATEKAL D3.


Side effects:

Can be observed: lock, diarrhea, meteorism, nausea, stomach ache. Hypercalcemia and hypercalcuria. Allergic reactions.


Interaction with other medicines:

- activity of D3 vitamin can decrease at its simultaneous use with Phenytoinum or barbiturates;
- at simultaneous treatment by cardiac glycosides control of an ECG and clinical condition of the patient since calcium increases risk of development of toxicity of cardiac glycosides is necessary;
- at simultaneous use of drug and antibiotics from group of tetracycline and a ftorkhinolon the interval between reception has to be not less than 3 hours since calcium and D3 vitamin increase absorption of tetracyclines and ftorkhinolon from digestive tract;
- absorbability of a bisfosfonat or sodium fluoride at simultaneous use with drug decreases;
- corticosteroids reduce absorbability of calcium;
- at simultaneous use of diuretics from group of tiazid the risk of emergence of a hypercalcemia due to strengthening of the return absorption increases
-
 - calcium from a gleam of renal tubules. Furosemide and other "loopback" diuretics, on the contrary, increase calcium removal by kidneys;
- simultaneous treatment by drugs of Colestyraminum or laxatives on the basis of mineral or vegetable oil can reduce D3 vitamin absorption;
- acid reaction of foodstuff increases, and alkalescent reaction of products reduces calcium absorption.


Contraindications:

- Hypersensitivity to one of drug components (including to a peanut or soy);
- intolerance of some types of sugars: lactoses, sucrose, fructose;
- fenilketonuriya;
- a pulmonary tuberculosis in an active form;
- a hypercalcemia (the increased content of calcium in blood – at persons with the strengthened function of epithelial bodies);
- a hypercalcuria (the increased release of calcium with urine);
- urolithiasis (formation of calcic stones);
- a sarcoidosis and metastasises of tumors in a bone;
- the osteoporosis caused by a long immobilization;
- vitamin D overdose;
- children's age.

With care
 To take drug to persons with a renal failure, a high-quality granulomatosis with caution.

Pregnancy and period of a lactation
 During pregnancy and a lactation the daily dose of drug should not exceed 1500 mg of calcium and 600 ME D3 vitamins. The overdose during pregnancy can lead to disturbance of mental and physical development of the child. Calcium and D3 vitamin gets into breast milk. During pregnancy and a lactation D3 should take Natekal no more than 1 pill a day.


Overdose:

Symptoms: thirst and polyuria, loss of appetite, nausea, vomiting, lock, dizziness, weakness, headache, unconscious states, coma; at prolonged use: calcification of vessels and fabrics. Laboratory indicators at overdose: a hypercalcuria, a hypercalcemia (calcium in plasma about 2,6 mmol).
Treatment: a regidratation, "loopback" diuretics, glucocorticosteroids, a calcitonin, bisfosfonata, a diet with calcium restriction, carrying out a hemodialysis.


Storage conditions:

Period of validity 2 years. Not to use after a period of validity. To store at a temperature not over 30 ºС. To store in the place, unavailable to children.


Issue conditions:

Without recipe


Packaging:

Tablets for a rassasyvaniye.
On 60 or 12 tablets in bottles from polyethylene of high density with a cover from the same material with control of the first opening. On the cover interior (in a cap from polyethylene of high density) there is a silica gel disk. Each bottle together with the application instruction in a cardboard box.



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