Natekal 1000 (Tablets) Instructions for Use

Marketing Authorization Holder

Italfarmaco, S.p.A. (Italy)

ATC Code

A12AX (Calcium preparations in combination with vitamin D and/or other drugs)

Active Substances

Colecalciferol (Rec.INN registered by WHO)

Calcium carbonate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Natekal 1000

Orally disintegrating tablets 600 mg+1000 IU: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Orally disintegrating tablets white or almost white, round, flat-cylindrical, with a bevel on both sides; the presence of light orange inclusions is allowed.

Excipients: maltodextrin – 166 mg, aspartame – 8.67 mg, low-substituted hydroxypropylcellulose – 106.07 mg, lactose monohydrate – 57.65 mg, anhydrous citric acid – 208.11 mg, orange flavor – 4.2 mg, stearic acid – 42.03 mg, alpha-tocopherol – 0.02 mg, partially hydrogenated soybean oil – 0.75 mg, gelatin – 3.8 mg, sucrose – 3.8 mg, corn starch – 1.605 mg.

30 pcs. – polyethylene bottles (1) – cardboard packs with or without first-opening control.
60 pcs. – polyethylene bottles (1) – cardboard packs with or without first-opening control.

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Mineral supplements; calcium preparations; calcium preparations with vitamin D and/or other agents

Pharmacological Action

A combined drug that regulates the metabolism of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles). Reduces resorption and increases bone density, compensating for the deficiency of calcium and vitamin D₃ in the body, enhances calcium absorption in the intestine and phosphate reabsorption in the kidneys, promotes mineralization of bone tissue and dental tissue.

Calcium is involved in the formation of bone tissue, in maintaining stable cardiac activity, in the regulation of nerve conduction, muscle contractions, hormone production and is a component of the blood coagulation system. Adequate calcium intake is especially important during periods of growth, pregnancy and breastfeeding.

Vitamin D₃ (Colecalciferol) increases calcium absorption in the intestine, promotes the formation and mineralization of bone tissue and dental tissue.

The use of calcium and vitamin D₃ prevents an increase in the production of PTH, which is a stimulator of increased bone resorption (leaching of calcium from bones).

Pharmacokinetics

Colecalciferol

Vitamin D₃ is easily absorbed from the small intestine (about 80% of the dose taken). Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycalciferol. It is then converted in the kidneys to the active form 1,25-hydroxycalciferol. 1,25-hydroxycalciferol is the metabolite responsible for increasing calcium absorption. Non-metabolized vitamin D₃ is deposited in adipose and muscle tissue. It is excreted through the intestines and kidneys.

Calcium

Calcium is absorbed in ionized form from the proximal small intestine via an active, vitamin D-dependent transport mechanism. Typically, the amount of calcium absorbed from the gastrointestinal tract is approximately 30% of the dose taken. 99% of the calcium in the body is concentrated in the hard tissues of teeth and bones. The remaining 1% is found in intra- and extracellular fluids. About 50% of the total calcium content in the blood is in the physiologically active ionized form, of which approximately 10% is in complex with citrate, phosphate or other anions, the remaining 40% is bound to proteins, primarily albumin. Calcium is excreted by the intestines, kidneys and sweat glands. Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.

Indications

Treatment and prevention of calcium and vitamin D₃ deficiency: osteoporosis, including menopausal, senile, “steroid”, idiopathic (prevention and supplement to specific treatment); osteomalacia (associated with impaired mineral metabolism in patients over 45 years of age); hypocalcemia (including after following diets with avoidance of milk and dairy products); with increased need during pregnancy and lactation, as well as in children over 12 years of age during periods of intensive growth.

ICD codes

Dosage Regimen

Take orally. Chew the tablet or swallow it whole. Do not take on an empty stomach.

For adults and children over 12 years of age, the standard dosage is one tablet twice daily.

For the treatment and prevention of osteoporosis, adhere to this regimen as a supplement to specific therapy.

To manage calcium and vitamin D deficiency, follow the twice-daily schedule with meals to enhance calcium absorption.

During pregnancy and lactation, use with caution. The total daily intake from all sources must not exceed 1500 mg of calcium and 600 IU of vitamin D3.

For elderly patients, the recommended daily calcium intake is approximately 1.5 grams and for vitamin D3, 500-1000 IU.

Adjust dosage based on dietary calcium intake to avoid exceeding the recommended daily allowance.

Monitor plasma and urine calcium levels periodically during long-term therapy. Discontinue or reduce dosage if hypercalciuria develops.

Do not use concurrently with other calcium or vitamin D containing preparations due to the risk of overdose.

Adverse Reactions

From the digestive system constipation, flatulence, nausea, stomach pain, diarrhea.

From laboratory parameters hypercalcemia and hypercalciuria.

Other allergic reactions.

Contraindications

Hypersensitivity; hypercalcemia (including as a result of primary or secondary hyperparathyroidism); hypercalciuria; calcium nephrourolithiasis; hypervitaminosis D; sarcoidosis; osteoporosis due to immobilization; pulmonary tuberculosis (active form).

With caution

In renal failure, benign granulomatosis, during pregnancy, during lactation, simultaneously with the use of glycosides and thiazide diuretics, in children (under 12 years of age).

Use in Pregnancy and Lactation

With caution used during pregnancy and during lactation. During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D₃.

Overdose during pregnancy can lead to impaired mental and physical development of the child.

Calcium and vitamin D₃ pass into breast milk.

Use in Renal Impairment

With caution used in renal failure.

Pediatric Use

With caution used in children (under 12 years of age).

Special Precautions

During treatment, it is necessary to constantly monitor the excretion of calcium in the urine and the concentration of calcium and creatinine in plasma (if calciuria appears exceeding 7.5 mmol/day (300 mg/day), it is necessary to reduce the dose or stop taking it).

To avoid overdose, it is necessary to take into account the additional intake of vitamin D₃ from other sources. Do not use simultaneously with vitamin complexes containing calcium and vitamin D₃.

In elderly people, the need for calcium is 1.5 g/day, for vitamin D₃ – 0.5-1 thousand IU/day.

Drug Interactions

Reduces the absorption of bisphosphonates, sodium fluoride and tetracyclines (the interval between doses should be at least 2-3 hours).

Increases the risk of toxicity of cardiac glycosides (monitoring of ECG and patient condition is necessary).

Phenytoin, barbiturates, corticosteroids reduce the effect of vitamin D₃, vitamin A – toxicity.

Corticosteroids reduce the absorption of calcium.

Cholestyramine, laxatives (mineral oil) reduce the absorption of vitamin D.

Thiazide diuretics increase the risk of hypercalcemia.

Furosemide and other “loop” diuretics increase the excretion of calcium by the kidneys.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.