COMPOSITION:

Active substances:

1 tablet contains calcium carbonate equivalent to 500 mg of calcium and 200 IU (5 mcg) of stabilized Vitamin D3(cholecalciferol);

Excipients:

Povidone

crospovidone

magnesium stearate

anhydrous colloidal silicon dioxide

Opadry21К58794 white coating: hypromellose

titanium dioxide (E 171)

ethylcellulose

triacetin.

INDICATIONS:

Prevention and treatment of calcium and/or vitamin D3 deficiency

prevention and complex therapy of osteoporosis.

DOSAGE:

Prevention and treatment of calcium and/or vitamin D3 deficiency.

Adults:

Recommended dose is 1 tablet 1 – 3 times per day.

Children above 5 years:

Recommended dose is 1 tablet 1 – 2 times per day upon doctor’s recommendation.

Prevention and complex therapy of osteoporosis.

Adults:

Recommended dose is 1 tablet 2 – 3 times per day.

Elderly patients do not require dose correction.

Patients with severe renal failure should not administer the drug.

ADVERSE REACTIONS:

Undesirable side effects are classified by the following categories depending on their frequency rate:

Uncommon(> 1/1000

< 1/100)

rare (> 1/10 000

< 1/1000)

very rare (< 1/10 000).

Metabolic disorders:

uncommon – hypercalcemia

hypercalciuria.

Gastrointestinal tract disorders:

Rare – constipation

flatulence nausea

abdominal pain

diarrhea.

Disorders of skin and subcutaneous tissues:very rare – itching

rash

urticaria.

Drug interactions:

Thiazide diuretics decrease calcium urine elimination. At concomitant therapy it is necessary to control serum calcium level considering that hypercalcemia risk is increased.

Calcium may inhibit absorption of tetracycline drugs

quinolone antibiotics

and levothyroxine

therefore these drugs should be administered 2 hours before or 4 – 6hours after Bonocal® intake.

At concomitant therapy with cardiac glycosides and thiazide diuretics

monitoring of ECG and clinical state of the patient is required since calcium drugs may potentiate therapeutic and toxic effects of cardiac glycosides.

In order to avoid bisphosphonates or sodium fluoride absorption decrease it is recommended to administer Bonocal® at least 1 hour after mentioned drugs intake.

Pregnancy and lactation:

Bonocal® tablets are indicated in pregnant women.

With a view to overdose avoiding

daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3.

Vitamin D3 and its metabolites may penetrate into breast milk therefore it is necessary to control calcium and vitamin D3 income from other sources in both

mother and child.

Children:

Drug is indicated for prevention and treatment of calcium and/or vitamin D3 deficiency in children above 5 years upon doctor’s recommendation.

PRECAUTIONS:

At long-term drug therapy it is necessary to control serum calcium and creatinine levels

particularly in elderly patients at concomitant administration with cardiac glycosides and thiazide diuretics

or patients with high dental calculus predisposition. At first signs of hypercalcemia or renal dysfunction it is necessary to decrease the dose or stop drug administration.

Patients with mild and moderate renal failure (elderly in particular) or insignificant hypercalciuriarequireregular monitoring of urine calcium excretion towards avoidinghypercalciuria.

Bonocal®is carefully prescribed in immobilized patients due to hypercalciuria development risk

and in sarcoidosis patients.

In order to exclude overdose

it is desirable to control calcium and vitamin D3 income from other sources within recommended calcium and vitamin D3 daily norms.

Overdose:

The most serious consequence of acute or chronic overdose is hypercalcemia driven by hypersensitivity to vitamin D.

Symptoms:

anorexia

nausea

vomiting

constipation

abdominal pain

muscle weakness

fatigue

mental disorders

polydipsia

polyuria

nephrocalcinosis

heart rhythm disorder in severe cases.Syncopal state and coma are possible. Long-term overdose of high drug doses may result in renal injury and tissue calcinosis.

Treatment:

Drug administration should be stopped. It is necessary to introduce large amount of water to the body and keep to the diet with limited calcium intake. Depending on overdose severity

there can be a necessity in loop diuretics

bisphosphonates

calcitonin

and corticosteroids therapy.

Ability to influence reaction velocity while driving or operating any other mechanisms.

Does not influence.

CONTRAINDICATIONS:

Hypercalcemia (elevated calcium level in blood)

hypercalciuria (elevated calcium level in urine)

nephrolithiasis (kidney stone disease)

hypervitaminosisD3.Hypersensitivity to soy and peanuts.Hypersensitivity to drug components.

PHARMACOLOGICAL PROPERTIES:

Pharmacotherapeutic group.

Mineral supplements.Calcium in combination with other drugs.Code АТСА12А Х.

Bonocal® is a combination medicinal product regulating calcium and phosphorus metabolism. It compensates calcium and vitamin D3 body deficiency and is necessary for teeth mineralization. Calcium participates in bone tissue formation

teeth mineralization

blood coagulation processes

regulation of nerve conductivity and muscle contraction

and nervous system stability maintenance.

Administration of calcium and vitamin D3 prevents increased production of parathyroid hormone (PTH) which stimulates increased bone resorption (excretion of calcium from bones). Vitamin D3 is absorbed in small intestine. Calcium is absorbed in ionized form in proximal part of small intestine via active vitamin D-dependent transport mechanism.

About 30% of administered calcium dose is absorbed via GIT. 99% of calcium is concentrated in solid body structures (bones

teeth)

1% is left in inner and extracellular area. About 50% of blood calcium is in physiologically active ionized form. Almost 10% is stored in complex with citrates

phosphates

and other anions. The remaining 40% are part of proteins

mainly albumins. Calcium is eliminated with feces

urine

and sweat.

Vitamin D3 is easily absorbed in thin intestine. Cholecalciferol and its metabolites circulate in blood as specific globulins. Cholecalciferolis transformed in the liver in active hydroxyl form of 25-hydroxycholecalciferol

and then it is transformed in kidneys into 1

25-hydroxycholecalciferol which is responsible for enhanced calcium absorption. Unmetabolized vitamin D3is preserved in muscle and adipose tissues. Vitamin D3is eliminated with feces and urine.

PHARMACEUTICAL CHARACTERISTICS:

General physico-chemical properties:

Smooth white film-coated capsule-shaped tablets.

Shelf-life:

2 years.

Storage:

Store at the temperature not more than 25°С in dry place. Protect from direct sunlight. Keep out of reach of children.

Package:

7 tablets in blister

4 or 10 blisters in carton pack.

10 tablets in blister

10 blisters in carton pack.

Conditions of supply:

Without prescription.