Complivit® Calcium D3 Forte (Tablets) Instructions for Use
ATC Code
A12AX (Calcium preparations in combination with vitamin D and/or other drugs)
Active Substances
Calcium carbonate (Ph.Eur.)
Colecalciferol (Rec.INN)
Clinical-Pharmacological Group
Drug regulating calcium and phosphorus metabolism
Pharmacotherapeutic Group
Calcium-phosphorus metabolism regulator
Pharmacological Action
A combined drug that regulates the metabolism of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles).
It reduces resorption and increases bone density, compensating for the deficiency of calcium and vitamin D3 in the body, enhances calcium absorption in the intestines and phosphate reabsorption in the kidneys, and promotes the 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 and 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 (parathyroid hormone), which is a stimulator of increased bone resorption (leaching of calcium from bones).
Pharmacokinetics
Colecalciferol
Vitamin D3 is readily absorbed from the small intestine (about 80% of the administered dose).
Colecalciferol and its metabolites circulate in the blood bound to a specific globulin.
Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycholecalciferol.
It is then converted in the kidneys to the active form 1,25-dihydroxycholecalciferol.
1,25-dihydroxycholecalciferol is the metabolite responsible for increasing calcium absorption.
Non-metabolized vitamin D3 is stored in adipose and muscle tissue.
It is excreted through the intestines and kidneys.
Calcium
Calcium is absorbed in ionized form from the proximal part of the small intestine via an active, vitamin D-dependent transport mechanism.
The amount of calcium absorbed from the gastrointestinal tract is typically about 30% of the administered dose.
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 complexed with citrate, phosphate, or other anions, and 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 that exclude 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
| ICD-10 code | Indication |
| E55 | Vitamin D deficiency |
| E58 | Dietary calcium deficiency |
| E83.5 | Disorders of calcium metabolism |
| M80.0 | Postmenopausal osteoporosis with pathological fracture |
| M80.1 | Osteoporosis with pathological fracture following oophorectomy |
| M80.4 | Drug-induced osteoporosis with pathological fracture |
| M80.5 | Idiopathic osteoporosis with pathological fracture |
| M80.8 | Other osteoporosis with pathological fracture |
| M81.0 | Postmenopausal osteoporosis |
| M81.1 | Postoophorectomy osteoporosis |
| M81.4 | Drug-induced osteoporosis |
| M81.5 | Idiopathic osteoporosis |
| M81.8 | Other osteoporosis (senile osteoporosis) |
| M82 | Osteoporosis in diseases classified elsewhere |
| M83 | Adult osteomalacia |
| O25 | Nutritional deficiencies in pregnancy |
| O99.2 | Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium |
| ICD-11 code | Indication |
| 5B57.Z | Vitamin D deficiency, unspecified |
| 5B5K.1Z | Calcium deficiency, unspecified |
| 5C64.5 | Disorders of calcium metabolism |
| 8D40.2 | Myopathy due to nutritional deficiency |
| FB83.10 | Premenopausal idiopathic osteoporosis |
| FB83.11 | Postmenopausal osteoporosis |
| FB83.13 | Drug-induced osteoporosis |
| FB83.1Z | Osteoporosis, unspecified |
| FB83.2Z | Adult osteomalacia, unspecified |
| JA64 | Nutritional disorders during pregnancy |
| JB64.2 | Endocrine, nutritional and metabolic diseases complicating pregnancy, childbirth and the puerperium |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Take orally. Chew the tablet thoroughly or swallow it whole with a glass of water.
For adults and children over 12 years of age, the standard dosage is one tablet twice daily, typically with meals to enhance calcium absorption.
For the treatment of osteoporosis, adhere strictly to the prescribed regimen as part of a comprehensive therapeutic program that includes adequate calcium intake from diet.
For the prevention of calcium and vitamin D deficiency in high-risk groups, use the same dosage unless otherwise directed by a physician.
Adjust the dosage based on individual patient requirements and dietary calcium intake. Do not exceed the recommended daily intake of calcium and vitamin D from all sources.
In elderly patients, the recommended daily calcium intake is approximately 1.5 grams, and for vitamin D3, it is 500-1000 IU. Adjust the dosage accordingly to meet these needs without exceeding them.
During pregnancy and lactation, use with caution. The total daily dose from all supplements must not exceed 1500 mg of calcium and 600 IU of vitamin D3 to avoid potential harm to the fetus or infant.
Monitor plasma and urine calcium levels periodically during long-term therapy. If urinary calcium excretion exceeds 7.5 mmol/day (300 mg/day), reduce the dosage or discontinue treatment.
Discontinue use and consult a physician if symptoms of hypercalcemia or hypercalciuria develop.
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).
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).
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).
To avoid overdose, additional intake of vitamin D3 from other sources must be taken into account.
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
Over-the-Counter
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.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Chewable tablets (orange) 1.25 g+0.01 mg (400 IU): 30, 60, 90, 100 or 120 pcs.
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Pharmstandard-UfaVITA OJSC (Russia)
Dosage Form
 |
Complivit® Calcium D3 Forte | Chewable tablets (orange) 1.25 g+0.01 mg (400 IU): 30, 60, 90, 100 or 120 pcs. |
Dosage Form, Packaging, and Composition
Chewable tablets (orange) from white to white with a creamy tint, round, biconvex, with a rough porous surface, with a characteristic odor; may have small inclusions of a grayish color.
| 1 tab. | |
| Calcium carbonate | 1.25 g, |
| Equivalent to calcium content | 500 mg |
| Colecalciferol (vit. D3)* | 0.01 mg (400 IU) |
* in the form of a granulate containing Colecalciferol – 0.27%, DL-α-tocopherol – 0.0275%, medium-chain triglycerides – 10.7%, sucrose – 36%, acacia gum – 22%, corn starch – 27%, calcium phosphate (E341) – 0.5%, water – up to 100%).
Excipients : lactose monohydrate – 333.118 mg, povidone (medium molecular weight polyvinylpyrrolidone, povidone K17) – 68.24 mg, potato starch – 18.969 mg, croscarmellose sodium – 45.713 mg, citric acid – 3.325 mg, aspartame (E951) – 5.95 mg, magnesium stearate – 15.75 mg, orange flavor – 8.925 mg.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.
Chewable tablets (mint) 1.25 g+0.01 mg (400 IU): 30, 60, 90, 100 or 120 pcs.
Marketing Authorization Holder
Otisipharm, JSC (Russia)
Manufactured By
Pharmstandard-UfaVITA OJSC (Russia)
Dosage Form
|
Complivit® Calcium D3 Forte | Chewable tablets (mint) 1.25 g+0.01 mg (400 IU): 30, 60, 90, 100 or 120 pcs. |
Dosage Form, Packaging, and Composition
Chewable tablets (mint) from white to white with a creamy tint, round, biconvex, with a rough porous surface, with a characteristic odor; may have small inclusions of a grayish color.
| 1 tab. | |
| Calcium carbonate | 1.25 g, |
| Equivalent to calcium content | 500 mg |
| Colecalciferol (vit. D3)* | 0.01 mg (400 IU) |
* in the form of a granulate containing Colecalciferol – 0.27%, DL-α-tocopherol – 0.0275%, medium-chain triglycerides – 10.7%, sucrose – 36%, acacia gum – 22%, corn starch – 27%, calcium phosphate (E341) – 0.5%, water – up to 100%).
Excipients : lactose monohydrate – 333.118 mg, povidone (medium molecular weight polyvinylpyrrolidone, povidone K17) – 68.24 mg, polysorbate 80 – 1.731 mg, potato starch – 18.969 mg, croscarmellose sodium – 50.282 mg, citric acid – 3.325 mg, aspartame (E951) – 5.95 mg, magnesium stearate – 15.75 mg, peppermint leaf oil – 2.625 mg.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.
![Complivit® Calcium D3 Forte [Tablets] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Complivit® Calcium D3 Forte [Tablets] 2")