Composition, form of production and packaging
? The tablets are effervescent round, flat, with a bevelled edge, from white to almost white, with a weak specific odor; tablets have a slightly rough surface.
1 tab.
calcium carbonate 875 mg
calcium lactogluconate 1132 mg,
which corresponds to a Ca 2+ content of 500 mg (12.5 mmol)
Auxiliary substances: citric acid - 1662 mg, macrogol 6000 - 125 mg, orange flavoring - 30 mg (orange flavor contains sulfur dioxide (E220), butyl hydroxy anisole (E320), sorbitol), aspartame 30 mg, sodium hydrogen carbonate 250 mg.
10 pieces. - polypropylene containers (1) - cardboard packs.
20 pcs. - polypropylene containers (1) - cardboard packs.
? The tablets are effervescent round, flat, with a bevelled edge, from white to almost white, with a weak specific odor; tablets have a slightly rough surface.
1 tab.
calcium carbonate 1750 mg
calcium lactogluconate 2263 mg,
which corresponds to a Ca 2+ content of 1000 mg (25 mmol)
Auxiliary substances: citric acid - 3323 mg, macrogol 6000 - 250 mg, orange flavoring - 30 mg (orange flavor contains sulfur dioxide (E220), butyl hydroxy anisole (E320), sorbitol), aspartame 30 mg, sodium hydrogen carbonate 500 mg.
10 pieces. - polypropylene containers (1) - cardboard packs.
20 pcs. - polypropylene containers (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Calcium preparation for oral administration. Calcium is a vital mineral element necessary to maintain the balance of electrolytes in the body and the adequate functioning of numerous regulatory mechanisms. It replenishes Ca 2+ deficiency in the body, participates in phosphate-calcium metabolism, renders vitamin, anti-cancer, anti-inflammatory and anti-allergic effects.
Calcium-SandozВ® Forte contains two calcium salts (calcium lactogluconate and calcium carbonate), which in the form of effervescent tablets quickly dissolve in water, becoming an active ionized form of calcium, which is easily digested. This dosage form provides an adequate intake of calcium in the body in the form of a tasty drink and is designed to prevent and treat acute and chronic calcium deficiency in the body, as well as to treat various types of metabolic disorders in bone tissue.
PHARMACOKINETICS
Suction
Approximately 25-50% of the ingested dose of calcium is absorbed mainly in the proximal part of the small intestine and enters the calcium exchange depots.
Distribution and Metabolism
99% of the calcium reserves in the body are found in bones and teeth, 1% is in the composition of intra- and extracellular fluid. Approximately 50% of the total calcium content in the blood is present in a physiologically active ionized form, about 5% forms complexes with citrate, phosphate and other anions. The remaining 45% of calcium in the serum binds to proteins, mainly albumin.
Excretion
About 20% of calcium is excreted through the kidneys and 80% through the intestine. The level of excretion through the kidneys depends on the glomerular filtration and tubular reabsorption. Through the intestine, both unabsorbed calcium and its absorbed part are excreted, which is secreted with bile and pancreatic secretion.
INDICATIONS
- prevention and treatment of calcium deficiency (including pregnancy, lactation, a period of intensive growth in children);
- the addition of calcium to specific therapy for the prevention and treatment of osteoporosis;
- Allergic reactions (maintenance therapy);
- osteomalacia (as an adjunct to the main therapy, including vitamin D 3 ).
DOSING MODE
Inside, regardless of food intake. Before taking the tablet, dissolve in a glass of water.
Children aged 3 to 9 years - 500 mg / day, adults and children from 10 years - 1000 mg / day.
In severe cases or with increased demand for calcium (for example, with bisphosphonates), an increase in the dose to 2000 mg / day is possible.
Prevention and treatment of osteoporosis: children aged 3 to 9 years - 500 mg / day, adults and children from 10 years - 1000 mg / day.
Duration of therapy: when applied to compensate for calcium deficiency, the average duration of treatment is at least 4-6 weeks. When used for prevention in the complex therapy of osteoporosis, the duration of treatment is determined individually.
SIDE EFFECT
Very rarely (<1/10 000): hypersensitivity reactions, incl. rash, itching, hives, hypercalcemia. In isolated cases it was reported about systemic allergic reactions (anaphylactic reactions, facial swelling, angioedema edema). Some medical publications reported the development of hypercalciuria on the background of calcium supplements.
Rarely (> 1/10 000, <1/1000): flatulence, constipation, diarrhea, nausea, vomiting, epigastric pain.
When taken in high doses (2000 mg / day with daily intake for several months), there may be headache, fatigue, thirst, polyuria.
CONTRAINDICATIONS
- hypercalcemia;
- hypercalciuria;
- chronic renal failure;
- nefrourolitiaz;
- nephrocalcinosis;
- phenylketonuria;
- deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption;
- Hypersensitivity to the components of the drug.
Calcium Sandoz В® Forte is not recommended for use in children under 3 years of age due to lack of data on efficacy and safety in this category of patients.
PREGNANCY AND LACTATION
The drug can be administered during pregnancy and breastfeeding on the recommendation of a doctor. Calcium enters the breast milk.
In pregnancy, the daily dose of calcium should not exceed 1500 mg. Hypercalcemia in pregnancy can cause disturbances in the development of the fetus.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe renal failure
In patients with mild or moderate impairment of renal function, and if there is a history of urolithiasis, regular monitoring of calcium excretion in the urine is required. If necessary, reduce the dose of the drug or cancel it.
APPLICATION FOR CHILDREN
The preparation of Calcium Sandoz В® Forte is not recommended for use in children under the age of 3 due to the lack of data on efficacy and safety in this category.
SPECIAL INSTRUCTIONS
Patients with minor hypercalciuria (exceeding 300 mg or 7.5 mmol / day), with mild or moderate renal impairment, and with a history of urolithiasis, require regular monitoring of urinary calcium excretion. If necessary, reduce the dose of the drug or cancel it. Patients with a tendency to form concrements in the urinary tract are encouraged to increase fluid intake.
In patients with impaired renal function, calcium salt intake should be performed under medical supervision. It is necessary to monitor the levels of calcium and phosphate in the blood serum.
When treating calcium drugs should avoid taking vitamin D or its derivatives in high doses, unless there is special evidence for this.
Patients on a diet with salt restriction should take into account the sodium content in effervescent tablets:
- 1 tablet of effervescent 500 mg contains 2.976 mmol (corresponding to 68.45 mg) of sodium;
- 1 tablet of effervescent 1000 mg contains 5.95 mmol (corresponding to 136.90 mg) of sodium.
Information for patients with diabetes mellitus
1 effervescent tablet contains 0.002 XE, so the drug can be used in patients with diabetes mellitus.
Special precautions when destroying an unused preparation
There is no need for special precautions when destroying an unused preparation of Calcium Sandoz В® Forte.
Impact on the ability to drive vehicles and manage mechanisms
The preparation of Calcium Sandoz В® Forte does not affect the ability to drive or work with machinery.
OVERDOSE
Overdose leads to the development of hypercalciuria and hypercalcemia. Symptoms of hypercalcemia: nausea, vomiting, thirst, polydipsia, polyuria, dehydration and constipation.
Chronic overdose in the development of hypercalcemia can lead to liming vessels and organs. The threshold of calcium intoxication - with the intake of calcium preparations for several months at a dose exceeding 2000 mg / day.
Therapy in case of an overdose
In case of intoxication, immediately stop therapy and restore the water-electrolyte balance.
In chronic overdose, if there are signs of hypercalcemia at the initial stage, hydration is performed with the help of 0.9% sodium chloride solution. To enhance the excretion of calcium, as well as to avoid edema in the tissues (for example, with congestive heart failure), loop diuretics, such as furosemide, can be used. In this case, one should refrain from the use of thiazide diuretics.
In patients with renal insufficiency, hydration is ineffective, such patients are shown dialysis. In the case of persistent hypercalcemia, it is necessary to exclude other factors contributing to its development, incl. hypervitaminosis of vitamin A or D, primary hyperparathyroidism, malignant tumors, renal failure, stiffness of movements.
DRUG INTERACTION
The combination of calcium carbonate + calcium lactogluconate can reduce the absorption of estramustine, etidronate, and possibly other bisphosphonates, phenytoin, quinolones, oral tetracycline antibiotics, and fluoride preparations. The interval between the intake of tablets of effervescent calcium carbonate + calcium lactogluconate and the above preparations should be at least 3 hours.
Simultaneous administration of vitamin D and its derivatives increases the absorption of calcium. When administered in high doses along with vitamin D and its derivatives, calcium can reduce the effects of verapamil and possibly other calcium channel blockers.
With the simultaneous use of tablets of effervescent calcium carbonate + calcium lactogluconate and preparations of the tetracycline series, absorption of the latter may be impaired. For this reason, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after ingestion of calcium preparations.
Thiazide diuretics reduce the excretion of calcium in the urine, so when they are simultaneously used with effervescent calcium carbonate + calcium lactogluconate tablets, regular monitoring of serum calcium should be performed because there is a risk of developing hypercalcemia.
Systemic corticosteroids reduce absorption of calcium. At their simultaneous application it may be necessary to increase the dose of tablets of effervescent calcium carbonate + calcium lactogluconate.
When ingested calcium carbonate + calcium lactogluconate tablets in patients receiving cardiac glycosides, an increase in the toxicity of cardiac glycosides is possible due to the development of hypercalcemia. Such patients should regularly take ECG and monitor the level of calcium in the blood serum.
With the simultaneous ingestion of bisphosphonate or sodium fluoride, these preparations should be taken at least 3 hours prior to the reception of the tablets of effervescent calcium carbonate + calcium lactogluconate, since absorption from the gastrointestinal tract bisphosphonate or sodium fluoride can decrease.
Absorption of calcium from the gastrointestinal tract may decrease with the simultaneous intake of certain foods containing oxalic acid (for example, spinach, rhubarb) or phytic acid (in all cereals), in connection with the formation of insoluble complexes with calcium ions. Patients should not take effervescent calcium carbonate + calcium lactogluconate tablets 2 hours before or after eating a meal rich in oxalic or phytic acid.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a tightly closed case at a temperature of no higher than 30 В° C. Shelf life - 3 years.
