Calcium Sandoz Forte - instructions for use, dose, side effects, contraindications

Active substanceCalcium carbonate + Calcium lactogluconateCalcium carbonate + Calcium lactogluconate

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Dosage form: & nbsptablets, effervescent

Composition:

In 1 tablet of effervescent 500 mg contains:

Active substances: calcium lactogluconate 1132.00 mg and calcium carbonate 875.00 mg, which is equivalent to 500 mg or 12.5 mmol of ionized calcium.

Excipients: citric acid 1662.00 mg, macrogol-6000 125.00 mg, orange flavoring 30.00 mg (orange flavoring contains sulfur dioxide (E220), butylhydroxyanisole (E320), sorbitol), aspartame 30.00 mg, sodium hydrogen carbonate 250.00 mg.

In 1 tablet of effervescent 1000 mg contains:

Active substances: calcium lactogluconate 2263.00 mg and calcium carbonate 1750.00 mg, which is equivalent to 1000 mg or 25 mmol ionized calcium.

Excipients: citric acid 3323.00 mg, macrogol-6000 250.00 mg, orange flavoring 30.00 mg (orange flavoring contains sulfur dioxide (E220), butyl hydroxy anisole (E320), sorbitol), aspartame 30.00 mg, sodium hydrogen carbonate 500.00 mg.

Description:Round flat tablets with beveled edges, from white to almost white, with a weak specific odor. Tablets have slightly rough surface.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

ATX: & nbsp

A.12.A.A.20 The combination of different calcium salts

Pharmacodynamics:

Calcium is a vital mineral element necessary for maintaining the balance of electrolytes in the body and adequate functioning numerous regulatory mechanisms. Replenishes the deficit of Ca²⁺ in the body, is involved in phosphate-calcium exchange, renders vitamin, anti-cancer, anti-inflammatory and antiallergic effect. Calcium Sandoz® Forte contains two calcium salts (calcium lactogluconate and calcium carbonate), which in the form of effervescent tablets dissolve rapidly in water, in 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, approximately 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 % 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 D3.)

Contraindications:

Hypersensitivity to the components of the drug,elevated calcium concentration in blood and urine (hypercalcemia, hypercalciuria), chronic renal failure, nephrourolythiasis, nephrocalcinosis, phenylketonuria and sucrose deficiency / isomaltoses, fructose intolerance, glucose-galactose malabsorption. The preparation of Calcium Sandoz® 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.

Pregnancy and lactation:

The drug can be administered during pregnancy and breastfeeding on the recommendation of a doctor. Calcium enters the breast milk. During pregnancy, the daily dose of calcium should not exceed 1500 mg.

Hypercalcemia during pregnancy can cause disturbances in the development of the fetus.

Dosing and Administration:

Inside, regardless of food intake.

Before taking the tablet, dissolve in a glass of water.

- Children from 3 to 9 years: 500 mg per day.

- Adults and children from 10 years: 1000 mg per day.

In severe cases or with an increased need for calcium (for example, in the treatment of bisphosphonates), it is possible to increase the dose to 2000 mg per day.

Prevention and treatment of osteoporosis:

- Children from 3 to 9 years: 500 mg per day.

- Adults and children from 10 years: 1000 mg per 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 complex therapy of osteoporosis, the duration of treatment is determined individually.

Side effects:

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 / 1,000): 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.

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 may have led to the liming of 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 is evidence of hypercalcemia at the initial stage, hydration with 0.9 % solution of sodium chloride. To increase the excretion of calcium, as well as to avoid edema in the tissues (for example, with congestive heart failure), loop diuretics can be used, for example, furosemide. 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, other factors contributing to its development should be excluded, including hypervitaminosis of vitamin A or D, primary hyperparathyroidism, malignant tumors, renal failure, stiffness of movements.

Interaction:

Combination 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 effervescent tablets calcium carbonate + calcium lactogluconate & and the above preparations should be at least 3 hours.

Simultaneous administration of vitamin A 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 action of verapamil and, possibly, other calcium channel blockers.

At simultaneous application of tablets effervescent calcium carbonate + calcium lactogluconate & and tetracycline drugs may be impaired absorption of the latter. 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 used simultaneously with effervescent tablets calcium carbonate + calcium lactogluconate & should regularly monitor the concentration of calcium in the blood serum,because there is a risk of hypercalcemia.

Systemic corticosteroids reduce absorption of calcium. At their simultaneous application it may be necessary to increase the dose of effervescent tablets calcium carbonate + calcium lactogluconate &.

When ingested tablets of effervescent calcium carbonate + calcium lactogluconate & in patients receiving cardiac glycosides, it is possible to increase the toxicity of cardiac glycosides 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 drugs should be taken at least 3 hours before taking the effervescent tablets calcium carbonate + calcium lactogluconate &, as absorption from the gastrointestinal tract (GIT) of the bisphosphonate or sodium fluoride can be reduced.

Calcium absorption 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) due to the formation of insoluble complexes with calcium ions. Patients should not take effervescent tablets calcium carbonate + calcium lactogluconate & 2 hours before or after a meal rich in oxalic or phytic acid.

Special instructions:

In patients with minor hypercalciuria (exceeding 300 mg / 24 hours or 7.5 mmol / day), with little or moderate renal impairment, and with anamnestic indications of urolithiasis, regular monitoring of calcium excretion in the urine is required. If necessary, reduce the dose of the drug or cancel it. Patients with a tendency to form concrements in the urinary tract are recommended 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 large doses of vitamin A D or its derivatives, if there is no special indication for this.

Patients on a low-salt diet should take into account the sodium content in 1 tablet effervescent calcium carbonate + calcium lactogluconate &:

Calcium carbonate + calcium lactogluconate &, effervescent tablets 500 mg, contain 2.976 mmol (corresponding to 68.45 mg) of sodium in one tablet.

Calcium carbonate + calcium lactogluconate &, effervescent tablets 1000 mg, contain 5.95 mmol (equivalent to 136.90 mg) of sodium in one tablet.

Information for patients with diabetes:

One effervescent tablet calcium carbonate + calcium lactogluconate & contains 0.002 bread units, so the drug can be used in patients with diabetes mellitus.

Special precautions for the destruction of unused medicinal product.

There is no need for special precautions for the destruction of the unused preparation of Calcium Sandoz® Forte.

Effect on the ability to drive transp. cf. and fur:The preparation of Calcium Sandoz® Forte does not affect the ability to drive or work with machinery.

Form release / dosage:

Tablets effervescent 500 mg, 1000 mg.

Packaging:For 10 or 20 tablets in a polypropylene case, capped with a polypropylene cover containing silica gel and equipped with a first-opening control system. The pencil case together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 30 ° C in a tightly closed pencil case.

Keep out of the reach of children.

Shelf life:

3 years.

The drug should not be used after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000343

Date of registration:22.02.2011

The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia

Manufacturer: & nbsp

FAMAR ORLEANS France

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp10.09.2015

Illustrated instructions

Instructions

Calcium Sandoz® Forte (Calcium-Sandoz® forte)