Accrete D3

Accumulate D3 Once a Day 1000 mg / 880 IU Chewable Tablets

Each chewable tablet contains:

2500 mg of calcium carbonate (equivalent to 1000 mg of calcium).

8.8 mg of colecalciferol concentrate (powder form) (equivalent to 22 mcg of colecalciferol = 880 IU of vitamin D₃).

Excipients:

Each chewable tablet contains 1.00 mg of aspartame (E951), 119.32 mg of sorbitol (E420), 370.00 mg of isomalt (E953), and 1.694 mg of sucrose.

Chewable tablet.

A round white tablet with a flawless surface and a tear mark.

The tablet can be divided into equal halves.

Accretion of D3 One chewable tablet per day is indicated:

- for the prevention and treatment of vitamin D and calcium deficiency in the elderly

- as a vitamin D and calcium supplement as an adjunct to the specific treatment of osteoporosis in patients at risk of vitamin D and calcium deficiency.

Dosage

Adults and the elderly

1 chewable tablet per day (corresponds to 1000 mg of calcium and 880 IU of vitamin D).

Dosage for liver failure

No dose adjustment is required

Dosage for renal failure

Increase D3 by one chewable tablet per day should not be used in patients with severe renal insufficiency.

Dosage during pregnancy

During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 mg of vitamin D₃ Therefore, the daily dose should not exceed half of the tablet.

Method of application

Oral administration.

Accumulate D3 One chewable tablet a day at any time, with or without food. Chewable tablets should be chewed and swallowed.

Accret D3, one chewable tablet per day, is not intended for use in children or adolescents.

- Hypersensitivity to active substances or to any of the excipients

- Hypercalciuria and hypercalcemia, as well as diseases and / or conditions that lead to hypercalcemia and / or hypercalciuria (for example, myeloma, bone metastases, primary hyperparathyroidism, prolonged immobilization accompanied by hypercalciuria and / or hypercalcemia).

- Nephrolithiasis

- Nephrocalcinosis

- Hypervitaminosis D

- Severe renal failure

Due to the high content of vitamin D in it, the use in children or adolescents is not indicated.

During long-term treatment, serum calcium levels should be monitored and kidney function monitored by measuring serum creatinine levels. Monitoring is particularly important in patients receiving concomitant treatment with cardiac glycosides or thiazide diuretics, as well as in patients with a high tendency to stone formation. In the case of hypercalcemia or signs of impaired renal function, if the excretion of calcium in the urine exceeds 300 mg/24 hours (7.5 mmol/24 hours), the dose should be reduced or treatment should be discontinued.

Vitamin D should be used with caution in patients with impaired renal function and its effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolized normally, and other forms of vitamin D should be used.

Increase D3 One chewable tablet a day should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D in its active form. These patients should be monitored for serum and urine calcium levels.

Accrete D3 one chewable tablet per day with caution in immobilized patients with osteoporosis due to the increased risk of hypercalcemia.

The content of vitamin D (880 IU) in increted D3, one chewable tablet per day, should be taken into account when prescribing other medications containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases, it is often necessary to monitor the level of calcium in the blood serum and the excretion of calcium in the urine.

Concomitant use with tetracyclines or quinolones is usually not recommended or should be carried out with caution.

This medication contains aspartame (E951), a source of phenylalanine that can be harmful to people with phenylketonuria. It also contains sorbitol (E420), isomalt (E953), and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency should not take this drug.

Thiazide diuretics reduce the excretion of calcium in the urine. Due to the increased risk of hypercalcemia, serum calcium levels should be regularly monitored with the simultaneous use of thiazide diuretics.

Systemic corticosteroids reduce the absorption of calcium. In addition, the effect of vitamin D may be reduced. With simultaneous use, it may be necessary to increase the dose of Accreta D3 by one chewable tablet per day.

Concomitant treatment with phenytoin or barbiturates may reduce the effect of vitamin D due to metabolic activation.

Concomitant treatment with ion-exchange resins, such as cholestyramine, or laxatives, such as paraffin oil, can reduce the gastrointestinal absorption of vitamin D. Therefore, it is recommended to use as long a time interval between doses as possible.

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole grains) can inhibit calcium absorption by forming insoluble compounds with calcium ions. The patient should not take calcium products for two hours after eating foods high in oxalic and phytic acids.

Calcium carbonate may interfere with the absorption of simultaneously administered tetracycline drugs. For this reason, tetracycline drugs should be administered at least two hours before or four to six hours after oral calcium intake.

Hypercalcemia may increase the toxicity of cardiac glycosides when treated with calcium and vitamin D. Patients should be monitored taking into account the electrocardiogram (ECG) and the level of calcium in the blood serum.

With simultaneous use of bisphosphonate or sodium fluoride, this drug should be administered at least three hours before taking Accrete D3 chewable tablets, one per day, as gastrointestinal absorption may be reduced.

The effectiveness of levothyroxine may be reduced with the simultaneous use of calcium due to a decrease in the absorption of levothyroxine. The administration of calcium and levothyroxine should be separated for at least four hours.

The absorption of quinolone antibiotics may be impaired when used concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after taking calcium.

Pregnancy

If you are deficient in calcium and vitamin D, you can use Accrete D3 chewable tablets once a day during pregnancy. During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 mg of vitamin D₃ Therefore, the daily dose should not exceed half of the tablet.

In animal experiments, an overdose of vitamin D has been shown to have a teratogenic effect.

In pregnant women, overdose of calcium and vitamin D should be avoided, as long-term hypercalcemia is sometimes associated with delayed physical and mental development, supravalvular aortic stenosis and retinopathy in the child.

Breastfeeding

Accumulate D3 one chewable tablet per day while breastfeeding. Calcium and vitamin D₃ switch to breast milk. This should be taken into account when adding vitamin D to the child.

Fecundity

No data available.

The accumulation of D3 on one chewable tablet per day does not affect the ability to drive a car and use cars.

The evaluation of adverse reactions is based on the following determination of the frequency:

Immune system disorders

Unknown (cannot be evaluated from available data): Hypersensitivity reactions, such as angioedema or laryngeal edema.

Metabolic and nutritional disorders

Infrequently: Hypercalcemia, hypercalciuria.

Gastrointestinal disorders

Rarely: Nausea, diarrhea, abdominal pain, constipation, flatulence, bloating.

Diseases of the skin and subcutaneous tissue

Rarely: Rash, itching, urticaria.

Special patient groups

Impaired renal function

Patients with impaired renal function are at increased risk of hyperphosphatemia, nephrolithiasis, and nephrocalcinosis.

Overdose can lead to hypervitaminosis and hypercalcemia. Symptoms of hypercalcemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, kidney stones, and in severe cases, cardiac arrhythmias. Extreme hypercalcemia can lead to coma and death. Persistently high levels of calcium can lead to permanent kidney damage and soft tissue calcification.

Treatment of hypercalcemia: Treatment with calcium and vitamin D should be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D, and cardiac glycosides should also be discontinued. Gastric emptying in patients with impaired consciousness. Rehydration, as well as, depending on the severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, kidney function, and diuresis should be monitored. In severe cases, ECG and KVP should be performed.

Pharmacotherapy Group:

Combination of calcium with other drugs, PBX code A12AX

Mechanism of action

Accrete D3 One chewable tablet per day is a fixed combination of calcium and vitamin D₃ High content of calcium and vitamin D₃ the concentration in each dose unit provides sufficient calcium absorption at a limited number of doses. vitamin D₃ participates in calcium-phosphorus metabolism. It provides active absorption of calcium and phosphorus from the intestine and their assimilation by the bone. Calcium and Vitamin D supplements₃ corrects latent vitamin D deficiency and secondary hyperparathyroidism.

Pharmacodynamic effects

In an 18-month, double-blind, placebo-controlled trial involving 3,270 women aged 84+ 6 years and living in nursing homes, supplemented with calcium cholecalciferol (800 IU/day) (1.2 g/day), there was a significant decrease in PTH secretion. After 18 months, the results of the intent to treat analysis showed 80 hip fractures in the calcium and vitamin D group and 110 hip fractures in the placebo group (p=0.004). In this study, the treatment of 1387 women prevented 30 hip fractures.. After 36 months of follow-up, 137 women had at least one hip fracture in the calcium and vitamin D group (n=1176) and 178 in the placebo group (n=1127) (p≠‰ 0.02)

Calcium

Takeover

30-40% of the ingested dose of calcium is absorbed, mainly in the proximal small intestine.

Distribution and biotransformation

99% of the calcium in the body is concentrated in the mineral component of bones and teeth. The remaining 1% is present in intracellular and extracellular fluids. About 50% of the total calcium content in the blood is in the physiologically active ionized form, and about 5% - in combination with citrate, phosphate or other anions. The remaining 45% is associated with proteins, mainly albumin.

Elimination

Calcium is excreted in the urine, feces, and sweat. Urinary excretion depends on glomerular filtration and tubular resorption.

vitamin D₃

Takeover

vitamin D₃ it is absorbed in the intestine.

Distribution and biotransformation

vitamin D₃ it is transported by binding the protein in the blood to the liver (where it undergoes first hydroxylation to 25-hydroxycholecalciferol) and to the kidneys (second hydroxylation to 1,25-dihydroxycholecalciferol, the active metabolite of vitamin D₃).

Non-hydroxylated Vitamin D₃ it is stored in muscle and adipose tissues.

Elimination

The plasma half-life is on the order of several days, vitamin D₃ it is excreted in the feces and urine.

At doses significantly exceeding the human therapeutic range, teratogenicity has been observed in animal studies. There is no other relevant data that is not mentioned in other sections of the SmPC.

Isomalt (E953)

Xylitol

Sorbitol (E420)

Citric acid, anhydrous

Sodium Dihydrophosphate Citrate

Magnesium Stearate

Sodium carmellose

Orange flavor " CPB "(contains natural orange oil concentrate, natural / natural identical tangerine oil, natural / natural identical liquid tropical fruit flavor, natural / natural identical orange oil, natural / natural identical solid multifruit flavor, mannitol (E421), maltodextrin, gluconolactone, sorbitol (E420))

Orange flavor " CVT "(contains natural orange oil, natural tangerine oil, natural identical powder flavor orange, mannitol (E421), gluconolactone, sorbitol (E420), medium chain triglyceride)

Aspartame (E951)

Acesulfame potassium

Sodium Ascorbate

All-rac-alpha-tocopherol

Modified (corn) starch

Sucrose

Medium chain Triglycerides

Colloidal silicon dioxide

Unsuitable.

2 years

For the pill container:

Keep the pill container tightly closed to protect it from moisture.

For strips: This drug does not require special storage conditions.

Chewable tablets are available in polypropylene tablet containers with polyethylene stoppers containing desiccant, in the following package sizes:

10, 20, 28, 30, 40, 50, 56, 60, 90, 100 (complete package 5x20) chewable tablets

Chewable tablets are available in strips of laminated aluminum paper foil of the following sizes:

10, 20, 28, 30, 40, 48, 56, 60, 60 (packaging 2x30), 90, 90 (packaging 3x30), 96, 100 (packaging 5x20) and 120 chewable tablets

Not all package sizes can be sold.

No special requirements.

Sandoz Society

Frimley Business Park,

Frimley,

Camberley,

Light double carriage,

WATT GU16 7SR.

United Kingdom

PL 04416/1318

19/12/2011

12/01/2017