Metocal Vitamin D3 - Package Leaflet

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Active principles: Calcium carbonate, Vitamin D (Cholecalciferol)

Metocal Vitamin D3 Tablets - 1500mg + 4mg

01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the pack 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08.0 .09.0 MARKETING AUTHORIZATION NUMBER 10.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 11.0 DATE OF REVISION OF THE TEXT 12.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY XNUMX FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

METOCAL VITAMIN D3 600



02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One chewable tablet contains:

Calcium carbonate 1500 mg

Equivalent to calcium 600 mg

Concentrated cholecalciferol (powder) 4 mg

Vitamin D3 equivalent 10 mcg (400 IU)

Excipient:

Sucrose 1,54 mg

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Chewable tablets.


White flat tablets with a break mark and the letters C / D.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Correction of concomitant vitamin D and calcium deficiency states in elderly subjects.


Vitamin D and calcium supplement as an adjunct to specific therapies for the treatment of osteoporosis in individuals with known or high-risk concomitant calcium and vitamin D deficiency.

04.2 Posology and method of administration

Adults and the elderly

One chewable tablet twice a day (e.g. one tablet in the morning and one in the evening equivalent to 1200 mg of calcium and 800 IU of Vitamin D3).

A dose reduction should be considered necessary following the monitoring of calcium levels as indicated in sections 4.4 and 4.5.

Pregnant women

One chewable tablet per day (see section 4.6)

Dosage in cases of hepatic insufficiency

The dose does not require adjustments.

Dosage in cases of renal insufficiency

Dosage in patients with impaired renal function: METOCAL VITAMIN D3 600 MG / 400 IU chewable tablets should not be used in patients with severe renal insufficiency.

Chew the tablets and then swallow them with some liquid.

In exceptional cases (eg with disabled patients) the tablets can be dissolved in the mouth, after consulting the doctor.

The product is indicated for adults only.

04.3 Contraindications

- Hypersensitivity to the active substances or to any of the excipients (see section 6.1)


- Kidney failure

- Hypercalciuria and hypercalcemia and diseases and / or health conditions involving hypercalcemia and / or hypercalciuria (e.g. myeloma, bone metastases, primary hyperparathyroidism)

- Kidney stones (nephrolithiasis and nephrocalcinosis)

- Hyperavitaminosis D

04.4 Special warnings and appropriate precautions for use

In the case of prolonged treatment, it is justified to monitor blood calcium and renal function by determining serum creatinine levels. This control is particularly important in the elderly, in the case of concomitant treatment with cardiac glycosides and diuretics (see section 4.5) and in patients who are frequently prone to kidney stone formation. In the presence of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued. The dose should be reduced or treatment should be prematurely stopped if the calcium level in the urine exceeds 7.5 mmol / 24 hours (300 mg / 24 hours).


METOCAL VITAMIN D3 600 MG / 400 IU should be prescribed with caution to immobilized patients with osteoporosis, as it increases the risk of hypercalcaemia.

Before prescribing METOCAL VITAMIN D3 chewable tablets pay attention to the administration of Vitamin D, calcium and alkali such as carbonate from other sources (eg food supplements or foods). Since these products already contain Vitamin D and calcium carbonate, an additional administration of vitamin D or calcium carbonate can lead to Burnett's Syndrome (hypercalcemia, metabolic alkalosis, renal insufficiency and soft tissue calcification) it is therefore necessary to be under close medical supervision during therapy. with regular monitoring of calcium and calcium.


METOCAL VITAMIN D3 600 MG / 400 IU chewable tablets should be used with caution by patients suffering from sarcoidosis, as it is possible that the transformation of Vitamin D3 into its active form is increased.

Calcaemia and calciumuria should be monitored in these patients.

In patients with decreased renal function METOCAL VITAMIN D3 600 MG / 400 IU should be used with caution and calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be considered. In patients with severe renal insufficiency, vitamin D3 in the form of cholecalciferol is not metabolised in a normal way and other forms of vitamin D3 should be used (see section 4.3).

METOCAL VITAMIN D3 600 MG / 400 IU is not indicated in children and adolescents.

This product contains sucrose, therefore patients with rare hereditary conditions of fructose intolerance, glucose / galactose malabsorption, sucrose-isomaltase deficiency should not take this medicine.

Note for diabetics:

The amount of digestible carbohydrates in METOCAL VITAMIN D3 600 MG / 400 IU chewable tablets is 0.47 g per tablet. The daily dose of two tablets corresponds to 0.08 carbohydrate units (CU).


04.5 Interactions with other medicinal products and other forms of interaction

Thiazide diuretics reduce the excretion of calcium in the urine. Due to the increased risk of hypercalcaemia it is recommended to monitor calcium levels when thiazide diuretics are given concomitantly.

Systemic corticosteroids reduce calcium absorption.

In case of concomitant administration of corticosteroids, an increase in the dosage of METOCAL VITAMIN D3 600 MG / 400 IU may be necessary.

Orlistat, a combined treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil can reduce the gastrointestinal absorption of Vitamin D3. There should be an interval of at least two hours between the intake of ion exchange resins (eg cholestyramine) or laxatives and the chewable tablets of METOCAL VITAMIN D3 600 MG / 400 IU otherwise the absorption of Vitamin D3 is reduced.

Calcium carbonate can alter the absorption of tetracyclines when administered simultaneously. It is recommended to take tetracyclines at least 2 hours before or 4 or 6 hours after taking calcium by mouth.

Hypercalcaemia may increase the toxicity of cardiac glycosides, in the case of concomitant administration of calcium and vitamin D. Consequently these patients must be monitored constantly (ECG and calcium).

Rifampicin, phenytoin and barbiturates can reduce the effect of vitamin D3 as they increase its metabolism.

Calcium salts can decrease the absorption of iron, zinc or strontium. It is therefore recommended to take iron, zinc or strontium-based preparations two hours after taking calcium-based preparations.

Calcium salts can decrease the absorption of estramusin or thyroid hormones. Therefore, an interval of at least two hours should be observed between the administration of METOCAL VITAMIN D3 600 MG / 400 IU chewable tablets and these drugs.

In case of concomitant administration of bisphosphonates, sodium fluoride, or fluoroquinolones, it is recommended to take METOCAL VITAMIN D3 600 MG / 400 IU chewable tablets with an interval of at least 3 hours, as their absorption during digestion may be reduced.

Oxalic acid (present in spinach and rhubarb) and phytinic acid (present in cereals) can inhibit calcium absorption by forming an insoluble complex with calcium ions. Patients should therefore not take calcium-containing products in the two hours following the intake of foods rich in oxalic and phytinic acids.

04.6 Pregnancy and breastfeeding

Pregnancy

METOCAL VITAMIN D3 600 MG / 400 IU can be administered during pregnancy in case of calcium and Vitamin D3 deficiency.

During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. The daily dose must therefore not exceed one tablet.

In animal experiments, overdoses of vitamin D have shown toxic effects on reproduction.

Overdoses of vitamin D3 or calcium should be avoided during pregnancy since prolonged hypercalcemia can cause the infant to delay physical and mental development, supravalvular aortic stenosis and retinopathy.

There are no indications of the teratogenicity of Vitamin D3 at therapeutic doses in humans.

Feeding time

METOCAL VITAMIN D3 600 MG / 400 IU chewable tablets can be used during breastfeeding.

Calcium and vitamin D3 pass into breast milk. This must be considered when Vitamin D3 is concomitantly given to the baby.

In pregnancy and breastfeeding, calcium should be taken at least two hours after meals due to a possible reduction in iron absorption.

04.7 Effects on ability to drive and use machines

The effects of this medicine on the ability to drive are unknown. However, such effects are unlikely.

04.8 Undesirable effects

The assessment of undesirable effects is generally based on the following frequency conventions:

very common (≥ 1/10), common (≥ 1/100,

Immune system disorders:

Not known (incidence cannot be estimated from the available data):

Hypersensitivity reactions such as angioedema or larynx edema.

Metabolism and nutrition disorders

Uncommon (≥ 1/1000,

Diseases of the gastrointestinal system

Rare (≥ 1/10000, constipation, flatulence, bloating, abdominal distension, nausea, abdominal pain, diarrhea

Not known (incidence cannot be estimated from the available data): Vomiting

Skin and subcutaneous tissue disorders

Rare (≥ 1 / 10.000 in itching, rash and hives

04.9 Overdose

An overdose can cause hypervitaminosis and hypercalcemia. Symptoms of hypercalcaemia are: anorexia, thirst, nausea, vomiting, constipation, dehydration, abdominal pain, muscle weakness, fatigue, mental disorders, polydpsia, polyuria, bone pain, renal calcinosis, kidney stones, and in severe cases cardiac arrhythmia. Excessive hypercalcemia can lead to coma and death. Prolonged hypercalcemia can lead to irreversible kidney damage and soft tissue calcification.

Treatment of hypercalcemia: All calcium and vitamin D treatments should be discontinued. Treatments with diazide diuretics, lithium, vitamin A and cardiac glycosides should also be discontinued. Gastric lavage should be performed in unconscious patients.

The patient should be rehydrated and, depending on severity, considered isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids.

Serum electrolytes, renal function, and diuresis should be monitored. In severe cases, ECG and calcium should be monitored.

The limit for vitamin D intoxication in people with normal parathyroid function is between 40000 and 100000 IU per day for 1-2 months, while the limit for calcium is 2000 mg per day.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: mineral supplement, calcium in combination with other substances

(ATC Code): A12AX

Vitamin D supplement corrects insufficient vitamin D intake and increases intestinal absorption of calcium. The optimal daily dose of vitamin D in elderly subjects is 500-1000 IU. Calcium supplement corrects a deficiency of dietary calcium. The normal need for calcium in the elderly is 1500 mg per day. Vitamin D and calcium supplement corrects secondary senile hyperparathyroidism.

In an 18-month double-blind placebo-controlled study conducted on 3270 women of 84 ± 6 years, admitted to nursing homes, a supplement of Vitamin D3 (800 IU / day) and calcium phosphate (corresponding to 1299 mg / day of elemental calcium) showed a significant decrease in parathyroid hormone secretion. After 18 months, 80 hip fractures were detected in the calcium and vitamin D3 group and 110 hip fractures in the placebo group (P = 0,004). After 36 months of follow-up, at least one hip fracture was found in 137 women in the calcium and vitamin D3 group (n = 1176) versus 178 women in the placebo group (n = 1127) (p ≤ 0,02 , XNUMX)

05.2 Pharmacokinetic properties

Soccer

Absorption:

Calcium carbonate releases calcium ions into the stomach in a pH-dependent manner. Calcium absorbed in the gastrointestinal tract is 30% of that administered.

Distribution and metabolism:

99% of calcium is stored in the bones and teeth. The remaining 1% is found in intracellular and extracellular fluids.

Approximately 50% of total blood calcium is found in physiologically active ionized form, of which approximately 10% in complexes with citrate, phosphate, or other anions, 40% remains bound to plasma proteins, especially albumin.

elimination

Calcium is eliminated in faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium reabsorption through the tubules.

Vitamin D

Absorption:

Vitamin D is well absorbed from the small intestine.

Distribution and metabolism:

Cholecalciferol and its metabolites circulate in the blood bound to a specific alpha globulin. Cholecalciferol is metabolised in the liver via hydroxillation to the active form 25-hydroxycholecalciferol. It is then metabolised in the kidney to 1,25 di-hydroxycholecalciferol. The metabolite 1,25 di-hydroxycholecalciferol is responsible for the increase in calcium absorption.

Vitamin D3 that is not metabolized is stored in fat and muscle tissue.

elimination

Vitamin D3 is excreted through the faeces and urine.

The plasma half-life is of the order of several days.

05.3 Preclinical safety data

A teratogenic effect has been observed in animals at much higher dosages than therapeutic doses in humans.

There is no additional product safety information beyond what is reported in this summary of product characteristics.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Xilitolo,

Mannitolo (E421)

Magnesium stearate

Anhydrous colloidal silica

Pregelatinised maize starch

Idrossitoluene butylated (E321)

Medium-chain triglycerides

Sucrose

Gelatin

Modified corn starch

Sodium aluminum silicate

Flavors (All fruits 77919-31 Givaudan: allyhexanoate, amyl- / isoamylbutyrate, ethylacetate, ethylbutyrate, ethylvanillin, geraniol, isoamylacetate,? -Ionone, maltodextrin, propylene glycol).

06.2 Incompatibility

Not relevant.

06.3 Period of validity

30 months.

06.4 Special precautions for storage

Do not store above 25 ° C

06.5 Nature of the immediate packaging and contents of the package

PVC / PVDC / Aluminum blisters each containing 10 chewable tablets

Packs of 20, 30, 50, 60, 100, 300 chewable tablets

Not all pack sizes may be marketed.

06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

Madaus GmbH - 51101 Colonia - Germany

Dealer for sale: TEOFARMA srl - Via F.lli Cervi, 8 - 27010 Valle Salimbene (PV)

08.0 MARKETING AUTHORIZATION NUMBER

METOCAL VITAMIN D3 20 chewable tablets AIC: 035027010 / M

METOCAL VITAMIN D3 30 chewable tablets AIC: 035027022 / M

METOCAL VITAMIN D3 60 chewable tablets AIC: 035027034 / M

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

Date of first authorization:

April 6 2001

10.0 DATE OF REVISION OF THE TEXT

2011 August

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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