Vigantol 1000 I.E. Vitamin D3 (200 Tablets)

For prevention when there is a recognizable risk of vitamin D deficiency

VIGANTOL 1000 IE has long proven itself in the prevention of vitamin D deficiency and for the supportive treatment of osteoporosis and rickets prophylaxis. 

The vitamin D3 tablets are used to prevent rickets, when there is a recognizable risk of vitamin D deficiency in otherwise healthy people without resorption disorders, and for the supportive treatment of osteoporosis (breakdown of bone tissue).

Application:

Take 1/2 to 1 tablet per day with sufficient water.

active ingredients

• 0.03 mg Colecalciferol

excipients

• Magnesium stearate
• Silica, colloidal
• Cellulose, microcrystalline
• starch, modified
• Carboxymethyl Starch, Sodium Type C
• Mannitol
• Triglycerides, medium chain
• Sodium ascorbate
• Sucrose
• cornstarch
• DL-α-Tocopherol
• Talc

- prevention of rickets
- prevention of softening of bones (osteomalacia)
- prevention of vitamin D deficiency
- osteoporosis (bone loss)

The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Older children and adults: Take the medicine with liquid (eg 1 glass of water). Infants and young children: Dissolve the medicine on a teaspoon in a small amount of water. The dissolved tablet can be given directly to the child's mouth.

Duration of use?
The duration of use depends on the type of complaint and/or duration of the illness and is therefore only determined by your doctor. To prevent rickets, infants receive the medicine from the 2nd week of life until the end of the 1st year of life. Additional doses are recommended from the age of two, especially in the winter months.

overdose?
An overdose can lead, among other things, to increased calcium levels in the blood with cardiac arrhythmias, thirst, dehydration, powerlessness or weakness, disturbances of consciousness and calcium deposits in vessels and tissues. If you suspect an overdose, contact a doctor immediately.

In general, pay attention to a conscientious dosage, especially for babies, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.

Indication

• The medicinal product is a vitamin preparation: it contains colecalciferol (equivalent to vitamin D3).
• It is applied:
  • For the prevention of rickets (calcification disorders of the skeleton during growth) and osteomalacia (softening of the bones in adults)
  • For the prevention of rickets (calcification disorders of the skeleton during growth) in premature babies
  • For the prevention of a recognizable risk of vitamin D deficiency disease in otherwise healthy people without resorption disorders (disorder of the absorption of vitamin D in the intestine) in children and adults
  • For the supportive treatment of osteoporosis (breakdown of bone tissue) in adults

Dosage:

• Always take the medicine exactly as your doctor has told you. Please check with your doctor or pharmacist if you are not sure.
• Unless otherwise prescribed by the doctor, the usual dose is:
  • To prevent rickets, take ½ tablet daily (equivalent to 0.0125 mg or 500 IU of vitamin D).
  • The dosage is to be determined by the attending physician. In general, 1 tablet daily (equivalent to 0.025 mg or 1000 IU of vitamin D) is recommended for the prevention of rickets in premature babies.
  • For prevention of a recognizable risk of vitamin D deficiency, take ½ tablet daily (equivalent to 0.0125 mg or 500 IU of vitamin D).
  • For the supportive treatment of osteoporosis, 1 tablet daily (equivalent to approx. 0.025 mg or 1000 IU of vitamin D).
• Daily doses over 500 IU/d
  • During long-term treatment, blood and urine calcium levels should be monitored regularly and renal function should be checked by measuring serum creatinine. If necessary, a dose adjustment should be made according to the blood calcium levels.
• duration of use
  • Infants receive from the second week of life until the end of the first year of life. In the second year of life further doses are recommended, especially during the winter months.
  • Please ask your doctor about the necessary duration of use!
  • Please talk to your doctor or pharmacist if you have the impression that the effect of is too strong or too weak.
• If you take more than you should
  • Daily doses up to 500 IU/d
    • a) Symptoms of overdose
      • Long-term overdose of vitamin D can lead to hypercalcaemia (increased calcium concentration in the blood) and hypercalciuria (increased calcium concentration in the urine). If the requirement is exceeded significantly and for a long time, calcification of organs can occur.
    • b) Therapeutic measures in case of overdose
      • Symptoms of a chronic overdose of vitamin D may require an increase in urination and the administration of glucocorticoids (medicines used to treat certain allergic diseases) and calcitonin (hormone that regulates the concentration of calcium in the blood).
  • Daily doses over 500 IU/d
    • a) Symptoms of overdose
      • Ergocalciferol (vitamin D2) and colecalciferol (vitamin D3) only have a relatively narrow therapeutic index. In adults with normal parathyroid function, the threshold for vitamin D intoxication is between 40,000 and 100,000 IU per day for 1 to 2 months. Babies and young children can be sensitive to much lower doses.
      • Therefore, a warning is given against taking vitamin D without medical supervision.
      • In the case of an overdose, in addition to an increase in phosphorus in the blood and urine, hypercalcaemia syndrome (increased calcium concentration in the blood) occurs, which later also leads to calcium deposits in the tissues and especially in the kidneys (kidney stones and kidney calcification) and the vessels.
      • The symptoms of intoxication are not very characteristic and are expressed in nausea, vomiting, initially often diarrhea, later constipation (constipation), loss of appetite, exhaustion, headache, muscle and joint pain, muscle weakness and persistent drowsiness, azotemia (increased nitrogen concentration in the blood), increased thirst, increased urge to urinate and in the final phase dehydration. Typical laboratory findings are hypercalcaemia (increased calcium concentration in the blood), hypercalciuria (increased calcium concentration in the urine) and increased serum values ​​for 25-hydroxycalciferol.
    • b) Therapeutic measures in case of overdose
      • In the event of an overdose, measures to treat the often long-lasting and potentially dangerous hypercalcaemia (increased calcium concentration in the blood) are required.
      • The first step is to stop taking the vitamin D preparation; normalization of hypercalcaemia (increased calcium concentration in the blood) as a result of vitamin D intoxication takes several weeks.
      • Graded according to the extent of the hypercalcaemia (increased calcium concentration in the blood), calcium-poor or calcium-free nutrition, copious fluid intake, increased urination with the drug furosemide and the administration of glucocorticoids (medicines to treat certain allergic diseases) and calcitonin (hormone to regulate the Calcium concentration in the blood) can be used.
      • With sufficient kidney function, infusions with isotonic sodium chloride solution (3 - 6 l in 24 hours) with the addition of furosemide (medicine to increase urine excretion) and possibly also 15 mg/kg body weight/hour Sodium edetate (medicine that binds calcium in the blood) reliably reduces calcium under continuous calcium and ECG monitoring. In the case of reduced urine excretion, on the other hand, hemodialysis treatment (blood washing) with a calcium-free dialysate is indicated.
      • There is no specific antidote. Please ask your doctor about the symptoms of a vitamin D overdose.
• If you forget to take a dose
  • If you have taken too little of the preparation or have forgotten to take it, please do not take twice the amount of medicine next time, but continue to take it as planned.
• If you stop taking it
  • If treatment is interrupted or ended prematurely, your symptoms may worsen or reappear. Please ask your doctor about this!
• If you have any further questions on the use of the medicine, ask your doctor or pharmacist.

way

• infants and young children
  • Disintegrate the tablet with a teaspoon or in a small transparent container (eg a small glass) in approx. 5 - 10 ml of water. The disintegration of the tablet takes some time (at least 2 minutes).
  • Slightly moving it back and forth speeds up the decay. In order to avoid undesirable complications, such as accidental entry of the tablet into the airways ("swallowing"), the tablet should never be given to infants and young children undissolved. The dissolved tablet should then be put directly into the child's mouth, preferably during a meal give.
  • The addition of the tablets to a bottle or porridge meal for infants is not recommended, as full intake cannot be guaranteed.
  • If the tablets are nevertheless to be administered with food, they are only added after boiling and subsequent cooling. When using vitaminized food, the amount of vitamin D it contains must be taken into account.
• Adult
  • Take the tablets with enough water.

side effects

• Like all medicines, this medicine can cause side effects, although not everyone gets them.
• The frequencies of side effects are not known as no major clinical trials have been conducted to estimate the frequencies.
• possible side effects
  • Metabolic and nutritional disorders:
    • Hypercalcaemia (increased calcium concentration in the blood) and hypercalciuria (increased calcium concentration in the urine).
  • Gastrointestinal diseases:
    • Gastrointestinal symptoms such as constipation, flatulence, nausea, abdominal pain or diarrhea.
  • Skin and subcutaneous tissue disorders:
    • Hypersensitivity reactions such as itching, rash or hives.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

• When taken with other medicines
  • Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines.
  • What other medicines affect the effect?
    • Phenytoin (medicines used to treat epilepsy) or barbiturates (medicines used to treat epilepsy and sleep disorders and for anaesthesia) can impair the effect of vitamin D.
    • Thiazide diuretics (drugs to increase urine output) can cause hypercalcaemia (high levels of calcium in the blood) by reducing calcium excretion via the kidneys. Calcium levels in the blood and urine should therefore be monitored during long-term treatment.
    • The simultaneous administration of glucocorticoids (medicines used to treat certain allergic diseases) can impair the effect of vitamin D.
    • Vitamin D metabolites or analogues (e.g. calcitriol): A combination with this preparation is only recommended in exceptional cases. Blood calcium levels should be monitored.
    • Rifampicin and isoniazid (medicines used to treat tuberculosis): The metabolism of vitamin D can be increased and its effectiveness reduced.
  • How does the preparation affect the effects of other medicines?
    • The risk of an undesirable effect when taking cardiac glycosides (medicines that stimulate the heart muscles) may increase as a result of an increase in blood calcium levels during treatment with vitamin D (risk of cardiac arrhythmias). Patients should be monitored for ECG and blood and urine calcium levels and, if necessary, blood drug levels.
    • Please note that this information may also apply to recently used medicines.

Contraindications

• The drug must not be taken
  • if you are allergic (hypersensitive) to colecalciferol or any of the other ingredients of the preparation.
  • if you suffer from hypercalcaemia (high levels of calcium in the blood) and/or
  • if you have hypercalciuria (high levels of calcium in the urine).

pregnancy and breast feeding period

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• pregnancy
  • Daily doses up to 500 IU/d
    • So far, no risks are known in the specified dose range.
    • Prolonged overdoses of vitamin D must be avoided during pregnancy, since the resulting hypercalcaemia (increased calcium concentration in the blood) can lead to physical and mental disabilities as well as congenital heart and eye diseases in the child.
  • Daily doses over 500 IU/d
    • During pregnancy, the preparation should only be taken when strictly indicated and only dosed as is absolutely necessary to remedy the deficiency.
    • Overdoses of vitamin D during pregnancy must be prevented, since prolonged hypercalcaemia (elevated calcium concentration in the blood) can lead to physical and mental disability as well as congenital heart and eye diseases in the child.
• lactation
  • Vitamin D and its metabolites pass into breast milk. An overdose in infants produced in this way has not been observed.

patient notes

• Particular caution is required when ingesting
  • with a tendency to form calcium-containing kidney stones,
  • if you have impaired excretion of calcium and phosphate via the kidneys,
  • during treatment with benzothiadiazine derivatives (medicines to promote urination),
  • in immobilized patients,
    • since there is a risk of hypercalcaemia (increased calcium concentration in the blood) and hypercalciuria (increased calcium concentration in the urine). Blood and urine calcium levels should be monitored in these patients.
  • if you suffer from sarcoidosis, as there is a risk of increased conversion of vitamin D to its active form. In this case, you should have your blood and urine calcium levels monitored.
  • if you have pseudohypoparathyroidism (disorder of the parathyroid hormone balance), since the vitamin D requirement may be reduced due to the phase-wise normal vitamin D sensitivity. Then there is the risk of a long-term overdose. For this purpose, more easily controllable active ingredients with vitamin D activity are available.
  • In patients with impaired renal function who are treated with the preparation, the effect on calcium and phosphate balance should be monitored.
  • infants and young children
    • The preparation should be used with particular caution in infants and young children as they may not be able to swallow the tablets. It is recommended to dissolve the tablets as directed or use drops instead.
    • If other medicines containing vitamin D are prescribed, the dose of vitamin D must be taken into account. Additional administrations of vitamin D or calcium should only be carried out under medical supervision. In such cases, calcium levels in the blood and urine must be monitored.
  • Daily doses over 500 IU/d
    • During long-term treatment with this preparation, blood and urine calcium levels should be monitored and renal function should be checked by measuring serum creatinine. This check is particularly important in elderly patients and during concomitant treatment with cardiac glycosides (medicines that stimulate heart muscle function) or diuretics (medicines that stimulate urination). In case of hypercalcaemia (increased calcium concentration in the blood) or signs of reduced kidney function, the dose must be reduced or the treatment interrupted. It is recommended to reduce the dose or interrupt treatment if the urinary calcium content exceeds 7.5 mmol/24 hours (300 mg/24 hours).
  • Daily doses over 1,000 IU/d
    • During long-term treatment with daily doses of more than 1,000 IU of vitamin D, serum calcium levels must be monitored.
• Driving and using machines
  • There are no special precautions required.

What adverse effects may occur?

Only side effects that have only occurred in exceptional cases so far are currently described for the drug.

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Storage

The medicinal product must be stored   in the dark (eg in the outer carton)
  protected from heat .

What should you consider?
- Be careful if you are allergic to ascorbic acid (vitamin C)!
- Beware of intolerance to sucrose. If you have to follow a diabetic diet, you should consider the sugar content.

How does the ingredient of the medicine work?

The active ingredient intervenes in protein production. It triggers the formation of a protein that binds calcium and releases it into the bloodstream. In this way, the blood calcium level is increased, and this calcium is then available for bone formation.

What is included in medicines?

What speaks against an application?

- Hypersensitivity to the ingredients
- Increased calcium levels
- Increased calcium excretion in the urine

Which age group should be considered?
- Children and adolescents under the age of 18: In this age group, the drug should only be used in certain areas of application. Please ask your doctor or pharmacist, if you have questions regarding this topic.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: consult your doctor or pharmacist. He will examine your particular starting position and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

Manufacturer: WICK Pharma - branch of Procter & Gamble GmbH