Vigalex Bio, 1000 IU, tablets, 90 pcs., Biofarm

Product information

1 tablet contains 10 mg of cholecalciferol powder, corresponding to 0.025 mg (1000 IU) of cholecalciferol (vitamin D3).

Excipients: microcrystalline cellulose (type 102), calcium hydrogen phosphate dihydrate, pregelatinized starch, maize starch, crospovidone (type A), sucrose, magnesium stearate, sodium ascorbate, medium chain saturated fatty acid triglycerides, colloidal anhydrous silica, all-rac- α-Tocopherol.

Dosage

Always use this medicine exactly as described in the package leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The medicinal product should be taken orally, washed down with tablets with a sufficient amount of water. Dosage of Vigalex Bio depends on the patient’s age and therapeutic indication:

The drug should not be used for more than 3 months or in higher doses than recommended without consulting a doctor. When using the medicinal product, do not use other drugs, supplements or foodstuffs containing vitamin D, calcitriol or other metabolites and vitamin D analogues at the same time, unless your doctor recommends otherwise.

Action

Vigalex Bio works by providing the body with vitamin D, which influences the bone formation process.

Indications

Vigalex Bio is administered in the prevention of vitamin D deficiency in adults, children or, upon a doctor’s recommendation, in pregnant women, those planning it and during lactation. The indication for the use of the product is the prevention of rickets and osteomalacia in adults and children. Vigalex Bio is also used in the adjunctive treatment of osteoporosis. The product can be used by people with a healthy body weight.

Contraindications

Do not use in people with hypersensitivity to the active substance or any of the excipients. Contraindications to the use of the drug are: hypercalcemia (too high calcium levels in the blood), hypercalcuria (too much calcium excretion in the urine); nephrolithiasis or severe renal failure; alleged hypoparathyroidism.

Side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Not known (frequency cannot be estimated from the available data): gastrointestinal symptoms such as constipation, flatulence, nausea, abdominal pain or diarrhea; hypersensitivity reactions such as itching, rash or hives; hypercalcaemia (too much calcium in the blood) and hypercalciuria (excessive excretion of calcium in the urine) occur in the event of long-term use of high doses. Fatalities have been reported in individual cases.

The drug contains sucrose, so if a patient has previously been diagnosed with an intolerance to some sugars, consult a physician before taking the medicinal product.

The drug is sodium-free.

Keep the drug out of the sight and reach of children.
Store below 30ºC.
Store in the original package in order to protect from light.

Use of other medications

Tell your doctor or pharmacist about all the drugs you are taking or have recently taken, and about any drugs you plan to take, including those sold without a prescription.

Vigalex Bio may interact with:

• antacids containing aluminum or magnesium
• fentyoin and barbiturates,
• some diuretics
• glucocorticoids,
• cardiac glycosides,
• metabolites and analogues of vitamin D (e.g. calcitriol) (possible overdose),
• rifampicin, isoniazid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Ask your doctor for advice on the dose of vitamin D you should take during pregnancy. The usual recommended dose is 2,000 IU per day irrespective of the season of the year, unless your doctor prescribes a different dosing regimen. During pregnancy, women should follow the recommendations of their treating physician, as their vitamin D requirements may vary depending on the body’s own vitamin D. Do not take vitamin D in doses higher than 2000 IU / day without medical supervision. 

Breastfeeding
Ask your doctor for advice on the dose of vitamin D you should take while breastfeeding. The usual recommended dose is 2,000 IU per day irrespective of the season of the year, unless your doctor prescribes a different dosing regimen. During breastfeeding, women should follow the recommendations of their doctor, as their need for vitamin D may vary depending on the body’s vitamin D resources. Vitamin D should not be taken in doses higher than 2000 IU / day without medical supervision.

Use of the drug in children and adolescents

The drug is intended for children over 6 years of age. In younger children, it can only be administered on the recommendation of a doctor.

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