Vigalex Bio 1000 IU prevention

Vitamin D deficiency

90 tablets

Product description:

Vigalex Bio 1000 IU is a medicine containing vitamin D3 (cholecalciferol), which is the active substance of this medicine. Vitamin D3 contributes to maintaining healthy bones. When vitamin D deficiency occurs, bone calcification disorders (rickets) or loss of calcium from bones (osteomalacia) may occur.

Composition:

1 tablet contains:

• active substance: cholecalciferol 10 mg, powder, equivalent to 0.025 mg (1000 IU) of cholecalciferol (vitamin D3),
• excipients: microcrystalline cellulose (type 102), calcium hydrogen phosphate dihydrate, pregelatinized corn starch, crospovidone (type A), sucrose, magnesium stearate, sodium ascorbate, medium chain triglycerides, colloidal anhydrous silica, all-rac-α-tocopherol.

Indications:

Vigalex Forte 1000 IU is used in patients aged 6 years and over with normal body weight:

• to prevent vitamin D deficiency in children and adults,
• in the prevention of vitamin D deficiency in women planning a pregnancy, pregnant and breastfeeding in consultation with a doctor,
• in the prevention of rickets and osteomalacia in children and adults,
• supportively in the treatment of osteoporosis in adults.

Action:

Prevention of vitamin D3 deficiency.

Dosage:

Take the medicine as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

• Children from 6 to 10 years of age with normal body weight: 1000 IU daily.
• Youth aged 11 to 18 with normal body weight:to prevent vitamin D deficiency: 1000 to 2000 IU per day,

  prevention of rickets and osteomalacia: 2000 IU daily.

• Adults with normal body weight:prevention of vitamin D deficiency: 1000 to 2000 IU per day,

  prevention of rickets and osteomalacia: 2000 IU per day,

  Supportive treatment of osteoporosis: 2000 to 4000 IU daily.

• Women planning a pregnancy, who are pregnant or breastfeeding: consult your doctor to determine the dose for you.
• Patients with renal impairment: Should not be used in patients with renal impairment without medical supervision.
• Patients with hepatic impairment:  there are no special dosage recommendations.

Contraindications:

• If you have kidney stones or severe kidney failure.
• In cases of pseudohypoparathyroidism.
• If you are allergic to the active substance or any of the other ingredients of these medicines.
• If you have hypercalcaemia (too much calcium in the blood) or hypercalciuria (excessive excretion of calcium in the urine).

Storage:

Store the medicine out of the sight and reach of children, at a temperature below 30ºC.

Side effects:

This medicine can cause side effects, although not everybody gets them.

Frequency unknown (cannot be estimated based on available data):

• gastrointestinal complaints such as constipation, flatulence, nausea, abdominal pain or diarrhea,
• hypersensitivity reactions such as skin itching, rash or hives;
• In case of long-term use of high doses, hypercalcaemia (too high concentration of calcium in the blood) and hypercalciuria (excessive excretion of calcium in the urine) occur. In isolated cases, fatalities have been reported.

Interactions:

• Antacids used to treat hyperacidity and containing aluminium, when used together with Vigalex Bio, may lead to increased levels of aluminium in the blood, thereby increasing the risk of aluminium toxicity to the bones.
• Antacids containing magnesium, when used concomitantly with Vigalex Bio may lead to increased levels of magnesium in the blood.

• Certain antiepileptic, sedative or sleep-inducing medicines (containing phenytoin or barbiturates) used concomitantly with Vigalex Bio may reduce its effect.
• Diuretics may lead to hypercalcemia (increased calcium levels) due to decreased renal excretion of calcium.
• Concomitant use of glucocorticosteroids (adrenal cortex hormones) may reduce the effect of Vigalex Bio.
• Vigalex Bio may cause increased effects and toxicity of digitalis glycosides, which leads to the risk of developing cardiac arrhythmias.
• The simultaneous use of metabolites or analogues of vitamin D and the drug Vigalex Bio is possible only on the recommendation of a doctor, only in exceptional cases, provided that the concentration of calcium in the serum is monitored.
• Rifampicin and isoniazid may reduce the effect of Vigalex Bio.

Warnings and precautions:

• If you are taking other preparations containing vitamin D, please inform your doctor, as additional doses of vitamin D should only be taken under medical supervision.

• Vigalex Bio should be used under medical supervision:if you have sarcoidosis (an immune system disease that may increase the levels of vitamin D in the body),

  when kidney function is impaired,

  during treatment with cardiac glycosides or diuretics,

  for children under 6 years of age,

  when vitamin D is used for a long time (over 3 months), because in such a case the doctor should check the calcium level in the serum and urine and check the kidney function by determining the patient’s blood creatinine level,

  This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy, breastfeeding:

• 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.

Driving and operating machinery:

• Vigalex Bionie affects the ability to drive and operate machinery.