Important! Before use, read the leaflet, which contains indications, contraindications, data on adverse effects and dosage, and information on the use of the medicinal product, or consult a doctor or pharmacist, because any drug used improperly threatens your life or health.
Package leaflet: Information for the patient Vigalex Max, 100 micrograms (4000 IU), tablets
Cholecalciferol
Read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
– Keep this leaflet. You may need to read it again.
– If you need advice or more information, ask your pharmacist. – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
– If there is no improvement or if you feel worse, contact your doctor.
Leaflet Contents
- What is Vigalex Max and what is it used for?
- Important information before using Vigalex Max
- How to use Vigalex Max
- Possible side effects
- How to store Vigalex Max
- Package contents and other information
1. What is Vigalex Max and what is it used for?
Vigalex Max contains the active substance vitamin D3 (cholecalciferol), which is important in the bone formation process.
Vitamin D3 (cholecalciferol) is produced by the body in the skin under the influence of sunlight (UV radiation), and can also be supplied to the body with food.
Vitamin D deficiency causes disturbances in bone calcification (rickets) or loss of calcium from the bones (osteomalacia).
Vigalex Max is used for:
– in the prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults
with obesity [body mass index (BMI) ≥ 30].
2. Important information before using Vigalex Max
When not to use Vigalex Max
- if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6), if you have hypercalcaemia (too much calcium in the blood) or hypercalciuria (excessive excretion of calcium in the urine),
- – if you have kidney stones or severe renal impairment, in case of pseudohypoparathyroidism, in children and adolescents under 18 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Vigalex Max. Vigalex Max should be used under medical supervision:
- – if you are also taking other products containing vitamin D, as additional doses of vitamin D should only be taken under medical supervision,
- – if you have sarcoidosis (an immune system disease that may increase the level of vitamin D in the body),
- – if you have kidney problems,
- – if the patient is treated with cardiac glycosides or diuretics,
- – if the treatment with vitamin D is long-term (over 3 months), because in such a case the doctor should monitor the patient’s calcium level in serum and urine and check kidney function by measuring the level of creatinine in the blood.
Vigalex Max and other medications
- Tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take.
- Antacids used to treat hyperacidity that contain aluminium, when taken together with Vigalex Max, may increase the level of aluminium in the blood, increasing the risk of aluminium toxicity to bones.
- Antacids containing magnesium, when used concomitantly with Vigalex Max may increase the level of magnesium in the blood.
- Certain antiepileptic, sedative or sleep-inducing medicines (containing phenytoin or barbiturates) used concomitantly with Vigalex Max may reduce its effectiveness.
- Some diuretics may cause hypercalcaemia (increased calcium levels), due to decreased renal excretion of calcium. During long-term treatment, serum and urinary calcium levels should be monitored.
- Concomitant use of glucocorticosteroids (adrenal cortex hormones) may nullify the effect of Vigalex Max.
- Vigalex Max may increase the effects and toxicity of digitalis glycosides, which poses a risk of developing cardiac arrhythmias. In such cases, the doctor should monitor the concentration of calcium in the patient’s serum and urine and conduct periodic ECG examinations.
- Concomitant use of vitamin D metabolites or analogues (e.g. calcitriol) and Vigalex Max 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 effectiveness of Vigalex Max.
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.
Pregnancy
- You should consult your doctor to determine the dose of vitamin D you should take during pregnancy.
- Vitamin D should not be taken in doses higher than 2000 IU/day without medical supervision.
- Breast-feeding
- You should consult your doctor to determine the dose of vitamin D you should take while breastfeeding.
- Vitamin D should not be taken in doses higher than 2000 IU/day without medical supervision.
Driving and operating machinery
Vigalex Max does not affect the ability to drive or operate machinery.
Vigalex Max contains sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol (23 mg) of sodium.
in the recommended dosage unit, i.e. the medicine is considered to be “sodium-free”.
3. How to use Vigalex Max
Always use these medicines exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The medicinal product should not be used long-term (longer than 3 months) or in doses higher than recommended without medical supervision.
Do not use other medications, dietary supplements or other types of food containing vitamin D (cholecalciferol), calcitriol or other metabolites and analogues of vitamin D simultaneously without medical supervision.
Dosage
Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in obese adults
Typically 4000 IU (1 tablet) daily, from October to April or throughout the year if effective cutaneous synthesis of vitamin D is not ensured during the summer months.
Patients with renal failure
The drug should not be used in patients with renal failure without medical supervision.
Patients with liver failure
No special dosage recommendations.
Children and adolescents under 18 years of age
Vigalex Max is contraindicated in children and adolescents under 18 years of age.
How to take the medicine
Take the tablet with a sufficient amount of fluid.
Taking more than the recommended dose of Vigalex Max
If you use more Vigalex Max than you should, contact your doctor. Your doctor will decide on the appropriate treatment.
Symptoms of overdose: nausea, vomiting, diarrhea followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased concentration of nitrogen compounds in the blood), excessive thirst, polyuria, and dehydration. With high concentrations of calcium in the blood, heart disorders, kidney failure, psychosis, and even coma occur.
Laboratory tests show hypercalcemia (increased calcium levels in the blood), hypercalciuria (excessive urinary calcium excretion) and increased serum 25-hydroxycalciferol levels. Overdose requires taking measures to control the often prolonged and sometimes life-threatening hypercalcemia.
Missing the use of Vigalex Max
Do not take a double dose to make up for a missed dose.
Stopping the use of Vigalex Max
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur while taking Vigalex Max:
Frequency unknown (cannot be estimated based on available data):
– gastrointestinal complaints such as constipation, flatulence, nausea, abdominal pain or diarrhea;
– hypersensitivity reactions such as itching, rash or hives;
– in case of long-term use of high doses, hypercalcaemia occurs (too much
- calcium levels in the blood) and hypercalciuria (excessive excretion of calcium in the urine). In isolated cases, fatal outcomes have been reported.
5. How to store Vigalex Max
Keep the medicine out of the sight and reach of children.
Store at a temperature below 30oC.
Store in original packaging to protect from light.
Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These actions will help protect the environment.
6. Package contents and other information
What does Vigalex Max contain?
– The active substance is cholecalciferol.
One tablet contains 40 mg of cholecalciferol, powder, equivalent to 0.1 mg of cholecalciferol (vitamin D3).
– The other ingredients are: microcrystalline cellulose (type 102), calcium hydrogen phosphate dihydrate, pregelatinized maize starch, crospovidone (type A), sucrose, magnesium stearate, sodium ascorbate, medium chain triglycerides, colloidal anhydrous silica, all-rac-α-tocopherol.
What Vigalex Max looks like and what the package contains
White, round, biconvex tablets with a diameter of 10 mm ± 0.3 mm.
The tablets are packed in PVC/PVDC/Aluminium foil blisters, placed together with a patient leaflet in a cardboard box.
Package size: 15, 30, 60, 90 or 120 tablets
Not all pack sizes may be marketed.
Important information about the medicine
This is a medicine. For safety, use it according to the leaflet included in the package. Do not exceed the maximum dose of the medicine. If in doubt, consult your doctor or pharmacist.
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