Vigalex Max

Leaflet attached to the packaging: patient information

Vigalex Max, 100 micrograms (4000 IU), tablets

Cholecalciferol

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Vigalex Max and what is it used for
• 2. Important information before taking Vigalex Max
• 3. How to take Vigalex Max
• 4. Possible side effects
• 5. How to store Vigalex Max
• 6. Package contents and other information

1. What is Vigalex Max and what is it used for

Vigalex Max contains the active substance vitamin D (cholecalciferol), which plays an important role in the process of bone formation, supporting immunity, and in numerous physiological processes of the body.
Vitamin D (cholecalciferol) is produced by the body in the skin under the influence of sunlight (UV radiation) and can also be delivered to the body with food.
In vitamin D deficiencies, there are disorders of bone calcification (rickets) or loss of calcium from bones (osteomalacia) and weakening of the body's immunity.
Vigalex Max is used in:

• prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity [body mass index (BMI) ≥ 30] and elderly patients (over 75 years old) with overweight or obesity.

2. Important information before taking Vigalex Max

When not to take Vigalex Max

• if the patient is allergic to cholecalciferol or any of the other ingredients of this medicine (listed in section 6),
• in case of hypercalcemia (too high calcium levels in the blood) or hypercalciuria (excessive excretion of calcium in the urine),
• if the patient has kidney stones or severe kidney failure,
• in case of alleged hypoparathyroidism,
• in children and adolescents under 18 years of age.

Warnings and precautions

Before starting treatment with Vigalex Max, the patient should discuss it with their doctor or pharmacist.
Vigalex Max should be taken under medical supervision:

• if the patient is also taking other products containing vitamin D, as additional doses of vitamin D can only be taken under medical supervision,
• if the patient has sarcoidosis (an immune system disease that can increase vitamin D levels in the body),
• if the patient has kidney function disorders,
• if the patient is being treated with cardiac glycosides or diuretics,
• if vitamin D treatment is long-term (over 3 months), as the doctor should monitor the patient's calcium levels in serum and urine and check kidney function by measuring creatinine levels in the blood.

Vigalex Max and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Antacids (used to treat hyperacidity, containing aluminum) taken with Vigalex Max may increase aluminum levels in the blood, increasing the risk of toxic aluminum effects on bones.
Antacids containing magnesium, taken simultaneously with Vigalex Max, may increase magnesium levels in the blood.
Certain anti-epileptic, sedative, or hypnotic drugs (containing phenytoin or barbiturates) taken with Vigalex Max may reduce its effectiveness.
Certain diuretics may lead to hypercalcemia (increased calcium levels) caused by reduced calcium excretion by the kidneys. During long-term treatment, calcium levels in serum and urine should be monitored.
Concomitant use of glucocorticosteroids (adrenal cortex hormones) may counteract the effect of Vigalex Max.
Vigalex Max may enhance the effect and toxicity of digitalis glycosides, posing a risk of developing heart rhythm disorders. In such cases, the doctor should monitor calcium levels in the patient's serum and urine and perform periodic ECG examinations.
Concomitant use of vitamin D metabolites or analogs (e.g., calcitriol) and Vigalex Max is only possible on a doctor's recommendation, in exceptional cases, provided that serum calcium levels are monitored.
Rifampicin and isoniazid may reduce the effectiveness of Vigalex Max.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The doctor should be consulted to determine the dose of vitamin D that the patient should take during pregnancy.
Without medical supervision, vitamin D should not be taken in doses higher than 2000 IU per day.
Breastfeeding
The doctor should be consulted to determine the dose of vitamin D that the patient should take during breastfeeding.
Without medical supervision, vitamin D should not be taken in doses higher than 2000 IU per day.

Driving and using machines

Vigalex Max does not affect the ability to drive and use machines.

Vigalex Max contains sucrose.

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodiumin the maximum daily dose, which means the medicine is considered "sodium-free".

3. How to take Vigalex Max

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Without medical supervision, the medicine should not be taken for a long time (over 3 months) or in doses higher than recommended.
Without medical supervision, the patient should not take other medicines or dietary supplements, or other types of food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs.

Dosage

Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults with obesity and elderly patients (over 75 years old) with overweight or obesity
Usually 4000 IU (1 tablet) per day, from October to April or throughout the year, if effective skin synthesis of vitamin D is not ensured during the summer months.
Patients with kidney failure
The medicine should not be taken in patients with kidney 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.

Method of taking the medicine

The patient should take a tablet with a sufficient amount of liquid.

Taking a higher dose of Vigalex Max than recommended

In case of taking a higher dose of Vigalex Max than recommended, the patient should contact their doctor. The 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 levels of nitrogen compounds in the blood), excessive thirst, polyuria, and dehydration. At high calcium levels in the blood, there are disorders of heart function, kidney failure, psychoses, and even coma.
In laboratory tests, hypercalcemia (elevated calcium levels in the blood), hypercalciuria (excessive excretion of calcium in the urine), and increased levels of 25-hydroxycholecalciferol in serum are found. Overdose requires measures to control often prolonged and sometimes life-threatening hypercalcemia.

Missing a dose of Vigalex Max

The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Vigalex Max

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vigalex Max can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Vigalex Max:
Frequency not known(frequency cannot be estimated from the available data):

• gastrointestinal disorders, such as constipation, bloating, nausea, abdominal pain, or diarrhea;
• hypersensitivity reactions, such as skin itching, rash, or urticaria;
• in case of long-term use of high doses, hypercalcemia (too high calcium levels in the blood) and hypercalciuria (excessive excretion of calcium in the urine) occur. In individual cases, deaths have been reported.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Vigalex Max

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vigalex Max contains

• The active substance of Vigalex Max is cholecalciferol. One tablet contains 40 mg of cholecalciferol powder, which corresponds to 0.1 mg of cholecalciferol (vitamin D).
• Other ingredients are: microcrystalline cellulose (type 102), calcium hydrogen phosphate dihydrate, cornstarch, crospovidone (type A), sucrose, magnesium stearate, sodium ascorbate, saturated fatty acid triglycerides, colloidal silica anhydrous, all-rac-α-tocopherol.

What Vigalex Max looks like and what the pack contains

White, round, biconvex tablets with a diameter of 10 mm ± 0.3 mm.
Tablets are packaged in PVC/PVDC/Aluminum blisters, along with the patient leaflet, in a cardboard box.
Package size: 60, 90, or 120 tablets
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]
Date of last revision of the leaflet:12.12.2024