Vigalex Bio

Package Leaflet: Information for the Patient

Vigalex Bio, 25 micrograms (1000 IU), tablets

Vigalex Forte, 50 micrograms (2000 IU), tablets

Cholecalciferol

Read the package 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 package leaflet for the patient, or as directed by a doctor or pharmacist.

• Keep this package leaflet, so you can read it again if you need to.
• If you need advice or additional information, ask your pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this package leaflet, they should tell 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 Package Leaflet

• 1. What are Vigalex Bio and Vigalex Forte and what are they used for
• 2. Important information before taking Vigalex Bio and Vigalex Forte
• 3. How to take Vigalex Bio and Vigalex Forte
• 4. Possible side effects
• 5. How to store Vigalex Bio and Vigalex Forte
• 6. Contents of the package and other information

1. What are Vigalex Bio and Vigalex Forte and what are they used for

Vigalex Bio and Vigalex Forte contain the active substance vitamin D (cholecalciferol), which plays an important role in bone formation, immune system support, and numerous physiological processes in the body.
Vitamin D (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.
In vitamin D deficiencies, there are disorders of bone calcification (rickets) or loss of calcium from bones (osteomalacia) and weakening of the body's immune system.
Vigalex Bio and Vigalex Forte are used in:

• preventing vitamin D deficiency in children and adults,
• preventing vitamin D deficiency in women planning pregnancy, during pregnancy, and breastfeeding, in agreement with a doctor,
• preventing rickets and osteomalacia in children and adults,
• supportive treatment of osteoporosis in adults.

Vigalex Bio is intended for patients aged 6 years and older with a normal body mass.
Vigalex Forte is intended for patients aged 11 years and older with a normal body mass.

2. Important information before taking Vigalex Bio and Vigalex Forte

When not to take Vigalex Bio and Vigalex Forte

• if the patient is allergic to cholecalciferol or any of the other ingredients of these medicines (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.

Warnings and precautions

Before starting to take Vigalex Bio and Vigalex Forte, the patient should discuss it with their doctor or pharmacist.
Vigalex Bio and Vigalex Forte 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,
• in the case of children under 6 years of age,
• if vitamin D treatment is long-term (over 3 months), as the doctor should monitor the patient's calcium levels in the blood and urine, as well as check kidney function by measuring creatinine levels in the blood.

Vigalex Bio and Vigalex Forte and other medicines

The patient should tell 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 Bio or Vigalex Forte may increase aluminum levels in the blood, increasing the risk of toxic aluminum effects on bones.
Antacids containing magnesium, taken simultaneously with Vigalex Bio or Vigalex Forte, may increase magnesium levels in the blood.
Certain anti-epileptic, sedative, or hypnotic drugs (containing phenytoin or barbiturates), taken simultaneously with Vigalex Bio or Vigalex Forte, 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 the blood and urine should be monitored.
Concomitant use of glucocorticosteroids (adrenal cortex hormones) may counteract the effects of Vigalex Bio and Vigalex Forte.
Vigalex Bio and Vigalex Forte may enhance the effects and toxicity of digitalis glycosides, posing a risk of developing heart rhythm disorders. In such cases, the doctor should monitor the patient's calcium levels in the blood and urine, as well as perform periodic ECG tests.
Concomitant use of vitamin D metabolites or analogs (e.g., calcitriol) and Vigalex Bio or Vigalex Forte is only possible on a doctor's recommendation, in exceptional cases, provided that calcium levels in the blood are monitored.
Rifampicin and isoniazid may reduce the effectiveness of Vigalex Bio and Vigalex Forte.

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 these medicines.
Pregnancy
The patient should consult their doctor to determine the dose of vitamin D they should take during pregnancy.
Usually, the recommended dose is 2000 IU per day, regardless of the time of year, unless the doctor recommends a different dosing regimen.
During pregnancy, women should follow their doctor's recommendations, as their need for vitamin D may vary depending on their body's vitamin D reserves.
Without medical supervision, vitamin D should not be taken in doses higher than 2000 IU per day.
Breastfeeding
The patient should consult their doctor to determine the dose of vitamin D they should take during breastfeeding.
Usually, the recommended dose is 2000 IU per day, regardless of the time of year, unless the doctor recommends a different dosing regimen.
During breastfeeding, women should follow their doctor's recommendations, as their need for vitamin D may vary depending on their body's vitamin D reserves.
Without medical supervision, vitamin D should not be taken in doses higher than 2000 IU per day.

Driving and using machines

Vigalex Bio and Vigalex Forte do not affect the ability to drive and use machines.

Vigalex Bio and Vigalex Forte contain sucrose.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking these medicines.
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 Bio and Vigalex Forte

These medicines should always be taken exactly as described in this package leaflet for the patient, 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 larger 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

Childrenaged 6 to 10 years with a normal body mass
1000 IU per day
Adolescentsaged 11 to 18 years with a normal body mass

• preventing vitamin D deficiency: 1000 to 2000 IU per day
• preventing rickets and osteomalacia: 2000 IU per day

Adults with a normal body mass

• preventing vitamin D deficiency: 1000 to 2000 IU per day
• preventing rickets and osteomalacia: 2000 IU per day
• supportive treatment of osteoporosis: 2000 to 4000 IU per day

Elderly patients (over 75 years of age)

• preventing vitamin D deficiency: 2000 to 4000 IU per day

Women planning pregnancy, during pregnancy, and breastfeeding
The patient should consult their doctor to determine the dose of vitamin D they should take during pregnancy.
Usually, the recommended dose is 2000 IU per day, regardless of the time of year, unless the doctor recommends a different dosing regimen.
During pregnancy, women should follow their doctor's recommendations, as their need for vitamin D may vary depending on their body's vitamin D reserves.
Patients with kidney failure
The medicine should not be taken by patients with kidney failure without medical supervision.
Patients with liver failure
There are no special dosage recommendations.
Children under 6 years of age
It is not recommended to give the medicine to children under 6 years of age, due to the form of the medicine (tablets).

Method of administration

The patient should take a tablet, washing it down with a sufficient amount of liquid.

Taking a higher dose of Vigalex Bio or Vigalex Forte than recommended

In case of taking a higher dose of Vigalex Bio or Vigalex Forte 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 may be heart function disorders, kidney failure, psychosis, and even coma.
In laboratory tests, hypercalcemia (increased calcium levels in the blood), hypercalciuria (excessive excretion of calcium in the urine), and increased levels of 25-hydroxycholecalciferol in the blood are found. Overdose requires measures to control the often prolonged and sometimes life-threatening hypercalcemia.

Missing a dose of Vigalex Bio or Vigalex Forte

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

Stopping treatment with Vigalex Bio or Vigalex Forte

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 Bio and Vigalex Forte can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Vigalex Bio and Vigalex Forte:
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) may 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 package leaflet, they should tell 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vigalex Bio and Vigalex Forte

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 month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Vigalex Bio and Vigalex Forte contain

• The active substance of the medicine is cholecalciferol.

Vigalex Bio (1000 IU)
One tablet contains 10 mg of cholecalciferol powder, which corresponds to 0.025 mg (1000 IU) of cholecalciferol (vitamin D).
Vigalex Forte (2000 IU)
One tablet contains 20 mg of cholecalciferol powder, which corresponds to 0.05 mg (2000 IU) of cholecalciferol (vitamin D).

• Other ingredients are: microcrystalline cellulose (type 102), calcium hydrogen phosphate dihydrate, corn starch, crospovidone (type A), sucrose, magnesium stearate, sodium ascorbate, saturated fatty acid triglycerides, colloidal silica anhydrous, all-rac-α-tocopherol.

What Vigalex Bio and Vigalex Forte look like and what the package contains

Vigalex Bio (1000 IU)
White, round, biconvex tablets with a diameter of 6 mm ± 0.3 mm, with a dividing line embossed on one side.
The dividing line on the tablet is only to facilitate breaking it, for easier swallowing, and not for dividing into equal doses.
Vigalex Forte (2000 IU)
White, round, biconvex tablets with a diameter of 8 mm ± 0.3 mm, with the marking "○" embossed on one side.
The tablets are packaged in PVC/PVDC/Aluminum blisters, together with the patient package leaflet, in a cardboard box. Package size:
Vigalex Bio: 30, 60, 90, or 120 tablets
Vigalex Forte: 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 package leaflet:09.12.2024