Package leaflet: Information for the patient

Vigalex Max, 100 micrograms (4000 IU), tablets
Cholecalciferolum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet, or as directed by
the doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, contact your doctor.

Table of contents of the leaflet

What Vigalex Max is and what it is used for
Important information before taking Vigalex Max
How to take Vigalex Max
Possible side effects
How to store Vigalex Max
Contents of the pack and other information

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

Vigalex Max contains the active substance vitamin D (cholecalciferol), which plays an important role
in bone formation, immune support, and numerous physiological processes in the body.
Vitamin D (cholecalciferol) is produced in the skin under the influence of sunlight (UV radiation), and
can also be supplied through diet.
Deficiency of vitamin D leads to disturbances in bone mineralization (rickets) or loss of calcium from
bones (osteomalacia), as well as weakened immune function.
Vigalex Max is used for:

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

2. Important information before using Vigalex Max

When not to use Vigalex Max

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

Warnings and precautions
Before starting to use Vigalex Max, consult your doctor or pharmacist.
Vigalex Max should be used under medical supervision:

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

Vigalex Max and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Antacids (used to treat acidity, containing aluminium) taken together with Vigalex Max may increase aluminium levels in the blood, increasing the risk of aluminium's toxic effects on bones.
Antacids containing magnesium, taken simultaneously with Vigalex Max, may increase magnesium levels in the blood.
Certain antiepileptic, sedative, or hypnotic drugs (containing phenytoin or barbiturates), when used concurrently with Vigalex Max, may reduce its effectiveness.
Some diuretics may lead to hypercalcemia (elevated calcium levels) due to reduced renal excretion of calcium. During long-term treatment, serum and urinary calcium levels should be monitored.
Concomitant use of glucocorticosteroids (adrenal cortex hormones) may counteract the effect of Vigalex Max.
Vigalex Max may enhance the action and toxicity of cardiac glycosides, increasing the risk of cardiac arrhythmias. In such cases, the doctor should monitor serum and urinary calcium levels and perform periodic ECG examinations.
Concurrent use of vitamin D metabolites or analogs (e.g. calcitriol) and Vigalex Max is possible only on a doctor's recommendation, only in exceptional cases, and with monitoring of serum calcium levels.
Rifampicin and isoniazid may reduce the effectiveness of Vigalex Max.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Consult a doctor to determine the appropriate dose of vitamin D during pregnancy.
Vitamin D should not be taken in doses exceeding 2000 IU per day without medical supervision.

Breastfeeding
Consult a doctor to determine the appropriate dose of vitamin D during breastfeeding.
Vitamin D should not be taken in doses exceeding 2000 IU per day without medical supervision.

Driving and operating machinery
Vigalex Max has no influence on the ability to drive or operate machinery.

Vigalex Max contains sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose and is therefore considered "sodium-free".

3. How to use Vigalex Max

This medicine should always be used exactly as described in this patient leaflet, or as directed by a
physician or pharmacist. If in doubt, consult a physician or pharmacist.
Do not use this medicine long-term (for more than 3 months) or in doses higher than recommended
without medical supervision.
Without medical supervision, do not use other medicines, dietary supplements, or other food products
containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites and analogs
concurrently.

Dosage
Prevention of vitamin D deficiency and conditions resulting from vitamin D deficiency in adults
with obesity and elderly individuals (over 75 years of age) with overweight or obesity
Typically, 4000 IU (1 tablet) daily, from October to April, or throughout the year if effective cutaneous
vitamin D synthesis is not ensured during summer months.

Patients with renal insufficiency
Do not use this medicine in patients with renal insufficiency without physician supervision.

Patients with hepatic insufficiency
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 administration
Take one tablet with sufficient liquid.

Overdose of Vigalex Max
If an overdose of Vigalex Max is taken, contact a physician immediately. The physician will decide
on 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 blood
nitrogen compounds), excessive thirst, polyuria, and dehydration. With markedly elevated serum
calcium levels, cardiac arrhythmias, renal failure, psychoses, and even coma may occur.

Laboratory findings include hypercalcemia (elevated serum calcium), hypercalciuria (excessive
urinary calcium excretion), and increased serum 25-hydroxycholecalciferol levels. Overdose
requires prompt intervention to manage hypercalcemia, which may be prolonged and sometimes
life-threatening.

Missed dose of Vigalex Max
Do not take a double dose to make up for a missed dose.

Discontinuation of Vigalex Max
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during the use of Vigalex Max:
Frequency unknown (frequency cannot be estimated from the available data):

gastrointestinal disorders such as constipation, bloating, nausea, abdominal pain, or diarrhoea;
hypersensitivity reactions such as skin itching, rash, or urticaria;
prolonged use of high doses may lead to hypercalcaemia (excess calcium in the blood) and hypercalciuria (excessive excretion of calcium in urine). Fatalities have been reported in isolated cases.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Vigalex Max
Keep the medicine out of sight and reach of children.
Store below 30°C.
Keep 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Vigalex Max contains

The active substance is cholecalciferol. One tablet contains 40 mg of cholecalciferol powder, equivalent to 0.1 mg of cholecalciferol (vitamin D).
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, anhydrous colloidal silicon dioxide, all-rac-α-Tocopherol.

What Vigalex Max looks like and contents of the pack
White, round, biconvex tablets with a diameter of 10 mm ± 0.3 mm.
The tablets are packed in blisters made of PVC/PVDC/Aluminium foil, placed together with the patient leaflet in a cardboard box.
Pack sizes: 60, 90 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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]