Vigalex bio

Package leaflet: Information for the patient

Vigalex Bio, 25 micrograms (1000 IU), tablets
Vigalex Forte, 50 micrograms (2000 IU), tablets
Cholecalciferolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any 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

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 support, and numerous physiological processes in the body.
Vitamin D (cholecalciferol) is produced in the body in the skin under the influence of sunlight (UV radiation), and can also be obtained from food.
Vitamin D deficiency may lead to impaired bone mineralization (rickets) or loss of calcium from bones (osteomalacia), as well as weakened immunity.
Vigalex Bio and Vigalex Forte are used for:

• prevention of vitamin D deficiency in children and adults,
• prevention of vitamin D deficiency in women planning pregnancy, during pregnancy, and breastfeeding, under medical supervision,
• prevention of rickets and osteomalacia in children and adults,
• adjunctive treatment of osteoporosis in adults.

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

2. Important information before using Vigalex Bio and Vigalex Forte medicines

When not to use Vigalex Bio and Vigalex Forte medicines

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

Warnings and precautions
Before starting to use Vigalex Bio and Vigalex Forte medicines, discuss this with your doctor or
pharmacist.
Vigalex Bio and Vigalex Forte should be used under medical supervision:

• if the patient is also taking other products containing vitamin D, as additional doses of vitamin D should only be taken under medical supervision,
• if the patient has sarcoidosis (an immune system disorder which 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 diuretic medicines,
• in children under 6 years of age,
• if vitamin D treatment is long-term (over 3 months), as in such cases the doctor should monitor the patient’s serum and urinary calcium levels and assess kidney function by measuring blood creatinine levels.

Vigalex Bio and Vigalex Forte with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any
medicines the patient plans to take.
Antacids (used to treat acidity, containing aluminium) taken together with Vigalex Bio or Vigalex
Forte may increase aluminium levels in the blood, increasing the risk of aluminium toxicity on bones.
Antacids containing magnesium, taken simultaneously with Vigalex Bio or Vigalex Forte, may
increase magnesium levels in the blood.
Certain antiepileptic, sedative or hypnotic medicines (containing phenytoin or barbiturates), when
used concurrently with Vigalex Bio or Vigalex Forte, may reduce its effectiveness.
Some diuretic medicines may lead to hypercalcemia (increased calcium levels) caused by reduced
calcium excretion by the kidneys. During prolonged treatment, serum and urinary calcium levels
should be monitored.
Concomitant use of glucocorticosteroids (adrenal cortex hormones) may counteract the effect of
Vigalex Bio and Vigalex Forte.
Vigalex Bio and Vigalex Forte may enhance the effect 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 analogues (e.g. calcitriol) and Vigalex Bio or Vigalex
Forte is possible only on a doctor’s recommendation, only in exceptional cases, and under serum
calcium level monitoring.
Rifampicin and isoniazid may reduce the effectiveness of Vigalex Bio and Vigalex Forte.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she
should consult her doctor or pharmacist before using these medicines.

Pregnancy
Consult your doctor to determine the appropriate vitamin D dose during pregnancy.
The usual recommended dose is 2000 IU per day, regardless of the season, unless the doctor
recommends otherwise.
During pregnancy, women should follow the advice of their attending physician, as their vitamin D
requirements may vary depending on the body's vitamin D stores.
Vitamin D doses exceeding 2000 IU per day should not be taken without medical supervision.

Breastfeeding
Consult your doctor to determine the appropriate vitamin D dose during breastfeeding.
The usual recommended dose is 2000 IU per day, regardless of the season, unless the doctor
recommends otherwise.
During breastfeeding, women should follow the advice of their attending physician, as their vitamin
D requirements may vary depending on the body's vitamin D stores.
Vitamin D doses exceeding 2000 IU per day should not be taken without medical supervision.

Driving and operating machinery
Vigalex Bio and Vigalex Forte medicines do not affect the ability to drive or operate machinery.

Vigalex Bio and Vigalex Forte contain sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should
consult a doctor before taking these medicines.

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

3. How to use Vigalex Bio and Vigalex Forte medicines

These medicines should always be used exactly as described in this patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Do not use the medicine long-term (for more than 3 months) or in doses higher than recommended without medical supervision.
Do not take other medicines, dietary supplements, or other food products containing vitamin D (cholecalciferol), calcitriol, or other vitamin D metabolites or analogues simultaneously without medical supervision.

Dosage

Children aged 6 to 10 years with normal body weight
1000 IU per day

Adolescents aged 11 to 18 years with normal body weight

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

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 per day

Elderly persons (over 75 years of age)

• Prevention of vitamin D deficiency: 2000 to 4000 IU per day

Women planning pregnancy, pregnant or breastfeeding
Consult a doctor to determine the appropriate vitamin D dose during pregnancy.
The usual recommended dose is 2000 IU per day, regardless of the season, unless otherwise advised by a doctor.
During pregnancy, women should follow the advice of their attending physician, as their vitamin D requirements may vary depending on the body's vitamin D stores.

Patients with renal insufficiency
Do not use this medicine in patients with kidney failure without medical supervision.

Patients with hepatic insufficiency
No special dosage recommendations.

Children under 6 years of age
Not recommended for children under 6 years of age due to the pharmaceutical form (tablets).

Method of administration
Take one tablet with sufficient liquid.

Use of a higher than recommended dose of Vigalex Bio or Vigalex Forte
If a higher than recommended dose of Vigalex Bio or Vigalex Forte is taken, contact a doctor. The doctor will decide on appropriate treatment.
Symptoms of overdose: nausea, vomiting, diarrhoea followed by constipation, loss of appetite, fatigue, headache, muscle pain, joint pain, muscle weakness, drowsiness, azotemia (increased concentration of nitrogen compounds in blood), excessive thirst, polyuria, and dehydration. At high calcium levels in blood, cardiac function disturbances, renal failure, psychoses, and even coma may occur.
Laboratory tests reveal hypercalcemia (increased calcium concentration in blood), hypercalciuria (excessive excretion of calcium in urine), and increased serum 25-hydroxycholecalciferol concentration. Overdose requires measures to control hypercalcemia, which may be prolonged and sometimes life-threatening.

Missed dose of Vigalex Bio and Vigalex Forte
Do not take a double dose to make up for a missed dose.

Discontinuation of Vigalex Bio and Vigalex Forte
If you have any further doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during the use of Vigalex Bio and Vigalex Forte:
Frequency unknown (frequency cannot be determined from the available data):

• gastrointestinal disturbances such as constipation, bloating, nausea, abdominal pain, or diarrhea;
• hypersensitivity reactions such as skin itching, rash, or urticaria;
• with long-term use of high doses, hypercalcemia (excessively high calcium concentration in blood) and hypercalciuria (excessive excretion of calcium in urine) may occur. Deaths 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 Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 authorization holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety and helps provide more information on its safe use.

5. How to store Vigalex Bio and Vigalex Forte medicines

Keep the medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Vigalex Bio and Vigalex Forte contain

• The active substance is cholecalciferol.

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

• The other ingredients are: microcrystalline cellulose (type 102), calcium hydrogen phosphate dihydrate, gelatinized corn starch, crospovidone (type A), sucrose, magnesium stearate, sodium ascorbate, medium-chain triglycerides, colloidal anhydrous silica, all-rac-α-Tocopherol.

What Vigalex Bio and Vigalex Forte look like and contents of the packaging
Vigalex Bio (1000 IU)
White, round, biconvex tablets with a diameter of 6 mm ± 0.3 mm, with a score line embossed
on one side.
The score line on the tablet is intended only to facilitate breaking for easier swallowing and does not ensure
equal dose division.
Vigalex Forte (2000 IU)
White, round, biconvex tablets with a diameter of 8 mm ± 0.3 mm, with an embossed
marking "○" on one side.
The tablets are packed in PVC/PVDC/Aluminium blisters, placed together with the patient leaflet in a cardboard box. Pack sizes:
Vigalex Bio: 30, 60, 90 or 120 tablets
Vigalex Forte: 60, 90 or 120 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Tel.: +48 61 66 51 500
Fax: +48 61 66 51 505
E-mail: [email protected]