Company

05.10.2020

Vigalex® - a new OTC drug in our portfolio

Vigalex® - a new OTC drug in our portfolio

In September,  Biofarm expanded the portfolio of products by three new OTC drugs. As the first pharmaceutical company in Poland, we introduced the only over-the-counter medicinal product in Poland with vitamin D3 in three doses*. This enables patients to supplement vitamin D3 deficiency in the best variant.

Vigalex® Bio, Vigalex® Forte and Vigalex® Max contain cholecalciferol tablets, which prevents vitamin D deficiency, rickets and osteomalacia in children and adults. It is also indicated for the adjunctive treatment of osteoporosis1.

Vigalex® Bio

Vigalex® Forte

Vigalex® Max

1000 IU

2000 IU

4000 IU

0,025 mg of cholecalciferol

0,05 mg of cholecalciferol

0,1 mg of cholecalciferol

Pack size: 30 or 90 tablets

Pack size: 60 or  120 tablets

Pack size: 60 tablets

Dosage recommended for children from 6 years of age and adults

Dosage recommended for adolescents, adults or women planning pregnancy, pregnant and breastfeeding women

Dosage recommended for adults with obesity

Vitamin D deficiency may be a threat in the development of bone diseases (in children - rickets, in adults - osteomalacia and osteoporosis) and chronic diseases not related to bones (e.g. autoimmune, infectious, neurocognitive disorders). Before starting the treatment, it is advisable to measure the level of vitamin 25(OH)D in blood and consult your doctor2.

* Vigalex OTC drug at a dosage of: 1000 IU, 2000 IU and 4000 IU. There is no brand on the Polish market with 3 doses of OTC drug status according to IQVIA data (05/2020).

  1. SmPC Vigalex® Bio 08/2020
  2. A. Rusińska, P. Płudowski, M. Walczak, Maria K. Borszewska-Kornacka, A. Bossowski, D. Chlebna-Sokół, J. Czech-Kowalska, A. Dobrzańska, E. Franek, E. Helwich, T. Jackowska, M. Kalina, J. Konstantynowicz, J. Książyk, A. Lewiński, J. Łukaszkiewicz, E. Marcinowska-Suchowierska, A. Mazur, I. Michałus, J. Pergud-Pogorzelski, H. Romanowska, M. Ruchała, P. Socha, M. Szalecki, M. Wielgoś, D. Zwolińska, A. Zygmunt, Zasady suplementacji i leczenia witaminą D – nowelizacja 2018 r.
OTC Medicine

Vigalex® BIO

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OTC MEDICINE

Vigalex® FORTE

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OTC MEDICINE

Vigalex® MAX

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Summary of drug characteristics: Vigalex® Bio, Vigalex® Forte

Vigalex® Bio (1000 IU) - one tablet contains 10 mg of cholecalciferol powder, which corresponds to 0.025 mg (1000 IU) of cholecalciferol (vitamin D3).

Vigalex® Forte (2000 IU) - one tablet contains 20 mg of cholecalciferol, powder, which corresponds to 0.05 mg (2000 IU) of cholecalciferol (vitamin D3).

Indications for use: Prevention of rickets and osteomalacia in children and adults, prevention of vitamin D deficiency in women planning pregnancy, pregnant and breastfeeding women in consultation with a doctor, prevention of vitamin D deficiency in children and adults, supportive treatment of osteoporosis in adults.

Contraindications: hypersensitivity to the active substance (cholecalciferol) or to any of the excipients, hypercalcaemia and / or hypercalciuria, nephrolithiasis and / or severe renal failure, pseudo-hypoparathyroidism (the need for vitamin D may be reduced due to periods of normal sensitivity to this vitamin leading to overdose). In such cases, there are vitamin D derivatives that are easier to control available.

Marketing Authorisation Holder: Biofarm Sp. z o.o., ul. Wałbrzyska 13, 60-198 Poznań, Poland.
 

Summary of drug characteristics: Vigalex® Max

Vigalex® Max (4000 IU) - one tablet contains 40 mg of cholecalciferol, powder, which corresponds to 0.1 mg of cholecalciferol (vitamin D3).

Indications for use: Prophylaxis of vitamin D deficiency and conditions resulting from vitamin D deficiency (e.g. osteomalacia, osteoporosis) in obese adults (body mass index (BMI) ≥ 30 kg / m2).

Contraindications: hypersensitivity to the active substance (cholecalciferol) or to any of the excipients, hypercalcaemia and / or hypercalciuria, nephrolithiasis and / or severe renal failure, pseudo-hypoparathyroidism (vitamin D requirements may be decreased due to periods of normal sensitivity to this vitamin leading to overdose). In such cases, there are vitamin D derivatives that are easier to control available. Children and adolescents under 18 years of age.

Marketing Authorisation Holder: Biofarm Sp. z o.o., ul. Wałbrzyska 13, 60-198 Poznań, Poland.

Before use, please read the information leaflet, which contains indications, contraindications, data on adverse effects and dosage, as well as information on the use of the medicinal product, or consult a doctor or pharmacist, as any drug used contrary to its purpose can be dangerous to your life and health.

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