Biostatine - primernost za 70 letnike?

Customer question:

I wonder why Biostatine is not suitable for people over 70 years old. Lovely to welcome you. Anonymous customer's question

Pharmacist's answer:

Dear,

Thank you for your question regarding our product Biostatine.

The European Commission prepared a regulation that places monacolins from red yeast rice in Annex III of Regulation (EC) no. 1925/2006 with the following limitation: the recommended daily amounts of foods or food supplements should contain less than 3 mg monacolins from red yeast rice. Since legislative frameworks are the critical foundation of Sanofarm's operations, we were accordingly the first to prepare in time for changes in legislation and reduce the amount of monacolin K in the Biostatine product. The new formulation now contains 2.9 mg of monacolin K.

In addition, we have considered all legislative obligations, including warnings on the packaging. The new packaging of the Biostatine product bears the warning: "The product is not suitable for pregnant women, nursing mothers, children under the age of 18, and adults over the age of 70." As a result of the above, we would like to explain that it is a mandatory safety warning of the new Regulation (EC) no. 1925/2006 and related to the lack of reliable data on the use of monacolins from red fermented rice in particular vulnerable groups of people such as pregnant women, nursing mothers, older than 70 years and children. We want to emphasize that the restriction of use does not stem from the adverse effects of monacolins but from the lack of data on the impact on these specific groups of people.

Our manufacturer, Pharmalife Research, has a lot of experience and knowledge in products based on the active ingredient from fermented rice. Even with higher doses of monacolins, products have been on the market for more than 15 years and have proven to be very effective and safe. The production of the product itself takes place under constant internal and external control, as the company has introduced certified good manufacturing practices (GMP). Biostatine contains a rich formulation that ensures its primary action in the future due to the synergistic effect of various active ingredients (predominantly plant sterols, which contribute to maintaining normal cholesterol levels in the blood - EFSA, 2022). The product's target group remains people with exceeded cholesterol values who are not yet on medication (total cholesterol 5-8 mmol/L), have problems taking synthetic statins because of their side effects, or want a natural solution despite elevated cholesterol values.

We are at your disposal for any questions.

Greetings

Isabel Petronio, M.Sc. farm.