Fertina Inosit 1000 mg Folic acid 100 mkg (Powder) Instructions for Use

Marketing Authorization Holder

Orion Pharma, LLC (Russia)

Manufactured By

Fine Foods & Pharmaceuticals N.T.M., S.p.A. (Italy)

On Behalf Of

VALENTA PHARM, JSC (Russia)

Contact Information

VALENTA PHARM JSC (Russia)

Dosage Form

Fertina Inositol 1000 mg Folic acid 100 mcg

Soluble powder 1000 mg+100 mcg: 30 pcs.

Dosage Form, Packaging, and Product Composition

Excipients: filler maltodextrin, vanilla flavor, sweetener sucralose, anticaking agent silicon dioxide.

Nutritional value per 1 sachet: carbohydrates – 2 g, proteins – <0.1 g, fats – <0.1 g.
Energy value per 1 sachet: 8 kcal (33 kJ).

3 g – sachets (30) – cardboard packs.

Therapeutic Category

Dietary supplement for maintaining the function of the reproductive system

Properties

The properties of the product are determined by the properties of its constituent components (Inositol and Folic acid).

Action of the components of the Fertina dietary supplement

Inositol

Inositol (Myo-Inositol, Vitamin B₈) is a minor biologically active component. Inositol functions as a signaling molecule necessary for intracellular signal transduction from receptors. Inositol ensures the functioning of sex hormone receptors, insulin, catecholamines, thyroid-stimulating hormone (TSH), and others.

The daily requirement for inositol is 4-8 g/day. Inositol can be synthesized by healthy human kidneys and obtained from food. The highest amounts of inositol are found in citrus fruits, whole grains, dried fruits, peanuts, wheat germ, beans, yeast, and leafy greens. Fruits and fresh vegetables contain more inositol than frozen, canned, and heat-treated foods. When synthesis, renal excretion, or dietary intake is impaired, inositol metabolism is disrupted. Low inositol levels are one of the factors in the development of polycystic ovary syndrome (PCOS) [1]. Taking inositol for 6 months has a positive effect on the hormonal status of patients with PCOS – the level of luteinizing hormone (LH) decreases, the LH/FSH ratio normalizes; restoration of the menstrual ovulatory cycle is noted [2,3,4].

Even if a woman is not planning a pregnancy in the near future, reducing testosterone levels while taking inositol helps reduce the manifestations of hyperandrogenism (hirsutism, acne, excessive oiliness and hair loss, androgenic obesity). Taking inositol has a positive effect on metabolic status: a significant decrease in fasting glucose and insulin levels is noted; the HOMA index (a measure of insulin resistance), a decrease in plasma triglyceride and total cholesterol levels, body mass index, and regulation of leptin levels – the hormone that controls appetite [4].

Inositol can have a positive effect on female reproductive function. Regular intake of inositol can contribute to the restoration of the menstrual cycle with spontaneous ovulation. Inositol plays an important role in the process of follicle formation and quality oocytes [5]. The use of inositol as part of pregravid preparation helps improve the outcomes of assisted reproductive technologies (ART): the doses of recombinant FSH and the duration of stimulation are reduced, which may reduce the risk of developing ovarian hyperstimulation syndrome; the number of good quality oocytes and embryos increases. In women undergoing repeated ovulation stimulation cycles in IVF protocols, taking inositol and folic acid allows to reduce the number of mature oocytes used (by reducing the hormonal load during stimulation and improving the quality of the obtained oocytes and embryos) without reducing the number of clinical pregnancies. Conducted studies demonstrate a significant increase in the frequency of pregnancy in various ART protocols while taking inositol. Moreover, such results were obtained both in patients with PCOS and in women with other causes of reproductive dysfunction [6,7].

Taking inositol can significantly reduce the risk of developing gestational diabetes in high-risk pregnant women (women with obesity or insulin resistance) [8]. Inositol can provide protection for the embryo from hyperglycemia, helps reduce the number of premature births and the birth of children with macrosomia [9].

Inositol plays an important role in the prevention of congenital neural tube defects in the fetus, which in 70% of cases can be prevented by taking folic acid. However, 30% of such defects remain folate-resistant. The use of inositol in such situations can significantly reduce the risk of neural tube defect formation [10,11].

The use of inositol can have a positive effect on male fertility. According to research, taking inositol helps restore the balance of gonadotropic hormones in men with idiopathic infertility (the amounts of LH, FSH, prolactin significantly decrease, and the concentrations of Inhibin B (a marker of spermatogenesis) and testosterone increase) [12]; sperm quality improves (concentration, total count, and number of progressively motile spermatozoa increase, morphological properties of sperm improve) [13, 14].

Taking inositol has a beneficial effect on skin condition, promotes the acceleration of reparative processes in it [15]. The important role of inositol in hair growth processes, ensuring normal hair density and healthy hair shine has been proven [16].

Folic acid

Folic acid is a water-soluble B vitamin (vitamin B₉). Folic acid plays an important role in amino acid metabolism, protein synthesis and nucleic acid synthesis (primarily in the production of DNA and RNA), and chromosome repair. Therefore, it is very important for normal cell division and tissue growth.

Folic acid is found in green leafy vegetables, liver, eggs, and legumes, while its content in fruits (except oranges), meat, and milk is quite low. During cooking, it is almost completely destroyed to folates (90%) in just a few minutes.

A deficiency of folic acid during pregnancy preparation and during pregnancy can lead to pathology of the egg, placental abruption (both partial and complete), missed abortion, spontaneous abortion (miscarriage); congenital malformations in the child: anencephaly, neural tube defect, hydrocephalus, hypotrophy, cleft lip, mental retardation, anemia, which can lead to fetal hypoxia.

Folic acid practically does not accumulate in the human body, therefore, to prevent complications during pregnancy and the development of fetal nervous system defects, it is advisable to take folic acid even at the stage of pregnancy planning.

Scope of Application

Of the product Fertina Inositol 1000 mg Folic acid 100 mcg

• As a dietary supplement to food, an additional source of inositol and folic acid.

ICD codes

Dosage Regimen

Take orally, with meals. Immediately before use, dissolve 1 sachet in 200 ml of water at room temperature.

Adults are recommended to take 1 sachet per day.

The recommended daily dose contains

* TR CU 022/2011 “Food products regarding their labeling”.
** Does not exceed the upper permissible intake level, Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary-epidemiological surveillance (control).

Duration of intake is 1 month. If necessary, the course of application can be repeated.

Determination of the daily dose and duration of intake can be made by a doctor individually and may differ from the recommended dose in this leaflet.

Contraindications

• Individual intolerance to the components.

Special instructions

A dietary supplement to food, not a medicinal product.

It is recommended to consult a doctor before use.

Dispensing Status

Places of sale are determined by the national legislation of the member states of the Eurasian Economic Union.

Storage Conditions

The product should be stored in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date stated on the packaging.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.