Frequently Asked Questions by Patients

When you hear the term Polycystic Ovary Syndrome (PCOS), it’s easy to focus on your ovaries alone. But this complex disorder affects your hormones, metabolism, and reproductive system.

PCOS is a hormonal disorder that can affect women during their reproductive years. It usually develops when you begin menstruating, but it can also start later in life.

The signs and symptoms of PCOS can vary, but it typically involves one or more of the following issues:

• Irregular periods: Abnormal menstruation involves missing periods or not having a period at all. It may also involve heavy bleeding during periods.
• Abnormal hair growth: You may grow excess facial hair or experience heavy hair growth on your arms, chest and abdomen (hirsutism). This affects up to 70% of people with PCOS.
• Acne: PCOS can cause acne, especially on your back, chest and face. This acne may continue past your teenage years and may be difficult to treat.
• Obesity: Between 40% and 80% of people with PCOS have obesity and have trouble maintaining a weight that’s healthy for them.
• Darkening of the skin: You may get patches of dark skin, especially in the folds of your neck, armpits, groin (between the legs) and under your breasts. This is known as acanthosis nigricans.
• Cysts: Many people with PCOS have ovaries that appear larger or with many follicles (egg sac cysts) on ultrasound.
• Skin tags: Skin tags are little flaps of extra skin. They’re often found in your armpits or on your neck.
• Thinning hair: People with PCOS may lose patches of hair on their head or start to bald.
• Infertility: PCOS is the most common cause of infertility in women. Not ovulating regularly or frequently can result in not being able to conceive.

Myo-inositol is a form of inositol which is a group of molecules that are involved in various regulatory and metabolic processes in the human body. Myo-inositol helps improve insulin sensitivity and helps reduce serum testosterone in women with PCOS.

There is individual variation in the response to Inofolic^® based on the type and severity of signs and symptoms. Clinical evidence has shown that it may take 3-4 months to restore ovulation,¹ and up to 6 months to reduce symptoms related to skin such as acne and hirsutism in women with PCOS.²

1. Costantino D, Minozzi G, Minozzi E, Guaraldi C. Metabolic and hormonal effects of myo-inositol in women with polycystic ovary syndrome: a double blind trial. Eur Rev Med Pharmacol Sci. 2009 Mar-Apr;13(2):105-10.
2. Zacchè MM, Caputo L, Filippis S, Zacchè G, Dindelli M, Ferrari A. Efficacy of myo-inositol in the treatment of cutaneous disorders in young women with polycystic ovary syndrome. Gynecol Endocrinol. 2009 Aug;25(8):508-13. doi: 10.1080/09513590903015544. PMID: 19551544.

The hormonal imbalance in PCOS interferes with the growth and release of eggs from the ovaries (ovulation). If you don’t ovulate, you can’t get pregnant.

Inofolic helps to improve insulin sensitivity in women with PCOS and it helps in the management of PCOS’s hormonal and metabolic conditions.

Myo-inositol helps to reduce blood testosterone level, which in turn helps reduce excess facial hair in women with PCOS (hirsutism) and helps control acne.

Myo-inositol helps restore ovulation, normalize menstrual cycle irregularities, and improve ovary egg (oocyte) quality.

• It also helps promote and restore pregnancy rates and fertility in women under 36 years old with PCOS who undergo in vitro fertilization (IVF).
• The combination of myo-inositol and folic acid in Inofolic helps support normal early fetal development and helps reducing the risk of neural tube defects.

You can start taking it at any moment, regardless of where you are in your menstrual cycle.

It is recommended that you take it separated from meals.

It is recommended to take 2 capsules, 1 time per day; or take 1 capsule twice daily (preferably 12 hours apart) separated from meals. Once you start taking Inofolic, try to take it consistently everyday at the same time of the day.

If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.

Store at controlled room temperature (15°C – 30°C). Do not store in areas of high humidity. Keep out of reach of children.

1. Myo-inositol in the powder form is susceptible to factors that may impair its absorption; higher amounts of Myo-inositol would be required to provide the desired therapeutic level in the body, which may potentially increase the dose-dependent adverse effects of Myo-inositol and lead to reduced patients’ compliance.
   
   Bioavailability is one of the most important properties in any drug/supplement design and development; it is a key indicator of drug/supplement absorption and is defined as the extent (proportion) and rate at which the administered dose (of a drug or metabolite) enters the systemic circulation when taken orally or through other dosing routes.
   
   Aiming to develop a pharmaceutical form of Myo-inositol to address the above issues, Inofolic® soft-gel capsule was designed and evaluated in a study* versus powder form to assess the absorption of Myo-inositol. Compared with the powder form, Myo-inositol in soft-gel capsule displayed an improved bioavailability, allowing to substantially reduce the administered dose to almost three times less. In other words, 600 mg Myo-inositol in soft-gel capsule had similar plasma concentration compared with 2,000 mg of Myo-inositol as powder. This helps to reduce the daily administered dose while maintaining the same concentration of myo-inositol in the blood.

2. Furthermore, each capsule of Inofolic® contains 600 milligrams (mg) of “Myo-inositol” as well as 200 micrograms (mcg) of “Folic Acid”. Other products (in powder and capsule forms) may contain other types of inositol, or even other (active) ingredients, as well.

*Carlomagno G, De Grazia S, Unfer V, Manna F. Myo-inositol in a new pharmaceutical form: a step forward to a broader clinical use. Expert Opin Drug Deliv. 2012 Mar;9(3):267-71. doi: 10.1517/17425247.2012.662953. PMID: 22339497