For professional public

INDONAL
Dietary supplement containing 150 mg of indole-3-carbinol in single capsule.

Qualitative and quantitative composition
Each capsule of the dietary supplement INDONAL contains 150 mg ofindole-3-carbinol, a substance naturally occurring in cruciferous plants such as cabbage, broccoli, turnip, cole and cauliflower.

Excipients: maize starch, 150 mg
Form: capsules (cps)

Indications
The results of the scientific research to date demonstrate that one of the active components possibly supporting the positive reaction of human organism in response to certain tumors is the indole-3-carbinol. Indole-3-carbinol has a positive effect on the estrogen metabolism by shifting the balance between the estrogen metabolites towards 2α- hydroxyestrone helping to suppress the growth of pre-cancer and cancer cells and supporting the programmed death of cancer and HPV-altered cells.

INDONAL is suitable for individuals with health concerns or with confirmed diagnosis of
  • Cervical dysplasia (histological finding CIN I-III) and cervical cancer
  • Infection by human papillomavirus virus HPV
  • Genital warts and disorders affecting the anal and genital area (itching, keratosis, condylomatosis)
  • Mastopathy (nodular and cystic changes in breasts)
  • Breast cancer
  • Uterine myomatosis
  • Ovarian cysts
  • Hormonal dysbalance in women

Prostate and testicular cancer, polyps and cancer of colon and stomach, laryngeal mucosa tumors

Recommended dosage
INDONAL is intended for oral application, to be taken 5-10 minutes before food, with sufficient quantity of liquids.

Adults:
For prevention 2 capsules should be taken per day, over 1 – 2 months.

In presence of a disorder and female sex organ soft tissue cancer, infection by HPV in the anal and genital area, 2 capsules should be used per day over 3 months (3 capsules per day over 3 months are recommended for women over 70 kg)
For prostate and testicular tumors, polyps, cancer of colon, stomach and larynx, 2 capsules should be used per day over 3 months (3 capsules per day over 3 months are recommended for men over 70 kg)

Children:

Children over 3 years of age and body weight over 25 kg, the dosage recommendation is 6-7 mg per kg of body weight.
The recommended dosage must not be exceeded. Repetition of the INDONAL treatment cycle is dependent on the results of the follow-up GYN examination. A 2-month pause is recommended before repeating the treatment cycle. Consult your specialist if you want to repeat the treatment cycle.
INDONAL may be used during radiotherapy. It can be used before and after chemotherapy, when using together with chemotherapy, reduced effect of INDONAL has been demonstrated.
INDONAL dietary supplement may be used together with hormonal contraception. It is suitable for diabetic patients.
Contraindications
Use of the INDONAL dietary supplement is highly contraindicated in pregnancy and during breast feeding!
It is not recommended to children younger below 3 years of age.
Use of the INDONAL dietary supplement is contraindicated in case of hypersensitivity to any of the components of the product.
Warning

INDONAL is not recommended in combination with medications reducing the secretion of gastric juices (antacids, H2 blockers, proton pump inhibitors (PPI)).
INDONAL is not effective in patients with mutation of cytochrome P450. In these patients indole-3-carbinol is not capable of affecting the transformation of estrogen to 2α- hydroxyestrone.
No adverse effects have been described when using the recommended daily dosage . In case of overdose, i.e. when more than 800 mg – corresponding to the maximum recommended daily dose - of the INDONAL dietary supplement is used, balance disruption, tremor, nausea and indigestion have been observed.
In some cases the product may cause flatulence, bloating, which resolves within several days.
It is important to observe the dosage schedule since irregular use and interruptions lead to the reduced effects of the INDONAL dietary supplement.

Packaging:
3x10 capsules
6x10 capsules

Minimum shelf life is indicated on outer packaging.
Interaction with other medicinal products and other forms of interaction
INDONAL and Tamoxifen have a synergic protective effect against cancer, breast cancer.

Properties

Origin
Indole-3-carbinol is a substance naturally occurring in cruciferous plants such as cabbage, broccoli, turnip, cole, cauliflower. Indole-3-carbinol is obtained through hydrolysis of indole-3-glukozinolátu. The reaction is facilitated by myrosinase enzyme which is activated after maceration of vegetables.

Chemical formula:

C9 H9 NO


Pharmacodynamic properties
Continuous supply of 2α-hydroxyestron is very important for the soft tissue cells of female sex organs such as breasts, uterus and ovaries. 2α-hydroxyestron ensures proper development of breast glands, lining of uterus as well as ovulation cycle. Regulation of the cell growth and multiplication is one of the major specific and physiological functions of estrogen. Estrogen metabolites are divided into so called “good” (2α-hydroxyestron) and „bad“ (16α-hydroxyestron). Under normal conditions these two metabolites are contained in the body at an ideal ratio. When this balance is disrupted towards increased levels of 16α-hydroxyestron, pathological changes may develop in the organism. A direct link between the effects of estrogen and development of estrogen-dependent soft tissue tumors has been demonstrated. In a malnourished female organism, estrogen cannot be metabolized in a proper way and alternative metabolic pathway is used, so called „16α-hydroxylation of estrogen, resulting in production of 16α-hydroxyestron.

This metabolic pathway maintains sufficient effect of the hormone to enable the transformation of the breast gland and other soft tissue cells. Over time these cells may transform into cancer cells. Indole-3-carbinol prevents the binding of 16α-hydroxyestron to the cell by binding to it itself and the cell is self-programmed for death – apoptosis – the programmed cellular death. When sufficient nutrition is supplied to the female organism, estrogen is metabolized through 2α-hydroxylation, with production of 2α-hydroxyestron. This metabolite never causes pathological transformation and cancer. Indole-3-carbinol is used by the body to direct estrogen to the correct metabolic pathway. Indole-3-carbinol shifts the mutual balance between estrogen metabolites towards 2α- hydroxyestrone. Indole-3-carbinol induces the liver cytochrome P450, which participates on 2α-hydroxylation of estrogen and increases the level of 2α-hydroxyestron. Indole-3-carbinol reduces the expression of estrogen receptors in target tissues. Indole-3-carbinol restores and increases the activity of the tumor suppression genes p21 and p53 and blocks growth factors thus preventing the proliferation of pre-cancer and cancer cells. Indole-3-carbinol increases the expression of the tumor-suppression gene BRCA 1, which is responsible for the repair of the damaged DNA in cancer cells.

Indole-3-carbinol reduces the production of cytokines in epithelial cells, which reduce local immune response of the organism Indole-3-carbinol suppresses the activity of antigens E6 and E7, which are specific for HPV infections. By inhibition of these antigens indole-3-carbinol helps to change the HPV-altered cells to normal phenotype cells and supports the programmed death of cancer and HPV-altered cells. An important role in apoptosis is played by genes BAX and BCL. Increased levels of BAX gene induce apoptosis of cancer cells, whereas the BCL gene inhibits the apoptosis. Therefore the balance between the genes is very important. It has been shown that indole-3 carbinol inhibits the production of BCL gene in cancer cells for a period of 48 hours and increases the production of BAX gene in the first 24 hours after use. Indole-3 carbinol stimulates the increased permeability of mitochondrial membrane, leading to translocation of BAX gene from cytoplasm into mitochondrias, release of the cytochrome c and activation of caspase – key enzyme of cellular apoptosis, leading to the death of the cancer or HPV-infected cell. Due to the capability of indole-3-carbinol to induce the synthesis of 2α-hydroxyestron, which inhibits the oxidation of low-density lipoproteins (LDL), it can be shown that it also has antioxidant effects. It appears that 2α-hydroxyestron inhibits the proliferation of smooth muscle. Inhibition of the smooth muscle proliferation and LDL oxidation could explain the possible antiatherogenic effects of indole-3-carbinol.

Pharmacokinetic properties
The pharmacokinetics of indole-3-carbinol in human body has not been fully established. Indole-3-carbinol is metabolized into DIM (diindolylmethan) and ICZ (indolecarbazol) in the stomach, by the effect of gastric acid. DIM and ICZ is ingested in gastrointestinal system. The exact location of absorption of indole-3-carbinol, DIM, ICZ, and the distribution and excretion pathways are subject to further scientific research.
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