Indinol Forto^® (Capsules) Instructions for Use

Marketing Authorization Holder

Alcea LLC (Russia)

Manufactured By

MiraxBioPharma JSC (Russia)

ATC Code

G03XC (Selective estrogen receptor modulators)

Active Substance

Indolcarbinol (Grouping name)

Dosage Form

Indinol Forto®

Capsules 200 mg: 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Capsules No. 0, with a white body and an orange cap; the capsule contents are a powder from white to light yellow or light brown in color, with a characteristic odor.

Excipients: lactose monohydrate (milk sugar) – 110 mg, modified corn starch – 95 mg, microcrystalline cellulose type 102 – 64 mg, sodium carboxymethyl starch (sodium starch glycolate) – 30 mg, magnesium stearate – 1 mg.

Capsule shell composition: hydroxypropyl methylcellulose (hypromellose) – up to 100%.

Composition of the capsule body dyes: titanium dioxide (E171) – 2%.
Composition of the capsule cap dyes: sunset yellow dye (E110) – 1%, titanium dioxide (E171) – 1%.

20 pcs. – blister packs (3) – cardboard packs.
20 pcs. – blister packs (6) – cardboard packs.

Clinical-Pharmacological Group

Selective estrogen receptor modulator

Pharmacotherapeutic Group

Selective estrogen receptor modulator

Pharmacological Action

Selective estrogen receptor modulator. It has antiestrogenic and antiproliferative effects. It causes selective death of breast cells with abnormally high proliferative activity.

Indolcarbinol modulates the cytochrome system in such a way that the resulting isoform of cytochrome P450 – CYP1A1 hydroxylates estrogens in the 2nd position, forming 2-hydroxyestrone (2-OHE1). The resulting metabolite is an antagonist of the estrogen receptor and blocks its activation by estrogens themselves, as well as by their dangerous metabolites, in particular, 16-α-hydroxyestrone (16α-OHE1), the proportion of which among metabolites decreases. This suppresses the induction of estrogen-dependent genes and the cell ceases to receive excessive estrogen-dependent stimulation. The drug also blocks other signaling mechanisms (cytokine) that stimulate pathological cell growth in breast tissues by suppressing signaling cascades from the corresponding receptors.

Course use of indolcarbinol helps to reduce the intensity and disappearance of pain in the mammary gland with cyclic mastalgia (mastodynia).

Indications

Treatment of cyclic mastalgia (mastodynia), including against the background of benign breast hyperplasia.

ICD codes

Dosage Regimen

Take the capsules orally with a sufficient amount of water.

Administer the drug twice daily, every 12 hours, to maintain stable plasma concentrations.

The single dose is 200 mg (one capsule).

The total daily dose is 400 mg (two capsules).

Adhere to a treatment course duration of six months for full therapeutic effect.

Do not exceed the recommended daily dose.

If a dose is missed and less than 6 hours have passed, take the capsule immediately.

If more than 6 hours have passed, skip the missed dose and continue the regular schedule.

Do not double the dose to make up for a forgotten one.

Continue the regimen for the entire prescribed period, even if symptoms improve.

Adverse Reactions

Reproductive system: menstrual cycle disorders in the form of lengthening or shortening.

Digestive system: pain in the epigastrium.

Laboratory parameters: increase in the concentration of TSH and FSH, prolactin and estradiol, decrease in the concentration of creatinine, eosinophilia.

Other: weight loss.

Contraindications

Hypersensitivity to the components of the drug; pregnancy, lactation period; age under 18 years.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and lactation.

Pediatric Use

Use is contraindicated under the age of 18 years.

Drug Interactions

Considering the effect of indolcarbinol on the activity of cytochrome P450 isoenzymes, caution should be exercised when used concomitantly with drugs whose metabolism involves cytochrome P450 isoenzymes (indirect anticoagulants, corticosteroids, oral hypoglycemic agents, antiarrhythmic and antiepileptic drugs, digitalis preparations, sex hormone preparations), as dose adjustment may be required.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.