Cernilton^® Forte (Capsules) Instructions for Use

Marketing Authorization Holder

Graminex-Pharma Group of Companies, LLC (Russia)

Manufactured By

Graminex, L.L.C. (USA)

Contact Information

Graminex-Pharma Group of Companies, LLC (Russia)

ATC Code

G04CX (Other preparations for the treatment of benign prostatic hyperplasia)

Dosage Form

Cernilton® Forte

Capsules: 50 pcs.

Dosage Form, Packaging, and Composition

Capsules hard, size 00, transparent, dark green in color; capsule contents – light yellow powder.

* microbiologically fermented extract of pollen from plants of the Poaceae family: rye (Secale cereale L.), corn (Zea mays L.), timothy grass (Phleum pratense L.).

Excipients: microcrystalline cellulose – 266 mg, colloidal silicon dioxide – 7.6 mg, maltodextrin 10DE – 176.2 mg, calcium stearate – 16 mg, calcium dihydrogen phosphate – 3.2 mg.

Capsule shell composition: sodium copper chlorophyllin – 0.83 mg, hypromellose – 117.17 mg.

50 pcs. – dark glass bottles (1), sealed in plastic film – cardboard packs.
50 pcs. – high-density polyethylene bottles (1), sealed in plastic film – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation, used for prostate gland diseases

Pharmacotherapeutic Group

Herbal remedy for benign prostatic hyperplasia

Pharmacological Action

Cernilton^® Forte has anti-inflammatory and anti-edema effects, and helps regulate metabolic processes.

One of the pharmacological properties of Cernilton^® Forte is dose-dependent inhibition of COX and 5-lipoxygenase, which leads to suppression of the synthesis of arachidonic acid cycle inflammatory mediators – prostaglandins and leukotrienes – and, as a result, to a reduction in inflammation and edema of the prostate tissue. The drug helps eliminate pain syndrome.

Cernilton^® Forte has a muscle relaxant effect, which leads to relaxation of the smooth muscle elements of the posterior urethral wall and improvement of urination.

The drug reduces the volume of the prostate gland by inhibiting 5α-reductase, selectively blocks α₁-adrenergic receptors of the smooth muscle elements of the urethra, and has an antiandrogenic effect. It helps improve erectile function.

Pharmacokinetics

No data available. The pharmacokinetic properties of Cernilton^® Forte are determined by the combined action of its components, therefore conducting pharmacokinetic studies is not feasible; the transformation of all components cannot be traced using markers or biological studies.

Indications

As part of complex therapy

• Acute and chronic prostatitis;
• Benign prostatic hyperplasia;
• Benign prostatic hyperplasia in combination with prostatitis.

ICD codes

Dosage Regimen

The drug is taken orally 30 minutes before meals, with a small amount of water.

For acute prostatitis, 2 capsules 3 times/day are prescribed. The duration of the treatment course is determined by the attending physician and is usually 3 months.

For chronic prostatitis, 1 capsule 3 times/day is prescribed. The duration of the treatment course is determined individually by the attending physician and is usually from 3 to 6 months.

For benign prostatic hyperplasia, 1 capsule 3 times/day is prescribed. The duration of the treatment course is determined individually by the attending physician and is usually from 6 to 12 weeks, but can be extended up to 6 months.

Adverse Reactions

Allergic reactions are possible; in rare cases, nausea may occur.

If side effects occur, including those not described above, the attending physician should be informed.

Contraindications

• Age under 18 years;
• Hypersensitivity to the drug components.

Use in Pregnancy and Lactation

The use of the drug in women, including during pregnancy and breastfeeding, is not intended.

Pediatric Use

Contraindicated for use in children under 18 years of age.

Special Precautions

Consult a physician before using the drug. The optimal regimen and repeated courses of treatment are established and prescribed by the doctor individually in each specific case based on diagnostic examination. The use of the drug for chronic bacterial prostatitis is possible in combination with antibacterial agents (as prescribed and under the supervision of a physician).

Effect on the ability to drive vehicles and operate machinery

The use of the drug does not affect the performance of potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms).

Overdose

To date, no cases of overdose with Cernilton^® Forte have been reported.

Drug Interactions

No information is available on the interaction of Cernilton^® Forte with other medicinal products.

Storage Conditions

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

Shelf Life

Shelf life – 5 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

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.