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Cernilton® (Tablets) Instructions for Use

ATC Code

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

Clinical-Pharmacological Group

Herbal preparation, used for prostate gland diseases

Pharmacotherapeutic Group

Herbal remedy for the treatment of prostate adenoma

Pharmacological Action

Cernilton® is a microbiologically fermented extract of pollen from plants of the Gramineae family.

Cernilton® has anti-inflammatory and anti-edema effects and helps to regulate metabolic processes.

One of the pharmacological properties of the drug is the dose-dependent inhibition of cyclooxygenase and 5-lipoxygenase, which leads to the suppression of the synthesis of inflammatory mediators of the arachidonic acid cascade: prostaglandins and leukotrienes and, as a result, to a reduction in inflammation and edema of the prostate tissue. The drug helps to eliminate the pain syndrome. Cernilton® has a myorelaxant effect, which leads to relaxation of the smooth muscle cells of the posterior wall of the urethra and improvement of urination.

The drug reduces the volume of the prostate gland by inhibiting 5-alpha-reductase, selectively blocks alpha1-adrenergic receptors of the smooth muscle cells of the urethra, and has an antiandrogenic effect. It helps to improve erectile function.

Pharmacokinetics

No data available.

Indications

As part of complex therapy

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

ICD codes

ICD-10 code Indication
N40 Hyperplasia of prostate
N41 Inflammatory diseases of prostate
ICD-11 code Indication
GA90 Hyperplasia of prostate
GA91.Z Inflammatory and other diseases of prostate, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

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

For acute prostatitis, 4 tablets are prescribed 3 times/day. The duration of the treatment course is determined by the attending physician and is usually 3 months.

For chronic prostatitis, 1 tablet is prescribed 3-4 times/day. 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, 2 tablets are prescribed 3 times/day. The duration of the treatment course is determined individually by the attending physician and is usually from 6 to 12 weeks, but can be increased to 6 months.

Adverse Reactions

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

Contraindications

  • Hypersensitivity to the components of the drug.

Special Precautions

The use of the drug for chronic bacterial prostatitis is possible only in combination with antibacterial agents, as prescribed and under the supervision of a physician.

Effect on the ability to drive vehicles and mechanisms

Cernilton® does not affect the ability to engage in potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, including driving vehicles, working with moving mechanisms, work of a dispatcher and operator.

Overdose

To date, no cases of overdose have been observed.

Drug Interactions

There is no information on the interaction of Cernilton® with other medicinal products.

Storage Conditions

In a dry, light-protected place, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 5 years.

Dispensing Status

Over-the-counter.

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Graminex-Pharma Group of Companies, LLC (Russia)

Manufactured By

Graminex, L.L.C. (USA)

Labeled By

GRAMINEX, L.L.C. (Russia)

Dosage Form

Bottle OTC Icon Cernilton® Film-coated tablets, 311.5 mg: 100, 200, or 5000 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light yellow to yellow in color, round, biconvex, with small inclusions of a darker shade, with an engraved company logo on one side, with a specific odor.

1 tab.
Graminex G60 (water-soluble fraction of microbiologically fermented plant pollen extract) 60 mg
Graminex GFX (fat-soluble fraction of microbiologically fermented plant pollen extract) 3 mg

Excipients: microcrystalline cellulose 237.8 mg, colloidal silicon dioxide 5.6 mg, magnesium stearate 3.6 mg.

Film coating composition Opadry NS clear 1.5 mg (sodium carboxymethylcellulose 0.543 mg, dextrin 0.735 mg, dextrose 0.173 mg, lecithin 0.042 mg, sodium citrate 0.007 mg).

100 pcs. – bottles (1) – cardboard packs.
200 pcs. – bottles (1) – cardboard packs.
5000 pcs. – high-density polyethylene (HDPE) bags size 10 x 18 inches, which are placed into high-density polyethylene (HDPE) bags size 30 x 36 inches with a moisture absorber – fiber drums.

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)

Dosage Form

Bottle OTC Icon Cernilton® Tablets: 100 or 200 pcs.

Dosage Form, Packaging, and Composition

Tablets round, biconvex, from pale yellow to light yellow in color, with small inclusions of a darker shade, with an engraved company logo on one side, with a specific odor.

1 tab.
Graminex® G60 (water-soluble fraction of microbiologically fermented plant pollen extract) 60 mg
Graminex® GFX (fat-soluble fraction of microbiologically fermented plant pollen extract) 3 mg

Excipients: microcrystalline cellulose – 237.8 mg, colloidal silicon dioxide – 5.6 mg, magnesium stearate – 3.6 mg.

100 pcs. – dark glass bottles (1) – cardboard packs.
100 pcs. – high-density polyethylene bottles (1) – cardboard packs.
200 pcs. – dark glass bottles (1) – cardboard packs.
200 pcs. – high-density polyethylene bottles (1) – cardboard packs.

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