Grammidin^® (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

R02AA20 (Other antiseptics)

Active Substances

Cetylpyridinium chloride (Rec.INN registered by WHO)

Gramicidin S (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical antiseptic for use in ENT practice and dentistry

Pharmacotherapeutic Group

Drugs for the treatment of throat diseases; antiseptics

Pharmacological Action

A combined drug for the treatment of infectious and inflammatory diseases of the pharynx and oral cavity. The drug contains the antimicrobial agent gramicidin C and the antiseptic agent cetylpyridinium chloride.

The mechanism of action of gramicidin C is associated with an increase in the permeability of the cytoplasmic membrane of the microbial cell, which disrupts its stability and causes cell death.

Gramicidin C has a pronounced antimicrobial effect against pathogens of infectious diseases of the oral cavity and pharynx.

Cetylpyridinium chloride belongs to antiseptic agents. It suppresses the growth and reproduction of pathogens of infectious diseases of the oral cavity.

The drug reduces inflammation, has an antimicrobial effect, softens unpleasant sensations in the throat, facilitates swallowing, and when dissolved, causes hypersalivation, which promotes mechanical cleansing of the oral cavity and pharynx from microorganisms.

Pharmacokinetics

The drug has a local action and is practically not absorbed from the gastrointestinal tract, which determines the almost complete absence of systemic effects.

Indications

For adults and children aged 4 years and older

Infectious and inflammatory diseases of the oral cavity and pharynx: sore throat, pharyngitis, tonsillitis, periodontosis, gingivitis, stomatitis.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
J02	Acute pharyngitis
J03	Acute tonsillitis
J31.2	Chronic pharyngitis
J35.0	Chronic tonsillitis
K05	Gingivitis and periodontal diseases
K12	Stomatitis and related lesions

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

For local use. Applied after meals, by dissolving in the mouth, without chewing. Immediately after using the drug, you should refrain from eating and drinking for 1-2 hours.

Dosage for adults and children over 12 years old – 1 tablet 3-4 times a day.

Dosage for children from 4 to 12 years old – 1 tablet 1-2 times a day.

If there is no therapeutic effect within 7 days of taking the drug, it is recommended to consult a doctor.

Adverse Reactions

In some cases, allergic reactions to the components of the drug are possible.

Reporting of Suspected Adverse Reactions

It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

Hypersensitivity to gramicidin C, cetylpyridinium chloride or to any of the excipients included in the drug;
Pregnancy (first trimester);
Period of breastfeeding;
Children under 4 years of age.

Use in Pregnancy and Lactation

Pregnancy

It is not recommended to use the drug during pregnancy (first trimester).

Breastfeeding period

Breastfeeding should be discontinued during the drug administration.

Pediatric Use

The drug can be prescribed to children over 4 years of age.

Special Precautions

The drug should not be used in the presence of open wounds in the oral cavity, since cetylpyridinium chloride slows down wound healing.

Excipients

Patients with rare hereditary fructose intolerance should not take this drug.

Effect on ability to drive vehicles and mechanisms

The drug does not affect the performance of potentially hazardous activities requiring increased attention and rapid reactions (driving vehicles, working with moving mechanisms, work of a dispatcher and operator, etc.).

Overdose

Symptoms from the gastrointestinal tract – nausea, vomiting, diarrhea.

Treatment: the use of the drug should be discontinued.

Drug Interactions

Grammidin^® neo enhances the effects of other antimicrobial agents for local and systemic use.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

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.

Medical Disclaimer

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

Grammidin^® neo [Valenta Pharm, JSC (Russia)]
Sublingual tablets 3 mg+1 mg: 12, 18, or 24 pcs.

Marketing Authorization Holder

Valenta Pharm, JSC (Russia)

Contact Information

VALENTA PHARM JSC (Russia)

Dosage Form

Grammidin^® neo

Sublingual tablets 3 mg+1 mg: 12, 18, or 24 pcs.

Dosage Form, Packaging, and Composition

Sublingual tablets white, round, biconvex, with an engraving “GR” on one side.

	1 tab.
Gramicidin C dihydrochloride (calculated as gramicidin C)	3.2 mg (3 mg)
Cetylpyridinium chloride monohydrate (calculated as cetylpyridinium chloride)	1.05 mg (1 mg)

Excipients: colloidal silicon dioxide, talc, acesulfame potassium, mint flavor, sorbitol, magnesium stearate.

6 pcs. – blister packs (2) – cardboard packs.
6 pcs. – blister packs (3) – cardboard packs.
6 pcs. – blister packs (4) – cardboard packs.
9 pcs. – blister packs (2) – cardboard packs.

Grammidin^® with anesthetic neo [Valenta Pharm, JSC (Russia)]
Sublingual tablets 3 mg+0.2 mg+1 mg: 12, 18, or 24 pcs.