Nefluan (Gel) Instructions for Use

Marketing Authorization Holder

L.Molteni & C. dei F.Lli Alitti Societa di Esercizio, S.p.A. (Italy)

Marketing and Distribution

Stada PharmDevelopment, LLC (Russia)

ATC Code

G04BX (Other drugs for the treatment of urological diseases)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Neomycin (Rec.INN registered by WHO)

Fluocinolone acetonide (Rec.INN registered by WHO)

Dosage Form

Nefluan

Gel for topical application 5 mg+250 mcg+25 mg/1 g: tube 10 g in a set with urethral extenders

Dosage Form, Packaging, and Composition

Gel for topical application transparent, homogeneous, practically colorless.

Excipients: sodium carboxymethylcellulose, sodium citrate, glycerol, propylene glycol, methylparaben, ethylparaben, propylparaben, sodium benzoate, purified water.

10 g – aluminum tubes (1) in a set with plastic urethral extenders (2 pcs.) – cardboard packs.

Clinical-Pharmacological Group

Preparation with antibacterial, anti-inflammatory and local anesthetic action for topical use in urology and proctology

Pharmacotherapeutic Group

Antibiotic + glucocorticosteroid + local anesthetic

Pharmacological Action

Combined preparation for topical application.

Lidocaine hydrochloride has a local anesthetic effect.

Neomycin sulfate is an antibiotic from the aminoglycoside group with a broad spectrum of bactericidal action.

Active against gram-positive cocci, gram-negative rods and actinomycetes.

Fluocinolone acetonide is a synthetic glucocorticosteroid that has an anti-inflammatory effect when applied topically. It does not affect the antibacterial activity of neomycin and enhances the local anesthetic effect of lidocaine.

Indications

• Diagnostic and therapeutic procedures (including cystoscopy, bladder catheterization, urethral dilation, colposcopy, rectoscopy, colonoscopy);
• Acute and chronic nonspecific inflammatory diseases of the lower urinary tract (including acute cystitis, exacerbation of chronic cystitis, urethritis);
• Infectious and inflammatory diseases of the rectum (including hemorrhoids, acute anal fissure, cryptitis, anusitis);
• Inflammatory skin changes with active fistulas of the rectum.

ICD codes

Dosage Regimen

During endourethral procedures, the gel is squeezed out of the tube directly into the urethra by compressing the tube and simultaneously massaging the posterior wall of the urethra. Then a clamp is applied to the urethra, which is removed after 10 minutes, after which endourethral procedures are performed.

To simplify the administration of the drug and relieve pain that may occur when the metal part of the tube tip touches pain-sensitive areas, a plastic extender is supplied with the tube, which is screwed onto its tip immediately before using the drug.

The gel is recommended to be administered a few minutes before the start of diagnostic or therapeutic manipulations, and also repeated immediately after their completion.

The contents of one tube are sufficient to fill the entire urethra, however, in some cases, the dose can be changed depending on the extent of the lesion and the desired effect.

During endoscopic examinations in proctology (sigmoidoscopy, colonoscopy), the gel is administered into the anal canal 10-15 minutes before the procedure and repeated immediately before its start.

For infectious and inflammatory diseases of the lower urinary tract, the gel is administered into the urethra 1-2 times/day for 5-10 days.

For infectious and inflammatory diseases of the rectum, the gel is applied to the affected surface of the skin and mucous membrane and administered into the anal canal using an extender (after bowel movement and hygiene procedures) 3 times/day for 10-14 days.

Adverse Reactions

Allergic reactions skin itching, burning sensation, skin hyperemia.

Contraindications

• Hypersensitivity to lidocaine and other amide-type anesthetics;
• Hypersensitivity to neomycin, fluocinolone and other components of the drug.

Use with caution in children, elderly patients and debilitated patients.

Use in Pregnancy and Lactation

Adequate and strictly controlled studies on the use of the drug during pregnancy and lactation have not been conducted. Therefore, the prescription of the drug during pregnancy (especially in the early stages) and during lactation (breastfeeding) is undesirable or should be thoroughly justified.

Special Precautions

The efficacy and safety of Nefluan, like any other local anesthetic, depends on proper dosing and application technique.

To prevent side effects, the minimum effective doses of the drug should be used whenever possible.

For complete anesthesia of the urethra during any instrumental interventions, one tube of Nefluan is usually sufficient.

The risk of side effects increases with very long-term or continuous use, use in high doses, or in the presence of extensive lesions of the skin and mucous membranes.

Effect on ability to drive vehicles and operate machinery

No effect of the drug on the ability to perform work requiring concentration has been established.

Overdose

Data on overdose of Nefluan are not provided.

Drug Interactions

Data on drug interactions of Nefluan are not provided.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature from 8°C (46.4°F) to 30°C (86°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by 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.