Expiration date: 03/2025

Composition and form of issue:

Tablets, film-coated. 1 tablet contains:

nifuratel 200 mg

auxiliary ingredients: starch polyethylene glycol 6000 talc magnesium stearate gelatin gum Arabic sucrose magnesium carbonate titanium dioxide e wax

10 PCs in the paper cartons 2 blister pack (with instructions).

Description of dosage form:

Biconvex tablets, coated, white.

Characteristic:

It belongs to the group of nitrofurans.

Pharmacokinetics:

When ingestion is rapidly absorbed from the gastrointestinal tract. Penetrates the GEB and gematoplatzentarnyi barrier, excreted in breast milk. It is metabolized in the liver and muscle tissue. Completely excreted by the kidneys (30-50% - unchanged), providing a strong antibacterial effect in the urinary tract.

Description of pharmacological action:

Nifuratel, antimicrobial agent from the group of nitrofurans has antiprotozoynoe, antifungal and antibacterial effect.

Nifuratel has a high efficiency and low toxicity, which causes a wide range of clinical applications.

Highly effective against Papiliobacter and Helicobacter pylori, gram-positive and gram-negative microorganisms: at a minimum inhibitory concentration (MPC) of 12, 5 -25 µg/ml suppresses from 44, 3 to 93, 2% of cultures.

It is highly active against both aerobic and anaerobic pathogens.

Spectrum of activity includes Enterococcus faecalis, Enterococcus faecium, Staphylococcus aureus, Bacillus subtilis, Escherichia coli, Shigella flexneri 2a, Shigella flexneri 6, Shigella sonnei, Salmonella typhi, Salmonella typhimurium, Salmonella enteritidis, Klebsiella spp., Enterobacter sph., Serratia spp., Citrobacter spp., Morganella spp., Rettgerella spp., Pragia fontium, Budvicia aquatica, Rachnella aquatilis and Acinetobacter spp. other atypical enterobacteria, and protozoa (amoeba, Giardia) are less active against Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa.

It is the drug of choice for the treatment of salmonellosis, shigellosis and other intestinal bacterial infections.

Active against Trichomonas vaginalis, highly active against fungi of the genus Candida.

Especially effective against strains of Helicobacter pylori resistant to metronidazole.

Data indicating high activity of nifuratel (in vitro and in vivo) against Atopobium vaginae, the main marker of bacterial vaginosis, were obtained.

Indications:

• vulvovaginal infections caused by drug-sensitive pathogens (pathogens, Candida, Trichomonas, bacteria, chlamydia)
  
• chronic inflammatory diseases of the upper gastrointestinal tract associated with Helicobacter pylori (chronic gastritis, gastric and duodenal ulcer, gastroesophageal reflux disease)
  
• intestinal amoebiasis and giardiasis
  
• pyelonephritis, urethritis, cystitis, pyelitis and other diseases of the urinary system.
  

Contraindications:

Hypersensitivity to the active substance or any component of the drug.

Use during pregnancy and breast-feeding:

Nifuratel penetrates the blood-placental barrier after an overdose, so the use of the drug is possible only on strict indications, if the expected effect of therapy exceeds the potential risk to the fetus.

Nifuratel excreted in breast milk, so if necessary, the appointment of the drug during lactation should decide on the termination of breastfeeding.

Side effect:

Dyspeptic disorders: nausea, vomiting, bitterness in the mouth, diarrhea, heartburn, gastralgia.

Allergic reactions: skin rash, itching.

Drug interaction:

Enhances the antifungal effect of nystatin.

Dosage and administration:

The drug is taken orally, following the recommendations.

In vaginal infections: adults - 1 table. 3 times a day after meals for 7 days (take the drug should both sexual partners) children recommended dose — 10 mg/kg body weight 2 times a day for 10 days.

Infection of the gastrointestinal tract, associated with Helicobacter pylori: adults — 2 tab. 2 times a day for 7 days children recommended dose-15 mg / kg body weight 2 times a day for 7 days. The duration of the course may vary depending on the chosen eradication scheme.

In intestinal amoebiasis: adults - 2 table. 2-3 times a day for 10 days children-10 mg / kg body weight 3 times a day. The course of treatment-7-10 days.

In giardiasis: adults - 2 table. 2-3 times a day for 7 days children-15 mg / kg body weight 2 times a day for 7 days.

In urinary tract infections: adults, depending on the severity of the disease — 3-6 table. daily for 7-14 days children recommended dose-15-30 mg / kg body weight 2 times a day for 7-14 days. On the recommendation of a doctor, the course of treatment of urinary tract infections can be extended or repeated.

Special instruction:

Monotherapy vaginal infections drug Macmiror it is recommended to increase daily dose up to 4-6 table. During treatment should refrain from sexual contact.

Influence on the ability to drive a car or other mechanisms: no negative action was revealed.