Efloran tablets are used for infections caused by microorganisms sensitive to the drug:
amebiasis; urogenital trichomoniasis; nonspecific vaginitis; giardiasis; surgical infections caused by anaerobic microorganisms sensitive to metronidazole; replacement of intravenous treatment of infections caused by anaerobic microorganisms sensitive to metronidazole.
When using metronidazole, national and international recommendations for the appropriate use of antibacterial drugs should be taken into account.
Composition
The active substance is metronidazole (one tablet contains 400 mg of metronidazole).
Excipients: lactose monohydrate; povidone; corn starch; microcrystalline cellulose; sodium starch glycolate; talc; magnesium stearate.
Contraindication
hypersensitivity to metronidazole or to drugs of the imidazole group, or to other components of the drug; age up to 6 years, which is due to the dosage form; pregnancy and breastfeeding.
Method of application
Use orally. The drug in this dosage (400 mg) can be prescribed to children aged 6 years and older and adults. The tablet can be divided into equal parts.
The tablets should be swallowed without chewing, with water, during or after meals.
Prevention of anaerobic infections, especially during abdominal surgery (mainly colorectal) and gynecological surgeries
The adult dose is 400 mg every 8 hours immediately before surgery, followed by intravenous or rectal administration as long as the patient is able to take tablets.
Administer to children aged 6 years and older at 20-30 mg/kg in a single dose 1-2 hours before surgery.
Treatment of anaerobic infections
Treatment lasts for 7 days, taking into account the patient's condition and the type of infection.
The dose for adults is 800 mg, then 400 mg every 8 hours.
For children from 6 years of age, 20-30 mg/kg 2 times a day. The maximum daily dose is 40 mg/kg, depending on the severity of the infection. Treatment usually lasts for 7 days.
Eradication of Helicobacter pylori in children
Use in complex therapy for 7-14 days at a dose of 20 mg/kg/day, not exceeding 500 mg twice a day. When using, national and international recommendations should be taken into account.
Application features
Drivers
"Efloran" may have a minor or moderate influence on the ability to drive or use machines, especially when alcohol is consumed during treatment. Patients should be warned about the possibility of drowsiness, dizziness, confusion, hallucinations, seizures and transient visual disturbances. The doctor should draw the patient's attention to this and advise him not to drive or use machines.
Overdose
Metronidazole intake in doses up to 12 g has been recorded in suicide attempts and as a result of accidental overdose.
Symptoms: vomiting, dizziness, and mild disorientation.
Treatment: There is no specific antidote. In suspected severe overdose, symptomatic and supportive treatment should be used.
Side effects
Gastrointestinal: minor gastrointestinal disorders (epigastric pain, nausea, vomiting, diarrhea, weakness), oral mucositis, glossitis with dry mouth, stomatitis, taste disturbance, anorexia; cases of pancreatitis, which are reversible; tongue discoloration/coated (hairy) tongue (e.g. due to excessive development of fungal flora).
On the part of the immune system: urticaria, angioedema, anaphylactic shock.
From the skin and subcutaneous tissue: hot flashes, itching, skin rash, in some cases accompanied by an increase in body temperature, GHEP; SDS, TEN; fixed toxicodermia.
Nervous system: headache; sensory peripheral neuropathies or transient epileptic seizures, paresthesias; convulsions, dizziness, ataxia, drowsiness; cases of encephalopathy (e.g. confusion, fever, headache, hypersensitivity to light, rigidity of the occipital muscles, hallucinations, paralysis, visual and motor disorders) and subacute cerebellar syndrome (e.g. ataxia, dysarthria, gait disturbance, nystagmus, tremor), which may resolve after discontinuation of the drug; aseptic meningitis.
On the part of the organs of vision: temporary disturbances of visual functions, such as diplopia, myopia, blurred vision, decreased visual acuity, changes in color vision; optic neuropathy / neuritis.
From the side of the organs of hearing and labyrinth: hearing impairment/hearing loss (including sensorineural); tinnitus.
On the part of the psyche: psychotic reactions with paranoia and/or delusions, which in some cases may be accompanied by the emergence of suicidal thoughts or suicide attempts, hallucinations; depressed mood.
Blood and lymphatic system disorders: cases of agranulocytosis, neutropenia, thrombocytopenia.
Hepatobiliary system: there have been reports of increased activity of liver enzymes (AST, ALT, LF), cholestatic or mixed hepatitis and damage to liver cells, sometimes with jaundice; cases of liver failure requiring liver transplantation have been reported, mainly when used in combination with other antibiotics.
Infections and infestations: oral candidiasis and vaginal candidiasis.
Store at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 5 years.
