Description

Compound:

Each hard gelatin capsule contains:

Fluconazole – 150 mg.

Auxiliary components:

lactose monohydrate, corn starch, colloidal silicon dioxide, magnesium stearate, sodium lauryl sulfate.

Properties:

Fluconazole is an antifungal triazole. It is a potent and selective inhibitor of fungal enzymes required for the synthesis of ergosterol. Active against opportunistic mycoses such as infections caused by Candida spp. including systemic candidiasis in immunocompromised animals; with Cryptococcus neoformans, including intracranial infections, with Microsporum spp. and with Trichophyton spp. Fluconazole is very specific for fungal cytochrome P450-dependent enzymes. Fluconazole has not been shown to affect plasma testosterone concentrations in men or steroid concentrations in women of childbearing age when taken at 50 mg daily for up to 28 days. No clinically significant effect was observed on endogenous steroid levels or on the ACTH-stimulated response in healthy male volunteers taking fluconazole 200-400 mg daily. Interaction studies with antipyrine show that a single or multiple dose of fluconazole 50 mg does not affect metabolism.

Indications:

Treatment of acute or recurrent candidal vaginitis, as well as for the treatment of partners with associated candidal balanitis.

Mode of application:

Adults (16 to 60 years): 1 capsule to be swallowed whole. Not recommended for patients over 60 years of age. In patients with renal insufficiency, there is no separate dosing regimen for single therapy.
Contraindications:

Children under 16 years of age, hypersensitivity to fluconazole, related azole compounds or any of the excipients in the composition. Fluconazole should not be taken concomitantly with terfenadine, cisapride or ergot derivatives. Pregnancy, breastfeeding.

Precautionary measures:

Do not use the drug without first consulting your doctor. If you have had thrush more than 2 times in the last 6 months, liver disease, kidney disease, or patients with jaundice. If you are suffering from any other chronic disease. If you or your partner have been exposed to sexually transmitted diseases.

For women only: if you have abnormal or irregular vaginal bleeding or spotting, vaginal or vaginal sores, or blisters. If you experience pain in the lower abdomen or a burning sensation when urinating.

For men only: if your sexual partner does not have thrush. If you have penile sores, sores or blisters, odor and abnormal discharge from the penis, pain when urinating. The product should never be used again if a rash or anaphylaxis develops after using the drug.

Repeated use (men and women): a doctor should be consulted if symptoms do not disappear within 1 week after taking the capsule. Flucoral can be used if the Candida infection returns after 7 days. Use with caution in patients with cardiovascular disease. Patients with rare hereditary problems of galactose intolerance or glucose-galactose malabsorption should not take this medicine.

Side effects:

Most common: headache, abdominal pain, diarrhea, nausea, vomiting, elevated alkaline phosphatase, and rash. Diseases of the blood and lymphatic system: anemia. Rare: agranulocytosis, leukopenia, thrombocytopenia, neutropenia. Immune system disorders: rare anaphylaxis. Metabolism and malnutrition: infrequently: loss of appetite. Rarely: hypercholesterolemia, hypertriglyceridemia, hypokalemia. Mental disorders: drowsiness, insomnia. Disorders of the nervous system: infrequently: convulsions, paresthesia, dizziness, taste perversion. Rare: tremor. Gastrointestinal disorders: infrequently: constipation, dyspepsia, flatulence, dry mouth. Rare: liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage. Diseases of the skin and subcutaneous tissue: common: rash. Uncommon: drug rash, urticaria, itching, increased sweating. Rare: angioedema, facial edema, alopecia. Musculoskeletal system and connective tissue: infrequently: myalgia. General disorders: fatigue, malaise, asthenia, fever.

Pregnancy and lactation. Fluconazole should not be used during pregnancy. Fluconazole is excreted in breast milk and therefore should not be used during breastfeeding.

Impact on the ability to drive a car: patients should be warned about the possibility of dizziness or convulsions while taking the drug, and they are not recommended to drive and operate cars if these symptoms occur.

Storage:

Store at a temperature not exceeding 30C in a dry place out of the reach of children.