Flucoral - 150 mg 2 Capsules

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

Tradename: Flucoral

Flucoral

* Structure: Each hard gelatin capsule contains:

Fluconazole 150mg

* 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 animals with weakened immunity; with Cryptococcus neoformans, including intracranial infections, with Microsporum spp. and with Trichophyton spp. Fluconazole is very specific for fungal cytochrome P450-dependent enzymes. It has been shown that fluconazole does not affect plasma testosterone concentration in men or steroid concentration in women of childbearing age when taken 50 mg daily for up to 28 days. No clinically significant effect was observed on endogenous steroid levels or on ACTH stimulated response in healthy male volunteers. taking fluconazole 200-400 mg day. Interaction studies with antipyrine sho 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 (16-60 years old): 1 capsule should be swallowed whole. Not recommended for patients over 60 years of age. In patients with renal impairment, there is no separate dosing regimen for a 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 with terfenadine, cisapride or ergot derivatives. Pregnancy, breastfeeding.

* Precautions: Do not use the drug without first consulting your doctor. If you have had thrush more than 2 times in the past 6 months, liver disease, kidney disease, or patients with jaundice. If suffer from any other chronic medical condition. 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 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 rash or anaphylaxis occurs after using the drug.

Re-use (men and women): You should consult your doctor if symptoms persist within 1 week after taking the capsule. Flucoral can be used if the candidal 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 medication.

* Side effects: Most common: headache, abdominal pain, diarrhea, nausea, vomiting, elevated alkaline phosphatase levels, and rash. Diseases of the blood and lymphatic system: anemia. Rarely: agranulocytosis, leukopenia, thrombocytopenia, neutropenia. Immune system disorders: rare anaphylaxis. Metabolism and nutritional disorders: infrequently: decreased appetite. Rarely:

hypercholesterolemia, hypertriglyceridemia, hypokalemia. Mental disorders: drowsiness, insomnia. Nervous system disorders: infrequently: convulsions, paresthesia, dizziness, taste perversion. Rare: tremor. Gastrointestinal disorders: infrequently:

constipation, dyspepsia, flatulence, dry mouth. Rarely: liver failure, hepatocellular necrosis, hepatitis, hepatocellular damage. Diseases of the skin and subcutaneous tissue: general: rash. Uncommon: drug rash, urticaria, itching, increased sweating. Rarely: angioedema, facial edema, alopecia. Musculoskeletal system and connective tissue: infrequently: myalgia. General disorders: fatigue, malaise, asthenia, fever.

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

* Impact on ability to drive: Patients should be warned of the possibility of dizziness or seizures while taking the drug, and they are not advised to drive or operate cars when these symptoms occur.

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

* Packaging: Cardboard box, consists of a blister with 2 capsules and paper instructions.