SHORT PRODUCT INFORMATION: NAME OF THE MEDICINAL PRODUCT: Itrazol 100 mg hard capsule. ACTIVE SUBSTANCE: Each capsule contains 100 mg itraconazole in pellet formulation. PHARMACOLOGICAL PROPERTIES: Pharmacotherapeutic classification: Antifungal for systemic use, triazole derivative ATC code: J02AC02 Itraconazole, a triazole derivative, has a broad spectrum of action. In vitro studies have shown that itraconazole impairs ergosterol synthesis in fungal cells. Ergosterol is an important component of the cell wall of fungi. Disruption of its synthesis results in an antifungal effect. THERAPEUTIC INDICATIONS: Itrazole is used in the treatment of the following conditions: • Gynecological indications: – Vulvovaginal candidosis • Dermatological / mucosal / ophthalmological indications: – Dermatomycoses – Pityriasis versicolor – Oral candidosis – Fungal keratitis • Dermatophytes and/or Systemic mycoses caused by: Systemic mycoses Aspergillosis and candidosis – Cryptococcosis (including cryptococcal meningitis): In immunocompromised patients with cryptococcosis and in all patients with central nervous system cryptococcosis, Itrazole is indicated only when first-line therapy has not been found suitable or has been shown to be ineffective. − Histoplasmosis − Blastomycosis − Sporotrichosis − Paracoccidioidomycosis − Other rare systemic or tropical mycoses. POZOLOGY AND METHOD OF APPLICATION: In order for itrazol to be absorbed in the best way, it should be taken immediately after a meal on a full stomach. Micropellet capsules should be taken whole. CONTRAINDICATIONS: • Itraconazole is contraindicated in patients who are hypersensitive to itraconazole or its ingredients. • Concomitant administration of a number of CYP3A4 substrates with Itrazole is contraindicated. The increase in the plasma concentrations of these drugs caused by itraconazole may increase or prolong the therapeutic and adverse effects to a potentially serious condition. Since methadone and felodipine interact with itraconazole, the use of itraconazole with any of these drugs is contraindicated. • Itrazole should not be used in patients with ventricular dysfunction, such as those with congestive heart failure (CHF) or a history of CHF, except for life-threatening or other serious infections. • Itrazole should not be used during pregnancy. • Contraceptive methods should be used in women of childbearing age using Itrazole. Effective contraceptive methods should be continued to be used from the end of treatment with Itrazole until the next menstrual period. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Cross-hypersensitivity There is no information on cross-hypersensitivity between itraconazole and other azole antifungals. Caution should be exercised when prescribing Itrazole to patients with hypersensitivity to another azole. INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER MODES OF INTERACTION: Itraconazole is mainly metabolized by CYP3A4. Other substances that share this metabolic pathway or modify CYP3A4 activity may affect itraconazole pharmacokinetics. Similarly, itraconazole can modify the pharmacokinetics of other substances that share this metabolic pathway. Itraconazole is a potent CYP3A4 inhibitor and a P-glycoprotein inhibitor. When using concomitant medication, it is recommended to refer to the relevant label for information about the metabolism pathway and the possible need for dosage adjustment. Concomitant use of cisapride, pimozide, methadone, levacetylmethadol (levomethadyl) or quinidine with itraconazole and/or other CYP3A4 inhibitors can lead to life-threatening cardiac arrhythmias and/or sudden death. PREGNANCY CATEGORY: C. EFFECTS ON DELIVERY AND MACHINE USE: No studies on the effects on the ability to drive and use machines have been performed. In some cases, side effects such as dizziness, visual impairment and hearing loss may occur while driving and using machines, so care should be taken. UNDESIRED EFFECTS: The most frequently reported adverse drug reactions (ADRs) with Itrazole identified from clinical studies and/or spontaneous reports are headache, abdominal pain and nausea. The most serious ADRs are severe allergic reactions, heart failure/congestive heart failure/pulmonary edema, pancreatitis, severe hepatotoxicity (including some fatal cases of acute liver failure), and severe skin reactions. QUALITY AND INGREDIENTS OF THE PACKAGING: 4, 15 and 28 purple-pink capsules each containing 100 mg of itraconazole in pellet formulation.
and 30 PVC / Aluminum foil blisters. REPORTING SUSPECTED ADVERSE REACTIONS: Reporting suspected adverse reactions after authorization is of great importance.
carries. Reporting allows continuous monitoring of the benefit/risk balance of the drug. Any suspected adverse reaction of healthcare professionals Turkey Pharmacovigilance
They should notify the Center (TÜFAM).

(www.titck.gov.tr, e-mail: [email protected]; tel: 0 800 314 00 08; fax: 0 312 218 35 99). LICENSE OWNER İstanbul İlaç San. and Tic. Inc. Eagle/
Istanbul LICENSE NUMBER 2020/176 First license date: 17.08.2020 SALES AND MARKETING: FARMAVIP ILAC VE KOZMETIK SANAYİ VE TİCARET A.Ş. Arabayatagi Mah. 2. Celik Sok. No:13/2
Yıldırım/BURSA Tel: 0 224 341 10 55 e-mail: [email protected] For more information, contact our company.