Contraindications : התוויות נגד

4.3. Contraindications
• Itranol capsules are contraindicated in patients with hypersensitivity to the active substance (itraconazole) or to any of the excipients listed in section 6.1.
• Co-administration of a number of CYP3A4 substrates is contraindicated with Itranol capsules (see sections 4.4 and 4.5). These include:


Analgesics; Anaesthetics
Ergot alkaloids
(e.g. dihydroergotamine, ergometrine, ergotamine,
methylergometrine)

Anti-bacterials for Systemic Use; Anti-mycobacterials; Antimycotics for Systemic Use 
Isavuconazole

Anthelmintics; Antiprotozoals


Halofantrine

Antihistamines for Systemic Use

Astemizole                                           Mizolastine                       Terfenadine 
Antineoplastic Agents
Venetoclax (in patients with chronic lymphocytic leukaemia
Irinotecan                                           during dose initiation/titration/ramp-up phase of venetoclax)

Antithrombotic Agents
Dabigatran                                           Ticagrelor

Antivirals for Systemic Use

Ombitasvir/Paritaprevir/Ritonavir (with or without
Dasabuvir)
Cardiovascular System (Agents Acting on the Renin-Angiotensin System; Antihypertensives; Beta Blocking Agents; Calcium Channel Blockers; Cardiac Therapy; Diuretics)

Aliskiren                                         Dronedarone                                    Nisoldipine 
Bepridil                                          Eplerenone                                     Quinidine 
Disopyramide                                      Ivabradine                                     Ranolazine 
Dofetilide                                        Lercanidipine                                  Sildenafil (pulmonary hypertension) 
Gastrointestinal Drugs, including Antidiarrheals, Intestinal Anti-inflammatory/Anti-infective Agents; Antiemetics and Antinauseants; Drugs for Constipation; Drugs for Functional Gastrointestinal Disorders 
Cisapride                                         Domperidone                                    Naloxegol 
Lipid Modifying Agents

Lovastatin                                        Lomitapide                                     Simvastatin 
Psychoanaleptics; Psycholeptics (eg, antipsychotics, anxiolytics, and hypnotics) Lurasidone                                        Pimozide                                       Sertindole 
Midazolam (oral)                                  Quetiapine                                     Triazolam 
Urologicals
Solifenacin (in patients with severe
Avanafil                                          Darifenacin                                    renal impairment or moderate to severe hepatic impairment)
Fesoterodine (in patients with moderate or     Vardenafil (in patients older than Dapoxetine severe renal or hepatic impairment).           75 years).

Miscellaneous Drugs and Other Substances

Eliglustat (in patients that are CYP2D6 poor metabolisers (PM), CYP2D6 intermediate
Colchicine (in patients with renal or hepatic metabolisers (IMs) or extensive impairment) metabolisers (EMs) that are taking a strong or moderate CYP2D6 inhibitor).


Increased plasma concentrations of these drugs, caused by coadministration with itraconazole, may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious situation may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia. Specific examples are listed in Section 4.5 Interaction with other medicinal products and other forms of interaction.

•   Itranol capsules should not be administered to patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF except for the treatment of life-threatening or other serious infections. (See section 4.4 Special warnings and precautions for use).
• Itranol capsules must not be used during pregnancy except for life-threatening cases (See section 4.6 Fertility, pregnancy and lactation).
Women of childbearing potential taking Itranol capsules should use contraceptive precautions.
Effective contraception should be continued until the menstrual period following the end of Itranol capsules therapy.