SPORANOX - PULSE

Sporanox-Pulse is for oral administration and must be taken immediately after a meal for maximal absorption. The capsules must be swallowed whole.

Treatment schedules in adults are as follows:

Indication Dose Remarks Tinea pedis and/or tinea manuum 1 pulse treatment A pulse treatment consists of 200 mg bd. for 7 days. Onychomycosis – fingernails 2 pulse treatments Pulse treatments are separated by a 3-week Onychomycosis – toenails 3 pulse treatments drug-free interval Use in children Clinical data on the use of Sporanox-Pulse in paediatric patients are limited.

The use of Sporanox-Pulse in paediatric patients is not recommended unless it is determined that the potential benefit outweighs the potential risks. See section

Summary of the safety profile The most frequently reported adverse drug reactions (ADRs) with Sporanox capsules treatment identified from clinical trials and/or from spontaneous reporting were headache, abdominal pain, and nausea. The most serious ADRs were serious allergic reactions, cardiac failure/congestive heart failure/pulmonary oedema, pancreatitis, serious hepatotoxicity (including some cases of fatal acute liver failure), and serious skin reactions.

Refer to subsection Tabulated list of adverse reactions for the frequencies and for other observed ADRs. 4 Special warnings and precautions for use for additional information on other serious effects. Tabulated list of adverse reactions The ADRs in the table below were derived from open-label and double-blind clinical trials with Sporanox capsules involving 8499 patients in the treatment of dermatomycoses or onychomycosis, and from spontaneous reporting.

The table below presents ADRs by System Organ Class. Within each System Organ Class, the ADRs are presented by incidence, using the following convention: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000).

, excluding the ADR term “Injection site inflammation”, which is specific to the injection route of administration.

Blood and lymphatic system disorders:

Granulocytopenia, Thrombocytopenia Immune system disorders: Anaphylactoid reaction Metabolism and nutrition disorders: Hyperglycaemia, Hyperkalaemia, Hypokalaemia, Hypomagnesaemia Psychiatric disorders: Confusional state Nervous system disorders: Peripheral neuropathy*, Dizziness, Somnolence Cardiac disorders: Cardiac failure, Left ventricular failure, Tachycardia Vascular disorders: Hypertension, Hypotension Respiratory, thoracic and mediastinal disorders: Pulmonary oedema, Dysphonia, Cough Gastrointestinal disorders: Gastrointestinal disorder Hepatobiliary disorders: Hepatic failure*, Hepatitis, Jaundice Skin and subcutaneous tissue disorders: Rash erythematous, Hyperhidrosis Musculoskeletal and connective tissue disorders: Myalgia, Arthralgia Renal and urinary disorders: Renal impairment, Urinary incontinence General disorders and administration site conditions: Generalised oedema, Face oedema, Chest pain, Pyrexia, Pain, Fatigue, Chills Investigations: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood lactate dehydrogenase increased, Blood urea increased, Gamma- glutamyltransferase increased, Hepatic enzyme increased, Urine analysis abnormal Paediatric population The safety of Sporanox capsules was evaluated in 165 paediatric patients aged 1 to 17 years who participated in 14 clinical trials (4 double-blind, placebo controlled trials; 9 open-label trials; and 1 trial had an open-label phase followed by a double-blind phase).

These patients received at least one dose of Sporanox capsules for the treatment of fungal infections and provided safety data. 2%). In general, the nature of ADRs in paediatric patients is similar to that observed in adult subjects, but the incidence is higher in the paediatric patients.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

In Elderly Clinical data on the use of Sporanox-Pulse in elderly patients are limited. It is advised to use Sporanox-Pulse in these patients only if it is determined that the potential benefit outweighs the potential risks. In general, it is recommended that the dose selection for an elderly patient should be taken into consideration, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

4 Special warnings and precautions for use. Renal impairment Limited data are available on the use of oral itraconazole in patients with renal impairment. The exposure of itraconazole may be lower in some patients with renal insufficiency.

Caution should be exercised when this drug is administered in this patient population and adjusting the dose may be considered. Hepatic impairment Limited data are available on the use of oral itraconazole in patients with hepatic impairment.

Caution should be exercised when this drug is administered in this patient population. 3 Contraindications • Sporanox-Pulse is contra-indicated in patients with known hypersensitivity to itraconazole or to any of the excipients. 5). 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 Irinotecan Venetoclax (in patients with chronic lymphocytic leukaemia 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 Avanafil Darifenacin Solifenacin (in patients with severe renal impairment or moderate to severe hepatic impairment) Dapoxetine Fesoterodine (in patients with moderate or severe renal or hepatic impairment).

Vardenafil (in patients older than 75 years). Miscellaneous Drugs and Other Substances Colchicine (in patients with renal or hepatic impairment) Eliglustat (in patients that are CYP2D6 poor metabolisers (PM), CYP2D6 intermediate metabolisers (IMs) or extensive 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.

Some specific examples are listed in section

• Sporanox-Pulse is contra-indicated in patients with known hypersensitivity to itraconazole or to any of the excipients. 5). 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 Irinotecan Venetoclax (in patients with chronic lymphocytic leukaemia 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 Avanafil Darifenacin Solifenacin (in patients with severe renal impairment or moderate to severe hepatic impairment) Dapoxetine Fesoterodine (in patients with moderate or severe renal or hepatic impairment).

Vardenafil (in patients older than 75 years). Miscellaneous Drugs and Other Substances Colchicine (in patients with renal or hepatic impairment) Eliglustat (in patients that are CYP2D6 poor metabolisers (PM), CYP2D6 intermediate metabolisers (IMs) or extensive 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.

Some specific examples are listed in section