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Sporanox 10 mg/ml oral solution

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Pharmacy Only: Prescription

Updated on 03 July 2024

File name

PI-Sporanox-oral solution-Ireland-English-WS230-CCDSv18-ERMC-10591.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

  • Section 4.1,4.2 : Editorial change for the symbol “μL” to be “microliter”
  • Section 4.3 : Editorial change related to section naming convention
  • Section 4.8 : Addition of unknown Adverse Drug Reactions related Endocrine disorders : Pseudoaldosteronism
  • Section 10 : Update of revision date to be 24-June 2024


Updated on 03 July 2024

File name

PIL-Sporanox-oral solution-Ireland-English-WS230-CCDSv18-ERMC-10591.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

  • Addition of unknown frequency side effect reported in patients taking SPORANOX :

·   symptoms of increased levels of the hormone ‘aldosterone’ (such as high blood pressure or low blood potassium levels), even though the ‘aldosterone’ blood level is normal or low

  • Update of revision date to be June 2024

Updated on 24 October 2023

File name

PI-Sporanox-oral solution-Ireland-English-WS 209-CCDS v16 + v17-RFI.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes are inline with addition of drug interaction with voclosporin

Updated on 24 October 2023

File name

PIL-Sporanox-oral solution-Ireland-English-WS 209-CCDS v16 + v17-RFI.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 6 - what the product contains

Free text change information supplied by the pharmaceutical company

Change is inline with the addition of drug interaction with voclosporin 

Updated on 09 March 2023

File name

PI-Sporanox-oral solution-Ireland-Eng-cl.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 March 2023

File name

PIL-Sporanox-oral solution-Ireland-Eng-cl.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 24 January 2023

File name

PIL-Sporanox-oral solution-Ireland-English-WS 178-CCDSv14-15.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 24 January 2023

File name

PI-Sporanox-oral solution-Ireland-English-WS 178-CCDSv14-15.pdf

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 14 May 2021

File name

RIMdocs PI-Sporanox-oral solution-Ireland-English-Excipient update (including AE reporting change).pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated in line with excipient guidelines. Plus corrected typos and made formatting changes across SPC.

Updated on 14 May 2021

File name

RIMdocs PIL-Sporanox-oral solution-Ireland-English-Excipient update (including AE reporting change).pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Updated in line with excipient guidelines. Plus typo corrections and formatting changes were made.

Updated on 14 May 2021

File name

Ire Sporanox OS PIL C03 21May20 clean EDMS-ERI-136485067_9.0.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Updated in line with excipient guidelines. Plus formatting and corrections.

Updated on 02 September 2020

File name

Ire Sporanox OS SmPC C19 21May20 clean EDMS-ERI-136485066_9.0.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

CCDS Revisions to SPC Sections 4.5, 4.6, 4.9 & 5.3 and Corresponding Revisions to PIL

Updated on 02 September 2020

File name

Ire Sporanox OS PIL C03 21May20 clean EDMS-ERI-136485067_9.0.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 6 - date of revision

Updated on 10 March 2020

File name

IE-Sporanox Oral Solution-SPC-C18-3mar20-clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 10 March 2020

File name

IE-PIL-Sporanox OS-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to date of revision

Updated on 12 April 2019

File name

IE-Sporanox Oral Solution-PIL-C01-29mar19-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 12 April 2019

File name

IE-Sporanox Oral Solution-SPC-C17-29mar19-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 February 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 26 February 2018

File name

PIL_8598_674.pdf

Reasons for updating

  • New PIL for new product

Updated on 26 February 2018

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

4.5     Interaction with other medicinal products and other forms of interaction

 

Drugs that may decrease itraconazole plasma concentrations

Co-administration of itraconazole with strong enzyme inducers of CYP3A4 may decrease the exposure of itraconazole and hydroxy-itraconazole to such an extent that efficacy may be largely reduced. Examples include:

Antibacterials: isoniazid, rifabutin (see also under ‘Drugs that may have their plasma concentrations increased by itraconazole’), rifampicin.

Anticonvulsants: carbamazepine, (see also under ‘Drugs that may have their plasma concentrations increased by itraconazole’), phenobarbital, phenytoin.

Antivirals: efavirenz, nevirapine.

Herbal medicine: Hypericum perforatum (St John’s Wort).

 

*************

 

Drugs that may increase itraconazole plasma concentrations

Strong inhibitors of CYP3A4 may increase the exposure of itraconazole. Examples include:

-            Antibacterials: ciprofloxacin, clarithromycin, erythromycin.

-            Antivirals: ritonavir-boosted darunavir, ritonavir-boosted fosamprenavir, indinavir (see also under ‘Drugs that may have their plasma concentrations increased by itraconazole’), ritonavir (see also under ‘Drugs that may have their plasma concentrations increased by itraconazole’) and telaprevir.

It is recommended that these drugs be used with caution when co-administered with itraconazole oral solution. It is recommended that patients who must take itraconazole concomitantly with strong inhibitors of CYP3A4 be monitored closely for signs or symptoms of increased or prolonged pharmacologic effects of itraconazole, and the itraconazole dose be decreased as deemed necessary. When appropriate, it is recommended that itraconazole plasma concentrations be measured.

 

************

 

Drug Class

Contraindicated

Not Recommended

Use with Caution

Alpha Blockers

 

tamsulosin

 

Analgesics

 

fentanyl

alfentanil,

buprenorphine IV and sublingual,

oxycodone,

methadonec,

sufentanil

Antiarrhythmics

disopyramide,

dofetilide,

dronedarone,

quinidine

 

digoxin

Antibacterials

telithromycin, in subjects with severe renal impairment or severe hepatic impairment

rifabutina

telithromycin

Anticoagulants and Antiplatelet Drugs

dabigatran

ticagrelor

apixaban,

rivaroxaban

coumarins,

cilostazol

Anticonvulsants

 

carbamazepinea

 

Antidiabetics

 

 

repaglinide,

saxagliptin

Antihelmintics and Antiprotozoals

halofantrine

 

praziquantel

Antihistamines

mizolastine,

terfenadine

ebastine

bilastine

 

Antimigraine Drugs

ergot alkaloids, such as

dihydroergotamine,

ergometrine (ergonovine),

ergotamine,

methylergometrine (methylergonovine)

eletriptan

 

Antineoplastics

irinotecan

axitinib,

dabrafenib,

dasatinib,

ibrutinib,

lapatinib,

nilotinib,

sunitinib,

trabectedin

bortezomib,

busulphan,

docetaxel,

erlotinib,

gefitinib,

imatinib,

ixabepilone,

ponatinib,

trimetrexate,

vinca alkaloids

Antipsychotics, Anxiolytics and Hypnotics

lurasidone,

oral midazolam,

pimozide,

quetiapine,

sertindole,

triazolam

 

alprazolam,

aripiprazole,

brotizolam,

buspirone,

haloperidol,

midazolam IV,

perospirone,

risperidone

Antivirals

 

simeprevir

 

maraviroc,

indinavirb,

ritonavirb,

saquinavir

Beta Blockers

 

 

nadolol

Calcium Channel Blockers

bepridil,

lercanidipine,

nisoldipine

felodipine

other dihydropyridines, verapamil

Cardiovascular Drugs, Miscellaneous

aliskiren,

ivabradine,

ranolazine

riociguat

bosentan

 

Diuretics

eplerenone

 

 

Gastrointestinal Drugs

cisapride

domperidone

 

aprepitant

Immunosuppressants

 

ciclesonide,

everolimus,

temsirolimus

budesonide,

cyclosporine,

dexamethasone,

fluticasone,

methylprednisolone,

rapamycin (also known as sirolimus),

tacrolimus

Lipid Regulating Drugs

lovastatin,

simvastatin

atorvastatin

 

Respiratory Drugs

 

salmeterol

 

SSRIs, Tricyclics and Related Antidepressants

 

 

reboxetine

Urological Drugs

darifenacin,

fesoterodine, in patients with moderate to severe renal or moderate to severe hepatic impairment,

sildenafil, when indicated for pulmonary arterial hypertension,

solifenacin, in patients with severe renal or moderate to severe hepatic impairment,

vardenafil, in men older than 75 years of age

 

tolterodine,

vardenafil, in men 75 years of age and younger

fesoterodine.

oxybutynin,

sildenafil, when indicated for erectile dysfunction,

solifenacin,

tadalafil

Other

colchicine, in patients with renal or hepatic impairment

colchicine

alitretinoin (oral formulation),

cinacalcet,

tolvaptan

a                 See also under ‘Drugs that may decrease itraconazole plasma concentrations’

b                 See also under ‘Drugs that may increase itraconazole plasma concentrations’

c                 Torsade de pointes has been reported

4.6     Fertility, pregnancy and lactation

 

Pregnancy

SPORANOX Oral Solution must not be used during pregnancy except for life-threatening cases where the potential benefit to the mother outweighs the potential harm to the foetus (see section 4.3).

 

In animal studies itraconazole has shown reproduction toxicity (see section 5.3).

 

Epidemiological data on exposure to SPORANOX during the first trimester of pregnancy – mostly in patients receiving short-term treatment for vulvovaginal candidosis – did not show an increased risk for malformations as compared to control subjects not exposed to any known teratogens. Itraconazole has been shown to cross the placenta in a rat model.

 

Women of childbearing potential

Women of childbearing potential taking SPORANOX Oral Solution should use contraceptive precautions. Effective contraception should be continued until the menstrual period following the end of SPORANOX therapy.

 

Breast-feeding

A very small amount of itraconazole is excreted in human milk. SPORANOX Oral Solution must not be used during lactation.

 

Updated on 26 February 2018

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision
  • Correction of spelling/typing errors

Updated on 16 November 2016

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Numerous updates

Updated on 11 November 2016

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 09 August 2013

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Addition of the following text into section 5.3

Hydroxypropyl-ß-cyclodextrin
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, and toxicity to reproduction and development. In a rat carcinogenicity study hydroxypropyl-β-cyclodextrin produced adenocarcinomas in the large intestine and exocrine pancreatic adenocarcinomas. These findings were not observed in a similar mouse carcinogenicity study. The clinical relevance of the large intestine adenocarcinomas is low and the mechanism of exocrine pancreatic adenocarcinomas induction not considered relevant to humans.

Updated on 24 April 2013

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 5.2:  Multiple changes including addition of section for Hydroxypropyl-ß-Cyclodextrin, deletion of section for Linearity/Non-linearity, additional information under General pharmacokinetic characteristics, Elimination and Renal impairment
Change to section 10: April 2013 

Updated on 13 March 2013

Reasons for updating

  • Change to section 4.9 - Overdose
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.9: Deletion of gastric lavage. Other minor changes to wording. 
Change to section 6.6:  Addition of instructions for measuring cup
Change to section 10: 5 March 2013

Updated on 13 March 2013

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 22 July 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 - Addition of dyspnoea and acute generalised exanthematous pustulosis
Change to section 10 - 2 July 2011

Updated on 19 July 2011

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 14 April 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.8 - Undesirable Effects

Paediatric Population

The safety of SPORANOX oral solution was evaluated in 250 paediatric patients aged 6 months to 14 years who participated in five open-label clinical trials. These patients received at least one dose of SPORANOX oral solution for prophylaxis of fungal infections or for treatment of oral thrush or systemic fungal infections and provided safety data.

Based on pooled safety data from these clinical trials, the very common reported ADRs in paediatric patients were Vomiting (36.0%), Pyrexia (30.8%), Diarrhoea (28.4%), Mucosal inflammation (23.2%), Rash (22.8%), Abdominal pain (17.2%), Nausea (15.6%), Hypertension (14.0%), and Cough (11.2%). The nature of ADRs in paediatric patients is similar to that observed in adult subjects, but the incidence is higher in the paediatric patients.

 

 

Change to section 5.1 - Pharmacodynamic Properties

Paediatric Population

The tolerability and safety of itraconazole oral solution was studied in the prophylaxis of fungal infections in 103 neutropenic paediatric patients aged 0 to14 years (median 5 years) in an open‑label uncontrolled phase III clinical study. Most patients (78%) were undergoing allogenic bone marrow transplantation for haematological malignancies. All patients received 5 mg/kg/day of itraconazole oral solution as a single or divided dose. Due to the design of the study, no formal conclusion with regard to efficacy could be derived. The most common adverse events considered definitely or possibly related to itraconazole were vomiting, abnormal liver function, and abdominal pain.

 

Change to section 5.2 - Pharmacokinetic Properties

Paediatric Population:

Two pharmacokinetic studies have been conducted in neutropenic children aged 6 months to 14 years in which itraconazole oral solution was administered 5 mg/kg once or twice daily. The exposure to itraconazole was somewhat higher in older children (6 to 14 years) compared to younger children. In all children, effective plasma concentrations of itraconazole were reached within 3 to 5 days after initiation of treatment and maintained throughout treatment.

 

Change to section 10 - Date of revision of the text

21 March 2011

Updated on 14 January 2011

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.4 - Addition of cross-resistance; revision of interaction potential; change to the order of paragraphs.
Change to section 4.5 - Addition of St. John's Wort.
Change to section 4.7 - Addition of visual disturbances and hearing loss.
Change to section 4.8 - Addition of reference to Section 4.4 for some ADRs.
Change to section 10 - 10 January 2011

Updated on 12 January 2011

Reasons for updating

  • Change to drug interactions
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 01 November 2010

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8 - addition of Pancreatitis and Pyrexia

Updated on 29 October 2010

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 19 August 2009

Reasons for updating

  • Change to date of revision

Updated on 17 December 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.4 - Hearing Loss

Transient or permanent hearing loss has been reported in patients receiving treatment with itraconazole. Several of these reports included concurrent administration of quinidine which is contraindicated (see sections 4.3 and 4.5). The hearing loss usually resolves when treatment is stopped, but can persist in some patients.

Change to section 4.8 - Transient or permanent hearing loss

 

Change to section 10 - Changed to December 2008

Updated on 17 December 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 02 October 2008

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

X

Change to section 7 – Marketing Authorisation Holder

Address Change

X

Change to section 10 – Date of revision of text

September 2008

Updated on 26 September 2008

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 14 December 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to date of revision

Updated on 13 December 2007

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and |Method of Administration

Changes to renal and hepatic impairment.

Change to section 4.3 – Contra-indications

Addition of Bepridil, Fluticasone, nisoldipine, fentanyl

Change to section 4.4 – Special Warnings and Precautions for Use

Changes to renal and hepatic impairment.

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Addition of Bepridil, Fluticasone, nisoldipine, fentanyl

Change to section 4.6 – Pregnancy and Lactation

All new information on pregnancy- additional statement for women of child-bearing age- additional lactation statement.

Change to section 5.1 - Pharmacodynamic properties

All new information

Change to section 5.2 - Pharmacokinetic properties

Information put ionto headings- Absoprtion, Distribution, Biotransformation, Elimination, Linearity/non-linearity, speial populations

Change to section 10 – Date of revision of text

November 2007

Updated on 01 August 2007

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.2 – Posology and |Method of Administration

Additional sentences to Use in children and use in elderly

Change to section 4.3 – Contra-indications

New groups of medicines contraindicated with Sporanox

Change to section 4.4 – Special Warnings and Precautions for Use

Additional headings- Use in Children, use in elderly, , treatment of severly neutropenic patients

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

4.5.2.1-additional contraindicated medicines. Additional  cautioned medicines including glucocorticosteroids such as budesonide, dexamethasone and methylprednisolone;

Change to section 4.6 – Pregnancy and Lactation

All new information on pregnancy- additional statement for women of child-bearing age- additional lactation statement.

Change to section 4.9 - Overdose

Additional treatment paragraph

Change to section 5.1 - Pharmacodynamic properties

All new information

Change to section 5.2 - Pharmacokinetic properties

Information put ionto headings- Absoprtion, Distribution, Biotransformation, Elimination, Linearity/non-linearity, speial populations

Change to section 5.3 - Preclinical Safety Data

All new information

Change to section 6.3 – Shelf Life

Changed from 24 months to 2 years

Change to section 10 – Date of revision of text

May 2007

Updated on 16 July 2007

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to storage instructions
  • Change to date of revision

Updated on 10 May 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 1 – trade name

NAME OF THE MEDICINAL PRODUCT

Change to Sporanox Oral Solution

Change to section 2 – quantitative and qualitative composition

Updated with excipient information

Change to section 3 – pharmaceutical form

Despcription expanded

Change to section 4.4 – Special Warnings and Precautions for Use

Inserted warning:  Sporanox oral solution contains sorbitol and should not be given to patients with rare hereditary problems of fructose intolerance.

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Inclusion of loperamide

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Updated text

Change to section 6.1 – List of Excipients

Expanded excipient information

Change to section 6.2 - Incompatibilities

Updated to ‘In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.’

Change to section 6.5 – Nature and Contents of Container

Updated text

Change to section 9 – Date of Renewal of Authorisation

April 2006

Change to section 10 – Date of revision of text

April 2007

Updated on 03 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 02 September 2004

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 06 August 2004

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 05 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)