Last Updated on eMC 26-10-2016 View medicine  | Janssen-Cilag Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or 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
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:18-09-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Numerous updates

Reasons for adding or updating:

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

Date of revision of text on the SPC:18-07-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Additon 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.

Reasons for adding or updating:

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

Date of revision of text on the SPC:26-03-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 5.2: Complete Revision
Change to section 10: 26 March 2013

Reasons for adding or 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

Date of revision of text on the SPC:20-02-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 4.9 Deletion of gastric lavage and other minor revisions
Change to section 6.6 Addition of instructions for use of the measuring cup.
Change to section 10 20 February 2013

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:02-07-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Dyspnoea and acute generalised exanthematous pustulosis have been added to Section 4.8 table

Reasons for adding or updating:

  • Change to section 10 date of revision of the text
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:21-03-2011

Legal Category:POM

Black Triangle (CHM): NO

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

Reasons for adding or 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

Date of revision of text on the SPC:13-12-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.4 -

Wording re-ordered. Only new text is:

Itraconazole should not be used within 2 weeks after discontinuation of treatment with CYP 3A4 inducing agents (rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, Hypericum perforatum (St. John´s wort)). The use of itraconazole with these drugs may lead to subtherapeutic plasma levels of itraconazole and thus treatment failure.

Section 4.5 - Addition of:
Hypericum perforatum (St John’s Wort)

Section 4.7 - Addition of:
visual disturbances and hearing loss

Section 4.8 - See Section 4.4 update 

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:06-10-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 4.8 - Addition of pyrexia and pancreatitis to table in 4.8.
Change to section 10 - 06 October 2010.

Reasons for adding or 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

Date of revision of text on the SPC:01-11-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to section 4.4 – Special Warnings and Precautions for Use

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 – Undesirable effects

, Transient or permanent hearing loss

Change to section 10 – Date of revision of the text

November 2008

Reasons for adding or updating:

  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-09-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 7 - new Company address
Change to section 10 - September 2008

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:01-11-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

REASON(S) FOR SUBMISSION

 

Change

eMC - Summary of Change Details Per Section

 

X

Change to section 4.8 – Undesirable effects

Updated table of undesirable effects

Reasons for adding or 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

Date of revision of text on the SPC:01-11-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 4.3 – Contra-indications

Addition of information for nisoldipine and bepridil

Change to section 4.4 – Special Warnings and Precautions for Use

Caution added for calcium channel blockers

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

Updated  for nisoldipine and bepridil

Updated info for digoxin, addition of fentanyl and fluticasone.

Change to section 4.8 – Undesirable effects

Additional post marketing events, MedDRA classification

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-10-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 5.1 - Pharmacodynamic properties

Updated information on Mode of Action, PK/PD relationship, mechanism of resistance, Breakpoints.

 

Change to section 10 – Date of revision of the text

October 2007

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties

Date of revision of text on the SPC:01-10-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

REASON(S) FOR SUBMISSION

 

Change

eMC - Summary of Change Details Per Section

 

X

Change to section 4.2 – Posology and |Method of Administration

Extra Information on Hepatic and Renal impairment

X

Change to section 4.4 – Special Warnings and Precautions for Use

Extra Information on Hepatic and Renal impairment

X

Change to section 5.2 - Pharmacokinetic properties

Extra Information on Special Populations-Hepatic Impairment/ Renal Impairment.

X

Change to section 10 – Date of revision of the text

October 2007

Reasons for adding or updating:

  • 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 first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-02-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 2 – quantitative and qualitative composition

Introduction of Sorbitol

Change to section 3 – pharmaceutical form

Changed to: Sporanox oral solution is clear, yellow to slightly amber solution with an odour of cherry.

 

Change to section 4.4 – Special Warnings and Precautions for Use

New text added related to fructose intolerance:

 

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

Addition of loperamide which should be used with caution, and their plasma concentrations, effects or side effects should be monitored. Their dosage, if co-administered with itraconazole, should be reduced if necessary

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

Updated

Change to section 6.1 – List of Excipients

Updated information about excipients

Change to section 6.2 - Incompatibilities

Updated with the following text:  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

Minor update

Change to section 9 – Date of Renewal of Authorisation

Updated with last renewal date

Change to section 10 – Date of revision of the text

Updated to Feb 2007

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 date of revision of the text

Date of revision of text on the SPC:01-12-2006

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 1 –Name of the medicinal product

Name Change to Sporanox 10mg/ml Oral Solution

Change to section 2 – quantitative and qualitative composition

Textual change

Change to section 4.2 – Posology and |Method of Administration

Textual change

Change to section 4.3 – Contra-indications

introduction of levacetylmethadol (levomethadyl), sertindole, certain ergot alkaloids, eletriptan and repaglinide, as drugs which are contraindicated with itraconazole.

 

Wording for contraindication in pregnancy also updated.

Change to section 4.4 – Special Warnings and Precautions for Use

This section has been modified to include the following subheadings: Interaction potential, Use in children, Use in elderly, Hepatic effects, Hepatic impairment, Renal impairment, Neuropathy, Cross hypersensitivity and Cardiac effects.

 

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

The significant changes include: the instruction to consult labels of other medicines used concomitantly with itraconazole to determine route of metabolism (Subsection 2. Effect of itraconazole on the metabolism of other drugs), the introduction of levacetylmethadol (levomethadyl), sertindole, certain ergot alkaloids, eletriptan as drugs which are contraindicated with itraconazole.

 The introduction of certain glucocorticoids, cilostazol, disopyramide, halofantrine and repaglinide as drugs that should be used with caution and monitored when coadministered with itraconazole.  In addition, there have been minor textual changes within this section.

 

Change to section 4.6 – Pregnancy and Lactation

Addition of epidemiological data on exposure to Sporanox and textual changes.

Change to section 4.9 - Overdose

Minor Textual change

Change to section 5.1 - Pharmacodynamic properties

Updated to include in vitro data to support the broad spectrum of itraconazole activity.  In conjunction with this, specific itraconazole-sensitive yeast and fungi are named within this section.  Furthermore, examples of less susceptible Candida species and resistant principal fungus types have also been provided.

 

Change to section 5.2 - Pharmacokinetic properties

Section 5.2.  Pharmacokinetic Properties includes more up to date and expanded data on the pharmacokinetic properties of itraconazole.  In order to accomodate this increase in data this section has subsequently been reorganised in to subsections titled General pharmacokinetic characteristics, Distribution, Biotransformation, Elimination and Linearity/non-linearity.

 

Change to section 5.3 - Preclinical Safety Data

Includes mainly textual changes and summary on non-clinical data.

 

Change to section 10 – Date of revision of the text

December 2006

Reasons for adding or 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 (partial) revision of the text

Reasons for adding or 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 (partial) revision of the text

Reasons for adding or updating:

  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use

Reasons for adding or updating:

  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC