Last Updated on eMC 23-04-2013 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 10 - Date of revision of the text

Date of revision of text on the SPC:16-04-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.2:
Addition of: The capsules must be swallowed whole.
Updated wording under Children, Elderly, renal impairment and hepatic impairment.

Section 4.3:
Additioon of: Co-administration of a number of CYP3A4 substrates is contraindicated with Sporanox-Pulse. 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.

Section 4.4:
Updated wording for hepatic affects, renal impairment and reduced gastric acidity. Also updated text under paediatrics and elderly.
Addition of Interchangeability and interaction potential statements.
 
Section 4.5:
Complete revision

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:10-04-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 4.8: Amended according to current requirements resulting in additional ADRs, deletion of some ADRs and change in some frequencies. 
Change to section 10: 10 April 2013

Reasons for adding or updating:

  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:06-02-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 4.9: Addition of Symptoms. Deletion of gastric lavage. 
Change to section 10: 06 February 2013 

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • 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:16-01-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 5.1: Change to some of the susceptible yeasts and fungi
Change to section 5.2: Complete revision including addition of information on Paediatrics
Change to section 10:  16 January 2013

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:02-10-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.5: Under point 3, addition of Once treatment is stopped, itraconazole plasma concentrations decrease to an almost undetectable concentration within 7-14 days depending on the dose of itraconazole. 

Section 10: 02 October 2012

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC:18-10-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Addition of dyspnoea and acute generalised exanthematous pustulosis to Section 4.8 table

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 4.6 - Pregnancy and Lactation
  • 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

Date of revision of text on the SPC:01-12-2010

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to section 4.3 - Contraindications

Addition of Atorvastatin

 

Women of childbearing potential taking Sporanox-Pulse should use contraceptive precautions. Effective contraception should be continued until the menstrual period following the end of Sporanox-Pulse therapy

Change to section 4.4 - Special warnings and precautions for Use

Cardiac effects

In a healthy volunteer study with Sporanox® IV, a transient asymptomatic decrease of the left ventricular ejection fraction was observed; this resolved before the next infusion. The clinical relevance of these findings to the oral formulations is unknown.

Sporanox should not be used in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk.  This individual benefit/risk assessment should take into consideration factors such as the severity of the indication, the dose and duration of treatment (e.g. total daily dose), and individual risk factors for congestive heart failure.  These risk factors include cardiac disease, such as ischemic and valvular disease; significant pulmonary disease, such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of congestive heart failure, should be treated with caution, and should be monitored for signs and symptoms of congestive heart failure during treatment; if such signs or symptoms do occur during treatment, Sporanox should be discontinued

Hepatic impairment

Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when the drug is administered in this patient population. (See Section 5.2)

Renal impairment

Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population. The oral bioavailability of itraconazole may be lower in patients with renal insufficiency. Dose adaptation may be considered.

 

Interaction Potential

Sporanox has a potential for clinically important drug interactions.  (See Section 4.5). 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.

 

 

 

 

 

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

Itraconazole is mainly metabolised through the cytochrome CYP3A4.  Interaction studies have been performed with rifampicin, rifabutin and phenytoin, which are potent inducers of CYP3A4.  Since the bioavailability of itraconazole and hydroxy-itraconazole was decreased in these studies to such an extent that efficacy may be largely reduced, the combination of itraconazole with these potent enzyme inducers is not recommended.  No formal study data are available for other enzyme inducers, such as carbamazepine, Hypericum perforatum (St John’s Wort), phenobarbital and isoniazid, but similar effects should be anticipated.

 

CYP3A4 metabolised HMG-CoA reductase inhibitors such as atorvastatin, lovastatin and simvastatin.

 

Change to section 4.6 - Pregnancy and Lactation

There is limited information on the use of Sporanox during pregnancy. During post-marketing experience, cases of congenital abnormalities have been reported. These cases included skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations. A causal relationship with Sporanox has not been established.

 

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

No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss (see Section 4.8), which may occur in some instances, must be taken into account.

 

Change to section 4.8 - Undesirable Effects

*see section 4.4

 

Change to section 10 - Date of revision of the text

01 December 2010

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:22-10-2010

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 - 22 October 2010.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • 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:23-10-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



1.             Trade Name of the Medicinal Product

 

SporanoxPORANOX® -Pulse

 

4.4.         Special Warnings and Precautions for Use

 

Addition of hearing loss warning

4.8.         Undesirable Effects

 

Complete section has been re-worded 

10.          Date of (Partial) Revision of the Text

 

Changed from April 2009 to 23 October 2009

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-04-2009

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

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Change to section 10 Date of Revision of the Text

Amended to ‘April 2009’

 

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 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:01-07-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Change to section 6.4 – Special Precautions for Storage

Store below 30C

X

Change to section 10 – Date of revision of the text

July 2008

Reasons for adding or 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 4.4 - 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text

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

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 4.1 – Therapeutic Indications

Treatment of aspergillosis and candidosis

Treatment of cryptococcosis (including cryptococcal meningitis): in immunocompromised patients with cryptococcosis and in all patients with cryptococcosis of the central nervous system.Maintenance therapy in AIDS patients to prevent relapse of underlying fungal infection.

Change to section 4.2 – Posology and |Method of Administration

1 The duration of treatment should be adjusted depending on the clinical response.

Additional statements on use in children and elderly, renal and hepatic impairment

Change to section 4.3 – Contra-indications

New layout and addition of Eletriptan and NIsoldipine

Change to section 4.4 – Special Warnings and Precautions for Use

New layout and addition of warnings to children and Elderly and renal and hepatic effects

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

New layout and addition of Eletriptan and Nisoldipine

Change to section 4.6 – Pregnancy and Lactation

New layout and new data.

Change to section 5.1 - Pharmacodynamic properties

All new information

 

Change to section 5.2 - Pharmacokinetic properties

New layout and new information on special populations

Change to section 5.3 - Preclinical Safety Data

All new information

Change to section 10 – Date of revision of the text

January 2008

Reasons for adding or updating:

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

Date of revision of text on the SPC:01-08-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Addition of interaction with Fluticasone

Change to section 10 – Date of revision of the text

August 2007

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 4.4 - Special Warnings and Precautions for Use

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • Transferred from eMC version 1

Reasons for adding or updating:

  • No reasons supplied

Reasons for adding or updating:

  • No reasons supplied