Last Updated on eMC 17-02-2018 View medicine  | Accord Healthcare Limited 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 6.1 - List of excipients
  • Correction of spelling/typing errors

Date of revision of text on the SPC:09-02-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



IN section 4.2 (Posology and method of administration), following is updated

 

Voriconazole may also be available as powder for solution for infusion, powder and solvent for solution for infusion and powder for oral suspension, however not under this tradename.

 

In section 6.1 (List of excipients), following is updated

Film-coating

 

Hypromellose

Titanium dioxide (E171)

Lactose monohydrate

Triacetin

 

 

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for use

Date of revision of text on the SPC:05-09-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



In section 4.4 (Special warnings and precautions for use), following is updated

Serious dermatological adverse reactions

 

  • Phototoxicity

In addition Voriconazole Accord  has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria. It is recommended that all patients, including children, avoid exposure to direct sunlight during Voriconazole Accord treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).

 

  • Squamous cell carcinoma of the skin (SCC)

Squamous cell carcinoma of the skin has been reported in patients, some of whom have reported prior phototoxic reactions. If phototoxic reactions occur multidisciplinary advice should be sought, Voriconazole Accord  discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist. If  Voriconazole Accord is continued, however, dermatologic evaluation should be performed on a systematic and regular basis, to allow early detection and management of premalignant lesions. Voriconazole Accord  should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).

 

  • Exfoliative cutaneous reactions

Reactions such as Stevens-Johnson syndrome developed during treatment with Voriconazole Accord. If a patient develops a rash he should be monitored closely and Voriconazole Accord  discontinued if lesions progress.

 

Long-term treatment

Long term exposure (treatment or prophylaxis) greater than 180 days (6 months) requires careful assessment of the benefit-risk balance and physicians should therefore consider the need to limit the exposure to Voriconazole Accord  (see sections 4.2 and 5.1).

 

Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term Voriconazole Accord treatment.

 

Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients. If a patient develops skeletal pain and radiologic findings compatible with periostitis Voriconazole Accord discontinuation should be considered after multidisciplinary advice.

·         Serious dermatological adverse reactions (including SCC)

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): NO