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Voriconazole Accord Film-coated Tablets

Last Updated on eMC 08-Sep-2017 View document  | 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.

Updated on 08-Sep-2017 and displayed until Current

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-Sep-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)

Updated on 28-Jul-2016 and displayed until 08-Sep-2017

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Accord Healthcare Limited

Company image
Address

Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, UK

Fax

+44 (0)208 861 4867

Medical Information e-mail
Medical Information Fax

+44 (0)208 861 4867

Telephone

+44 (0)208 8631 427

Medical Information Direct Line

+44 (0)208 901 3370

Customer Care direct line

0800 373 573

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

voriconazole

Legal categories

POM - Prescription Only Medicine

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