Diovan 40mg film-coated Tablets (Valsartan)-Revised SPC

Source: eMC (electronic Medicines Compendium)

Keywords: Valsartan, Diovan

Date published: 08/02/2012 11:28

Type of SPC Change: Revised SPC

Generic drug name: Valsartan

Drug brand name: Diovan

Legal status: POM - Black Triangle

Pharmaceutical manufacturer: Novartis Pharmaceuticals UK Limited

Summary
by: Atisha Sharma

There have been significant updates to several sections of the SPC, including the following:

 

Change to section 4.4 - Special warnings and precautions for Use

Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported in patients treated with valsartan; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Diovan should be immediately discontinued in patients who develop angioedema, and Diovan should not be re-administered.

 

Please refer to SPC link below for full information on all changes.

SPC

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