Di-Gesic

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

Dextropropoxyphene hydrochloride; Paracetamol

Verfügbar ab:

Aspen Pharmacare Australia Pty Ltd

Klasse:

Medicine Registered

Gebrauchsinformation

DI-GESIC
®

_dextropropoxyphene hydrochloride with paracetamol_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DI-GESIC. It does
not contain all the available
information and does not take the
place of talking with your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking DI-GESIC
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE OR HAVE ANY
QUESTIONS ABOUT THE BOXED
WARNINGS, TALK TO YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.

WARNING:
THE ADMINISTRATIVE
APPEALS TRIBUNAL IS
EXPECTED TO HEAR AN
APPEAL IN RELATION TO THE
CONTINUED REGISTRATION
OF THIS PRODUCT TOWARDS
THE END OF MAY 2012. IF THE
APPEAL AGAINST
CANCELLATION IS
REJECTED, THIS PRODUCT
MAY THEN CEASE TO BE
AVAILABLE WITHIN A SHORT
TIMEFRAME.

WARNING:
FOR PATIENTS CURRENTLY
USING
DEXTROPROPOXYPHENE-
CONTAINING PRODUCTS TO
MANAGE CHRONIC PAIN
WHO HAVE NOT RECENTLY
TRIALLED ALTERNATIVE
ANALGESIA, ATTEMPT TO
REPLACE
DEXTROPROPOXYPHENE
CONTAINING PRODUCTS
WITH ALTERNATIVE
ANALGESIA BEFORE
CONTINUING TO PRESCRIBE
DEXTROPROPOXYPHENE-
CONTAINING PRODUCTS. DO
NOT INITIATE THE USE OF
DEXTROPROPOXYPHENE-
CONTAINING PRODUCTS FOR
ANY NEW PATIENTS,
WHETHER FOR THE
TREATMENT OF ACUTE OR
CHRONIC PAIN.

WARNING:
DEXTROPROPOXYPHENE
PRODUCTS HAVE RECENTLY
BEEN ASSOCIATED WITH
SUBSTANTIAL
PROLONGATION OF THE QT
INTERVAL. DI-GESIC IS
CONTRAINDICATED IN
PATIENTS WITH
CONGENITAL LONG QT
SYNDROME OR KNOWN
ACQUIRED QT INTERVAL
PROLONGATION. DI-GESIC IS
ALSO CONTRAINDICATED IN
PATIENTS WITH A HISTORY
OF CLINICALLY SIGNIFICANT
CARDIOVASCULAR DISEASE,
CONGESTIVE HEART
FAILURE, CARDIAC
HYPERTROPHY,
ARRHYTHMIA OR
BRADYCARDIA AS THEY ARE
AT HIGHER RISK OF
DEVELOPING TORSADE DE
POINTES, A RARE TYPE OF
VENTRICULAR
TACHYCARDIA. (FOR OTHER
CONTRAINDICATIONS, SEE
MAIN TEXT.)
ELDERLY PATIENTS, AND
THOSE WITH RENAL
INSUFFICIENCY, ARE ALSO
BELIEVED TO BE AT

Fachinformation

 
DI-GESIC –Product Information                      

  Page 1 of 12 

PRODUCT INFORMATION 

DI-GESIC


(dextropropoxyphene hydrochloride with paracetamol) 

NAME OF THE MEDICINE 

DI-GESIC
®
 (dextropropoxyphene hydrochloride with paracetamol). 

WARNING: THE ADMINISTRATIVE APPEALS
TRIBUNAL IS EXPECTED TO HEAR AN APPEAL 
IN RELATION TO THE CONTINUED REGISTRATION
OF THIS PRODUCT TOWARDS THE END OF MAY 
2012.  IF THE APPEAL AGAINST CANCELLATION IS REJECTED, THIS
PRODUCT MAY THEN 
CEASE TO BE AVAILABLE WITHIN A SHORT TIMEFRAME. 

WARNING: FOR PATIENTS CURRENTLY USING
DEXTROPROPOXYPHENE-CONTAINING 
PRODUCTS TO
MANAGE CHRONIC PAIN WHO HAVE NOT RECENTLY TRIALLED ALTERNATIVE 
ANALGESIA, ATTEMPT TO REPLACE DEXTROPROPOXYPHENE-CONTAINING
PRODUCTS 
WITH ALTERNATIVE ANALGESIA BEFORE CONTINUING TO
PRESCRIBE DEXTROPROPOXYPHENE-
CONTAINING PRODUCTS.  DO NOT
INITIATE THE USE OF DEXTROPROPOXYPHENE-
CONTAINING
PRODUCTS FOR ANY NEW PATIENTS, WHETHER FOR THE TREATMENT OF 
ACUTE OR CHRONIC PAIN.  

WARNING: DEXTROPROPOXYPHENE PRODUCTS HAVE RECENTLY BEEN ASSOCIATED WITH 
SUBSTANTIAL PROLONGATION OF THE QT INTERVAL.  DI-GESIC  IS
CONTRAINDICATED IN 
PATIENTS WITH CONGENITAL LONG QT SYNDROME OR KNOWN ACQUIRED QT
INTERVAL 
PROLONGATION. DI-GESIC IS
ALSO CONTRAINDICATED IN PATIENTS  WITH A HISTORY OF  
CLINICALLY SIGNIFICANT CARDIOVASCULAR DISEASE, CONGESTIVE
HEART FAILURE, CARDIAC 
HYPERTROPHY, ARRHYTHMIA OR BRADYCARDIA  AS THEY ARE
AT HIGHER RISK OF 
DEVELOPING TORSADE DE POINTES, A RARE TYPE
OF VENTRICULAR TACHYCARDIA.  (FOR 
OTHER CONTRAINDICATIONS, SEE
MAIN TEXT.)  ELDERLY PATIENTS, AND THOSE WITH RENAL 
INSUFFICIENCY, ARE ALSO BELIEVED TO BE AT HIGHER RISK AS
THEY ARE LIKELY TO EXHIBIT 
HIGHER BLOOD LEVELS OF DEXTROPROPOXYPHENE�