Doloxene

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

Dextropropoxyphene napsylate

Disponibbli minn:

Aspen Pharmacare Australia Pty Ltd

Klassi:

Medicine Registered

Fuljett ta 'informazzjoni

DOLOXENE
®

_dextropropoxyphene napsylate_
CONSUMER MEDICINE INFORMATION (CMI)

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DOLOXENE. 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 using this medicine 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. DOLOXENE IS
CONTRAINDICATED IN
PATIENTS WITH
CONGENITAL LONG QT
SYNDROME OR KNOWN
ACQUIRED QT INTERVAL
PROLONGATION. DOLOXENE
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 T

Karatteristiċi tal-prodott

 
DOLOXENE

PRODUCT INFORMATION 
DOLOXENE
®

(dextropropoxyphene napsylate) 

NAME OF THE MEDICINE 

DOLOXENE
®
 (dextropropoxyphene napsylate). 

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.  DOLOXENE IS CONTRAINDICATED IN 
PATIENTS WITH CONGENITAL LONG QT
SYNDROME OR KNOWN ACQUIRED QT INTERVAL 
PROLONGATION. DOLOXENE 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 AND
NORPROPOXYPHENE.  IT IS 
STRONGLY RECOMMENDED THAT ALL PATIENTS UNDERGOING CHRONIC TREATMENT 
WITH
DEXTROPROPOXYPHENE PRODUCTS HAVE A RENAL FUNCTION BLOOD TEST AND AN 
ECG PERFORMED AT BASELINE�