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21 Jun 2011 - PBS listing of new treatment for enlarged prostate

Australian men who suffer from the symptoms of an enlarged prostate – like frequent urination, waking at night to urinate; a sense of incomplete emptying after urination; straining to urinate or a feeling of extreme urgency to urinate1 - now have a new treatment option with the listing of Duodart® (dutasteride/tamsulosin hydrochloride) on the Pharmaceutical Benefits Scheme (PBS) in Australia.

The technical name for an enlarged prostate gland is “Benign Prostatic Hyperplasia” – or BPH – and it is the most common prostate disease in men2. BPH is a widespread problem that increases with age and can cause significant deterioration in quality of life, changes in sleep patterns and daily living activities, anxiety and embarrassment3.

Benign Prostatic Hyperplasia becomes worse over time, so if it is left untreated complications can develop such as the complete blockage of urine flow (which is a serious emergency condition known as Acute Urinary Retention where a man can no longer pass urine at all) and the need for prostate surgery to reduce the size of the prostate.4

Duodart is indicated for the treatment of moderate to severe symptomatic benign prostatic hyperplasia and combines two different types of medicines used for BPH treatment into the one tablet. These two medicines, dutasteride (a 5 alpha-reductase inhibitor) and tamsulosin (an alpha-blocker) have commonly been used separately in the past to treat BPH by:

• lowering production of the hormone dihydrotestosterone, leading to shrinkage of the enlarged prostate gland (dutasteride); and
• relaxing the smooth muscle of the prostate gland, making it easier to pass urine (tamsulosin)

Henry Woo, who is a urologist and an Associate Professor of Surgery with the Sydney Medical School of the University of Sydney says there is confusion about the options available for treating urinary symptoms associated with prostate disease in Australia. Many men believe that their options are to either put up with the symptoms or face surgery in spite of their being alternate effective options available. Consequently, some men are either reluctant or too embarrassed to seek medical attention at the price of diminished quality of life.

“Men with urinary symptoms are encouraged to consult their doctor so that solutions could be explored.” said Professor Woo.

Dr Eugene Goh, Associate Medical Director Urology GSK, says there is enormous confusion about prostate disease in Australia and the fact that enlarged prostates can affect bladder control and can lead to much anxiety and embarrassment for those affected. “It is very important that men suffering from symptoms of frequent night time urination or who have a sense of not fully emptying their bladder after urination consult their doctor.” said Dr Goh.

Safety Information 5

The most common adverse events reported in a study of 4,844 men with BPH and an enlarged prostate, occurring in greater than or equal to 1% of patients in the combined dutasteride/tamsulosin-treated group, were: impotence (inability to achieve or maintain an erection); decrease in libido (sex drive); difficulty with ejaculation; breast swelling or tenderness and dizziness.
Precautions: Women who are pregnant or may be pregnant, and children, must avoid handling punctured or leaking capsules. Inform the doctor before undergoing cataract surgery or having a blood test to measure PSA (prostate specific antigen) levels. Donating blood must be avoided during, and for 6 months after stopping, Duodart therapy. Duodart can cause dizziness so caution should be taken when getting up from a sitting or a lying position. Duodart must be taken 30 minutes after the same meal each day.
Contraindications: Women; children; severe liver disease; severe kidney disease; history of orthostatic hypotension (a sudden drop in blood pressure upon standing up); concurrent use of an alpha-blocker; and hypersensitivity to dutasteride, tamsulosin or any other component of the medicine.

For further information about BPH and treatment options available, please speak to your healthcare professional. For Consumer Medicine Information on Duodart see


PBS Information: This product will be available on the PBS  from 1 August 2011

Authority Required (STREAMLINED)
Treatment of moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH) where treatment has been initiated by a urologist



 For more information on Duodart please see the Consumer Medicines Information (CMI) attached.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit


1. Andrology Australia BPH Symptoms Accessed 14/2/11
2. Andrology Australia (2010) Prostate Enlargement or BPH. Accessed on 22/6/10 at
3. Emberton M, et al. Int J Clin Pract 2008; 62:18-26.
4. Anderson JB, et al. Eur Urol 2001; 39: 390-399.
5. See Duodart Product Information