Please read this leaflet carefully before you take DUODART.

This leaflet answers some common questions about DUODART. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the expected benefits of you taking DUODART against the risks this medicine could have for you.

You may need to read it again.

DUODART is a combination of two medicine; dutasteride and tamsulosin hydrochloride. Dutasteride belongs to a group of medicines called 5-alpha reductase enzyme inhibitors and tamsulosin hydrochloride belongs to a group of medicines called alpha-blockers. These medicines can be used either alone or in combination in men who have a condition known as benign prostatic hyperplasia (BPH).

BPH is a non-cancerous enlargement of the prostate gland which is located at the lower portion of the urinary bladder surrounding the urethra (urine carrying tube). In men with BPH, the prostate gland becomes large enough to squeeze the urine tube running through it. If the urine tube is squeezed it narrows, making it more difficult for you to pass urine normally and you may have some or all of the following symptoms:

As the disease progresses, untreated BPH can lead to an increased risk of complete blockage of urine flow (acute urinary retention) and/or the need for surgery.

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). The dutasteride component of DUODART lowers DHT production in the body, leading to shrinkage of the enlarged prostate in most men. The tamsulosin hydrochloride component of DUODART acts by relaxing the smooth muscle in your prostate gland, making it easier to pass urine. Just as your prostate became large over a long period of time, reducing the size of your prostate and improving your symptoms may take time.

Your doctor may have prescribed DUODART for another reason. Ask your doctor if you are unsure why DUODART was prescribed for you.

DUODART is not addictive.

You must not take DUODART if:

You must tell your doctor if:

 

Women who are pregnant or may be pregnant, and children, must avoid handling punctured or leaking capsules. Wash the affected area immediately with soap and water if there is any contact with the skin.

If dutasteride is absorbed through the skin by a woman who is pregnant with a male baby, it may cause the male baby to be born with abnormalities of the genital organs.

Dutasteride has been found in the semen of men taking dutasteride. If your partner is or may be pregnant, you must avoid exposing her to your semen as dutasteride may affect the normal development of a male baby. You must use a condom during sex.

You must not donate blood until 6 months after you've stopped taking DUODART.

Take DUODART as directed by your doctor or pharmacist.

The usual dose in men is one capsule daily.

Swallow your DUODART capsules whole with some water, approximately 30 minutes after the same meal each day. It is very important that DUODART is not taken on an empty stomach as this may increase the risk of adverse effects.

Don't chew or open the capsules. Contact with the contents of the capsule may make your mouth or throat sore.

It is important to continue to take DUODART for as long as your doctor prescribes it, even if you do not feel any immediate benefit. Some men notice an early improvement in their symptoms however others may need to continue for 3-6 months to see if DUODART helps them. You must also continue to take your medicine as your symptoms improve.

If you forget to take a capsule, don't worry, just take the next dose as normal and continue as before.

DUODART decreases your PSA (prostate-specific antigen) levels. Therefore, if you are having a blood test to measure your PSA levels, tell your doctor you are taking DUODART.

Some patients may experience dizziness or feel light headed.

Be careful driving or operating machinery until you know how DUODART affects you.

If you are having a cataract operation and are already taking or have taken DUODART, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the operation (floppy iris syndrome). This can be managed if your surgeon knows beforehand that you have taken DUODART. If you are going to have eye surgery for cataracts, please tell your surgeon that you are taking or have taken DUODART.

In clinical studies where patients were taking both the individual components of DUODART, the rate of heart failure was higher than in patients taking the individual components alone. However, this was seen in less than 1% of patients. (Heart failure means your heart does not pump blood as well as it should.)

If you are taking DUODART, talk to your doctor about this and other possible side effects.

In a clinical study of men at increased risk of developing prostate cancer, a serious form of prostate cancer was reported more often in men taking DUODART than men who did not take DUODART. The reasons for this is currently unknown but may be due to the design of the clinical study.

A blood test to measure the amount of a substance called PSA (prostate specific antigen) in your blood can help your doctor to tell if you have prostate disease, including prostate cancer. If you have a higher than normal amount of PSA in your blood it could mean that you are at a higher risk of prostate cancer.

Men taking DUODART should have their PSA measured 6 months after starting treatment and then regularly after that. Taking DUODART will reduce the amount of PSA measured in your blood. You could still be at risk for prostate cancer even though your PSA is lower. Your doctor can still use PSA to help detect prostate cancer, by comparing your test results each time you have a PSA test.

It is important to take your medicine as your doctor recommends. If you do not take it regularly it may interfere with your doctor's ability to monitor your PSA.

Like other medicines, DUODART can cause some side effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

The most commonly reported side-effects are:

The following uncommon side effects have been reported:

Rarely, the following side effects have been reported:

Very rarely, the following side effects have been reported:

DUODART can cause dizziness, light-headedness and on rare occasions fainting. Take care when moving from a lying down or sitting position to sitting or standing, particularly if you wake up in the night, until you know how this medicine affects you.

If you are switching to DUODART from another tamsulosin containing product dizziness or light headedness may occur when standing up.

If you feel dizzy or light-headed at any time during treatment, sit or lie down until the symptoms pass.

You may also experience a decrease in sperm count and semen volume.

One side effect of DUODART is known as "retrograde ejaculation". When this happens most of the ejaculation fluid runs back into the bladder instead of being squirted out. Retrograde ejaculation is painless.

Extremely rarely, medications similar to DUODART have caused prolonged painful erections, which is unrelated to sexual activity. If you have a prolonged erection, call your doctor or go to the Emergency Room as soon as possible.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

DUODART capsules contain the active ingredients:

DUODART capsules also contain the inactive ingredients: