Duodart 0.5 mg/ 0.4 mg 30 capsules

Trade Name:

Duodart 0.5 mg/ 0.4 mg

30 capsules

Composition:

Dutasteride 500 mg

Tamsulosin hydrochloride 400 mg

Inactive ingredients:

glyceryl caprylate/caprate, butylated hydroxytoluene, gelatin, glycerol, titanium dioxide, microcrystalline cellulose, methacrylic acid, ethyl acrylate, copolymer, purified talc, purified water, triethyl citrate, carrageenan, potassium chloride, hypromellose, medium chain triglycerides, lecithin, carnauba wax, maize starch, iron oxide yellow, iron oxide red, sunset yellow FCF

Properties:

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:

• difficulty in starting to urinate an interrupted, weak urinary stream

• more frequent urination, especially at night
• feeling that you need to urinate right away
• leaking or dribbling
• a feeling that you cannot empty your bladder completely.

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.

Indications:

Treatment of benign prostatic hyperplasia (BPH) in men.

Dosage and administration:

• Take Duodart as directed by your doctor.
• 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.

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

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

• 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.

• Do not stop taking Duodart, or change the dose without first checking with your doctor.
• Tell your doctor if, for any reason, you have not taken your medicine exactly as directed.
• If you forget to take a capsule, don’t worry, just take the next dose as normal and continue as before.

• Do not take a double dose to make up for the one you have missed.

Side effects:

Common:

• impotence (inability to achieve or maintain an erection)
• decrease in libido (sex drive)
• difficulty with ejaculation
• breast swelling or tenderness. If this becomes troublesome or if you notice breast lumps or nipple discharge you should talk to your doctor about these changes as these may be signs of a serious condition, such as breast cancer.
• dizziness
• difficulty in sleeping (insomnia)

Rare:

• constipation, diarrhea, vomiting, weakness or loss of strength
• low blood pressure on standing
• itchy, blocked or runny nose
• hair loss (usually from the body) or hair growth
• fainting

Very rare:

• depressed mood

serious skin reactions (such as

Stevens-Johnson syndrome)

• testicular pain and testicular swelling

• nose bleeding
• changes in vision
• dry mouth
• 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.

• Tell your doctor immediately if you notice any of the following:

Wheezing, swelling of the lips/mouth, difficulty in breathing, hay fever, lumpy

rash (hives) or fainting. These could be a symptom of an allergic reaction.

• A widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals. These could be the symptoms of a serious skin reaction known as Stevens-Johnson syndrome.

Contraindications:

-allergy to dutasteride, other 5-alpha reductase enzyme inhibitors, tamsulosin

hydrochloride or any of the ingredients 

-women or children

-history of orthostatic hypotension (sudden drop in blood pressure upon standing up)

-severe liver disease

-severe kidney disease

-taking other medication that relaxes the smooth muscle of blood vessels 

Warnings and precautions:

Inform your doctor if:

-you are allergic to foods, dyes, preservatives or any other medicines;

-you suffer from liver or kidney disease and/or other medical conditions;

-you are going to have cataract (cloudy lens) surgery;

-you are taking medicine to lower blood pressure (alpha-blocker medicines that relax the smooth muscle of the blood vessels);

-you are taking any antifungal medicine such as ketoconazole;

-you are taking any other medicines, including medicines you buy without a prescription such as vitamin supplements or herbal medicines;

-you have any allergies to sulfur.

• 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 sperm of men taking dutasteride. If your partner is or may be pregnant, you must avoid exposing her to your sperm 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.
• 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.

• Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

• Do not use Duodart to treat any other complaints unless your doctor told you.
• 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.

• 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.
• Keep out of reach of children.

Storage:

Keep Duodart in a cool, dry place where it stays below 25°C.

Do not leave in a car, on a window sill or in a bathroom.

Package:

Carton box holds a plastic bottle of 30 capsules and paper instructions.