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COMBODART"

0.5 mg/0.4 mg

hard capsules

dutasteride/tamsulosin

hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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In this leaflet:

1    What Combodart is and what it is used for

2    What you need to know before you take Combodart

3    How to take Combodart

4    Possible side effects

5    How to store Combodart

6    Contents of the pack and other information

1 What Combodart is ¹ and what it is used for

Combodart is used to treat men with an enlarged prostate (benign prostatic hyperplasia) - a non-cancerous growth of the prostate gland, caused by producing too much of a hormone called dihydrotestosterone.

Combodart is a combination of two different medicines called dutasteride and tamsulosin. Dutasteride belongs to a group of medicines called 5-alpha reductase inhibitors and tamsulosin belongs to a group of medicines called alpha-blockers.

As the prostate grows, it can lead to urinary problems, such as difficulty in passing urine and a need to go to the toilet frequently. It can also cause the flow of the urine to be slower and less forceful. If left untreated, there is a risk that your urine flow will be completely blocked (acute urinary retention). This requires immediate medical treatment. Sometimes surgery is necessary to remove or reduce the size of the prostate gland.

Dutasteride lowers the production of a hormone called dihydrotestosterone, which helps to shrink the prostate and relieve the symptoms. This will reduce the risk of acute urinary retention and the need for surgery. Tamsulosin acts by relaxing the muscles in your prostate gland, making it easier to pass urine and rapidly improving your symptoms.

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2

What you need to know before you take Combodart

Do not take Combodart

•    if you're a woman (because this medicine is for men only).

•    if you're a child or adolescent less than 18 years old.

•    if you're allergic to dutasteride, other 5-alpha reductase inhibitors, tamsulosin, soya, peanut or to any of the other ingredients of this medicine (listed in section 6).

•    if you have low blood pressure which makes you feel dizzy, lightheaded or faint (orthostatic hypotension).

•    if you have a severe liver disease.

If you think any of these apply to you, don't take this medicine until you have checked with your doctor.

Warnings and precautions

Talk to your doctor before taking

Combodart

•    In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker like tamulosin experienced heart failure than patients taking only dutasteride or only an alpha-blocker. Heart failure means your heart does not pump blood as well as it should.

•    Make sure your doctor knows about liver problems. If you have had any illness affecting your liver, you may need some additional check-ups while you are taking Combodart.

•    Make sure your doctor knows if you have severe problems with your kidney.

•    Cataract (cloudy lens) surgery. If you

are going to have surgery to remove a cataract, your doctor may ask you to stop taking Combodart for a while before your operation. Tell your eye specialist before your operation that you are taking Combodart or tamsulosin (or have previously taken it). Your specialist will need to take appropriate precautions to help prevent complications during your operation.

•    Women, children and adolescents

must not handle leaking Combodart capsules, because the active ingredient can be absorbed through the skin. Wash the affected area immediately with soap and water if there is any contact with the skin.

•    Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Combodart. 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. Dutasteride has been shown to decrease sperm count, semen volume and sperm motility. This could reduce your fertility.

Combodart affects a blood test for

PSA (prostate-specific antigen), which is sometimes used to detect prostate cancer. Your doctor should be aware of this effect and can still use the test to detect prostate cancer. If you are having a blood

test for PSA, tell your doctor that you are taking Combodart. Men taking Combodart should have their PSA tested regularly.

•    In a clinical study of men at increased risk of prostate cancer, men taking dutasteride had a

serious form of prostate cancer more often than men who did not take dutasteride. The effect of dutasteride on this serious form of prostate cancer is not clear.

•    Combodart may cause breast enlargement and 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.

Contact your doctor or pharmacist

if you have any questions about taking Combodart.

Other medicines and Combodart

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Don't take Combodart with these medicines:

•    other alpha-blockers (for enlarged prostate or high blood pressure)

Combodart is not recommended with these medicines:

•    ketoconazole (used to treat fungal infections)

Some medicines can react with Combodart and may make it more likely that you'll have side effects. These medicines include:

•    PDE5 inhibitors (used to help achieve or maintain an erection) such as vardenafil, sildenafil citrate and tadalafil

•    verapamil or diltiazem (for high blood pressure)

•    ritonavir or indinavir (for HIV)

•    itraconazole or ketaconazole (for fungal infections)

•    nefazodone (an antidepressant)

•    cimetidine (for stomach ulcers)

•    warfarin (for blood clotting)

•    erythromycin (an antibiotic used to treat infections)

•    paroxetine (an antidepressant)

•    terbinafine (used to treat fungal infections)

•    diclofenac (used to treat pain and inflammation)

Tell your doctor if you are taking any of these medicines.

Combodart with food and drink

Combodart should be taken 30 minutes after the same meal each day.

Pregnancy, breast-feeding and fertility

Combodart must not be taken by women.

Women who are pregnant (or may be) must not handle leaking capsules.

Dutasteride is absorbed through the skin and can affect the normal development of a male baby. This is a particular risk in the first 16 weeks of pregnancy.

Use a condom during sexual intercourse. Dutasteride has been found in the semen of men taking Combodart. If your partner is or may be pregnant, you must avoid exposing her to your semen.

Combodart has been shown to reduce sperm count, semen volume and sperm movement. Therefore male fertility may be reduced.

Contact your doctor for advice if a pregnant woman has come into contact with Combodart.

Driving and using machines

Combodart makes some people feel dizzy, so it may affect your ability to drive or operate machinery safely.

Don't drive or operate machinery if you are affected in this way.

Important information about some of the ingredients of Combodart

Combodart contains the colouring agent sunset yellow (E110) which may cause allergic reactions.

Combodart contains lecithin from soya. If you are allergic to peanut or soya, do not use this medicinal product.

PHARMA CODE READING DIRECTION

5

How to store Combodart

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the bottle. The expiry date refers to the last day of that month.

Don't store Combodart above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 Contents of the pack and other information

Marketing Authorisation Holder

GlaxoSmithKline UK Limited,

Stockley Park West, Uxbridge,

Middlesex UB11 1BT

Manufacturer

Catalent Germany Schorndorf GmbH, Steinbeisstrasse 2, 73614 Schorndorf, Germany

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