Informations for option: Dutasteride 0.5mg Soft Capsules, show other option

Select option:

1. Dutasteride 0.5mg Soft Capsules
2. Dutasteride 0.5mg Soft Capsules

Document: document 14 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8
• document 9
• document 10
• document 11
• document 12
• document 13
• document 14
• document 15
• document 16
• document 17
• document 18
• document 19
• document 20
• document 21
• document 22
• document 23
• document 24
• document 25
• document 26
• document 27
• document 28
• document 29
• document 30
• document 31
• document 32
• document 33
• document 34
• document 35

---

Avodart® 0.5 mg Soft Capsules Dutasteride 0.5mg Soft Capsules

(dutasteride)

Patient Information Leaflet

This medicine is available using any of the above names but will be referred to as Avodart throughout this leaflet. This leaflet has been written to help you get the best effect from your medicine.

In this leaflet:

1)    What Avodart is and what it's used for

2)    Before you take Avodart

3)    How to take Avodart

4)    Possible side effects

5)    How to store Avodart

6)    Further information

Avodart 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.

The active ingredient is dutasteride. It belongs to a group of medicines called 5-alpha reductase inhibitors.

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. In some situations surgery is necessary to remove or reduce the size of the prostate    gland. Avodart lowers the production of

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.

Avodart may also be used with another medicine called tamsulosin (used to treat the symptoms of an enlarged prostate).

2) BEFORE YOU TAKE AVODART|

Do not take Avodart

. if you’re allergic (hypersensitive) to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or

to any of the other ingredients of Avodart

. if you have a severe liver disease.

^ Tell your doctor if you think any of these apply to you.

This medicine is for men only. It must not be taken by women, children or adolescents.

Take special care with Avodart

. In some clinical studies, more patients taking dustasteride and another medicine called an alpha-blocker, like tamsulosin experienced heart failure than patients taking only dustasteride 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 Avodart.

. Women, children and adolescents must not handle leaking Avodart 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 Avodart. 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.

. Avodart 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 Avodart. Men taking Avodart should have their PSA tested regularly.

•    In a clinical study of men at increased risk of prostate cancer, men taking Avodart had a serious form of prostate cancer more often than men who did not take Avodart. The effect of Avodart on this serious form of prostate cancer is not clear.

•    Avodart 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 Avodart.

Taking other medicines

Tell your doctor if you’re taking, or have recently taken, any other medicines. This includes any medicines you've bought without a prescription.

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

•    verapamil or diltiazem (for high blood pressure)

•    ritonavir or indinavir (for HIV)

•    itraconazole or ketaconazole (for fungal infections)

•    nefazodone (an antidepressant)

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

^ Tell your doctor if you are taking any of these medicines. Your dose of Avodart may need to be reduced.

Food and drink with Avodart

Avodart can be taken with or without food.

Pregnancy and breast-feeding

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 Avodart. If your partner is or may be pregnant, you must avoid exposing her to your semen.

Avodart 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 dutasteride.

Driving and using machines

Avodart is unlikely to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Avodart

This medicine contains lecithin from soya, which may contain soya oil. If you are allergic to peanut or soya, do not use this medicinal product.

Always take Avodart exactly as your doctor has told you

to. If you do not take it regularly the monitoring of your PSA levels may be affected. Check with your doctor or pharmacist if you are not sure.

How much to take

The usual dose is one capsule (0.5 mg) taken once a day.

Swallow the capsules whole with water. Do not chew or break open the capsule. Contact with the contents of the capsules may make your mouth or throat sore.

Avodart is a long term treatment. Some men notice an early improvement in their symptoms. However, others may need to take Avodart for 6 months or more before it begins to have an effect. Keep taking Avodart for as long as your doctor tells you.

If you take too much Avodart

Contact your doctor or pharmacist for advice if you take too many Avodart capsules.

If you forget to take Avodart

Don't take extra capsules to make up for a missed dose. Just take your next dose at the usual time.

Don’t stop Avodart without advice

Don't stop taking Avodart without talking to your doctor first. It may take up to 6 months or more for you to notice an effect.

^ If you have any further questions on the use of this product, ask your doctor or pharmacist.

Product: Avodart 0.5mg Capsules	PLPI: 17211/0997	Dimensions: 210mm x 400mm
Colours: Black	Item Code: AVO2001I/I	Proof: 2