Product Details

1. 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.

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

2. What you need to know before you take

3. Do not take Dutasteride

   • if you are allergic to dutasteride, other 5-alpha reductase inhibitors, soya, peanut or to any of the

     other ingredients of this medicine (listed in section 6)

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

4. Warnings and Precautions

   Talk to your doctor before taking Dutasteride.

   • 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 Dutasteride.

   • 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 . 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.

5. Dutasteride 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.

6. 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.

7. Dutasteride 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.

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

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

8. verapamil or diltiazem (for high blood pressure)

9. ritonavir or indinavir (for HIV)

10. itraconazole or ketoconazole (for fungal infections)

11. nefazodone (an antidepressant)

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