Product Details

Product Information of Avodart Capsules

What you need to know before you take Avodart

Do not take Avodart • 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. Warnings and Precautions Talk to your doctor before taking Avodart. • 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. 2 • 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. Other medicines and Avodart Tell your doctor if you are taking, have recently taken, or might take any other medicines. 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 ketoconazole (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. Avodart with food and drink Avodart can be taken with or without food. Pregnancy, breast-feeding and fertility 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. Avodart contains lecithin from soya 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.