Product Details

Product Information of Duodart Capsules

What you need to know before you take Duodart

Do not take Duodart:

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 Duodart. In some clinical studies, more patients taking dutasteride and another medicine called an alpha-blocker, like tamsulosin 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 Duodart. 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 Duodart for a while before your operation. Tell your eye specialist before your operation that you are taking Duodart 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 Duodart 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 Duodart. 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. Duodart 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 Duodart. Men taking Duodart 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. Duodart 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 Duodart. Other medicines and Duodart Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Don’t take Duodart with these medicines: • other alpha-blockers (for enlarged prostate or high blood pressure) Duodart is not recommended with these medicines: • ketoconazole (used to treat fungal infections) Some medicines can react with Duodart 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 ketoconazole (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. Duodart with food and drink Duodart should be taken 30 minutes after the same meal each day. Pregnancy, breast-feeding and fertility Duodart 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 Duodart. If your partner is or may be pregnant, you must avoid exposing her to your semen. Duodart 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 Duodart. Driving and using machines Duodart 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 Duodart Duodart contains the colouring agent Sunset Yellow (E110) which may cause allergic reactions. Duodart contains lecithin from soya. If you are allergic to peanut or soya, do not use this medicinal product