Alfuzosin + Dutasteride

Alfuzosin + Dutasteride is a combination of two medicines which work in different ways to treat men with an enlarged prostate gland. It helps to relieve symptoms such as difficulty urinating or needing to go to the toilet more often. It is not used to prevent prostate cancer. Alfuzosin + Dutasteride should be taken at the same time each day. Take it as a whole – do not break, chew or crush them. Your doctor will prescribe the dose most suitable for you. To gain the most benefit and treat your symptoms effectively you should not miss doses, even if you feel well. It may take up to 4 weeks to notice an improvement in symptoms but keep taking them regularly. Tell your doctor if your symptoms do not improve after 4 weeks or if they get worse. The most common side effects of this medicine include reduced sex drive, inability to get an erection (impotence) and tenderness or enlargement of your breasts. If these effects worry you or do not go away, call your doctor for advice. You may also feel dizzy or drowsy. These risks are higher when you first start taking this drug. Remember, your doctor has given you this medicine because the benefits are greater than the risks of the side effects. Alfuzosin + Dutasteride should not be taken by women or children. Before taking it, tell your doctor if you have low blood pressure or liver or kidney disease. This medicine may not be suitable. It can also affect, or be affected by, other drugs so let your doctor know all other medicines you are taking. You may be advised to wear a condom during sex and to have your blood pressure checked frequently. Talk to your healthcare team if you drink alcohol. Alfuzosin + Dutasteride is a combination of two medicines: Alfuzosin and Dutasteride, which relieves the symptoms of benign prostatic hyperplasia. Alfuzosin is an alpha-blocker. It works by relaxing the muscle around the bladder exit and prostate gland so as to allow easy passage of urine. Dutasteride is a 5-alpha-reductase inhibitor which helps in shrinking the prostate gland by decreasing the level of the hormone which helps the prostate gland grow.

• Benign prostatic hyperplasia

Alfuzosin is a quinazoline derivative which exhibits selectivity for α1-adrenergic receptors in the lower urinary tract. Blockade of these adrenoreceptors causes relaxation of smooth muscle in the bladder neck and prostate, resulting in improvement in urine flow and a reduction in symptoms of benign prostatic hyperplasia (BPH). Dutasteride, a 4-azo analog of testosterone, is a selective inhibitor of steroid 5α-reductase isoenzymes type 1 (skin and hepatic) and type 2 (reproductive tissues). This results in inhibition of the conversion of testosterone to dihydrotestosterone and markedly suppresses serum dihydrotestosterone levels.

Adult Dose: Oral 1 tablet once a day

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Alfuzosin + Dutasteride is to be taken with food.

Common: • Impotence • Decreased libido • Breast pain • Ejaculation disorder • Dizziness • Headache

[UNSAFE] Alfuzosin + Dutasteride may decrease alertness, affect your vision or make you feel sleepy and dizzy. Do not drive if these symptoms occur. You have been prescribed Afdura Tablet ER to relieve the symptoms of benign prostatic hyperplasia (BPH). Take it approximately 30 minutes after the same meal each day. Afdura Tablet ER may cause dizziness or blurring of vision. Do not drive or do anything requiring concentration until you know how it affects you. To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. If you are scheduled to undergo an eye surgery due to cataract or glaucoma, inform your eye doctor about the usage of Afdura Tablet ER. It may cause difficulty achieving or maintaining an erection (impotence), decreased sex drive, and ejaculation disorders such as decreased amount of semen produced or decreased sperm count. Do not donate blood for 6 months after taking the last dose of Afdura Tablet ER.

History of orthostatic hypotension. Severe hepatic impairment. Concurrent use w/ potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir).

Additive effect on QT interval prolongation when used w/ QT-prolonging drugs. Concomitant admin w/ other α1-adrenergic blocking agents, atenolol or diltiazem may result in additive CV effects. Increased plasma alfuzosin concentrations w/ cimetidine. Potentially Fatal: Concurrent use w/ potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, ritonavir) increase plasma alfuzosin levels.

[UNSAFE] Alfuzosin + Dutasteride may cause excessive drowsiness with alcohol.

[UNSAFE] Alfuzosin + Dutasteride is highly unsafe to use during pregnancy. Seek your doctor's advice as studies on pregnant women and animals have shown significant harmful effects to the developing baby.

[CONSULT YOUR DOCTOR] Information regarding the use of Alfuzosin + Dutasteride during breastfeeding is not available. Please consult your doctor.

[SAFE IF PRESCRIBED] Alfuzosin + Dutasteride is probably safe to use in patients with kidney disease. Limited data available suggests that dose adjustment of Alfuzosin + Dutasteride may not be needed in these patients. Please consult your doctor. [CAUTION] Alfuzosin + Dutasteride should be used with caution in patients with liver disease. Dose adjustment of Alfuzosin + Dutasteride may be needed. Please consult your doctor. Use of Alfuzosin + Dutasteride is not recommended in patients with severe liver disease.