Dutagen Capsules (Generic Dutasteride Capsules)

1. Dutagen Capsules (Generic Dutasteride Capsules) © The Swiss Pharmacy

2. Dutagen Capsules (Generic Dutasteride Capsules) Dutagen (Generic Dutasteride Capsules) are used for the treatment of moderate to severe symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to reduce the risk of acute urinary retention (AUR) and surgery. Dutasteride Capsules are not approved for the prevention of prostate cancer. © The Swiss Pharmacy

3. Dutagen Capsules (Generic Dutasteride Capsules) Dutagen Capsules are manufactured by Sun Pharmaceutical Industries Limited, India in the strength of 0.5 mg. © The Swiss Pharmacy

4. Dutagen Capsules (Generic Dutasteride Capsules) Chemical Structure © The Swiss Pharmacy

5. Dutagen Capsules (Generic Dutasteride Capsules) The active ingredient contained in Dutagen Capsules is Dutasteride. Each soft gelatin Dutagen capsule contains 0.5 mg of Dutasteride. © The Swiss Pharmacy

6. Dutagen Capsules (Generic Dutasteride Capsules) Uses of Dutagen 0.5 mg Capsules: Dutagen Capsules (Dutasteride Capsules) are used alone (monotherapy) in the treatment of symptomatic benign prostatic hyperplasia (BPH) in men who have symptoms of an enlarged prostate gland. Dutagen Capsules are also used in combination with the alpha-blocker, Tamsulosin, in the treatment of moderate to severe symptomatic BPH in men with enlarged prostates. As the prostate gland enlarges, certain muscles in the gland may become tight and get in the way of the tube that drains urine from the bladder. This can cause problems with urinating, such as a need to urinate often, a weak stream when urinating, or a feeling of not being able to empty the bladder completely. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

7. Dutagen Capsules (Generic Dutasteride Capsules) Uses of Dutagen 0.5 mg Capsules: Combination therapy was also shown to be better than Tamsulosin, but not Dutasteride at reducing the risk of acute urinary retention (or where patient suddenly cannot urinate at all) and/or the need for BPH related surgery. The effect of dutasteride lasts only as long as the medicine is taken. If it is stopped, the prostate begins to grow again. Dutasteride Capsules are not approved for use in the prevention of prostate cancer. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

8. Dutagen Capsules (Generic Dutasteride Capsules) Recommended Adult Dosage The dose of Dutagen Capsules Dutagen Capsules (Generic Dutasteride Capsules) is 0.5mg capsule taken orally once a day. The capsule should be swallowed whole. Dutagen capsules may be administered with or without food. Although an improvement may be observed at an early stage, it can take up to 6 months before a response to the treatment can be achieved. No dose adjustment is necessary in the elderly. Renal Impairment: No dose adjustment is necessary for Dutasteride in patients with renal impairment. Hepatic Impairment: The effect of hepatic impairment on Dutasteride pharmacokinetics has not been studied. Because Dutasteride is extensively metabolized, exposure could be higher in hepatically impaired patients. © The Swiss Pharmacy

9. Dutagen Capsules (Generic Dutasteride Capsules) Contraindications ➔Dutagen capsules are contraindicated in patients with a known hypersensitivity to Dutasteride (e.g. serious skin reactions, angio- oedema), other 5 alpha-reductase inhibitors or any component of the tablet. ➔Dutagen is contraindicated in Pregnancy. In animal reproduction and developmental toxicity studies, Dutasteride inhibited development of the external genitalia of the male foetus. Therefore, Dutasteride may cause foetal harm when administered to a pregnant woman. If Dutasteride is used during pregnancy or if the patient becomes pregnant while taking Dutasteride, the patient should be apprised of the potential hazard to the foetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

10. Dutagen Capsules (Generic Dutasteride Capsules) Contraindications ➔Dutagen Capsules are contraindicated in women of childbearing potential. ➔Dutagen Capsules are contraindicated in Paediatric, children and adolescent patients. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

11. Dutagen Capsules (Generic Dutasteride Capsules) Storage Instructions Dutagen Capsules (Generic Dutasteride Capsules) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

12. Dutagen Capsules (Generic Dutasteride Capsules) Warnings Before starting treatment with Dutasteride, consideration should be given to other urological conditions that may cause similar symptoms. In addition, BPH and prostate cancer may coexist. In men aged 50 to 75 years with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL, who were taking Dutasteride in the 4-year Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (Dutasteride 1.0% versus placebo 0.5%).The 5 alpha- reductase inhibitors may increase the risk of development of high- grade prostate cancer. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

13. Dutagen Capsules (Generic Dutasteride Capsules) Warnings Dutagen capsules should not be handled by a woman who is pregnant or who could become pregnant. Dutasteride is absorbed through the skin and could result in unintended foetal exposure. If a woman who is pregnant or who could become pregnant comes in contact with leaking Dutasteride capsules, the contact area should be washed immediately with soap and water. Men being treated with Dutasteride should not donate blood until at least 6 months have passed following their last dose, so as to prevent pregnant women from receiving Dutasteride through blood transfusion. The effects of Dutasteride 0.5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 years (n=27 Dutasteride, n=23 placebo) throughout 52 weeks of treatment and 24 weeks of post-treatment follow-up. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume and sperm motility were 23%, 26% and 18%, respectively, in the Dutasteride group when adjusted for changes from baseline in the placebo group. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

14. Dutagen Capsules (Generic Dutasteride Capsules) Warnings In clinical studies, Dutasteride reduced serum prostate-specific antigen (PSA) concentration by approximately 50% within 3 to 6 months of treatment. To interpret serial PSAs in men taking Dutasteride capsules, a new PSA baseline should be established at least 3 months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on Dutasteride may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5 alpha-reductase inhibitor. Noncompliance with Dutasteride may also affect the PSA test results. The free-to-total PSA ratio (percent-free PSA) remains constant, even under the influence of Dutasteride. If clinicians elect to use percent-free PSA as an aid in the detection of prostate cancer in men receiving Dutasteride, no adjustment to its value appears necessary. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

15. Dutagen Capsules (Generic Dutasteride Capsules) Effects On Ability To Drive And Use Machines Based on the pharmacodynamic properties of Dutasteride (Dutagen Capsules), treatment with Dutasteride would not be expected to interfere with the ability to drive or operate machinery. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

16. Dutagen Capsules (Generic Dutasteride Capsules) Dutagen Capsules and Alcohol Dutasteride (Dutagen Capsules) reduces alcohol’s sedative effects in men in a human laboratory setting and reduces drinking in the natural environment. Research finds that men who drink heavily while taking Dutasteride lose the drug's protective benefit against high-grade prostate cancer. Ask your doctor before using ethanol together with Dutasteride. Using ethanol with Dutasteride can lower your blood pressure. This can cause dizziness or feeling like you might pass out, especially when getting up from a sitting or lying position. This may be more likely to occur when you first start taking either of these medications. You may need a dose adjustment or need your blood pressure checked more often if you take both medications. You may develop flushing, warmth or redness under your skin or tingly feeling after alcohol intake (especially in you are of Asian descent) and should be advised to avoid alcohol or limit your intake. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

17. Dutagen Capsules (Generic Dutasteride Capsules) Possible Side Effects Most common Dutasteride (Dutagen Capsules) side effects were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders. The most common adverse reactions reported in subjects receiving combination therapy (Dutasteride plus Tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness. Ejaculation disorders occurred significantly more in subjects receiving combination therapy (11%) compared with those receiving Dutasteride (2%) or Tamsulosin (4%) as monotherapy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

18. Dutagen Capsules (Generic Dutasteride Capsules) Dutagen Capsules Overdosage During volunteer trials, single doses of Dutasteride (Dutagen capsules) up to 40 mg (80 times the therapeutic dose) for 7 days have been administered without significant safety concerns. In a clinical trial, daily doses of 5 mg (10 times the therapeutic dose) were administered to 60 subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. There is no specific antidote for Dutasteride (Dutagen capsules). Therefore, in cases of suspected overdosage, symptomatic and supportive treatment should be given as appropriate, taking the long half-life of Dutasteride into consideration. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

19. Dutagen Capsules (Generic Dutasteride Capsules) Dutagen Capsules during Pregnancy Dutasteride (Dutagen capsules) has been classified by the US FDA as Pregnancy Category X. Dutasteride is contraindicated for use in women of childbearing potential and during pregnancy. Dutasteride is a 5 alpha-reductase inhibitor that prevents conversion of testosterone to DHT, a hormone necessary for the normal development of male genitalia. In animal reproduction and developmental toxicity studies, Dutasteride inhibited normal development of external genitalia in male foetuses. Therefore, Dutasteride may cause foetal harm when administered to a pregnant woman. In case Dutasteride capsules are used during pregnancy or if the patient becomes pregnant while taking Dutasteride, the patient should be apprised of the potential hazard to the foetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy

20. Dutagen Capsules (Generic Dutasteride Capsules) Dutagen Capsules Dutagen Capsules (Generic Dutasteride Capsules) are manufactured by Sun Pharmaceutical Industries Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9546_Dutagen-Capsules.html © The Swiss Pharmacy