Fincar Tablets (Generic Finasteride 5mg Tablets)

1. Fincar Tablets (Generic Finasteride 5mg Tablets) © The Swiss Pharmacy

2. Fincar Tablets (Generic Finasteride 5mg Tablets) Fincar (Generic Finasteride 5mg Tablets) is used for the treatment and control of benign prostatic hyperplasia (BPH) in patients with an enlarged prostate to cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH. It is also used to reduce the incidence of acute urinary retention and the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. © The Swiss Pharmacy

3. Fincar Tablets (Generic Finasteride 5mg Tablets) Fincar Tablets are manufactured by Cipla Limited, India in the strength of 5 mg. © The Swiss Pharmacy

4. Fincar Tablets (Generic Finasteride 5mg Tablets) Chemical Structure © The Swiss Pharmacy

5. Fincar Tablets (Generic Finasteride 5mg Tablets) The active ingredient contained in Fincar tablets is Finasteride. Each film-coated Fincar tablet contains 5 mg of Finasteride. © The Swiss Pharmacy

6. Fincar Tablets (Generic Finasteride 5mg Tablets) Uses of Fincar 5 mg tablets: Fincar tablets are used for the treatment of benign prostatic hyperplasia (BPH) in adult men. Fincar is used for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH, Reduce the risk of acute urinary retention, Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Fincar administered in combination with the alpha-blocker Doxazosin is indicated to reduce the risk of symptomatic progression of BPH. Finasteride 5 mg tablets should be administered in patients with an enlarged prostate (prostate volume above ca. 40ml). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

7. Fincar Tablets (Generic Finasteride 5mg Tablets) Recommended Adult Dosage The dose of Fincar Tablets Fincar Tablets (Generic Finasteride 5 mg Tablets) is one tablet of 5 mg orally once a day, with or without meals. Combination with Doxazosin: Combination with Doxazosin: One Fincar tablet (5 mg) taken once a day in combination with the alpha-blocker Doxazosin. Even though improvement can be seen within a short time, treatment for at least 6 months may be necessary in order to determine objectively whether a satisfactory response to treatment has been achieved. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

8. Fincar Tablets (Generic Finasteride 5mg Tablets) Contraindications ➔Fincar tablets are contraindicated in patients with a known hypersensitivity to Finasteride or any component of the tablet. ➔ Fincar (Generic Finasteride 5mg Tablets) Tablets is not indicated for use in women or children and adolescents. ➔Fincar use is contraindicated in women when they are or may potentially be pregnant. Because of the ability of Type II 5 alpha-reductase inhibitors to inhibit the conversion of testosterone to 5alpha-dihydrotestosterone (DHT), Finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while taking this medication, the pregnant woman should be apprised of the potential hazard to the male foetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

9. Fincar Tablets (Generic Finasteride 5mg Tablets) Contraindications ➔Crushed or broken tablets of Fincar should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of Finasteride and the subsequent potential risk to a male foetus. In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

10. Fincar Tablets (Generic Finasteride 5mg Tablets) Storage Instructions Fincar Tablets (Generic Finasteride 5mg Tablets) 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=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

11. Fincar Tablets (Generic Finasteride 5mg Tablets) Warnings Finasteride 5mg (Fincar) should not be used in pediatric patients or women. There are no data demonstrating efficacy or safety of Finasteride in children under the age of 18. During clinical studies with Finasteride 1 mg in men 18 to 41 years of age, the mean value of serum prostate-specific antigen (PSA) decreased from 0.7 ng/ml at baseline to 0.5 ng/ml at month 12. Doubling the PSA level in men taking Finasteride 1mg should be considered before evaluating this test result. The effect of hepatic insufficiency on the pharmacokinetics of Finasteride has not been studied. Caution must be exercised for the administration of Fincar Tablets in patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

12. Fincar Tablets (Generic Finasteride 5mg Tablets) Warnings Breast cancer has been reported in men taking Finasteride 1 mg during the post-marketing period. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge. Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with Finasteride 1 mg. Patients should be monitored for psychiatric symptoms and if these occur, treatment with Finasteride should be discontinued and the patient advised to seek medical advice. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

13. Fincar Tablets (Generic Finasteride 5mg Tablets) Warnings Finasteride reduces serum prostate specific antigen (PSA) levelsby approximately 50%. However, any confirmed increase in PSA while on Fincar may signal the presence of prostate cancer and should be evaluated, even if those values are still within the normal range for men not taking a 5a-reductase inhibitor. Finasteride may increase the risk of high-grade prostate cancer. Women should not handle crushed or broken Finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus. Before starting treatment with Fincar for BPH, consideration should be given to other urological conditions that may cause similar symptoms. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

14. Fincar Tablets (Generic Finasteride 5mg Tablets) Possible Side Effects Most common side effects reported in 1% or more of patients treated with Finasteride 5mg (Fincar Tablets) and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash. The incidence rates of drug-related side effects reported by 2% or more of patients in any treatment group during the Medical Therapy of Prostatic Symptoms (MTOPS) Study are : Asthenia, Headache, Hypotension, Postural Hypotension, Peripheral Edema, Dizziness, Libido Decreased, Somnolence, Dyspnea, Rhinitis, Abnormal Ejaculation, Gynecomastia, Impotence and Sexual Function Abnormal URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

15. Fincar Tablets (Generic Finasteride 5mg Tablets) Possible Side Effects The following side effects have been identified during post approval use of Finasteride 5 mg (Fincar Tablets). Hypersensitivity reactions, such as pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face) Testicular pain Sexual dysfunction that continued after discontinuation of treatment, including Erectile dysfunction, decreased libido and ejaculation disorders (e.g., reduced ejaculate volume). These events were reported rarely in men taking Finasteride for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of Finasteride in these events is unknown. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

16. Fincar Tablets (Generic Finasteride 5mg Tablets) Possible Side Effects Male infertility and/or poor seminal quality were reported rarely in men taking Finasteride for the treatment of BPH. Normalization or improvement of poor seminal quality has been reported after discontinuation of Finasteride. The independent role of Finasteride in these events is unknown. Depression Male breast cancer. The following additional side effect related to sexual dysfunction that continued after discontinuation of treatment has been reported in post- marketing experience with Finasteride at lower doses used to treat male pattern baldness: orgasm disorders URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

17. Fincar Tablets (Generic Finasteride 5mg Tablets) Fincar Tablets Overdosage In clinical studies, single doses of Finasteride (Fincar 5 mg tablets) upto 400 mg and multiple doses of Finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with Finasteride can be recommended. Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m2 (400 mg/kg) and 5900 mg/m2 (1000 mg/kg), respectively. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

18. Fincar Tablets (Generic Finasteride 5mg Tablets) Fincar Tablets During Pregnancy Finasteride (Fincar 5mg Tablets) has been classified by the US FDA as Pregnancy Category X. Finasteride (Fincar 5 mg tablets) are not indicated for use in women. Women should not handle crushed or broken Fincar tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of Finasteride and the subsequent potential risk to a male foetus. In animal studies, Finasteride caused abnormal development of external genitalia in male fetuses. If a pregnant woman comes in contact with crushed or broken Fincar tablets, the contact area should be washed immediately with soap and water. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy

19. Fincar Tablets (Generic Finasteride 5mg Tablets) Fincar Tablets Fincar Tablets (Generic Finasteride 5mg Tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9556_Fincar-Tablets.html © The Swiss Pharmacy