Auro Finasteride 5mg Tablet

AURO FINASTERIDE is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostrate to:

• Improve urinary flow and improve the symptoms associated with BPH by causing regression of the enlarged prostrate.
• Decrease the incidence of acute urinary retention.
• Improve the symptoms associated with BPH.
• Decrease the incidence of the surgery including transurethral resection of the prostrate (TURP) prostatectomy.

The recommended dosage is one 5 mg tablet with or without food. Although early improvement in symptoms may be seen, a therapeutic trial of 6 u2014 12 months may be necessary to assess whether a beneficial response has been achieved.

Dosage in Renal Insufficiency: Adjustments in dosage are not required in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 mI/min) as there are no changes in the disposition of AURO FINASTERIDE as compared to healthy subjects.

Dosage in the Elderly: No adjustments in dosage are required even though the elimination of AURO FINASTERIDE S 5 mg is decreased in patients more than 70 years of age.

Hypersensitivity to any of the components of AURO FINASTERIDE:

• Pregnancy u2014 (See u201cPrecautions, Use in pregnancy and Lactation and Exposure to AURO FINASTERIDE - Risk to Male Foetus (see below)
• AURO FINASTERIDE - is not indicated for use in women.
• AURO FINASTERIDE - is not indicated for paediatric use.

AURO FINASTERIDE is contra-indicated for use in women when they are or may potentially be pregnant as it may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant women. (see Pregnancy and Exposure to AURO FINASTERIDE 5mg - Risk to Male Foetusu201d below). It is not known whether AURO FINASTERIDE is excreted in breast milk.

Serum Prostate Specific Antigens (S-PSA) levels decrease in patients treated with AURO FINASTERIDE.

No interactions of clinical importance have been identified. AURO FINASTERIDE does not appear to significantly affect the cytochrome P450-linked drug metabolising enzyme system. Compounds tested in men included digoxin, propranolol, warfarin, glibenclamide and theophylline and no clinically meaningful interactions were found.

Other Concomitant Therapy: AURO FINASTERIDE has been used concomitantly with ACE-inhibitors, paracetamol, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), quinolones and benzodiazepines with evidence of clinically significant adverse interactions.

Use in Pregnant and lactating Mothers: AURO FINASTERIDE is contra-indicated in pregnancy (see u201cContra-indicationsu201d). Because of the ability of Type II 5-alpha reductase inhibitors to inhibit conversion of testosterone to dihydrotesterone, these drugs, including AURO FINASTERIDE, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant women.

Lactation: It is not known if AURO FINASTERIDE is excreted in human milk.

Exposure to AURO FINASTERIDE - (by pregnant women) - Risk to Male Foetus: AURO FINASTERIDE are coated and will prevent contamination with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. Pregnant women should not handle crushed or broken AURO FINASTERIDE because of the possibility of absorption of AURO FINASTERIDE and the subsequent potential risk to male foetus (see u2018Use in Pregnancyu2019). In addition since AURO FINASTERIDE is present in semen, male patients should wear a condom or otherwise avoid exposure of female sexual partners at risk of becoming pregnant.

Side Effects: Reproductive system and breast disorders: Less frequent: Impotence, decrease in libido, decrease in volume of ejaculate and ejaculation disorder, breast tenderness. The following side effects have been reported and frequencies are unknown: Testicular pain. Skin and subcutaneous tissue disorder: Less frequent: Rash, hypersensitivity reactions, including pruritus, urticaria, and swelling of the lips and face.

No specific treatment of over-dosage with AURO FINASTERIDE is recommended. Treatment is symptomatic and supportive.