Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Generic Finasteride 5mg Tablets are 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.
This medication 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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Chemical Structure - Finasteride
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
The active ingredient contained in Generic
Finasteride 5mg tablets is Finasteride.
Each Generic Finasteride tablet contains 5 mg
of Finasteride.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Fincar Tablets
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Fincar Tablets
Manufactured By: Cipla Limited, India
Strengths Available: 5 mg
More details on Fincar Tablets
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Finast Tablets
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Finast Tablets
Manufactured By: Dr. Reddys Laboratories
Limited, India
Strengths Available: 5 mg
More details on Finast Tablets
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Uses of Generic Finasteride 5mg Tablets:
Generic Finasteride 5mg tablets are used for the treatment of benign
prostatic hyperplasia (BPH) in adult men.
Generic Finasteride 5mg is used for the treatment of symptomatic
benign prostatic hyperplasia (BPH) in men with an enlarged prostate
to: Improve symptoms, Reduce the risk of acute urinary retention,
Reduce the risk of the need for surgery including transurethral resection
of the prostate (TURP) and prostatectomy.
Generic Finasteride 5mg administered in combination with the alpha-
blocker Doxazosin is indicated to reduce the risk of symptomatic
progression of BPH.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Recommended Adult Dosage
The dose of Generic Finasteride is one tablet of 5 mg orally
once a day, with or without meals.
Combination with Doxazosin: One Generic Finasteride 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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Contraindications
➔
Generic Finasteride tablets are contraindicated in patients with a known
hypersensitivity to Finasteride or any component of the tablet.
➔
Generic Finasteride 5mg tablets are not indicated for use in women or children
and adolescents.
➔
Generic Finasteride 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 medicine 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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Contraindications
➔
Crushed or broken tablets of Generic Finasteride 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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Storage Instructions
Generic Finasteride 5 mg 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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Warnings
Finasteride 5mg 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 Generic
Finasteride Tablets in patients with liver function abnormalities, as Finasteride
is metabolized extensively in the liver.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Warnings
Finasteride reduces serum prostate specific antigen (PSA) levelsby
approximately 50%. However, any confirmed increase in PSA while on Generic
Finasteride 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 Generic Finasteride 5mg tablets for BPH,
consideration should be given to other urological conditions that may cause
similar symptoms.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Possible Side Effects
Most common side effects reported in 1% or more of patients treated with
Finasteride 5mg 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
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Possible Side Effects
The following side effects have been identified during post approval use of
Finasteride 5 mg 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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
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
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Finasteride Tablets Overdosage
In clinical studies, single doses of Finasteride 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.
Benign Prostatic Hyperplasia Treatment With
Generic Finasteride 5mg Tablets
© The Swiss Pharmacy
Finasteride tablets During Pregnancy
Finasteride (Generic Finasteride 5mg Tablets) has been classified by
the US FDA as Pregnancy Category X.
Finasteride tablets are not indicated for use in women. Women should
not handle crushed or broken Generic Finasteride 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.
If a pregnant woman comes in contact with crushed or broken Generic
Finasteride tablets, the contact area should be washed immediately with
soap and water.

Benign Prostatic Hyperplasia Treatment With Generic Finasteride 5mg Tablets

  • 1.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy
  • 2.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Generic Finasteride 5mg Tablets are 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. This medication 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.
  • 3.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Chemical Structure - Finasteride
  • 4.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy The active ingredient contained in Generic Finasteride 5mg tablets is Finasteride. Each Generic Finasteride tablet contains 5 mg of Finasteride.
  • 5.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Fincar Tablets
  • 6.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Fincar Tablets Manufactured By: Cipla Limited, India Strengths Available: 5 mg More details on Fincar Tablets
  • 7.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Finast Tablets
  • 8.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Finast Tablets Manufactured By: Dr. Reddys Laboratories Limited, India Strengths Available: 5 mg More details on Finast Tablets
  • 9.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Uses of Generic Finasteride 5mg Tablets: Generic Finasteride 5mg tablets are used for the treatment of benign prostatic hyperplasia (BPH) in adult men. Generic Finasteride 5mg is used for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: Improve symptoms, Reduce the risk of acute urinary retention, Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Generic Finasteride 5mg administered in combination with the alpha- blocker Doxazosin is indicated to reduce the risk of symptomatic progression of BPH.
  • 10.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Recommended Adult Dosage The dose of Generic Finasteride is one tablet of 5 mg orally once a day, with or without meals. Combination with Doxazosin: One Generic Finasteride 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.
  • 11.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Contraindications ➔ Generic Finasteride tablets are contraindicated in patients with a known hypersensitivity to Finasteride or any component of the tablet. ➔ Generic Finasteride 5mg tablets are not indicated for use in women or children and adolescents. ➔ Generic Finasteride 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 medicine 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.
  • 12.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Contraindications ➔ Crushed or broken tablets of Generic Finasteride 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.
  • 13.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Storage Instructions Generic Finasteride 5 mg 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.
  • 14.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Warnings Finasteride 5mg 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 Generic Finasteride Tablets in patients with liver function abnormalities, as Finasteride is metabolized extensively in the liver.
  • 15.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy 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.
  • 16.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Warnings Finasteride reduces serum prostate specific antigen (PSA) levelsby approximately 50%. However, any confirmed increase in PSA while on Generic Finasteride 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 Generic Finasteride 5mg tablets for BPH, consideration should be given to other urological conditions that may cause similar symptoms.
  • 17.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Possible Side Effects Most common side effects reported in 1% or more of patients treated with Finasteride 5mg 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
  • 18.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Possible Side Effects The following side effects have been identified during post approval use of Finasteride 5 mg 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.
  • 19.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy 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
  • 20.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Finasteride Tablets Overdosage In clinical studies, single doses of Finasteride 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.
  • 21.
    Benign Prostatic HyperplasiaTreatment With Generic Finasteride 5mg Tablets © The Swiss Pharmacy Finasteride tablets During Pregnancy Finasteride (Generic Finasteride 5mg Tablets) has been classified by the US FDA as Pregnancy Category X. Finasteride tablets are not indicated for use in women. Women should not handle crushed or broken Generic Finasteride 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. If a pregnant woman comes in contact with crushed or broken Generic Finasteride tablets, the contact area should be washed immediately with soap and water.