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FINASTERIDE is a brand name for Finasteride. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Finasteride 5 mg Tablets are indicated 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. - reduce the incidence of acute urinary retention and the…
Verbatim from this product's MHRA label. Tap a section to expand.
The recommended adult dose is one 5 mg tablet daily, with or without food. 1 'Pharmacodynamic properties'). Although early improvement in symptoms may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved.
Thereafter, treatment should be continued long term. No dosage adjustment is required in the elderly or in patients with varying degrees of renal insufficiency (creatinine clearances as low as 9 ml/min). There are no data available in patients with hepatic insufficiency.
Finasteride 5 mg Tablets are contra-indicated in children.
The most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur early in the course of therapy and resolve with continued treatment in the majority of patients. The adverse reactions reported during clinical trials and/or post-marketing use are listed in the table below.
Frequency of adverse reactions is determined as follows:
Very common (≥1/10), Common (≥1/100 to <1/10)>, Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000)>, Very rare (<1/10,000), not known (cannot be estimated from the available data). The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.
System Organ Class Frequency: adverse reaction Investigations Common: decreased volume of ejaculate Cardiac disorders Unknown: palpitation Skin and subcutaneous tissue disorders Uncommon: rash Unknown: pruritus, urticaria Immune system disorders Unknown: hypersensitivity reactions including swelling of the lips, tongue, throat and face Hepatobiliary disorders Unknown: increased hepatic enzymes Reproductive system and breast disorders Common: impotence Uncommon: ejaculation disorder, breast tenderness, breast enlargement , Unknown: testicular pain, sexual dysfunction (erectile dysfunction and ejaculation disorder) which may continue after discontinuation of treatment; male infertility and/or poor seminal quality.
Normalization or improvement of seminal quality has been reported after discontinuation of finasteride. Psychiatric disorders Common: decreased libido Unknown: decreased libido that may continue after discontinuation of therapy, depression Finasteride 5 mg Tablets are well tolerated.
In controlled clinical studies where patients received 5 mg of finasteride over periods of up to four years, the following adverse reactions were considered possibly, probably or definitely drug-related and occurred with a frequency greater than placebo and greater than or equal to 1%: impotence, decreased libido, ejaculation disorder, decreased volume of ejaculate; breast enlargement, breast tenderness and rash.
General To avoid obstructive complications it is important that patients with large residual urine and/or heavily decreased urinary flow are carefully controlled. The possibility of surgery should be an option. Effects on PSA and prostate cancer detection No clinical benefit has yet been demonstrated in patients with prostate cancer treated with ‘Finasteride’.
Patients with BPH and elevated serum prostate specific antigen (PSA) were monitored in controlled clinical studies with serial PSAs and prostate biopsies. In these BPH studies, ‘Finasteride’ did not appear to alter the rate of prostate cancer detection, and the overall incidence of prostate cancer was not significantly different in patients treated with ‘Finasteride’ or placebo.
Digital rectal examination, as well as other evaluations for prostate cancer, are recommended prior to initiating therapy with ‘Finasteride’ and periodically thereafter. Serum PSA is also used for prostate cancer detection. Generally, a baseline PSA> 10ng/ml (Hybritech) prompts further evaluation and consideration of biopsy; for PSA levels between 4 and 10 ng/ml, further evaluation is advisable.
There is considerable overlap in PSA levels among men with and without prostate cancer. Therefore, in men with BPH, PSA values within the normal reference range do not rule out prostate cancer, regardless of treatment with ‘Finasteride’.
A baseline PSA <4 ng/mL does not exclude prostate cancer. ‘Finasteride’ causes a decrease in serum PSA concentrations by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease in serum PSA levels in patients with BPH treated with ‘Finasteride’ should be considered when evaluating PSA data and does not rule out concomitant prostate cancer.
This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. In patients treated with ‘Finasteride’ for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.
6 Fertility, pregnancy and lactation, Exposure to finasteride – risk to male foetus)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There was no evidence of increased adverse experiences with increased duration of treatment with Finasteride 5 mg Tablets and the incidence of new drug-related sexual adverse experiences decreased with duration of treatment. Medical therapy of prostatic symptoms (MTOPS) The MTOPS study compared finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), combination therapy of finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), and placebo (n=737).
In this study, the safety and tolerability profile of the combination therapy was generally consistent with the profiles of the individual components. 9%. 4%) men receiving placebo. 1%). Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2).
The relationship between long-term use of finasteride and tumours with Gleason scores of 7-10 is unknown. 4 Special warnings and precautions for use). 4 Special warnings and precautions for use). In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilise to a new baseline.
The post- treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with Finasteride 5mg Tablets for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men.
For clinical interpretation see 'Special warnings and precautions for use', Effects on prostate-specific antigen (PSA) and prostate cancer detection. No other difference was observed in patients treated with placebo or Finasteride 5mg Tablets in standard laboratory tests.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer. Any sustained increase in PSA levels of patients treated with finasteride 5mg should be carefully evaluated, including consideration of non-compliance to therapy with ‘Finasteride’.
Women who are pregnant or may become pregnant should not handle crushed or broken finasteride tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus. 6). Drug/laboratory test interactions Effect on levels of PSA Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age.
When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels decrease in patients treated with Finasteride Tablets. In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilize to a new baseline.
The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with Finasteride Tablets for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men.
4 Special warnings and precautions for use, Effects on PSA and prostate cancer detection. Percent free PSA (free to total PSA ratio) is not significantly decreased by ‘Finasteride’. The ratio of free to total PSA remains constant even under the influence of ‘Finasteride’.
When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary. Breast cancer in men Breast cancer has been reported in men taking finasteride 5 mg during clinical trials and 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. Paediatric use Finasteride Tablets are not indicated for use in children. Safety and effectiveness in children have not been established.
Lactose Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The tablet contains lactose monohydrate. Hepatic Insufficiency The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.