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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) 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 reduce need for surgery including…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral use only. The recommended dosage is one 5 mg tablet daily with or without food. 6). 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.
Dosage in the elderly Dosage adjustments are not necessary although pharmacokinetic studies have shown that the elimination rate of finasteride is slightly decreased in patients over the age of 70. Dosage in hepatic insufficiency The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.
4). Dosage in renal insufficiency Dosage adjustments are not necessary in patients with varying degrees of renal insufficiency (starting from creatinine clearance as low as 9 ml/min) as in pharmacokinetic studies renal insufficiency was not found to affect the elimination of finasteride.
Finasteride has not been studied in patients on hemodialysis.
The adverse reactions during clinical trials and / or post-marketing use are listed in the table below. The frequencies of undesirable effects are following: 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.
Immune system disorders:
Not known: Hypersensitivity reactions, including rash, pruritus, urticaria and angioedema (swelling of the lips, tongue, throat, and face).
Cardiac disorders:
Not known: Palpitation Psychiatric disorder: Uncommon$: Decreased libido, depression Not known: Anxiety.
Hepatobiliary disorders:
Not known: Increased hepatic enzymes. 1%, respectively. 6% in finasteride-treated men over the following four years. Approximately 1% of men in each treatment group discontinued due to drug related sexual adverse experiences in the first 12 months, and the incidence declined thereafter.
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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
General: • Patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. • Consultation of an urologist should be considered in patients treated with finasteride.
• Obstruction due to trilobular growth pattern of the prostate should be excluded before starting treatment with finasteride. • There is no experience in patients with liver insufficiency. 2). Caution is advised in patients with decreased hepatic function as the plasma-levels of finasteride may be increased in such patients.
• This medicinal product contains lactose-monohydrate. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine. • 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 prostate-specific antigen (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, and, if necessary, determination of prostate- specific-antigen (PSA) in serum should be carried out on patients prior to initiating therapy with finasteride and periodically during treatment to rule out prostate Cancer.
Serum PSA is also used for prostate cancer detection. Generally a baseline PSA >10 ng/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.
1. 6 Pregnancy and lactation, Exposure to finasteride - risk to male fetus).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. This adjustment preserves the sensitivity or specificity of the PSA assay and maintains its ability to detect prostate Cancer.
Any sustained increase in PSA levels of patients treated with finasteride should be carefully evaluated, including consideration of non-compliance to finasteride therapy. Percent free PSA (free to total PSA ratio) is not significantly decreased by finasteride and 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 is necessary. 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.
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 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. 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.
Pediatric use Finasteride is not indicated for use in children. Safety and effectiveness in children have not been established. Lactose The tablet contains lactose monohydrate. Patients with any of the following genetic deficiencies should not take this drug: galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Mood alterations and depression Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and if these occur, the patient should be advised to seek medical advice.
Sodium This medicinal product contains less than 1 mmol (23 mg) sodium per dosage unit, that is to say essentially 'sodium-free'.