FINASTERIDE ASCEND

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 Ascend is 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 Immune system disorders Unknown: hypersensitivity reactions including swelling of thelips, tongue, throat and face Psychiatric disorders Common: decreased libido Unknown: decreased libido that may continue after discontinuation of therapy, anxiety, depression, suicidal ideation Cardiac disorders Unknown: palpitation Hepatobiliary disorders Unknown: increased hepatic enzymes Skin and subcutaneous tissue disorders Uncommon: rash Unknown: pruritus, urticaria Reproductive system and breast disorders Common: impotence Uncommon: ejaculation disorder, breast tenderness, breast enlargement.

Unknown: testicular pain; haematospermia; sexual dysfunction (erectile dysfunction and ejaculation disorders) 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.

4 Special warnings and precautions for use). 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. The incidence of ejaculation disorder in patients receiving combination therapy was comparable to the sum of incidences of this adverse experience for the two monotherapies.

4%) men receiving placebo. 1%) men in the placebo group. Additional analyses suggest that the increase in the prevalence of high-grade prostate cancer observed in the finasteride group may be explained by a detection bias due to the effect of finasteride on prostate volume.

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). 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 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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 Ascend.

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 > 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. Therefore, in men with benign prostatic hyperplasia (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 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.

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 stabilise 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. 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. Mood alteration and depression Mood alteration 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. Pediatric use Finasteride Ascend’ 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 medicine: problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Hepatic Insufficiency The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.

Sodium This medicinal product contains less than 1 mmol (23 mg) sodium per dosage unit, that is to say essentially ‘sodium-free’.

Finasteride is not indicated for use in women or children. Finasteride is contraindicated in the following: • Hypersensitivity to any component of this product. 6 Pregnancy and lactation, Exposure to finasteride - risk to male foetus).