Finasteride Tablets USP 5mg Taj Pharma

Finasteride Tablets USP 5mg

1. Name of the medicinal product

Finasteride 1mg Tablets USP Taj Pharma
Finasteride 5mg Tablets USP Taj Pharma

2. Qualitative and quantitative composition

One film-coated tablet contains
Finasteride                       1mg
Excipients                           q.s

One film-coated tablet contains
Finasteride                       5mg
Excipients                           q.s

For the full list of excipients, see section 6.1

3. Pharmaceutical form

Film-coated tablet.

4. Clinical particulars

4.1 Therapeutic indications

Finasteride 5mg 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 transurethral resection of the prostate (TURP) and prostatectomy.

Finasteride 5mg tablets should be administered in patients with an enlarged prostate (prostate volume above ca. 40 ml).

4.2 Posology and method of administration

For oral use only.

The recommended dosage is one 5mg tablet daily with or without food. The tablet should be swallowed whole and must not be divided or crushed (See section 6.6). 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. (See section 4.4).

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.

4.3 Contraindications

Hypersensitivity to finasteride or to any of the excipients listed in section 6.1.

Contra-indicated in women and children (see sections 4.4, 4.6 and 6.6)

Pregnancy – Use in women when they are or may potentially be pregnant (see 4.6 Pregnancy and lactation, Exposure to finasteride – risk to male fetus).

4.4 Special warnings and precautions for use

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. Since finasteride is metabolised in the liver (see section 5.2). 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. 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. Finasteride tablets have a film coating which prevents contact with the active ingredient provided that the tablets have not been broken or crushed (see sections 4.6 and 6.6).

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. For clinical interpretation, see 4.4 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 5mg 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 5mg. Patients should be monitored for psychiatric symptoms and if these occur, the patient should be advised to seek medical advice.

4.5 Interaction with other medicinal products and other forms of interaction

No clinically significant drug interactions have been identified. Finasteride does not appear to significantly affect the cytochrome P450-Iinked drug metabolizing enzyme system.

Although the risk for finasteride to affect the pharmacokinetics of other drugs is estimated to be small, it is probable that inhibitors and inducers of cytochrome P450 3A4 will affect the plasma concentration of finasteride. However, based on established safety margins, any increase due to concomitant use of such inhibitors is unlikely to be of clinical significance.

The following medicinal products have been investigated in man, and no clinically significant interactions have been found: propanolol, digoxin, glibenclamide, warfarin, theophylline, phenazone and antipyrine and no clinically meaningful interactions were found.

4.6 Fertility, pregnancy and lactation

Pregnancy: Finasteride is contra indicated in women when they are or may potentially be pregnant (see section 4.3 Contraindications).

Because of the ability of type II 5α-reductase-inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.

Exposure to finasteride – risk to male foetus.

Women should not handle crushed or broken tablets of finasteride 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 (see section 4.6 Pregnancy and lactation Pregnancy).

Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.

Small amounts of finasteride have been recovered from the semen in subjects receiving finasteride 5mg/day. It is not known whether a male foetus may be adversely affected if his mother is exposed to the semen of a patient being treated with finasteride. When the patient’s sexual partner is or may potentially be pregnant, the patient is recommended to minimise exposure of his partner to semen.

Lactation: Finasteride 5mg tablets are not indicated for use in women. It is not known whether finasteride is excreted in human milk.

4.7 Effects on ability to drive and use machines

There is no available information indicating that finasteride would have an influence on the ability to drive or use machines.

4.8 Undesirable effects

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 with finasteride 5mg and/or finasteride at lower doses 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.

In addition, the following has been reported in clinical trials and post-marketing use: male breast cancer (see 4.4 Special warnings and precautions for use).

Medical therapy of prostatic symptoms (MTOPS)

The MTOPS study compared finasteride 5mg/day (n=768), doxazosin 4 or 8mg/day (n=756), combination therapy of finasteride 5mg/day and doxazosin 4 or 8mg/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.

Other Long-Term Data

In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, of whom 9060 had prostate needle biopsy data available for analysis, prostate cancer was detected in 803 (18.4%) men receiving finasteride 5mg and 1147 (24.4%) men receiving placebo. In the finasteride 5mg group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Additional analyses suggest that the increase in the prevalence of high-grade prostate cancer observed in the finasteride 5mg group may be explained by a detection bias due to the effect of finasteride 5mg on prostate volume. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (clinical stage T1 or T2) at diagnosis. The clinical significance of the Gleason 7-10 data is unknown.

Laboratory Test Findings: When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels are decreased in patients treated with finasteride (see section 4.4 Special warnings and precautions for use).

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.

4.9 Overdose

Patients have received Single doses of finasteride up to 400mg and multiple doses up to 80mg/day without adverse effects. There is no specific recommended treatment of overdose of finasteride.

5. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Testosteron-5α-reductase-inhibitors

Finasteride is a synthetic 4-azasteroid, a specific competitive inhibitor of the intracellular enzyme Type-II-5a-reductase. The enzyme converts testosterone into the more potent androgen dihydrotestosterone (DHT). The prostate gland and, consequently, also the hyperplasic prostate tissue are dependent on the conversion, of testosterone to DHT for their normal function and growth. In benign prostatic hyperplasia (BPH), enlargement of the prostate gland is dependent upon the conversion of testosterone to DHT within the prostate. Finasteride is highly effective in reducing circulating and intraprostatic DHT.

Finasteride has no affinity for the androgen receptor.

Clinical studies show a rapid reduction of the Serum DHT levels of 70%, which leads to a reduction on prostate volume. After 3 months, a reduction of approx. 20% in the volume of the gland occurs, and the shrinking continues and reaches approx. 27% after 3 years. Marked reduction takes place in the periurethral Zone immediately surrounding the Urethra. Urodynamic measurements have also confirmed a significant reduction of detrusor pressure as a result of the reduced obstruction.

Significant improvements in maximum urinary flow rate and symptoms have been obtained after a few weeks, compared with the stand of treatment. Differences from Placebo have been documented at 4 and 7 months, respectively.

All efficacy parameters have been maintained over a 3-year follow-up period.

Effects of four years treatment with finasteride on incidence of acute urine retention, need for surgery, symptom-Score and prostate volume:

In clinical studies of patients with moderate to severe symptoms of BPH, an enlarged prostate on digital rectal examination and low residual urinary volumes, finasteride reduced the incidence of acute retention of urine from 7/1 00 to 3/100 over four years and the need for surgery (TURP or prostatectomy) from 10/100 to 5/100. These reductions were associated with a 2-point improvement in QUASJ-AUA Symptom Score (range 0-34), a sustained regression in prostate volume of approximately 20% and a sustained increase in urinary flow rate.

Medical therapy of prostatic symptoms

The Medical Therapy of Prostatic Symptoms (MTOPS) Trial was a 4- to 6-year study in 3047 men with symptomatic BPH who were randomised to receive finasteride 5mg/day, doxazosin 4 or 8mg/day*, the combination of finasteride 5mg/day and doxazosin 4 or 8mg/day*, or placebo. The primary endpoint was time to clinical progression of BPH, defined as a ≥ 4 point confirmed increase from baseline in symptom score, acute urinary retention, BPH-related renal insufficiency, recurrent urinary tract infections or urosepsis, or incontinence. Compared to placebo, treatment with finasteride, doxazosin, or combination therapy resulted in a significant reduction in the risk of clinical progression of BPH by 34 (p=0.002), 39 (p<0.001), and 67% (p<0.001), respectively.

The majority of the events (274 out of 351) that constituted BPH progression were confirmed ≥ 4 point increases in symptom score; the risk of symptom score progression was reduced by 30 (95% CI 6 to 48%), 46 (95% CI 25 to 60%), and 64% (95% CI 48 to 75%) in the finasteride, doxazosin, and combination groups, respectively, compared to placebo. Acute urinary retention accounted for 41 of the 351 events of BPH progression; the risk of developing acute urinary retention was reduced by 67 (p=0.011), 31 (p=0.296), and 79% (p=0.001) in the finasteride, doxazosin, and combination groups, respectively, compared to placebo. Only the finasteride and combination therapy groups were significantly different from placebo.

^* Titrated from 1mg to 4 or 8mg as tolerated over a 3-week period

In this study the safety and tolerability profile of combined treatment was broadly similar to the profile of each of the drugs taken separately. However, undesirable effects concerning the “nervous system” and “uro-genital system” organ classes were observed more frequently when the two drugs were used in combination (see section 4.8).

5.2 Pharmacokinetic properties

Absorption:

The oral bioavailability of finasteride is approx. 80%. Peak plasma concentrations are reached approx. 2 hours after drug intake, and absorption is complete after 6-8 hours.

Distribution:

Binding to plasma proteins is approx. 93%. Plasma clearance and volume of distribution are approx. 165 ml/min (70-279 ml/min) and 76 l (44-96 l), respectively. Accumulation of small amounts of finasteride is seen on repeated administration. After a daily dose of 5mg the lowest steady-state concentration of finasteride has been calculated to be 8-10 ng/ml, which remains stable over time.

Biotransformation:

Finasteride is metabolised in the liver. Finasteride does not significantly affect the cytochrome P 450 enzyme system. Two metabolites with low 5α-reductase-inhibiting effects have been identified.

Elimination:

The plasma half-life averages 6 hours (4-12 hours) (in men >70 years of age, 8 hours, range 6-15 hours). After administration of radioactively labelled finasteride, approx. 39% (32-46%) of the given dose is excreted in the urine in the form of metabolites. Virtually no unchanged finasteride is recovered in the urine. Approximately 57% (51-64%) of the total dose is excreted in the faeces.

Finasteride has been found to cross the blood-brain barrier. Small amounts of finasteride have been recovered in the seminal fluid of treated. In 2 studies of healthy subjects (n=69) receiving finasteride 5mg/day for 6-24 weeks, finasteride concentrations in semen ranged from undetectable (<0.1 ng/ml) to 10.54 ng/ml. In an earlier study using a less sensitive assay, finasteride concentrations in the semen of 16 subjects receiving finasteride 5mg/day ranged from undetectable (<1.0 ng/ml) to 21 ng/ml. Thus, based on a 5-ml ejaculate volume, the amount of finasteride in semen was estimated to be 50- to 100-fold less than the dose of finasteride (5 μg) that had no effect on circulating DHT levels in men (see also section 5.3.).

In patients with chronic renal impairment, whose creatinine clearance ranged from 9-55 ml/min, the disposition of a single dose of ¹⁴C-finasteride was not different from that in healthy volunteers (see section 4.2). Protein binding also did not differ in patients with renal impairment. A portion of the metabolites, which normally is excreted renally, was excreted in the faeces. It therefore appears that faecal excretion increases commensurate to the decrease in urinary excretion of metabolites. Dosage adjustment in non-dialysed patients with renal impairment is not necessary.

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity, genotoxicity, and carcinogenic potential.

Reproduction toxicology studies in male rats have demonstrated reduced prostate and seminal vesicular weights, reduced secretion from accessory genital glands and reduced fertility index (caused by the primary pharmacological effect of finasteride). The clinical relevance of these findings is unclear.

As with other 5-alpha-reductase inhibitors, femininisation of male rat foetuses has been seen with administration of finasteride in the gestation period. Intravenous administration of finasteride to pregnant rhesus monkeys at doses up to 800 ng/day during the entire period of embryonic and foetal development resulted in no abnormalities in male foetuses. This dose is about 60 to120 times higher than the estimated amount in semen of a man who have taken 5mg finasteride, and to which a woman could be exposed via semen. In confirmation of the relevance of the Rhesus model for human foetal development, oral administration of finasteride 2mg/kg/day (the systemic exposure (AUC) of monkeys was slightly higher (3x) than that of men who have taken 5mg finasteride, or approximately 1 to 2 million times the estimated amount of finasteride in semen) to pregnant monkeys resulted in external genital abnormalities in male foetuses. No other abnormalities were observed in male foetuses and no finasteride-related abnormalities were observed in female foetuses at any dose.

6. Pharmaceutical particulars

6.1 List of excipients

Tablet core:

Lactose monohydrate, Cellulose microcrystalline, Starch pregelatinized, Lauroyl macrogolglycerides, Sodium starch glycolate (type-A), Magnesium stearate

Film coating:

Hypromellose, Titanium dioxide, Indigo carmine, Macrogol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

An opaque white (PVC –PVdC /Aluminium) Blister

The Finasteride 5mg tablets are packed in blister pack of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 120 tablets.

Not all packs may be marketed.

6.6 Special precautions for disposal and other handling

Women who are pregnant or may become pregnant should not handle finasteride tablets especially if crushed or broken because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus (see section 4.6).

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Finasteride Tablets USP 1mg, 5mg

Package leaflet: Information for the user Finasteride 1mg, 5mg Film-coated Tablets Finasterid

• Read all of this leaflet carefully before you start taking this medicine  because  it  contains important information for
• Keep this leaflet. You may need to read it
• If you have any further questions, ask your doctor, pharmacist or
• This medicine has been prescribed for you Do not pass it on to others. It  may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

What is in this leaflet

1. What Finasteride 1mg, 5mg Tablets is and what it is used for
2. What you need to know before you take Finasteride 1mg, 5mg Tablets
3. How to take Finasteride 1mg, 5mg Tablets
4. Possible side effects
5. How to store Finasteride 1mg, 5mg Tablets
6. Contents of the pack and other information

What Finasteride 1mg, 5mg Tablets is and what it is used for

Finasteride belongs to the group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men.

Finasteride shrinks the prostate gland in men when it is swollen. Finasteride is used in the treatment and control of benign (i.e., non-cancerous) enlargement of the prostate (benign prostatic hyperplasia – BPH). The prostate gland is found underneath the bladder (but only in man). It produces the  fluid  found  in  semen. A swollen prostate gland can lead to a condition called ‘benign prostatic hyperplaia’ (BPH). Finasteride causes shrinkage of the enlarged prostate, improves urinary flow and symptoms caused by  BPH, and reduces the risk of you developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery.

What is BPH?

If you have BPH it means that your prostate gland is swollen. It can press on the tube that urine passes through, on its way out of your body.

This can lead to problems such as

• Feeling like you need to pass urine more often, especially at night
• Feeling that you must pass urine right away
• Finding it difficult to pass urine
• When you pass urine the flow of urine is weak
• When you pass urine the flow stops and starts

Feeling that you cannot empty your bladder completely In some men, BPH can lead to more serious problems, such as:

• Urinary tract infections
• A sudden inability to pass urine
• The need for surgery

What you need to know before you take Finasteride 1mg, 5mg Tablets

Do not take Finasteride 1mg, 5mg Tablets:

• If you are allergic to finasteride or any of the other ingredients of Finasteride 1mg, 5mg
• If you are a woman (because this medicine is for men)
• If you are a child

Do not take finasteride if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Finasteride 1mg, 5mg Tablets

• If you have a large amount of residual urine in your bladder after urinating  and/or  severely  reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract
• If you have impaired liver The level of finasteride in your blood may be increased if so
• If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen which could contain a tiny amount of the
• If you have a blood test called PSA (test used to detect prostate cancer). Tell your doctor that you are taking Finasteride can affect the blood levels of the substance being tested, PSA.

Children

Finasteride should not be used in children.

Other medicines and Finasteride 1mg, 5mg Tablets:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Finasteride does not usually interfere with other medicines. No significant drug interactions have been identified. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Finasteride 1mg, 5mg Tablets with food and drink:

Finasteride can be taken with or without food.

Pregnancy, breast-feeding and fertility:

Finasteride 1mg, 5mg Tablets are only intended for men. Finasteride should not be  taken  by women. Women who are or may potentially be pregnant should not handle Finasteride 1mg, 5mg Tablets especially if broken or crushed. If finasteride is absorbed  through the  skin or taken by mouth by women pregnant  with a male foetus, the child may be born with malformed genital organs. If a women who is pregnant comes  into contact with crushed or broken Finasteride tablets, speak to you doctor.

When the patient’s sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue treatment with finasteride.

Driving and using machines:

There is no information to suggest that Finasteride affects the ability to drive and use machines.

Important information about some of the ingredients of Finasteride 1mg, 5mg Tablets:

This medicinal product contains lactose. If  you  have been told by your doctor that  you  have intolerance  to some sugars contact your doctor before taking this medicinal product.

Mood alterations and depression

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have

been reported in patients treated with Finasteride 1mg, 5mg Tablets. If you experience any of these symptoms contact your doctor for further medical advice as soon as possible.

How to take Finasteride 1mg, 5mg Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet daily (equivalent to 1mg, 5mg finasteride).

The film-coated tablets can either be taken on an empty stomach or with a meal. This medicine should be taken by mouth, swallowed whole and should not be divided or crushed. Your doctor may prescribe finasteride along with another medicine (called doxazosin) to help control your BPH.

Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved.

Your doctor will tell you how long you should continue to take Finasteride  5 mg  Tablets.  Do  not interrupt treatment early or the symptoms may come back.

·  Patients  with  impaired liver function

There is no experience of the use of Finasteride in patients with impaired liver function (see also ‘Take special care with Finasteride 1mg, 5mg Tablets‘).

·  Patients with impaired kidney function

No dosage adjustment is required. The use of Finasteride in patients who have to undergo  haemodialysis has not been investigated yet.

·  Elderly patients

No dosage adjustment is required.

Please speak to your doctor or pharmacist if you feel that the effects of Finasteride 1mg, 5mg Tablets is too strong or too weak.

If you take more Finasteride 1mg, 5mg Tablets than you should:

If you have taken more tablets than you were told to, or if someone else has taken any tablets, contact accident and emergency department of your nearest hospital. Take any left over tablets or empty box with you for easier identification.

If you forget to take Finasteride 1mg, 5mg Tablets:

If you forget to take a dose of Finasteride 1mg, 5mg Tablets, you  can take it  as soon as you remember unless it  is time for the next dose, in which case you should continue with your medication as prescribed. Do  not take a double dose to make up for a forgotten dose.

If you stop taking Finasteride 1mg, 5mg Tablets:

Your condition may show an early improvement after taking Finasteride. However,  it  may take at  least  six months for the full effect to develop. It is important to keep taking Finasteride for  as long as your  doctor tells you, even if you do not feel any benefit straight away.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.Possible side effects

Like all medicines, Finasteride 1mg, 5mg Tablets can cause side effects, although not everybody gets them.

Stop taking finasteride and immediately contact a doctor if you experience  any  of  the  following  symptoms (angioedema):

• swelling of face, tongue or throat
• difficulty swallowing
• hives and breathing difficulties

The most common side effects are impotence and decreased sexual drive. These effects normally occur at the start of the treatment but do not usually last long in the majority of patients if treatment continues.

Common: (may affect up to 1 in 10 people)

• You may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to  affect normal sexual
• You may be unable to have an erection (impotence)
• You may have less desire to have sex

Uncommon: (may affect up to 1 in 100 people)

• rash
• Problems with ejaculation that may continue after stopping the medication
• Breast swelling or tenderness

Unknown:

• pruritus, urticaria
• palpitations (feeling your heartbeat)
• Swelling of face, lips, tongue or throat, difficulty swallowing and breathing difficulties (angioedema)
• changes in the way your liver is working, which can be shown by a blood test
• pain in your testicles
• an inability to obtain an erection which may continue after stopping the medication
• male infertility and/or poor seminal quality of Improvement in the quality of the semen has been reported after stopping medication
• depression
• decrease in sex drive that may continue after stopping the medication
• anxiety

You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement or nipple discharge as these may be signs of a serious condition, such as breast cancer.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

How to store Finasteride 1mg, 5mg Tablets

• Keep out of the sight and reach of
• This medicinal product does not require any special storage
• Do not use Finasteride 1mg, 5mg Tablets after the expiry date, which is stated on the label after Exp. The expiry date refers to the last day of that
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to  throw away medicines you no longer These measures will help to protect the environment.

Contents of the pack and other information

What Finasteride 1mg, 5mg Tablets contain:

The active substance is finasteride. One film-coated tablet contains 1mg, 5mg of finasteride.

The other ingredients are –

Tablet core- lactose monohydrate, cellulose microcrystalline, starch  pregelatinized  (maize),  sodium starch glycolate (type-A), lauroyl macrogolglycerides, and magnesium stearate.

Film coating- Hypromellose, titanium dioxide, indigo carmine, macrogol

What Finasteride 1mg, 5mg Tablets look like and content of the pack:

Film-coated Tablet.

Finasteride 1mg, 5mg Tablets are packed in opaque white PVC/PVdC – Alu blisters  in pack of 7, 10, 14, 15,  20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 120 tablets.

Not all packs may be marketed.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of  Commerce Lane,
   Fort, Mumbai – 400001
   at:Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com