NAME OF THE MEDICINAL PRODUCT
Finasteride Film Coated Tablet IP 1 mg,
Finasteride Film Coated Tablet IP 5 mg,
Finasteride Film Coated Tablet USP 1 mg,
Finasteride Film Coated Tablet USP 5 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains:
1 mg of finasteride as the active ingredient.
Each tablet contains 110.4 mg of lactose monohydrate. This medicinal product contains less than 1 mmol of sodium per tablet.
Each film coated tablet contains:
5 mg of finasteride as the active ingredient.
Excipients with known effect
Film-coated tablets. Tan octagonal, film-coated, convex tablets
Finasteride is indicated for the treatment of men with male pattern hair loss (androgenetic alopecia) to increase hair growth and prevent further hair loss.
‘ Finasteride ‘ is not indicated for use in women or children and adolescents.
Posology and method of administration
The recommended dosage is one 1 mg/5mg tablet daily. Finasteride may be taken with or without food.
There is no evidence that an increase in dosage will result in increased efficacy.
Efficacy and duration of treatment should continuously be assessed by the treating physician. Generally, three to six months of once daily treatment are required before evidence of stabilisation of hair loss can be expected. Continuous use is recommended to sustain benefit. If treatment is stopped, the beneficial effects begin to reverse by six months and return to baseline by 9 to 12 months.
Method of administration
Crushed or broken tablets of 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 . Finasteride tablets are coated to prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.
Patients with renal impairment
No dosage adjustment is required in patients with renal insufficiency.
No data are available on the concomitant use of Finasteride and topical minoxidil in male pattern hair loss.
Hypersensitivity to the active substance or to any of the excipients
Finasteride is not indicated for use in women or children and adolescents.
Finasteride 1mg should not be taken by men who are taking finasteride 5 mg or any other 5α-reductase inhibitor for benign prostatic hyperplasia or any other condition.
Special warnings and precautions for use
Finasteride should not be used in children. There are no data demonstrating efficacy or safety of finasteride in children under the age of 18.
Effects on Prostate Specific Antigen (PSA)
In clinical studies with Finasteride in men 18-41 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 should be considered before evaluating this test result.
The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.
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 and depression
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.
Interaction with other medicinal products and other forms of interaction
Finasteride is metabolized primarily via, but does not affect, the cytochrome P450 3A4 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.
Interaction studies have only been performed in adults
Fertility, pregnancy and lactation
Pregnancy Finasteride is contra-indicated for use in women due to the risk in pregnancy.
Because of the ability of type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone (DHT) in some tissues, 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
A small amount of finasteride, less than 0.001% of the 1 mg dose per ejaculation, has been detected in the seminal fluid of men taking Finasteride. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus
During continual collection of adverse experiences, post-marketing reports of exposure to finasteride during pregnancy via semen of men taking 1 mg or higher doses have been received for eight live male births, and one retrospectively-reported case concerned an infant with simple hypospadias. Causality cannot be assessed on the basis of this single retrospective report and hypospadias is a relatively common congenital anomaly with an incidence ranging from 0.8 to 8 per 1000 live male births. In addition, a further nine live male births occurred during clinical trials following exposure to finasteride via semen, during pregnancy, and no congenital anomalies have been reported.
|Immune system disorders:||Not known: Hypersensitivity reactions, including rash, pruritus, urticaria and angioedema (swelling of the lips, tongue, throat and face).|
|Psychiatric disorders:||Uncommon*: Decreased libido.
Not known: Anxiety.
|Cardiac disorder:||Not known: Palpitation|
|Hepatobiliary disorders:||Not known: Increased hepatic enzymes.|
|Reproductive system and breast disorders:||Uncommon*: Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate).
Not known: Breast tenderness and enlargement, Testicular pain, infertility
It is not known whether finasteride is excreted in human milk.
Long-term data on fertility in humans are lacking, and specific studies in subfertile men have not been conducted. The male patients who were planning to father a child were initially excluded from clinical trials. Although, animal studies did not show relevant negative effects on fertility, spontaneous reports of infertility and /or poor seminal quality were received post-marketing. In some of these reports, patients had other risk factors that might have contributed to infertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride.
Effects on ability to drive and use machines
Finasteride has no or negligible influence on the ability to drive and use machines.
The adverse reactions 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, < 1/10); Uncommon (≥ 1/1,000, < 1/100); Rare (≥1/10,000, < 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.
* Incidences presented as difference from placebo in clinical studies at Month 12.
† This adverse reaction was identified through post-marketing surveillance but the incidence in randomized controlled Phase III clinical trials (Protocols 087, 089, and 092) was not different between finasteride and placebo.
Side effects, which usually have been mild, generally have not required discontinuation of therapy.
Finasteride for male pattern hair loss has been evaluated for safety in clinical studies involving more than 3,200 men. In three 12-month, placebo-controlled, double-blind, multicentre studies of comparable design, the overall safety profiles of Finasteride and placebo were similar. Discontinuation of therapy due to any clinical adverse experience occurred in 1.7% of 945 men treated with Finasteride and 2.1% of 934 men treated with placebo.
In these studies, the following drug-related adverse experiences were reported in ≥1% of men treated with Finasteride: decreased libido (‘ Finasteride ‘, 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with Finasteride ‘Finasteride ‘ and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with Finasteride and in many who continued therapy. The effect of Finasteride on ejaculate volume was measured in a separate study and wa s not different from that seen with placebo.
By the fifth year of treatment with Finasteride ‘, the proportion of patients reporting each of the above side effects decreased to <0.3%.
Finasteride has also been studied for prostate cancer risk reduction at 5 times the dosage recommended for male pattern hair loss. 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 5 mg and 1147 (24.4%) men receiving placebo. In the finasteride 5 mg group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in placebo group. 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 5 mg and tumours with Gleason scores of 7-10 is unknown.
In addition, the following have been reported in post-marketing use: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorder) after discontinuation of treatment with Finasteride ; male breast cancer (
Drug-related sexual undesirable effects were more common in the finasteride 1 mg-treated men than the placebo-treated men, with frequencies during the first 12 months of 3.8% vs 2.1%, respectively. The incidence of these effects decreased to 0.6% in finasteride 1 mg-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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months (n=71) did not result in dose-related undesirable effects.
No specific treatment of overdosage with Finasteride is recommended.
Pharmacotherapeutic group: 5α-reductase inhibitor. ATC code D11AX10
Mechanism of action
Finasteride is a competitive and specific inhibitor of type II 5α-reductase. Finasteride has no affinity for the androgen receptor and has no androgenic, anti-androgenic, oestrogenic, anti-oestrogenic, or progestational effects. Inhibition of this enzyme blocks the peripheral conversion of testosterone to the androgen DHT, resulting in significant decreases in serum and tissue DHT concentrations. Finasteride produces a rapid reduction in serum DHT concentration, reaching significant suppression within 24 hours of dosing.
Hair follicles contain type II 5α-reductase. In men with male pattern hair loss, the balding scalp contains miniaturised hair follicles and increased amounts of DHT. Administration of finasteride decreases scalp and serum DHT concentrations in these men. Men with a genetic deficiency of type II 5α-reductase do not suffer from male pattern hair loss. Finasteride inhibits a process responsible for miniaturisation of the scalp hair follicles, which can lead to reversal of the balding process.
Clinical efficacy and safety
Studies in men
Clinical studies were conducted in 1879 men aged 18 to 41 with mild to moderate, but not complete, vertex hair loss and/or frontal/mid-area hair loss. In the two studies in men with vertex hair loss (n=1553), 290 men completed 5 years of treatment with Finasteride vs. 16 patients on placebo. In these two studies, efficacy was assessed by the following methods: (i) hair count in a representative 5.1cm2 area of scalp, (ii) patient self assessment questionnaire, (iii) investigator assessment using a seven point scale, and (iv) photographic assessment of standardised paired photographs by a blinded expert panel of dermatologists using a seven point scale.
In these 5- year studies men treated with Finasteride improved compared to both baseline and placebo beginning as early as 3 months, as determined by both the patient and investigator assessments of efficacy. With regard to hair count, the primary endpoint in these studies, increases compared to baseline were demonstrated starting at 6 months (the earliest time point assessed) through to the end of the study. In men treated with Finasteride these increases were greatest at 2 years and gradually declined thereafter to the end of 5 years; whereas hair loss in the placebo group progressively worsened compared to baseline over the entire 5 year period. In Finasteride treated patients, a mean increase from baseline of 88 hairs [p <0.01; 95% CI (77.9, 97.80; n=433] in the representative 5.1 cm2 area was observed at 2 years and an increase from baseline of 38 hairs [p <0.01; 95% CI (20.8, 55.6); n=219] was observed at 5 years, compared with a decrease from baseline of 50 hairs [p <0.01; 95% CI (-80.5, -20.6);n=47] at 2 years and a decrease from baseline of 239 hairs [p <0.01; 95% CI (-304.4, -173.4); n=15] at 5 years in patients who received placebo. Standardised photographic assessment of efficacy demonstrated that 48% of men treated with finasteride for 5 years were rated as improved, and an additional 42% were rated as unchanged. This is in comparison to 25% of men treated with placebo for 5 years who were rated as improved or unchanged. These data demonstrate that treatment with Finasteride for 5 years resulted in a stabilisation of the hair loss that occurred in men treated with placebo.
An additional 48-week, placebo-controlled study designed to assess the effect of Finasteride on the phases of the hair-growth cycle (growing phase [anagen] and resting phase [telogen]) in vertex baldness enrolled 212 men with androgenetic alopecia. At baseline and 48 weeks, total, anagen and telogen hair counts were obtained in a 1-cm2 target area of the scalp. Treatment with ‘Finasteride ‘ led to improvements in anagen hair counts, while men in the placebo group lost anagen hair. At 48 weeks, men treated with ‘Finasteride ‘ showed net increases in total and anagen hair counts of 17 hairs and 27 hairs, respectively, compared to placebo. This increase in anagen hair count, compared to total hair count, led to a net improvement in the anagen-to-telogen ratio of 47% at 48 weeks for men treated with ‘Finasteride ‘, compared to placebo. These data provide direct evidence that treatment with ‘Finasteride ‘ promotes the conversion of hair follicles into the actively growing phase.
Studies in women
Lack of efficacy was demonstrated in post-menopausal women with androgenetic alopecia who were treated with ‘Finasteride ‘ in a 12 month, placebo-controlled study (n=137). These women did not show any improvement in hair count, patient self-assessment, investigator assessment, or ratings based on standardised photographs, compared with the placebo group.
Relative to an intravenous reference dose, the oral bioavailability of finasteride is approximately 80%. The bioavailability is not affected by food. Maximum finasteride plasma concentrations are reached approximately two hours after dosing and the absorption is complete after six to eight hours.
Protein binding is approximately 93%. The volume of distribution of finasteride is approximately 76 litres.
At steady state following dosing with 1 mg/day, maximum finasteride plasma concentration averaged 9.2 ng/ml and was reached 1 to 2 hours post-dose; AUC (0-24 hr) was 53 ng•hr/ml.
Finasteride has been recovered in the cerebrospinal fluid (CSF), but the drug does not appear to concentrate preferentially to the CSF. A small amount of finasteride has also been detected in the seminal fluid of subjects receiving the drug.
Finasteride is metabolised primarily via the cytochrome P450 3A4 enzyme subfamily. Following an oral dose of 14C-finasteride in man, two metabolites of the drug were identified that possess only a small fraction of the 5α-reductase inhibitory activity of finasteride.
Following an oral dose of 14C-finasteride in man, 39% of the dose was excreted in the urine in the form of metabolites (virtually no unchanged drug was excreted in the urine) and 57% of total dose was excreted in the faeces.
Plasma clearance is approximately 165 ml/min.
The elimination rate of finasteride decreases somewhat with age. Mean terminal half-life is approximately 5-6 hours in men 18-60 years of age and 8 hours in men more than 70 years of age. These findings are of no clinical significance and hence, a reduction in dosage in the elderly is not warranted.
No adjustment in dosage is necessary in non-dialysed patients with renal impairment.
Preclinical safety data
In general, the findings in laboratory animal studies with oral finasteride were related to the pharmacological effects of 5α-reductase inhibition.
Intravenous administration of finasteride to pregnant rhesus monkeys at doses as high as 800 ng/day during the entire period of embryonic and foetal development resulted in no abnormalities in male foetuses. This represents at least 750 times the highest estimated exposure of pregnant women to finasteride from semen. In confirmation of the relevance of the Rhesus model for human foetal development, oral administration of finasteride 2 mg/kg/day (100 times the recommended human dose or approximately 12 million times the highest estimated exposure to finasteride from 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.
List of excipients
Lactose, microcrystalline cellulose E460, pregelatinised maize starch, sodium starch glycollate, docusate sodium, magnesium stearate E572,
hypromellose E464, hydroxypropyl cellulose E463, titanium dioxide, talc, yellow iron oxide E172, red iron oxide E172.
Special precautions for storage
Do not store above 30°C. Store in original package.
Nature and contents of container
Aluminium blisters lidded with aluminium foil, containing 28 tablets or 84 tablets.
Special precautions for disposal and other handling
Crushed or broken tablets of ‘Finasteride ‘ should not be handled by women when they are or may potentially be pregnant (see 4.6 ‘Pregnancy and lactation’).
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate, Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA
MARKETING AUTHORIZATION HOLDER:
Regal sun co., Ltd.Myanmar
Package leaflet: Information for the patient
Finasteride 1mg film coated tablet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. 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 side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
- What Finasteride 1mg Tablets are and what they are used for
2. What you need to know before you take Finasteride 1mg Tablets
3. How to take Finasteride 1mg Tablets
4. Possible side effects
5. How to store Finasteride 1mg Tablets
6. Contents of the pack and other information.
1.What Finasteride is and what it is used for
Finasteride 1 mg Tablets contain finasteride. Finasteride belongs to the group of medicines called 5- alpha reductase inhibitors.
Your doctor has prescribed Finasteride 1 mg Tablets because you have male pattern hair loss (also known as androgenetic alopecia). Finasteride 1 mg Tablets prevent further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Finasteride 1 mg Tablets. Finasteride 1 mg Tablets block an important enzyme (Type II 5α-reductase), which is involved in the regulation of the hair follicle.
In the scalp, Finasteride 1 mg Tablets specifically lower the levels of DHT, a major cause of male pattern hair loss. In this way, Finasteride 1 mg Tablets help to reverse the balding process and prevent further hair loss.
- What you need to know before you take Finasteride 1mg Tablets
Do not take Finasteride :
– if you are allergic to finasteride or any of the other ingredients of this medicine
– if you are a woman (because this medicine is for men)
– if you are a child.
– If you are already taking finasteride or any other 5α-reductase inhibitor for benign prostatic hyperplasia (BPH) or any other condition.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride.
Determination of prostate–specific-antigen (PSA) in serum should be carried out prior to initiating therapy with finasteride and during treatment. Finasteride may affect male fertility. Patients who are planning to father a child should consider stopping treatment.
Mood alterations and depression Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride 1 mg. If you experience any of these symptoms stop taking Finasteride 1 mg and contact your doctor for further medical advice as soon as possible.
Other medicines and Finasteride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Finasteride 1 mg Tablets do not usually interfere with other medicines. No information is available on the use of Finasteride 1 mg Tablets together with topical (applied to the skin) minoxidil in male pattern hair loss. The combination is not recommended
Finasteride with food and drink and alcohol Finasteride can be taken with or without food.
Pregnancy, breast-feeding and fertility Finasteride should not be taken by women.
Women who are pregnant or may become pregnant should not handle broken or crushed Finasteride tablets. If finasteride is absorbed through the skin or taken by mouth by a woman pregnant with a male foetus, the child may be born with malformed genital organs. The tablets are film-coated, which prevents contact with finasteride provided the tablets are not broken or crushed.
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
As far as is known, Finasteride has no influence on the ability to drive or operate machinery.
Finasteride contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars contact your doctor
before taking this medicinal product.
- How to take Finasteride 1mg tablet
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one Finasteride 1 mg tablet daily (equivalent to 1 mg finasteride).
The film-coated tablets can either be taken on an empty stomach or with a meal. The film-coated tablets should be swallowed whole and should not be divided or crushed.
·Finasteride 1 mg Tablets will not work faster or better if you take them more than once a day.
· Male pattern hair loss is a condition that develops over a long period of time. In general, daily use for three to six months may be necessary before you notice any increase in the hair density or reduction in hair loss.
- Your doctor will help you to assess if Finasteride 1 mg Tablets are working. It is important to continue taking Finasteride 1 mg Tablets for as long as your doctor prescribes them.
Patients with impaired liver function
There is no experience of the use of Finasteride 5 mg in patients with restricted liver function.
Patients with impaired kidney function
No dosage adjustment is required. The use of Finasteride 5 mg in patients who have to undergo haemodialysis has not been investigated to date.
If you take more Finasteride than you should
If you take more Finasteride than you should or if children have been taken medicine by accident please notify your doctor or pharmacist immediately.
If you forget to take Finasteride
If you forget to take a dose of Finasteride 1 mg, you can take it as soon as you remember unless it is almost 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you stop taking Finasteride 1 mg Tablets: Continued use of Finasteride 1 mg Tablets is recommended to obtain maximum benefit. If the treatment is stopped in between, you are likely to lose the hair you have gained within the next 9 to 12 months. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:
Common (may affect up to 1 in 10 people):
• You may be unable to have an erection (impotence)
• You may have less desire to have sex
• 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 function.
These side effects above may disappear after a while if you continue taking Finasteride. If not, they usually resolve after stopping Finasteride.
Uncommon (may affect up to 1 in 100 people): • Breast swelling or tenderness
Not known: frequency cannot be estimated from the available data
- Palpitations (feeling your heartbeat)
- Changes in the way your liver is working, which can be shown by a blood test • Pain in your testicles
- Allergic reactions If you have an allergic reaction, stop taking it and see your doctor straight away. The signs may include:
- Skin rashes, itching, or lumps under your skin (hives)
- Swelling of your lips and face.
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.
If you would like further information about the tumour grading system or this trial, please talk to your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
- How to store Finasteride
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Finasteride contains
– The active substance is finasteride.
Each film-coated tablet contains 1mg of finasteride.
– The other ingredients are –
Tablet core: Lactose monohydrate; cellulose, microcrystalline (E460); Starch, pregelatinised (maize); sodium starch glycolate (type-A); lauryl macrogolglycerides; magnesium stearate (E572).
Film coating: Hypromellose (E464), titanium dioxide (E171), macrogol 6000, iron oxide red (E172), iron oxide yellow (E172).
What Finasteride looks like and contents of the pack
Film-coated tablet. Finasteride 1 mg Tablets are reddish brown, round, biconvex, film-coated tablets marked ‘F1’ on one side and plain on other side.
Finasteride 1 mg Tablets are packed in Alu- Alu blisters in pack of 28 tablets, 30 tablets, 84 tablets and 98 tablets.
Taj Pharmaceuticals Limited
220, Mahagujarat Ind. Estate Moraiya, Tal. Sanand, Dist. Ahmedabad, Gujarat, INDIA
Marketing Authorization Holder:
Regal sun co., Ltd. Myanmar