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1. Name of the medicinal product

Finasteride 1 mg film-coated tablets

2. Qualitative and quantitative composition

A film-coated tablet contains 1 mg Finasteride.

Auxiliary substance (s): 95.58 mg lactose monohydrate.

For a full list of excipients, see section 6.1

3. Pharmaceutical

Film tablet.

Maroon, round, biconvex tablets, marked "F1" on one side and on the other side smooth.

4. Clinical data

4.1 therapeutic indications

Finasteride 1 mg is indicated for the treatment of the first stage of hair loss (androgenic alopecia) in men. Finasteride 1 mg stabilizes the process of androgenetic alopecia in the 18-year-old men -41. Its effectiveness in Bitemporary recession in the hair loss has not been determined.

Finasteride is not indicated for use in women or children and adolescents.

4.2 Posology and method of administration

Only for oral use.

The recommended dosage is one tablet of 1 mg per day. Finasteride 1 mg Accord can be taken with or without food. The tablet should be swallowed and may not be shared or crushed (see section 6.6).

There is no evidence that increasing the dose leads increased efficacy.

The efficacy and duration of treatment should be continuously evaluated by the treating doctor. Usually three to six months once-daily treatment required for the proofof stabilization of the hair loss is to be expected. Continuous use is recommended in order to obtain benefits. If treatment is stopped, the beneficial effects begin to reverse with six months and return to 9-12 months baseline.

Dosage in renal insufficiency

In patients with renal insufficiency dose adjustment is not required.

Dosage in hepatic insufficiency

There are no data in patients with impaired liver function.

4.3 Contra

This medicine should not be used in children/young people. When women and children is contraindicated (see section 4.4 "using special warning and caution for" 4.6 "pregnancy and breast-feeding" and 5.1 "pharmacodynamic properties"). Should not be taken by men who Finasteride 5α-reductase inhibitor 5 mg tablets or other for benign prostatic hyperplasia or other condition.

Hypersensitivity to Finasteride or one of the excipients.

4.4 Special warnings and precautions for use

Finasteride should not be used in children/youth (18 years <). There are no data that show efficacy and safety of Finasteride in children younger than 18 years of age.

In clinical studies of Finasteride 1 mg tablets in men 18-41 years old was reduced the average value of the serum prostate specific antigen (PSA) of 0.7 ng/ml at baseline to 0.5 ng/ml in month 12 this decrease in serum PSA concentration should be considered during treatment with Finasteride tablets 1 mg, a patient has a PSA test required. In this case, it is present in a double PSA values are compared with the results from untreated men.

Long-term data is missing on human fertility and specific studies are not performed in subfertile men. The male patients who were planning a child witnesses were initially excluded from clinical research. Although animal studies showed no relevant adverse effects on fertility, reduced post-market spontaneous reports of infertility and/or poor sperm quality. In some of these reports, further patients risk factors that may have contributed to infertility. Normalization or improvement of sperm quality has been reported after discontinuation of Finasteride. Patients who are planning a child witnesses must stop treatment (see also section 4.6).

Breast cancer has been reported in post-marketing experience in men under Finasteride during clinical studies and over time.

Physicians should instruct their patients report to without delay of any changes in their breast tissue such as lumps, pain or nipple, gynecomastia.

The effect of hepatic impairment on the pharmacokinetics of Finasteride is not examined.

Auxiliary materials

This medicine contains lactose. Patients with the rare hereditary disorders galactoseintolerance, the Lapp lactase deficiency or glucose-malabsorption should not take this medicine.

4.5 interaction with other medicinal products and other forms of interaction

No drug interactions of clinical significance identified. Finasteride is primarily metabolized by, but does not affect the cytochrome P450-linked drug metabolizing enzymesystem. Although the risk of Finasteride on the pharmacokinetics of other drugs affectundervalued, it is likely that affects the cytochrome P450 3A4 inhibitors and plasma concentration of Finasteride. However, under established safety margins, by simultaneous use of such inhibitors of clinical significance might be. Connections that have been tested in humans antipyrine, digoxin, glyburide, propranolol, theophylline and warfarin and no interactions were found.

Due to lack of data for the related use of Finasteride and topical minoxidil hair loss the combination is not recommended.

4.6 pregnancy and lactation

Use during pregnancy

Finasteride is contraindicated in women because of the risk of pregnancy (see section4.3).

Because of the ability of type II 5α-reductase inhibitors the conversion of testosterone (DHT) in some tissues dihydrotestosterone brakes making these drugs, which include Finasteride, anomalies of the external genitalia of a male fetus if a pregnant woman (see section 5.3) is administered.

Exposure to Finasteride: danger of the male fetus

Women who are pregnant or planning a pregnancy should not handle crushed or broken tablets become Finasteride, especially when due to the possibility of inclusion ofFinasteride and the potential risk to a male fetus (see section 6.6).

Small amounts of Finasteride are obtained from the seeds of the subjects Finasteride recovered 5 mg/day. It is not known whether a male fetus may be affected if his mother treated sperm from a patient is exposed with Finasteride. If the patient or sexual partner may be pregnant, the patient is advised the noise exposure of his partner seeds(e.g., through the use of condoms).

Breastfeeding: Finasteride 1 mg are not indicated for women. It is not known whetherFinasteride is excreted in breast milk.

4.7 effects on ability to operate machinery

There are no data suggest that Finasteride 1 mg affects the ability to drive or operate machinery.

4.8 side effects

Side effects in clinical trials and/or use monitoring in the table below. The frequency of the side effects are as follows: very common (≥1/10), common (≥1/100 to < 1/10), sometimes (≥ 1/1,000, < 1/100), rare (≥ 1/10,000 to ≤ 1/1,000), very rarely (< 1/10.000), not known (not based on the available data).

The incidence of side effects reported for cannot be determined during post-marketing use, because they are derived from spontaneous reports.

Immune system disorders: unknown: hypersensitivity reactions, including skin rash, itching, hives and swelling of the lips and face.

Heart disease: not known: heart palpitations.

Psychiatry: Unusual : decreased libido, mood change with depressive complaints.

Artichoke leaves disorders: unknown: elevated liver enzymes.

Reproductive system and Breast Disorders: sometimes $: erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate).

Not known: breasts and enlargement (gynecomastia), testicular pain, infertility * * See section 4.4

Cases presented as difference compared with placebo in clinical trials in month 12 Drug-related sexual side effects were treated with the Finasteride men are more likely than the placebo treated men, with frequencies in the first 12 months of 3.8% vs. 2.1% respectively. The incidence of these effects declined to 0.6% in Finasteride treated men over the next four years. About 1% of the men in each treatment group corrected for the related sexual side effects in the first 12 months, and the incidence then decreased.

In addition, the following have been reported in post-marketing use: persistence of erectile dysfunction after discontinuation of treatment with Finasteride 1 mg tables: male breast cancer (see section 4.4 Special warnings and precautions for use).

4.9 Overdose

Single dose to 400 mg in clinical study, Finasteride and multiple doses Finasteride to 80 mg/day for three months (n = 71) not to dosisgerelateerde side effects. There is no specific treatment of an overdose of Finasteride 1 mg tablets is recommended.

5. pharmacological properties

5.1 pharmacodynamic properties

Pharmacotherapeutic category: other Skin

ATC-code: D11 AX10

Finasteride is a 4-azasteroid 5α-reductase type 2, human (now in the hair follicles) with more than 100 x selectivity inhibits 5α-reductase type 1 superhuman and blocks theperipheral conversion of testosterone to the androgen dihydrotestosterone (DHT). In men with hair loss, balding scalp contains miniaturized hair follicles and increasedamounts of DHT. Finasteride inhibits a process responsible for miniaturization of the scalp hair follicles, the process can lead to reverse baldness.

Studies in men:

The effectiveness of finasteride 1 mg tablets was demonstrated in three studies in 1879 men from 18 to 41 years with a light to moderate, but not complete, vertex hair loss and frontal/mid-area hair loss. In these studies, the hair growth based on four separate measures, including her count, ratings of photos of the head by an expert panel of dermatologists, review by the researcher and the patient's own assessment was. In the two studies in men with vertex hair loss treatment with finasteride sat 1 mg tablets for 5 years, in which patients improved compared to baseline in men with Propecia 1 mg tablets are usually after 2 years and gradually fell afterwards treated (bv. B. amount of hair over a representative 5.1 cm2 area was increased hair 88 of the baseline at 2 years and 38 hairs of the baseline at 5 years), hair loss in the placebo group gradually deteriorated compared to baseline (reduction of 50 hair 2 years 239 hair 5 years). So although improvement over baseline in men with finasteride 1 mg tablets not covered after 2 years was the difference between the treatment groups continued to rise in the five years of the study. Treatment with finasteride 1 mg tablets for 5 years led to stabilisation of hair loss in 90% of the men on the basis of photographicassessment, 93% of the researchers reviewed.

In addition, 65% of the observed increased hair growth in men 1 mg tablets counts with Finasteride based on her, in 48% based on photographic assessment and at 77% of the treated researchers rating. Gradually, however, her loss in the time was in the placebo group counts in 100% of men, the hair, in 75% based on photographic assessment and 38% based on the assessment by the researcher based observed. In addition, patient self-assessment showed a significant increase in hair density, decreaseof hair loss and improve the appearance of the hair after treatment for 5 years withfinasteride 1 mg tablets (see table below).

† 1:1 randomization Finasteride 1 mg tablets with placebo.

Phone numbers route 9:1 randomization Finasteride 1 mg tablets with placebo

In a 12-month study, in men with frontal/mid-area hair loss hair counts were given in a representative area of 1 cm2 (about 1/5 the size of the area sampled in the vertex studies). Hair counts, set to a surface, with 49 5.1 cm2 haren (5%) compared to baseline 59 haren (6%) compared with placebo. This study also showed significant improvements in patient self-assessment, investigator assessment and reviewing photos of the head by an expert panel of dermatologists. Two studies of 12 and 24 weeks duration showed that a dose of 5 times the recommended dosage (Finasteride 5 mg per day), an average decrease in ejaculate volume of approximately 0.5 ml (-25%) compared with placebo. This decrease was reversible after cessation of treatment. In a study with a duration of 48 weeks, finasteride 1 mg per day produced an average decrease in ejaculate volume of 0.3 ml (-11%) in comparison with 0.2 ml (-8%) decrease for placebo. In the sperm count, motility and morphology, no effect was observed. Longer term data are not available. It was not possible clinical studies need to be carried out to the possible adverse effects on fertility directly. However, such effects are rated as highly unlikely (see also 5.3 Preclinical safety data).

Studies in women

Lack of efficacy was seen in postmenopausal women with androgenetic alopecia which with finasteride 1 mg tablets were treated in a 12-month, placebo-controlled study(n = 137). These women showed no improvement in her count, the patient self-assessment assessment by the researcher or reviews on the basis of standard values.