Medicinal Products

AVODART 0.5 mg

Generic drug of the therapeutic class: Urology nephrology
Active ingredients: Dutasteride
laboratory: Mediwin Limited

Soft capsule
Box of 3 blister packs of 10
All forms

Indication

Treatment of moderate to severe symptoms of benign prostatic hypertrophy (BPH).

Reduction of the risk of acute urinary retention (UAE) and surgery in patients with moderate to severe BPH symptoms.

For information on the effects of treatment and study populations in clinical trials, see section 5.1 Pharmacodynamic properties.

Dosage AVODART 0.5 mg Soft capsule Box of 3 blister packs of 10

AVODART can be administered alone or in combination with alpha-blocker tamsulosin (0.4 mg), (see sections Warnings and Precautions, Adverse Reactions and Pharmacodynamic Properties ).

Adults (including elderly patients)

The recommended dose of AVODART is one capsule (0.5 mg) per day orally.

The capsules should be swallowed whole, and should not be chewed or opened as contact with the contents of the capsule may result in irritation of the oropharyngeal mucosa. Capsules can be taken during or after meals.

Even if a rapid improvement can be seen, a treatment of at least 6 months may be necessary to obtain an optimal response.

It is not necessary to adjust the dosage in elderly patients.

Renal failure

The pharmacokinetics of dutasteride have not been studied in patients with renal impairment. However, it is not necessary to provide dosage adjustment for patients with renal impairment (see section Pharmacokinetic properties ).

Hepatic insufficiency

The pharmacokinetics of dutasteride have not been studied in patients with hepatic impairment and caution should be exercised in patients with mild to moderate hepatic impairment (see Warnings and Precautions and Pharmacokinetic Properties sections).

In patients with severe hepatic impairment, the use of dutasteride is contraindicated (see section 4.3 ).

Against indications

AVODART is contraindicated at:

· The woman, the child and the adolescent (see section on Pregnancy and breastfeeding ).

· Patients who are hypersensitive to dutasteride, other 5-alpha-reductase inhibitors, soy, peanut or other excipients.

· Patients with severe hepatic impairment.

Avodart side effects

AVODART IN MONOTHERAPY

Approximately 19% of the 2167 patients, who received dutasteride in placebo-controlled Phase III trials over 2 years, developed side effects during the first year of treatment. The majority of the effects were mild to moderate and involved the reproductive system. No change in the safety profile occurred during the open-label extension over 2 additional years of clinical studies. The following table describes adverse reactions reported in controlled and post-marketing clinical trials.

The listed adverse events reported during clinical trials were rated by the investigators as being treatment-related (with an incidence greater than or equal to 1%), with a higher incidence in patients treated with dutasteride than in patients treated with dutasteride. placebo during the first year of treatment. The incidence of post-marketing adverse reactions is unknown as it corresponds to an estimated rate from spontaneous reports rather than actual incidence.

Organ system

Side effects

Incidence of adverse reactions reported after marketing

Immune system disorders

Allergic manifestations including rash, pruritus, urticaria, localized edema and angioedema.

unknown

Skin and subcutaneous tissue disorders

Alopecia (mainly hair loss), hypertrichosis

Uncommon

Incidence of adverse events reported in clinical trials

Incidence during the first year of treatment (n = 2167)

Incidence during second year of treatment (n = 1744)

Disorders of reproductive organs and breast

Incapacity

6.0%

1.7%

Modification (decrease) of the libido

3.7%

0.6%

Ejaculation disorders

1.8%

0.5%

Breast disorders (including swelling and / or breast tenderness)

1.3%

1.3%

AVODART IN ASSOCIATION WITH ALPHA-BLOCKING TAMSULOSIN

Data from the CombAT 4-year study comparing dutasteride 0.5 mg alone (n = 1623), tamsulosin 0.4 mg alone (n = 1, 611) administered once daily, and in combination with = 1610) showed that the incidence of treatment-related adverse events, according to the investigator, during the first, second, third and fourth years of treatment was 22%, 6%, 4% and 2%, respectively for combination dutasteride / tamsulosin, 15%, 6%, 3% and 2% for dutasteride monotherapy and 13%, 5%, 2% and 2% for tamsulosin monotherapy. The higher incidence of adverse events in the combination group during the first year of treatment was due to a higher incidence of reproductive disorders, particularly ejaculatory disorders.

The following treatment-related adverse events (according to the investigator) were reported with an incidence greater than or equal to 1% during the first year of treatment in the CombAT study. The incidence of adverse events during the four years of treatment is presented in the table below:

Organ system

Side effects

Incidence during the treatment period

Year 1

Year 2

Year 3

Year 4

Association a (n)

(N = 1610)

(N = 1428)

(N = 1283)

(N = 1200)

dutasteride

(N = 1623)

(N = 1464)

(N = 1325)

(N = 1200)

tamsulosin

(N = 1611)

(N = 1468)

(N = 1281)

(N = 1112)

Nervous system disorders

Dizzying sensations

Association a

1.4%

0.1%

<0.1%

0.2%

dutasteride

0.7%

0.1%

<0.1%

<0.1%

tamsulosin

1.3%

0.4%

<0.1%

0%

Heart conditions

Heart failure (composite term b )

Association a

0.2%

0.4%

0.2%

0.2%

dutasteride

<0.1%

0.1%

<0.1%

0%

tamsulosin

0.1%

<0.1%

0.4%

0.2%

Disorders of the reproductive organs and breast,

Psychiatric disorders,

investigations

Incapacity

Association a

6.3%

1.8%

0.9%

0.4%

dutasteride

5.1%

1.6%

0.6%

0.3%

tamsulosin

3.3%

1.0%

0.6%

1.1%

Modification (decrease) of the libido

Association a

5.3%

0.8%

0.2%

0%

dutasteride

3.8%

1.0%

0.2%

0%

tamsulosin

2.5%

0.7%

0.2%

<0.1%

Ejaculation disorders

Association a

9.0%

1.0%

0.5%

<0.1%

dutasteride

1.5%

0.5%

0.2%

0.3%

tamsulosin

2.7%

0.5%

0.2%

0.3%

Breast disorders c

Association a

2.1%

0.8%

0.9%

0.6%

dutasteride

1.7%

1.2%

0.5%

0.7%

tamsulosin

0.8%

0.4%

0.2%

0%

a Association = dutasteride 0.5 mg once a day and tamsulosin 0.4 mg once a day.

b The composite term heart failure includes congestive heart failure, heart failure, left ventricular failure, acute heart failure, cardiogenic shock, acute left ventricular failure, right ventricular failure, acute right ventricular failure, ventricular failure, cardiopulmonary insufficiency and congestive cardiomyopathy.

c Including breast tension and breast swelling.

OTHER DATA

A higher incidence of prostate cancer with a Gleason score of 8 to 10 was observed in the REDUCE study in men treated with dutasteride compared with placebo (see sections Warnings and precautions for use and Pharmacodynamic properties ).

It has not been established whether the effect of dutasteride on the reduction of prostate volume or whether study-related factors have an impact on the results of this study.

The following effect has been reported in clinical trials and post marketing: breast cancer in humans (see Warnings and Precautions ) section.

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