Special populations : אוכלוסיות מיוחדות

Geriatric Use
                Clinical efficacy studies with PROPECIA did not include subjects aged 65 and over.
Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly for PROPECIA. However, the efficacy of PROPECIA in the elderly has not been established.

Patients with hepatic Impairment
Caution should be exercised in the administration of PROPECIA in those patients with liver function abnormalities, as finasteride is metabolized extensively in the liver 
Patients with renal Impairment
No dosage adjustment is necessary in patients with renal impairment


4.3    Contraindications

Contraindicated in women: see 4.6 ‘Fertility, pregnancy and lactation’ and 5.1 ‘Pharmacodynamic properties’.

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

PROPECIA is not indicated for use in women or children and adolescents.
PROPECIA should not be taken by men who are taking finasteride 5 mg or any other 5-reductase inhibitor for benign prostatic hyperplasia or any other condition.


4.4    Special warnings and precautions for use
Paediatric population
PROPECIA 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 PROPECIA 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 ‘Propecia’ should be considered before evaluating this test result.

Effects on fertility
See 4.6 Fertility, pregnancy and lactation

Hepatic impairment
The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.

Breast Cancer
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.

Lactose intolerance
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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


4.5    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.

There is no data on the concomitant use of PROPECIA and topical minoxidil in male pattern hair loss.

Interaction studies have only been performed in adults.

4.6    Fertility, pregnancy and lactation
Pregnancy
PROPECIA is contra-indicated for use in women due to the risk in pregnancy.

Because of the ability of type II 5-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 ‘Propecia’. Studies in Rhesus monkeys have indicated that this amount is unlikely to constitute a risk to the developing male foetus (see Section 5.3).

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.


Breast-feeding
It is not known whether finasteride is excreted in human milk.
Fertility
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.