Innopecia 1 mg. FC Tablets,

INNOPECIA temporarily delays further hair loss and increases the density of hair in the vertex and anterior mid-scalp area in males (between 18 and 41 years) displaying early signs of androgenetic alopecia. INNOPECIA is not effective in postmenopausal women with androgenetic alopecia.

Posology

Adults: S4 The recommended dose is one 1 mg tablet daily with or without food. In general, daily use for at least 3 months is necessary before increased hair growth and/or prevention of further hair loss is noticeable. Continued use is recommended for maximum benefit. Effects may be reversed within 12 months after withdrawal of treatment. INNOPECIA 1mg is not indicated for use in women or children (see section 4.3).

Method of administration

For oral use only, swallow film-coated tablet as a whole with full glass of water.

Hypersensitivity to INNOPECIA or any of the excipients listed in section 6.1. INNOPECIA is contraindicated in women, including during pregnancy (see section 4.4 and 4.6).

• INNOPECIA is not indicated for paediatric use.
• INNOPECIA should not be taken by men who are already taking other medicines containing finasteride or any other 5u03b1-reductase inhibitor such a dutasteride for benign prostatic hyperplasia or any other condition.

Paediatric population

INNOPECIA should not be used in children. There is no data demonstrating efficacy and safety of finasteride in children under the age of 18. (see section 4.3)

Effects on Prostate Specific Antigen (PSA)

In clinical studies the serum prostatic-specific antigen (S-PSA) levels decrease in patients treated with INNOPECIA. When INNOPECIA is used for treatment of male pattern hair loss in older men who also have benign prostatic hyperplasia (BPH), consideration should be given to the fact that in older men with BPH, PSA levels are decreased.

Effects on fertility

Male infertility and/or poor seminal quality have occurred. See also section 4.6.

Exposure to INNOPECIA (by pregnant women) u2013 risk to male foetus: INNOPECIA tablets are coated and will prevent contamination with finasteride during normal handling, provided that the tablets have not been crushed or broken. Pregnant women should not handle crushed or broken INNOPECIA tablets because of the possibility of absorption of INNOPECIA and subsequent potential risk to a male foetus (see section 4.6). In addition, since INNOPECIA is present in semen, male patients should wear a condom or otherwise avoid exposure of female sexual partners at risk of becoming pregnant.

Breast cancer

Breast cancer has been reported in men taking INNOPECIA during the post-marketing period. Healthcare providers 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 INNOPECIA. Patients should be monitored for psychiatric symptoms and if these occur, treatment with INNOPECIA should be discontinued and the patient advised to seek medical advice.

Liver disease

Risk of non-alcoholic fatty liver disease (NAFLD) and associated with liver diseases.

Lactose intolerance

INNOPECIA contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

No interactions of significant clinical importance have been established. INNOPECIA is metabolised primarily via, but does not appear to significantly affect the cytochrome P450-linked drug metabolising enzyme system. Although the risk for finasteride to affect the pharmacokinetics of other medicines 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. Compounds tested in males included digoxin, propranolol, warfarin, glibenclamide and theophylline and no clinically meaningful interactions were found.

Other Concomitant Therapy: INNOPECIA has been used concomitantly with ACE-inhibitors, paracetamol, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium-channel blockers, cardiac nitrates, diuretics, H2-antagonists, HMG-CoA reductase inhibitors, non-steroidal anti-inflammatory drugs (NSAIDu2019s), quinolones and benzodiazepines without any evidence of clinically significant interactions.

Pregnancy

INNOPECIA is contraindicated in women due to risk of pregnancy. Because of the ability of Type II 5-alpha-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, these medicines, including INNOPECIA may cause abnormalities of the external male foetus genitalia when administered to a woman during pregnancy. See also the boxed warning in section 4.4: u201cExposure to INNOPECIA (by pregnant women) u2013 risk to male foetusu201d.

Lactation

INNOPECIA is contraindicated for use in women. It is not known if finasteride is excreted in human milk.

Fertility

Male infertility and/or poor seminal quality have occurred. INNOPECIA is contraindicated in women who are or may potentially be pregnant as it may cause abnormalities of the external male foetus genitalia when administered during pregnancy.

INNOPECIA has no or negligible influence on the ability to drive and use machines.

The adverse reactions during clinical trials and/or postmarketing use are listed in the table below.

System Organ Class Frequency Side effects

Immune system disorders Frequency unknown Hypersensitivity reactions, including rash, pruritus, urticaria and angioedema (swelling of the lips, tongue, throat and face).

Psychiatric disorders Less frequent Decreased libido, depression. Frequency unknown Anxiety.

Cardiac disorders Frequency unknown Palpitation.

Hepatobiliary disorders Frequency unknown Increased hepatic enzymes and risk of non-alcoholic fatty liver disease (NAFLD) and associated with liver disease.

Reproductive system and breast disorders Less frequent Decrease in volume of ejaculate and ejaculation disorders, impotence and decreased libido. Frequency unknown Breast tenderness, breast enlargement and testicular pain, haematospermia, infertility, poor seminal quality*.

* Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in side effects. No specific treatment is recommended for overdosage with INNOPECIA. Treatment is symptomatic and supportive.