Innopecia 1 mg Film-Coated Tablets

INNOPECIA is a type of medicine called “Type II 5-alpha reductase inhibitors”. INNOPECIA is used for the treatment of male pattern hair loss (also known as androgenic alopecia). INNOPECIA increases hair growth on the scalp and prevents further hair loss in men between the ages of 18 to 41 years.

Do not take INNOPECIA:

• If you are allergic to finasteride or any of the other ingredients of INNOPECIA (listed in section 6).
• If you are a woman, including during pregnancy.
• If you are under 18 years of age
• If you are pregnant or may become pregnant. INNOPECIA may harm your unborn baby:

INNOPECIA tablets are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed INNOPECIA tablets. If a pregnant woman comes in contact with crushed or broken INNOPECIA tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in INNOPECIA, a healthcare provider should be consulted.

If a woman who is pregnant with a male baby swallows or comes in contact with the medicine in INNOPECIA, the male baby may be born with sex organs that are not normal.

Take special care with INNOPECIA:

• If you have other medical conditions, including problems with your prostate.
• Mood alterations and depression: Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride. If you experience any of these symptoms stop taking INNOPECIA and contact your doctor for further medical advice as soon as possible.
• Effects on Prostate Specific Antigen (PSA): INNOPECIA can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your doctor or pharmacist that you are taking INNOPECIA because INNOPECIA decreases PSA levels.
• Effects on fertility: Infertility has been reported in men who took INNOPECIA for long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of INNOPECIA. Long-term clinical studies about the effect of INNOPECIA on fertility in men have not been conducted.
• Effects on liver: A range conditions caused by a build-up of fat in the liver. (Non-alcoholic fatty liver disease (NAFLD)).

Children and adolescents: INNOPECIA should not be used in children and adolescents below 18 years.

Other medicines and INNOPECIA: Always tell your health care provider if you are taking any other medicines. This includes all complementary or traditional medicines.

Do not take INNOPECIA if you are already taking finasteride or dutasteride, used for a prostate problem called benign prostatic hyperplasia (BPH).

INNOPECIA with food, drink, and alcohol: INNOPECIA can be administered irrespective of whether food is taken or not.

Do not share medicines prescribed for you with any other person. Always take INNOPECIA exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

Adults: The usual dose for adults is one 1 mg INNOPECIA tablet daily. In general, daily use for at least 3 months is necessary before increased hair growth and/or prevention of further hair loss is noticeable. Your doctor will tell you how long your treatment with INNOPECIA will last. Do not stop treatment early. If you have the impression that the effect of INNOPECIA is too strong or too weak, tell your doctor or pharmacist.

If you take more INNOPECIA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take a dose of INNOPECIA: If you have missed a dose by only a few hours, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take INNOPECIA at the next regularly scheduled time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking INNOPECIA: Continued use is recommended for maximum benefit. Effects of the tablet may be reversed within 12 months after you stop treatment.

INNOPECIA can have side effects. Not all side effects reported for INNOPECIA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking INNOPECIA, please consult your health care provider for advice.

Stop taking INNOPECIA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had a serious reaction to INNOPECIA. You may need urgent medical attention or hospitalisation.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• Decrease in your blood Prostate Specific Antigen (PSA) levels. INNOPECIA can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking INNOPECIA because INNOPECIA decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare professional. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking INNOPECIA. You should also tell your healthcare provider if you have not been taking INNOPECIA as prescribed because this may affect the PSA test results.

These are all profoundly serious side effects. If you have them, you may have had a serious reaction to INNOPECIA. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• trouble getting or keeping an erection
• a decrease in the amount of semen

Less frequent side effects:

• Breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
• Depression.
• Decrease in sex drive that continued after stopping INNOPECIA.
• Allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face.
• Problems with ejaculation that continued after stopping INNOPECIA.
• Testicular pain.
• Difficulty in achieving an erection that continued after stopping the medication.
• Male infertility and/or poor quality of semen.
• Less frequent rare cases, male breast cancer.
• decrease in sex drive
• Blood in semen
• Fast heartbeat
• Elevated liver enzymes
• Anxiety

Frequent Unknown side effects:

• A range conditions caused by a build-up of fat in the liver. (Non-alcoholic fatty liver disease (NAFLD)).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor or pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse drug Reaction reporting Form”, found online under SAHPRA’s publications: https://sahpra.org.za/wp-content/uploads/2020/01/6.04_ARF1_v5.1_27Jan2020.pdf. By reporting side effects, you can help provide more information on the safety of INNOPECIA.

INNOPECIA should be stored in the original packaging (keep blisters in the carton until required for use). Store at or below 25 °C. Protect from moisture and sunlight. STORE ALL MEDICINE OUT OF REACH OF CHILDREN. Do not use after the expiry date stated on the label and carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).