Finasteride Aurobindo Pharma Italia

Package leaflet: Information for the user

Finasteride Aurobindo Pharma Italia 1 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Finasteride Aurobindo Pharma Italia is and what it is used for
2. What you need to know before taking Finasteride Aurobindo Pharma Italia
3. How to take Finasteride Aurobindo Pharma Italia
4. Possible side effects
5. How to store Finasteride Aurobindo Pharma Italia
6. Contents of the pack and other information

1. What Finasteride Aurobindo Pharma Italia is and what it is used for

• Finasteride Aurobindo Pharma Italia 1 mg film-coated tablets contain the active substance finasteride.

Finasteride Aurobindo Pharma Italia must be used only in men.

• Finasteride Aurobindo Pharma Italia is used for the treatment of male-pattern hair loss (also known as androgenetic alopecia) in men aged between 18 and 41 years. If, after reading this leaflet, you have any questions about hair loss in men, please consult your doctor.
• Male-pattern hair loss is a common condition believed to be caused by a combination of genetic factors and a specific hormone called dihydrotestosterone (DHT), which contributes to shortening the hair growth phase and leads to hair thinning.
• In the scalp, Finasteride Aurobindo Pharma Italia specifically reduces levels of DHT by blocking an enzyme (type II 5-alpha reductase) that converts testosterone into DHT. Only men with mild to moderate, but not complete, baldness can expect benefit from using Finasteride Aurobindo Pharma Italia. In most men treated with Finasteride Aurobindo Pharma Italia for 5 years, progression of hair loss has been slowed, and at least half of these men also experienced some improvement in hair growth.

2. What you need to know before taking Finasteride Aurobindo Pharma Italia

Do not take Finasteride Aurobindo Pharma Italia

• if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman (since this medicine is intended for men only, see 'Pregnancy'). Clinical studies have shown that Finasteride Aurobindo Pharma Italia is not effective in treating hair loss in women.

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Aurobindo Pharma Italia.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride Aurobindo Pharma Italia. If you experience any of these symptoms, stop taking Finasteride Aurobindo Pharma Italia and contact your doctor as soon as possible for further advice.
In some patients, impaired sexual function has been reported, which may contribute to mood changes, including suicidal thoughts. If you develop symptoms of impaired sexual function, contact your doctor for further advice. Your doctor may consider discontinuing treatment (see section 4 below for more information on these side effects).
A patient reminder card with the above information is provided in the packaging of Finasteride Aurobindo Pharma Italia.
Effects on Prostate-Specific Antigen (PSA)
Finasteride Aurobindo may affect a blood test called PSA (Prostate-Specific Antigen) used for prostate cancer screening. If you have had a PSA test, inform your doctor or pharmacist that you are taking Finasteride Aurobindo Pharma Italia, because Finasteride Aurobindo Pharma Italia reduces PSA levels.
Effects on fertility
Infertility has been reported in men who have taken finasteride for a long time and who had other risk factors that may affect fertility. Normalization or improvement in semen quality have been reported after discontinuation of finasteride. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
Breast cancer
See section 4.
Children and adolescents
Finasteride Aurobindo Pharma Italia must not be used in children. There are no data available demonstrating the efficacy or safety of finasteride in children under 18 years of age.
Other medicines and Finasteride Aurobindo Pharma Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Finasteride Aurobindo Pharma Italia is indicated only for the treatment of male-pattern hair loss in men. For effects on male fertility, see section 2.

• Women must not use Finasteride Aurobindo Pharma Italia due to the risk during pregnancy.
• If you are pregnant or could be pregnant, you must not handle crushed or broken tablets of Finasteride Aurobindo Pharma Italia.
• If the active ingredient of Finasteride Aurobindo Pharma Italia is absorbed orally or through the skin by a pregnant woman carrying a male fetus, the baby may be born with abnormalities of the genital organs.
• If a pregnant woman comes into contact with the active ingredient of Finasteride Aurobindo Pharma Italia, she must consult a doctor. The tablets of Finasteride Aurobindo Pharma Italia are coated, which prevents contact with the active ingredient during normal handling.

If you have any doubts, consult your doctor.
Driving and use of machines
There are no data indicating that Finasteride Aurobindo Pharma Italia affects the ability to drive or operate machinery.
Finasteride Aurobindo Pharma Italia contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Finasteride Aurobindo Pharma Italia contains lactose
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially 'sodium-free'.

3. How to take Finasteride Aurobindo Pharma Italia

Take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily. The tablet can be taken with or without food.
Your doctor will help you assess whether Finasteride Aurobindo Pharma Italia is working. It is important to
continue taking Finasteride Aurobindo Pharma Italia for as long as prescribed by your doctor. Finasteride
Aurobindo Pharma Italia works only in the long term if taken continuously.
If you take more Finasteride Aurobindo Pharma Italia than you should
If you take too many tablets by mistake, contact your doctor immediately. Finasteride
Aurobindo Pharma Italia does not work faster or better if taken more than once a day.
If you forget to take Finasteride Aurobindo Pharma Italia
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Finasteride Aurobindo Pharma Italia
It may take between 3 and 6 months for the medicine to become fully effective. It is important
to continue taking Finasteride Aurobindo Pharma Italia for the duration prescribed by your doctor. If you stop
treatment, you are likely to lose the hair that has regrown within the following 9–12 months.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Side effects have generally been temporary during continued treatment or disappeared after stopping treatment.
Stop taking Finasteride Aurobindo Pharma Italia and contact your doctor immediately if you experience any of the following symptoms: suicidal thoughts; swelling of the lips, face, tongue, and throat; difficulty swallowing; lumps under the skin (urticaria), and breathing difficulties.
You must immediately report to your doctor any changes in breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be signs of a serious condition such as breast cancer.

Uncommon (may affect up to 1 in 100 people):

• reduced sexual desire;
• difficulty in achieving erection;
• ejaculation problems, such as reduced volume of semen produced;
• depression.

Not known (frequency cannot be estimated from the available data):

• allergic reactions such as skin rash and itching;
• swelling or tenderness of the breasts;
• testicular pain;
• blood in the semen;
• rapid heartbeat;
• persistent reduction in sexual desire after stopping treatment;
• persistent difficulty in achieving erection after stopping treatment;
• male infertility and/or poor semen quality;
• elevated liver enzymes;
• anxiety;
• suicidal thoughts.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride Aurobindo Pharma Italia

Keep out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated clearly on the label, carton, or bottle after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Finasteride Aurobindo Pharma Italia contains

• The active substance is finasteride. One film-coated tablet contains 1 mg of finasteride.
• The other excipients are: Tablet core: Monohydrate lactose, microcrystalline cellulose, sodium starch glycolate, pregelatinized starch [corn starch], docusate sodium, magnesium stearate. Film coating: Hypromellose, hydroxypropylcellulose, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of Finasteride Aurobindo Pharma Italia and package contents:
Film-coated tablet.
Film-coated tablets, brown in colour, octagonal, biconvex, with 'J' engraved on one side and '81' on the other side.
The film-coated tablets of Finasteride Aurobindo Pharma Italia are available in PVC/PE/PVdC-Aluminium blister packs and in HDPE bottles with polypropylene cap containing silica gel as desiccant.
Pack sizes:
Blister pack: 28, 56, 84 and 98 film-coated tablets.
HDPE bottle: 30 and 100 film-coated tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder:
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: Finasteride Arrow Lab 1 mg, comprimé pelliculé
Germany: Finasterid Aurobindo 1 mg Filmtabletten
Italy: Finasteride Aurobindo Pharma Italia
Malta: Finasteride 1 mg film-coated tablets
Spain: Finasterida Aurovitas 1 mg comprimidos recubiertos con película EFG