FINASTERIDE TECNIGEN

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride TecniGen 5 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Finasteride TecniGen is and what it is used for

Finasteride TecniGen is a medicine presented in the form of film-coated tablets, each containing 5 mg of finasteride as the active substance. Finasteride belongs to a group of medicines known as "5-alpha-reductase inhibitors". These medicines affect the metabolism of testosterone (male hormone).
Your doctor has prescribed Finasteride TecniGen because you are affected by a condition known as benign prostatic hyperplasia (BPH). BPH is a benign enlargement of the prostate gland, common in men over 50 years of age.
Your prostate gland (located near the bladder) has become enlarged and makes it more difficult for urine to pass. Symptoms usually include the need to urinate frequently, especially at night, a sudden urge to urinate, difficulty starting urination, a weak or interrupted urine stream, or the sensation of not being able to completely empty the bladder.
The medicine works by reducing the size of the enlarged prostate in men. Finasteride TecniGen
can reduce the risk of developing sudden inability to urinate (known as acute urinary retention) and the need for surgical intervention.
BPH develops over a long period of time. Although some patients may experience symptom improvement within a short time, treatment with Finasteride TecniGen for at least 6 months may be necessary to determine whether symptoms improve.

2. What you need to know before taking Finasteride TecniGen

Do not take Finasteride TecniGen

• if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6). Finasteride TecniGen is prescribed only for men. Women and children must not take Finasteride TecniGen. Women who are known or suspected to be pregnant must not use Finasteride TecniGen. They must also avoid handling crushed or broken Finasteride TecniGen tablets (see "Pregnancy, breastfeeding and fertility"). Inform your doctor of any medical conditions you currently have or have had in the past, as well as any allergies.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Finasteride TecniGen.
Finasteride TecniGen is intended for the treatment of BPH (benign prostatic hyperplasia) in men only.
Finasteride TecniGen may affect a blood test called PSA (prostate-specific antigen).
If you have had a PSA test, inform your doctor that you are taking Finasteride TecniGen.
Finasteride TecniGen contains lactose. If you are intolerant to any sugar, inform your doctor before taking this medicine.

Other medicines and Finasteride TecniGen
Finasteride TecniGen usually does not interfere with other medicines. However, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Finasteride TecniGen with food, drinks and alcohol
Finasteride TecniGen may be taken with or without food.

Pregnancy, breastfeeding and fertility
Women who are known or suspected to be pregnant must not handle crushed or broken Finasteride TecniGen tablets, due to the possibility of absorption of finasteride and the consequent potential risk to a male fetus.
It is not known whether finasteride is excreted in human breast milk.
The Finasteride TecniGen tablets are film-coated, which, if the tablets are not broken or crushed, prevents contact with the active substance during normal handling.
If the active substance from Finasteride TecniGen tablets is absorbed orally or through the skin by a pregnant woman carrying a male fetus, it may cause abnormalities in the baby's genital organs. If a pregnant woman comes into contact with the active substance contained in Finasteride TecniGen, a doctor should be consulted.
If your partner is or may be pregnant, you should avoid exposing her to your semen, which may contain small amounts of the medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
There are no data suggesting that Finasteride TecniGen affects the ability to drive vehicles or operate machinery.

Finasteride TecniGen contains lactose
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption must not take this medicine.

3. How to take Finasteride TecniGen

Take Finasteride TecniGen exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. The recommended dose is one tablet daily.
If you take more Finasteride TecniGen than you should
If you take too many tablets, contact your doctor immediately.
If you forget to take Finasteride TecniGen
Take Finasteride TecniGen as prescribed by your doctor. If you miss a dose, do not take a double dose; simply take the next tablet as usual.

4. Possible side effects

Like all medicines, Finasteride TecniGen may cause side effects, although not everybody gets them. The following side effects have been reported with finasteride:
decrease in the amount of semen released during ejaculation, impotence (difficulty in achieving an erection, ejaculation disorders)
reduced sexual desire
palpitations
skin rashes, itching, and swelling of the lips or face
increased liver enzymes
breast enlargement or tenderness
testicular pain
depression
decreased libido that persists even after discontinuation of treatment
erectile dysfunction that persists even after discontinuation of treatment
Male infertility and/or poor semen quality. Improvement in semen quality has been reported after discontinuation of treatment.
You must promptly inform your doctor of any changes in your breast tissue, such as lumps, pain, breast enlargement, or nipple discharge, as these may be symptoms of a serious condition such as breast cancer.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride TecniGen

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines must not be disposed of 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 TecniGen contains

• The active substance is finasteride.
• The other components are:

Core
Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate (type A), pregelatinized corn starch, sodium docusate, yellow iron oxide (E172) and magnesium stearate.
Coating
OPADRY Y-1-7000 (hypromellose, titanium dioxide (E171), macrogol 400) and indigo carmine (E132).

Description of the appearance of Finasteride TecniGen and packaging contents
Blue, round, film-coated tablets.
Finasteride TecniGen is available in 5 mg tablets, packed in blisters in pack sizes of 10, 15, 28, 30, 50, 60 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TECNIMEDE – Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande, 2, Abrunheira
2710-089 Sintra - Portugal
Concessionaire for sale:
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI) - Italy
Responsible manufacturer for batch release:
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, nº11, Venda Nova, 2700 Amadora, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Finasterid Tecnimede 5 mg Filmtabletten
Italy: Finasteride TecniGen
Portugal: Finasterida Tecnilor
United Kingdom: Finasteride

This leaflet was last updated on