PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride Teva Generics 1 mg film-coated tablets

Generic medicine
Please read 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

1. What Finasteride Teva Generics is and what it is used for

Finasteride Teva Generics 1 mg film-coated tablets contain a medicine called finasteride.
Finasteride is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). If, after reading this leaflet, you have any doubts about male pattern hair loss, 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). DHT contributes to shortening the growth phase of hair and to hair thinning.
In the scalp, Finasteride Teva Generics specifically reduces DHT concentrations by blocking an enzyme (called type II 5-alpha reductase) that converts testosterone into DHT. Only men with mild to moderate, but not complete, hair loss may benefit from using Finasteride Teva Generics. In most men treated with finasteride for 5 years, progression of hair loss has been slowed, and at least half of these individuals have experienced improved hair growth.

2. What you need to know before taking Finasteride Teva Generics

Do not take Finasteride Teva Generics 1 mg film-coated tablets

if you are a woman (as this medicine is intended for men only, see section on Pregnancy). Clinical studies have shown that finasteride is not effective in women with hair loss.
if you are allergic (hypersensitive) to finasteride or to any of the excipients of this medicine (listed in section 6). If in doubt, consult your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Teva Generics 1 mg film-coated tablets

Finasteride Teva Generics must not be taken by children or adolescents under 18 years of age.
If you are due to have a blood test to measure prostate-specific antigen (PSA), inform your doctor or pharmacist that you are taking Finasteride Teva Generics, as this medicine may affect the test results.
Inform your doctor or pharmacist about any medical conditions you currently have or have had in the past, and about any allergies.

Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride 1 mg film-coated tablets. If you experience any of these symptoms, stop taking Finasteride 1 mg film-coated tablets and contact your doctor as soon as possible for further advice.

Other medicines and Finasteride Teva Generics 1 mg film-coated tablets
Finasteride Teva Generics can usually be taken together with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.

Finasteride Teva Generics 1 mg film-coated tablets with food and drink
Finasteride Teva Generics may be taken with or without food.

Pregnancy and breastfeeding

Finasteride Teva Generics is intended only for the treatment of hair loss in men.
Women must not take Finasteride Teva Generics due to the risk during pregnancy.
Pregnant women, or those who suspect they might be pregnant, must not handle crushed or broken Finasteride Teva Generics tablets.
If the active substance in Finasteride Teva Generics is absorbed orally or through the skin by a woman pregnant with a male fetus, it may cause abnormalities in the baby's genital organs.
If a pregnant woman comes into contact with the active substance in Finasteride Teva Generics, she should consult a doctor.
Finasteride Teva Generics tablets are film-coated, which prevents contact with the active substance during normal handling.

If your sexual partner is or could be pregnant, you should avoid exposing her to your semen (for example, by using a condom).
If you have any doubts, consult your doctor.

Driving and using machines
It is not known, nor is it expected, that finasteride affects the ability to drive vehicles or operate machinery.

Finasteride Teva Generics 1 mg film-coated tablets contain lactose
Patients with lactose intolerance should be aware that Finasteride Teva Generics 1 mg film-coated tablets contain lactose. If you know you are intolerant to certain sugars, ask your doctor for advice before taking this medicine.

3. How to take Finasteride Teva Generics

Always take Finasteride Teva Generics exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet per day.
The tablets can be taken with or without food.
Finasteride Teva Generics does not work faster or better if more tablets are taken each day.
Your doctor will help you determine whether Finasteride Teva Generics is working for you. It is important that you take Finasteride Teva Generics for the length of time prescribed by your doctor. Finasteride Teva Generics only works if taken continuously over a long period.

Use in children and adolescents
Finasteride must not be used in children. There are no data demonstrating the efficacy or safety of finasteride in children under 18 years of age.

If you take more Finasteride Teva Generics than you should
If you take too many tablets by mistake, inform your doctor immediately.

If you forget to take Finasteride Teva Generics
If you forget to take a tablet, skip the missed dose. Take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Finasteride Teva Generics
It may take 3 to 6 months to achieve the optimal effect of the medicine. It is important that you continue taking Finasteride Teva Generics for the full duration prescribed by your doctor. If you stop taking Finasteride Teva Generics, you will likely lose the hair you have regained within 9–12 months.

If you have any questions about how to use the medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Finasteride Teva Generics and contact your doctor immediately if you experience any of the following symptoms (angioedema):
swelling of the face, tongue or throat
difficulty swallowing
hives
difficulty breathing

Side effects have generally been transient during continued treatment or disappeared when treatment was stopped.

Uncommon side effects (may affect up to 1 in 100 people)

Decreased sexual desire
Difficulty in achieving an erection
Problems related to ejaculation, for example reduced amount of semen produced
Depression

Frequency not known

Allergic reactions such as skin rash, itching, lumps under the skin (urticaria), and angioedema (including swelling of the lips, tongue, throat and face)
Swelling or tenderness of the breast
Testicular pain
Increased heart rate
Anxiety
Persistent difficulty in achieving an erection after stopping treatment
Persistent erectile dysfunction after stopping treatment
Persistent ejaculation problems after stopping treatment
Infertility has been reported in men who have taken finasteride for a long time and who had other risk factors that could affect fertility. After stopping finasteride treatment, normalization or improvement in semen quality has been reported. Long-term clinical studies on the effect of finasteride on male fertility have not been conducted.
Increased liver enzymes

If you notice any changes in breast tissue, such as lumps, pain, breast enlargement or nipple discharge, you must inform your doctor immediately, as these could be symptoms of a serious disease, such as breast cancer.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Finasteride Teva Generics

Keep this medicine out of the sight and reach of children.
Do not use Finasteride Teva Generics after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Teva Generics contains

The active substance is finasteride.
The excipients are monohydrate lactose, pregelatinized maize starch, sodium lauryl sulfate, sodium starch glycolate (type A), povidone, microcrystalline cellulose, magnesium stearate, hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, red iron oxide (E172) and yellow iron oxide (E172).

Description of the appearance of Finasteride Teva Generics and package contents

Finasteride Teva Generics 1 mg film-coated tablets are brown and round. The tablets have the imprint “FNT1” engraved on one side and are smooth on the other side.
The product is available in blister packs containing 7, 28, 30, 50 (hospital pack), 84, 98 and 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy
Manufacturers
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)
TEVA UK Ltd
Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG (United Kingdom)
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem (Netherlands)
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren (Germany)