FINASTERIDE 1 мг Фильм-coated таблетки

Содержание инструкции

1. Finasteride Teva Generics 1 mg film-coated tablets
   1. What you need to know before taking Finasteride Teva Generics
   2. How to take Finasteride Teva Generics
   3. Possible side effects
   4. How to store Finasteride Teva Generics
   5. Contents of the pack and other information

Finasteride Teva Generics 1 mg film-coated tablets

Generic medicine
Read this leaflet carefully before using this medicine as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 contains a medicine called finasteride.
• Finasteride is used for the treatment of male pattern hair loss (also called androgenetic alopecia

maschile, consult your doctor.

• Male pattern hair loss is a common condition believed to be caused by a combination of genetic factors and a particular hormone called dihydrotestosterone (DHT). DHT contributes to the reduction of the hair growth phase and thinning.
• In the scalp, Finasteride Teva Generics specifically lowers 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 can benefit from the use of Finasteride Teva Generics. In most men treated with finasteride for 5 years, the progression of hair loss is slowed down and at least half of these individuals have experienced an improvement in 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, see the Pregnancy section). Clinical studies have shown that finasteride does not work in women affected by hair loss.
• if you are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in section 6). If you are unsure, ask your doctor or pharmacist.

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

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

Changes in mood and depression
Changes in mood, 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 1mg film-coated tablets and contact
your doctor as soon as possible for further information.

Other medicines and Finasteride Teva Generics 1 mg film-coated tablets
Usually, Finasteride Teva Generics can be taken with other medicines. Tell your doctor or
pharmacist if you are taking or have recently taken any other medicines, including those without
prescription.

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

Pregnancy and breastfeeding

• Finasteride Teva Generics is intended for the treatment of hair loss in men only.
• Women must not take Finasteride Teva Generics due to the risk in pregnancy.
• Pregnant or potentially pregnant women must not touch broken or crushed Finasteride Teva Generics tablets.
• If the active ingredient of Finasteride Teva Generics is absorbed after oral use or through the skin by a pregnant woman carrying a male fetus, this may cause abnormalities of the sexual organs of the newborn.
• If a pregnant woman comes into contact with the active ingredient of Finasteride Teva Generics, she should consult a doctor.
• Finasteride Teva Generics tablets are film-coated and prevent contact with the active ingredient during normal use.

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

Driving and using machines
It is not known or expected that finasteride will affect the ability to drive vehicles or use
machinery.

Finasteride Teva Generics 1 mg film-coated tablets contains lactose
Patients intolerant to lactoseshould note that Finasteride Teva Generics 1 mg film-coated tablets contains lactose. If you know you are intolerant to some sugars, ask your doctor for advice before
taking this medicine.

3. How to take Finasteride Teva Generics

Always take Finasteride Teva Generics exactly as your doctor has instructed. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one tablet a day.
The tablets can be taken with or without food.
Finasteride Teva Generics does not work faster or better if you take more tablets a day.
Your doctor will help you determine if Finasteride Teva Generics is working for you. It is important that you take
Finasteride Teva Generics for the duration prescribed by your doctor. Finasteride Teva Generics only works if
it is taken consistently for a long period.

Use in children and adolescents
Finasteride should not be used in children. There is no data to demonstrate the efficacy or safety of
finasteride in children under the age of 18 years.

If you take more Finasteride Teva Generics than you should
If you accidentally take too many tablets, 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 one at the scheduled time.
Do not take a double dose to make up for a missed 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 to take Finasteride Teva Generics for the entire duration prescribed by your doctor. If you stop
taking Finasteride Teva Generics, you will likely lose any hair you have regained within 9-12 months.
If you have any doubts about the use of the medicine, consult 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 have disappeared
after stopping treatment.

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

• Decreased sexual desire
• Difficulty getting an erection
• Problems related to ejaculation, such as reduced amount of semen produced Depression Frequency not known
• Allergic reactions such as rash, itching, lumps under the skin (urticaria) and angioedema (including swelling of the lips, tongue, throat and face)
• Breast enlargement or tenderness
• Testicular pain
• Increased heart rate
• Anxiety
• Persistent difficulty getting 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 period and who had other risk factors that could affect fertility. After stopping treatment with finasteride, normalization or improvement of semen quality has been reported. Long-term clinical studies on the effect of finasteride on fertility in men have not been conducted.
• Increased liver enzymes

If you notice any changes in breast tissue, such as lumps, pain, breast enlargement or
discharge from the nipples, you should inform your doctor immediately as these could be
symptoms of a serious illness, such as breast cancer.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system 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 which is stated on the blister and the carton. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Finasteride Teva Generics contains

• The active ingredient is finasteride.
• The excipients are lactose monohydrate, pregelatinized corn 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 iron

oxide yellow (E172).

Description of the appearance of Finasteride Teva Generics and contents of the pack

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milano

Manufacturer
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)