FINASTERIDE 1 мг Фильм-coated таблетки

Содержание инструкции

1. Finasteride Mylan Generics Italia 1 mg film-coated tablets
   1. What is Finasteride Mylan Generics Italia and what is it used for
   2. Before taking Finasteride Mylan Generics Italia
   3. How to take Finasteride Mylan Generics Italia
   4. Possible side effects
   5. How to store Finasteride Mylan Generics Italia
   6. Package Contents and Other Information

Finasteride Mylan Generics Italia 1 mg film-coated tablets

finasteride

Generic Medicine
Read this leaflet carefully before taking 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 Mylan Generics Italia is and what it is used for
• 2. What you need to know before you take Finasteride Mylan Generics Italia
• 3. How to take Finasteride Mylan Generics Italia
• 4. Possible side effects
• 5. How to store Finasteride Mylan Generics Italia
• 6. Contents of the pack and other information

1. What is Finasteride Mylan Generics Italia and what is it used for

Finasteride belongs to a group of medicines called 5-alpha-reductase inhibitors. It can be used
to treat hair loss in men.
Your doctor has prescribed Finasteride because you have male pattern baldness (also known as androgenetic
alopecia). Finasteride prevents further hair loss in men. Men with mild or
moderate, but not complete hair loss, may benefit from using Finasteride. Finasteride blocks an important enzyme (Type II 5α-reductase), which is involved in the regulation of the
hair follicle.
In the scalp, finasteride specifically lowers levels of DHT, a major cause of
hair loss. In this way, finasteride helps to reverse the process of baldness and prevent
further hair loss.

2. Before taking Finasteride Mylan Generics Italia

Do not take Finasteride Mylan Generics 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 child or adolescent.
• if you are a woman (see also “Pregnancy and breastfeeding”). In clinical studies, finasteride has proven to be ineffective in the treatment of hair loss (androgenic alopecia) in women.
• if you are already taking finasteride or any other 5α-reductase inhibitor (e.g. dutasteride) for an enlarged prostate (benign prostatic hyperplasia (BPH)) or any other condition.

Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride:

• if you intend to have a child (father of a child), as this medicine may affect the

During treatment
The medicine may affect the results of a blood test used to detect changes in the
prostate, including the development of prostate cancer. If you are planning to have a blood test, remind your
doctor, nurse or hospital staff that you are taking this medicine.
It has also been reported that Finasteride increases the risks of changes in the chest (breast) of men
taking this medicine. You should immediately report to your doctor any changes
in your breast tissue, such as lumps, pain, breast tissue enlargement or nipple discharge, as these may be symptoms of a serious illness, such as breast cancer.
Changes in mood and depression
Changes in mood, such as depressed mood, depression, and, less frequently, suicidal thoughts are
reported in patients treated with Finasteride Mylan Generics Italia. If you experience any of these
symptoms, contact your doctor as soon as possible for further information.

Children and adolescents
Do not give this medicine to children and adolescents under the age of 18 years.

Other medicines and Finasteride Mylan Generics Italia
Usually finasteride does not interfere with other medicines. Tell your doctor or pharmacist
if you are taking, have recently taken or might take any other medicines, including
those available without a prescription.
There is no information available on the use of finasteride together with topical minoxidil (applied to the
skin) in male pattern baldness. The combination is not recommended.

Pregnancy
Finasteride is intended for use only in men. If a woman takes it during pregnancy, it may
alter the normal development of the sex organs of a male fetus. Broken or
crushed tablets should not be handled by a pregnant woman due to the risk of
absorption of finasteride into the body.
Finasteride has been found in the semen of men who used the medicine. If your sexual partner is
pregnant, you should use a condom to avoid exposing her to your semen, which may contain
finasteride. Ask your doctor if you have any doubts.

Fertility
If you intend to have a child (father of a child), talk to your doctor or pharmacist before
taking finasteride, as the medicine may alter male fertility or sexual activity. See the
side effects that may affect you.

Breastfeeding
Finasteride is not prescribed to women. It is not known whether it is excreted in breast milk.

Driving and using machines
Finasteride should not alter your ability to drive vehicles or use machines.

Finasteride Mylan Generics Italia contains lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

Finasteride Mylan Generics Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take Finasteride Mylan Generics Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:

Adults
Swallow one tablet a day, with or without food.
In some patients, up to 6 months may be necessary to observe an improvement. Long-term use is recommended.
If you stop treatment, the beneficial effect will begin to disappear after 6 months
and will cease completely after 9-12 months.
Taking more than one tablet a day does not improve the effect of the medicine.

Patients with liver problems
There is no experience on the use of finasteride in patients with liver problems.

Patients with kidney problems
No dosage adjustment is necessary in patients with kidney problems

If you take more Finasteride Mylan Generics Italiathan you should
If you take more Finasteride Mylan Generics Italia than you should, inform your doctor or go to the
nearest hospital emergency room. Take the package and any remaining tablets with you.

If you forget to take Finasteride Mylan Generics Italia
If you forget to take Finasteride Mylan Generics Italia do not take a double dose to make up
for the missed dose. Take the next tablet according to the usual schedule.

If you stop taking Finasteride Mylan Generics Italia
If you stop taking Finasteride Mylan Generics Italia, you are likely to lose the hair that had
grown back within the next 12 months.
If you have any doubts about the use of Finasteride Mylan Generics Italia, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some of these side effects have generally been temporary with the continuation of treatment or
disappeared when the treatment was stopped.
The following side effects are important and require immediate action if they occur.

Stop treatment with this medicine and immediately inform your doctoror go to the
nearest hospital emergency room if you have the following symptoms:

• swelling of the face, lips, tongue or throat
• difficulty swallowing
• a skin rash, itching, lumps under the skin (urticaria)
• difficulty breathing.

If you notice any of the following symptoms, contact your doctor immediately:

• lumps, pain, thickening of breast (chest) tissue or nipple discharge. Thesemay be signs of a serious condition such as breast cancer.The following side effects have been reported:

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

• decreased sexual desire
• erectile dysfunction
• problems with ejaculation, such as a decrease in the volume of ejaculate
• depression.

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

• testicular pain
• blood in semen
• palpitations
• persistent difficulty achieving an erection after stopping treatment
• infertility has been reported in men who have taken finasteride for a long time and had other risk factors that may affect fertility. Normalization or improvement in semen quality has been reported after discontinuation of treatment. Long-term clinical studies on the effects of finasteride on fertility in men have not been conducted.
• changes in liver function, which may be revealed by a blood test.
• anxiety.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://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 Mylan Generics Italia

Keep this medicine out of the sight and reach of children .
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”. The expiry
date refers to the last day of the month.
Store in the original packaging to protect it from light.
Do not dispose of any medicine in 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 Mylan Generics Italia contains

• The active ingredient is finasteride. One film-coated tablet contains 1 g of finasteride.
• The other ingredients are: sodium docusate, magnesium stearate, microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, sodium starch glycolate, povidone. The tablet coating contains: yellow and red iron oxide (E172), titanium dioxide (E171), hypromellose, talc and hydroxypropylcellulose.

Description of the appearance of Finasteride Mylan Generics Italia and package contents
The medicine is presented in the form of film-coated tablets, brown, biconvex, round in blisters
in packs of 7, 14, 28, 30, 60, 84, 90 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan

Manufacturer:
Generics [UK] Ltd, Station Close, Potters Bar, Herts EN6 1AG, United Kingdom
McDermott Laboratories Ltd. t/a Gerard Laboratories, 35-36 Baldoyle Industrial Estate
Grange Road Dublin 13 Ireland
Mylan Dura, Alsfelder Str. 19, 64289 Darmstadt, Germany
Mylan SAS, ZAC des Gaulnes, 10 boulevard de Lattre de Tassigny, 69330 Meyzieu, France
Mylan SAS, 34 rue Saint Romain, 69359 Lyon Cedex 08, France
Mylan BV, Dieselweg 25, 3752 LB Bunschoten, Netherlands