Finasteride Mylan Generics Italia
Italy
Table of Contents
Package leaflet: Information for the user
Finasteride Mylan Generics Italia 1 mg film-coated tablets
finasteride
Generic medicinal product
Read this leaflet carefully before 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 others, even if they have the same symptoms as yours, as 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:
- What Finasteride Mylan Generics Italia is and what it is used for
- What you need to know before taking Finasteride Mylan Generics Italia
- How to take Finasteride Mylan Generics Italia
- Possible side effects
- How to store Finasteride Mylan Generics Italia
- Contents of the pack and other information
1. What Finasteride Mylan Generics Italia is and what it is 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 to moderate, but not complete, hair loss may benefit from using Finasteride. Finasteride blocks an important enzyme (Type II 5α-reductase), which is involved in regulating the hair follicle.
In the scalp, finasteride particularly reduces levels of DHT, one of the main causes of hair loss. In this way, finasteride helps to reverse the balding process 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 female (see also “Pregnancy and breastfeeding”). In clinical studies, finasteride proved ineffective in treating hair loss (androgenetic 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 are planning to have a child (as a father), since this medicine may affect male fertility or sexual function (see the "Fertility" section later in this leaflet).
During treatment
This 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 scheduled for a blood test, remember to inform your doctor, nurse, or hospital staff that you are taking this medicine.
Finasteride has also been reported to increase the risk of changes in the male breast tissue. You must immediately report to your doctor any changes in your breast tissue, such as lumps, pain, enlargement of breast tissue, or nipple discharge, as these may be symptoms of a serious disease, including breast cancer.
Mood changes and depression
Mood changes such as depressed mood, depression, and, less frequently, suicidal thoughts have been 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 advice.
In some patients, impaired sexual function has been reported, which may contribute to mood changes, including suicidal thoughts. If you experience symptoms of impaired sexual function, contact your doctor for further advice. Your doctor may consider discontinuing treatment (see section 4 for more information on these side effects).
A patient reminder card containing the above information is provided in the packaging of Finasteride Mylan Generics Italia.
Children and adolescents
Do not give this medicine to children or adolescents under 18 years of age.
Other medicines and Finasteride Mylan Generics Italia
Finasteride usually does not interfere with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
There is no information available on the use of finasteride together with topical minoxidil (applied to the skin) for male pattern baldness. The combination is not recommended.
Pregnancy
Finasteride is intended for use in men only. If a woman takes it during pregnancy, it may alter the normal development of the genital organs of a male fetus. Crushed or broken tablets must not be handled by pregnant women due to the risk of absorption of finasteride through the skin.
Finasteride has been found in the semen of men taking the medicine. If your sexual partner is pregnant, you must use a condom to avoid exposing her to semen that may contain finasteride. Ask your doctor if you have any doubts.
Fertility
If you are planning to have a child (as a father), talk to your doctor or pharmacist before taking finasteride, as the medicine may affect male fertility or sexual function. See section 4 "Possible side effects" later in this leaflet for more information on side effects that may affect you.
Breast-feeding
Finasteride is not prescribed for women. It is not known whether it is excreted in breast milk.
Driving and using machines
Finasteride should not affect your ability to drive or operate machinery.
Finasteride Mylan Generics Italia contains lactose monohydrate.
If your doctor has informed you that you have an intolerance to certain 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 exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults
Take one tablet daily, with or without food.
In some patients, it may take up to 6 months to observe an improvement. Long-term use is recommended.
If treatment is stopped, the beneficial effect begins to disappear after 6 months and ceases completely after 9–12 months.
Taking more than one tablet per day does not improve the effect of the medicine.
Patients with liver problems
There is no experience regarding the use of finasteride in patients with liver problems.
Patients with kidney problems
No dose adjustment is necessary in patients with kidney problems.
If you take more Finasteride Mylan Generics Italia than you should
If you take more Finasteride Mylan Generics Italia than you should, inform your doctor or go to the
nearest hospital emergency department. 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 at your usual time.
If you stop treatment with Finasteride Mylan Generics Italia
If you stop treatment with Finasteride Mylan Generics Italia, you are likely to lose the hair that had grown back within the following 12 months.
If you have any questions about the use of Finasteride Mylan Generics Italia, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some of these side effects have generally been temporary upon continuation of treatment or disappeared when treatment was discontinued.
The following side effects are important and require immediate action if they occur.
Stop taking this medicine and contact your doctor immediately or go to the emergency department of the nearest hospital if you experience any of the following symptoms:
- swelling of the face, lips, tongue or throat
- difficulty swallowing
- a skin rash, itching, lumps under the skin (urticaria)
- difficulty breathing
- suicidal thoughts.
If you notice any of the following symptoms, contact your doctor immediately:
- lumps, pain, swelling of breast tissue or nipple discharge. These may 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 reduced ejaculate volume
- depression.
Not known (frequency cannot be estimated from the available data):
- testicular pain
- blood in the semen
- palpitations
- persistent difficulty in achieving an erection after stopping treatment
- 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 of semen quality has been reported after discontinuation of treatment. Long-term clinical studies on the effects of finasteride on male fertility have not been conducted.
- changes in liver function, which may be revealed by a blood test.
- 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 the following address: 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 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 Mylan Generics Italia contains
- The active substance is finasteride. One film-coated tablet contains 1 g of finasteride.
- The other components are: sodium docusate, magnesium stearate, microcrystalline cellulose, lactose monohydrate, pregelatinized corn starch, sodium starch glycolate, povidone. The tablet coating contains: iron oxide yellow and red (E172), titanium dioxide (E171), hypromellose, talc, and hydroxypropylcellulose.
Description of the appearance of Finasteride Mylan Generics Italia and package contents
The medicine is presented as film-coated, brown, biconvex, round tablets in blisters
in packs containing 7, 14, 28, 30, 60, 84, 90 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Manufacturer:
McDermott Laboratories Ltd. t/a Gerard Laboratories, 35-36 Baldoyle Industrial Estate
Grange Road Dublin 13, Ireland
Mylan Hungary Kft,
H-2900 Komárom, Mylan utca 1, Hungary