1 mg Film-coated tablets
finasteride
WHAT PROSPERED IS AND WHAT IT IS USED FOR
Prosteride contains the active substance finasteride.
Prosteride should only be used by men.
Prosteride is used to treat male pattern baldness (so-called androgenic alopecia ) in men aged 18-41 years. If you have any questions about male pattern baldness after reading this leaflet, talk to your doctor.
Male hair loss is a common condition that is considered to be caused by a combination of hereditary factors and a special hormone called dihydrotestosterone ( DHT ). DHT helps to shorten the hair growth phase and to make the hair thinner.
Prosteride lowers DHT levels, especially on the scalp, by blocking an enzyme (Type II 5-alpha reductase) that converts testosterone to DHT. Only men with mild to moderate, but not complete, hair loss can be expected to benefit from the use of Prosteride. In most of the men who were treated with Prosteride for 5 years, the hair loss was slowed down and at least half of these men also had some form of improved hair growth.
Finasteride contained in Prosteride may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before taking Prosteride
Do not use Prosteride
- if you are a woman (as this medicine is for men, see the section on Pregnancy, breastfeeding, and fertility ). Clinical studies have shown that Prosteride does not work in female hair loss.
- if you are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Prosteride.
Effects on prostate-specific antigen (PSA)
Prosteride can affect a blood test called PSA (prostate-specific antigen ) which is used to detect prostate cancer. If you are having a PSA test, you should tell your doctor or pharmacist that you are taking Prosteride, as Prosteride lowers PSA levels.
Effects on fertility
Infertility has been reported among men who took finasteride for a long time and who had other national factors that may affect fertility. Normalization or improvement in sperm quality has been reported after the completion of finasteride treatment. There have been no long-term clinical studies on the effect of finasteride on male fertility.
Breast cancer
See section 4.
Mood swings and depression
Mood swings such as depression, and, less commonly, suicidal ideation have been reported with finasteride. If you experience any of these symptoms, stop taking Prosteride and contact your doctor as soon as possible for further medical advice.
Children and young people
Prosteride should not be used by children. No data are showing the efficacy or safety of finasteride in children younger than 18 years.
Other Drugs and Prosteride
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
Prosteride should only be used by men for the treatment of male pattern baldness. For effects on male fertility, see section 2.
- Women should not use Prosteride due to the risk of pregnancy.
- Women who are or may be pregnant should not handle crushed or divided tablets.
- If the active substance in Prosterid is absorbed by the body after swallowing or through the skin of a woman carrying a male fetus, the development of the baby’s genitals may be inhibited.
- If a pregnant woman comes in contact with the active substance in Prosteride, consult a doctor.
- The Prosteride tablets are film-coated, which protects against contact with the active substance of the medicine during normal use.
Contact your doctor if you have any questions.
Driving and using machines
There are no data to suggest that Prosterid affects the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Prosteride contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Prosteride contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘ sodium-free. is next to “sodium-free”.
HOW TO USE PROSTERID
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet a day. The tablet can be taken with or without food.
Your doctor will help you determine if Prosteride is working for you. It is important to use Prosteride for as long as your doctor prescribes it. Prosteride can only work long-term if you continue to use it.
If you use more Prosteride than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice. Prosteride does not have a faster or better effect if you take more tablets than one a day.
If you forget to take Prosteride
Do not take a double dose to make up for a forgotten tablet.
If you stop using Prosteride
It can take 3 to 6 months before you get the full effect. You must continue to take Prosteride for as long as your doctor tells you to. If you stop taking Prosteride, you will probably lose the hair you regained within 9 to 12 months.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects observed have usually been transient in those who continued the treatment or disappeared when the treatment was stopped.
Stop taking Prosteride and contact a doctor immediately if you get any of the following symptoms: swelling of the lips, face, tongue, or throat, difficulty swallowing, lumps under the skin (hives), and difficulty breathing.
Contact your doctor as soon as possible if you notice changes in the breasts such as lumps, pain, enlarged breasts, or discharge from the nipple, as this may be a sign of a serious condition such as breast cancer.
Uncommon: may affect up to 1 in 100 people
- decreased sex drive
- difficult to get an erection
- ejaculation problems such as the decreased amount of semen during ejaculation
- Depression
Has been reported: occurs in an unknown number of users
- allergic reactions, such as rash and itching
- breast enlargement or breast tenderness
- testicular pain
- blood in the sperm
- palpitation
- residual erection problems after treatment
- residual decreased sexual desire after completion of treatment
- residual ejaculation problems after completion of treatment
- male infertility and/or poor sperm quality
- elevated liver values
- anxiety
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.
The Medical Products Agency
Box 26
751 03 Uppsala
Website: www.lakemedelsverket.se
HOW TO STORE PROSPERED
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 carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
FURTHER INFORMATION
Content declaration
- The active substance is finasteride. Each tablet contains 1 mg of finasteride.
- Other ingredients are:
Tablet core: lactose monohydrate, pregelatinized maize starch, docusate sodium, yellow iron oxide (E172), sodium starch glycolate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate (E470b).
Tablet coating: hydroxypropylcellulose, hypromellose, talc, titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
– Prosteride film-coated tablets are packaged in blisters.
– The tablets are round, biconvex, red film-coated tablets with a nominal diameter of 6.5 mm.
Pack sizes: 14, 20, 28, 30, 50, 60, 84, 98 or 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
2care4 Generics ApS
Stenhuggervej 12-14
6710 Esbjerg V
Denmark
Manufacturer
Genepharm SA
18 km Marathon Avenue
15351 Pallini Attikis
Greece