1 mg Film-coated tablets
finasteride
What Propecia is and what it is used for
Propecia contains the active substance finasteride.
Propecia should only be used by men.
Propecia 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, ask your doctor.
Male hair loss is considered to be caused by a combination of heredity and a special hormone called dihydrotestosterone ( DHT ). DHT helps to shorten the hair growth phase and to make the hair thinner.
Propecia 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 (not complete) hair loss can be expected to benefit from the use of Propecia. In most of the men who were treated with Propecia for 5 years, the hair loss was slowed down and at least half of these men also get some form of improved hair growth.
Finasteride contained in Propecia may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Propecia
Do not use Propecia
- if you are a woman (because this medicine is for men, see Pregnancy, breastfeeding, and fertility ). Clinical studies have shown that Propecia 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 Propecia.
Effects on prostate-specific antigen (PSA)
Propecia can affect a blood test called PSA (prostate-specific antigen ) which is used to detect prostate cancer. If you are taking a PSA test, you should tell your doctor or pharmacist that you are taking Propecia, as Propecia 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. No long-term studies have been performed regarding 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 the use of Propecia. If you experience any of these symptoms, stop taking Propecia and contact your doctor as soon as possible for further medical advice.
Children and young people
Propecia should not be used by children. No data are showing the efficacy or safety of finasteride in children younger than 18 years.
Other medicines and Propecia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding, and fertility
Propecia 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 Propecia due to the risk of pregnancy
- Women who are or are likely to become pregnant should also not handle crushed or split tablets
- due to possible uptake into the body or through the skin of the active substance in Propecia, the drug, if used by a woman carrying a male fetus, may inhibit the development of the fetus’ genitals
- If a pregnant woman comes in contact with the active substance in Propecia, consult a doctor
- The Propecia 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 is no data to suggest that Propecia affects the ability to drive or use machines.
Propecia 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.
Propecia contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Propecia
Always use 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 Propecia works for you. It is important to use Propecia for as long as your doctor prescribes it. Propecia can only work long-term if you continue to use it.
If you use more Propecia than you should
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. Propecia does not have a faster or better effect if you take more tablets than one a day.
If you forget to use Propecia
Do not take a double dose to make up for a forgotten tablet.
If you stop using Propecia
It can take 3 to 6 months before you get the full effect. You must continue to take Propecia for as long as your doctor prescribes the medicine for you. If you stop taking Propecia, 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 using Propecia and contact your doctor immediately if you experience 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 desire for sex
- difficult to get an erection
- ejaculation problems such as the decreased amount of semen during ejaculation
- Depression
No known frequency (can not be calculated from the available data)
- allergic reactions, such as rash and itching
- breast tenderness/breast augmentation
- testicular pain
- blood in the sperm
- palpitation
- residual erection problems after treatment
- residual decreased desire for sex after completion of treatment
- residual ejaculation problems after completion of treatment
- male infertility and/or poor sperm quality
- elevated liver values
- anxiety
How to store Propecia
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 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.
Contents of the pack and other information
Content declaration
- The active substance is finasteride. Each tablet contains 1 mg of finasteride.
- Other ingredients are Tablet core: 110.4 mg lactose monohydrate (see section 2), microcrystalline cellulose, pregelatinized maize starch, sodium starch glycollate, docusate sodium, magnesium stearate, Coating: talc, hypromellose, hydroxypropylcellulose, titanium dioxide (dye E171), yellow and red iron oxide (dye E172).
What the medicine looks like and the contents of the pack
- Propecia film-coated tablets are packaged in pressure packs.
- The tablet is a brown, octagonal, film-coated, convex tablet, marked with “P” on one side and PROPECIA on the other side.
- Pack sizes: 7, 28, 30, 84 or 98 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation Holder | Information provided by: |
| NV OrganonKloosterstraat 65349 AB OssNetherlands | Organon Sweden ABTel +46 8 502 597 00dpoc.sweden@organon.com |
| Manufacturer | |
| Merck Sharp & Dohme BV PO Box 581 2003 PC Haarlem Netherlands or Schering-Plow Labo NV Industrial Park 30 Heist-op-den-Berg, 2220 Belgium |
This medicine is approved in Finland, France, Greece, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, Germany, and Austria under the name Propecia.