The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00025/0351.
Propecia 1mg tablets
Propecia® 1 mg film-coated Tablets
This medicine is for use in men only
1. What Propecia is and what it is used for
2. What you need to know before you take Propecia
3. How to take Propecia
4. Possible side effects
5. How to store Propecia
6. Contents of the pack and other information
Propecia contains a medicine called finasteride. This belongs to a group of medicines called Type II ‘5-alpha reductase inhibitors’.
Propecia is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). Propecia increases hair growth on the scalp and prevents further hair loss in men. Men with mild to moderate, but not complete hair loss, can benefit from using Propecia.
On average your hair grows about 1 centimetre (half an inch) each month. Hair grows from hair follicles, which are located under your skin.
A single scalp hair grows continuously for 2-4 years (growth phase) and then stops growing for 2-4 months (rest phase). After this the hair falls out. In its place a new healthy hair begins to grow, and the cycle is repeated. The hairs on your scalp are always in different stages of this cycle so it is normal to lose scalp hair every day.
Male pattern hair loss is a common condition in which men experience thinning of the hair on the scalp, often resulting in a receding hairline and/or balding on the top of the head. This condition is thought to be caused by a combination of genetic factors and a particular hormone, DHT (dihydrotestosterone).
DHT causes a decrease in the growth phase and thinning of the hair (see picture). This leads to male pattern hair loss. These changes can start to occur in some men in their 20s and become more common with age. Once hair loss has occurred over a long period of time, the hair may be permanently lost.
Propecia lowers the levels of DHT in the scalp. This helps to reverse the balding process, leading to an increased hair growth and prevention of further hair loss.
Do not take Propecia if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Talk to your doctor or pharmacist before taking Propecia if:
Infertility has been reported in men who took finasteride for long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride. Long-term clinical studies about the effects of finasteride on fertility in men have not been conducted.
See section 4.
Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Propecia. If you experience any of these symptoms stop taking Propecia and contact your doctor for further medical advice as soon as possible.
Propecia should not be used in children. There are no data demonstrating efficacy or safety of finasteride in children under the age of 18.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Propecia does not usually affect other medicines.
Propecia is for the treatment of male pattern hair loss in men only. For effects on fertility see section 2.
Propecia is not likely to affect you being able to drive, use tools or machines.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you take too many tablets by mistake, contact your doctor immediately. Propecia will not work faster or better if you take it more than once a day.
It may take 3 to 6 months for the full effect to develop. It is important to keep taking Propecia for as long as your doctor tells you. If you stop taking Propecia, you are likely to lose the hair you have gained within 9 to 12 months.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement or nipple discharge as these may be signs of a serious condition, such as breast cancer.
Uncommon: may affect up to 1 in 100 people
If any of these side effects gets serious, or if you notice any side effects not listed on this leaflet please tell your doctor or pharmacist. It will help if you make a note of what happened, when it started and how long it lasted.
Propecia does not affect hair on other parts of the body.
Finasteride can also be used for a type of prostate problem called ‘benign prostatic hyperplasia’ or BPH. Information collected from a clinical trial in men taking finasteride 5 mg (a dose 5 times higher than Propecia) for 7 years showed:
If you would like further information about the tumour grading system or this trial, please talk to your doctor.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 the letters EXP. The expiry date refers to the last day of that month.
Do not put the tablets into another container, they might get mixed up. Do not remove the tablet from the pack until you are ready to take it.
Do not store above 30°C. Keep them in the original package.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
The Marketing Authorisation Holder is
The Manufacturer of the tablets is
This leaflet was last revised in February 2021.
© Organon Pharma (UK) Limited 2021. All rights reserved.