Finasteride (Propecia) 1mg – Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents
- What Propecia is and what it is used for
- What you need to know before you take Propecia
- How to take Propecia
- Possible side effects
- How to store Propecia
- Contents of the pack and other information
1. What Propecia is and what it is used for
Propecia contains finasteride, which belongs to a group of medicines called Type II ‘5-alpha reductase inhibitors’. It is used to treat male pattern hair loss (androgenetic alopecia). Propecia increases hair growth on the scalp and prevents further hair loss in men with mild to moderate — but not complete — hair loss.
How does hair on the scalp grow?
Hair grows approximately 1 cm (half an inch) per month from follicles located under the skin. A single scalp hair:
- Grows continuously for 2–4 years (growth phase)
- Stops growing for 2–4 months (rest phase)
- Falls out — a new healthy hair then begins to grow and the cycle repeats
Because hairs are always at different stages of this cycle, it is normal to lose some scalp hair every day.
What is male pattern hair loss?
Male pattern hair loss is a common condition causing thinning of scalp hair, often resulting in a receding hairline and/or balding on the top of the head. It is caused by a combination of genetic factors and the hormone DHT (dihydrotestosterone). DHT shortens the growth phase and thins hair. These changes can begin in some men in their 20s and become more common with age. Long-standing hair loss may be permanent.
How does Propecia work?
Propecia lowers DHT levels in the scalp, helping to reverse the balding process by increasing hair growth and preventing further loss.
2. What you need to know before you take Propecia
Do NOT take Propecia if:
- You are a woman (this medicine is for men only; clinical trials have shown it does not work in women with hair loss)
- You are allergic to finasteride or any other ingredient (see Section 6)
- You are already taking finasteride or dutasteride for benign prostatic hyperplasia (BPH)
If any of the above apply to you, do not take Propecia. If you are unsure, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Propecia if you are going to have a PSA (prostate-specific antigen) blood test for prostate cancer, as Propecia can affect the result.
Effects on fertility
Infertility has been reported in men who took finasteride for a long time and had other risk factors affecting fertility. Improvement of seminal quality has been reported after stopping finasteride. Long-term clinical studies on fertility effects have not been conducted.
Breast cancer
Report any changes in your breast tissue to your doctor promptly — such as lumps, pain, enlargement or nipple discharge — as these may be signs of a serious condition, including breast cancer.
Mood alterations and depression
Depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients taking Propecia. If you experience any of these symptoms, stop taking Propecia and contact your doctor as soon as possible.
Children and adolescents
Propecia should not be used in children under 18. There are no data demonstrating efficacy or safety in this age group.
Other medicines and Propecia
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. Do not take Propecia if you are already taking finasteride or dutasteride for BPH. No information is available about combined use with minoxidil (another hair-loss treatment applied to the scalp).
Pregnancy, breast-feeding and fertility
Propecia is for men only.
- Women who are pregnant or planning to become pregnant must not touch crushed or broken tablets — the medicine may affect the baby’s sex organs. Whole tablets are coated to prevent contact during normal handling.
- If a pregnant woman comes into contact with crushed or broken tablets, speak to a doctor.
Driving and using machines
Propecia is not likely to affect your ability to drive, use tools or operate machinery.
Lactose content
Propecia contains lactose. If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Propecia
Always take this medicine exactly as your doctor or pharmacist has told you.
Recommended dose
One tablet each day, taken with or without food.
If you take more than you should
Contact your doctor immediately. Taking Propecia more than once a day will not make it work faster or better.
If you forget to take a dose
Do not take a double dose to make up for a forgotten one.
If you stop taking Propecia
It may take 3–6 months for the full effect to develop. Continue taking Propecia for as long as your doctor advises. If you stop, you are likely to lose any hair gained within 9–12 months.
4. Possible side effects
Like all medicines, Propecia can cause side effects, although not everybody gets them. Some side effects are temporary or disappear when treatment is stopped.
Stop taking Propecia and talk to your doctor immediately if you experience:
- Allergic reaction: swelling of lips, face, tongue or throat; difficulty swallowing; hives; breathing difficulties
- Depression: feelings of severe sadness and unworthiness
Uncommon side effects (may affect up to 1 in 100 people)
- Inability to have an erection (impotence)
- Decreased desire to have sex
- Problems with ejaculation (e.g. decrease in the amount of semen released — this does not appear to affect normal sexual function)
Side effects of unknown frequency
- Breast swelling or tenderness
- Palpitations (feeling your heartbeat)
- Changes in liver function (shown by a blood test)
- Pain in the testicles
- Blood in semen
- Persistent difficulty having an erection after stopping treatment
- Persistent decrease in sex drive after stopping treatment
- Persistent problems with ejaculation after stopping treatment
- Male infertility and/or poor quality semen
- Anxiety
If any side effect becomes serious, or if you notice any not listed here, tell your doctor or pharmacist. It helps to note what happened, when it started, and how long it lasted.
Effect on hair elsewhere on the body
Propecia does not affect hair on other parts of the body.
Reporting side effects
You can report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or by searching ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
Additional information: Propecia and prostate cancer
A clinical trial in men taking finasteride 5 mg (five times the Propecia dose) for 7 years found:
- Fewer men developed prostate cancer compared with those taking nothing
- A higher number of men had a high tumour grade score among those taking finasteride
- The effect of long-term use on tumours of this kind is unknown
Talk to your doctor if you would like more information about this trial or the tumour grading system.
5. How to store Propecia
- Keep out of the sight and reach of children
- Do not use after the expiry date printed on the carton (EXP)
- Keep in the original blister pack; do not transfer to another container
- Do not store above 30°C
- Do not dispose of via wastewater or household waste — ask your pharmacist how to dispose of medicines you no longer need
6. Contents of the pack and other information
What Propecia contains
Active substance: Finasteride 1 mg per tablet
Other ingredients: lactose, microcrystalline cellulose E460, pregelatinised maize starch, sodium starch glycollate, docusate sodium, magnesium stearate E572, hypromellose E464, hydroxypropyl cellulose E463, titanium dioxide, talc, yellow iron oxide E172, red iron oxide E172
What Propecia looks like and pack sizes
Tan, eight-sided, film-coated tablets marked with a ‘P’ logo on one side and ‘PROPECIA’ on the other. Available in blister packs of 28 or 84 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK
Manufacturer: Merck Sharp & Dohme Limited, Shotton Lane, Cramlington, Northumberland NE23 3JU, UK
This leaflet was last revised in May 2019. © Merck Sharp & Dohme Limited 2019. All rights reserved. PIL.PPC.18.UK.6468.WS-252