Finasteride 1 mg Tablet

• Keep this leaflet. You may want to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Finasteride Tablets are and what they are used for
2. What you need to know before you take Finasteride Tablets
3. How to take Finasteride Tablets
4. Possible side effects
5. How to store Finasteride Tablets
6. Contents of the pack and other information

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.

Finasteride Tablets lower 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.

• are a woman (because this medicine is for men). It has been shown in clinical trials that Finasteride Tablets do not work in women with hair loss.
• are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in Section 6).
• are already taking finasteride or dutasteride used for a prostate problem called benign prostatic hyperplasia (BPH).

Do not take Finasteride Tablets 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 Finasteride Tablets if:

• you are going to have a blood test for prostate cancer called PSA (prostate-specific antigen). This is because Finasteride Tablets can affect the result of this test.

Infertility has been reported in men who took finasteride for a 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 Finasteride Tablets. If you experience any of these symptoms stop taking Finasteride Tablets and contact your doctor for further medical advice as soon as possible.

Impaired sexual function that may contribute to mood alterations, including suicidal thoughts, has been reported in some patients. If you experience symptoms of impaired sexual function, contact your doctor for further medical advice. Your doctor may consider stopping the treatment (see section 4 below for more information about these side effects).

Impaired sexual function has also been reported without mood alterations or suicidal thoughts.

A patient card reminding of the above is provided with the package of Finasteride tablets

Finasteride Tablets should not be used in children. There is 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. Finasteride Tablets do not usually affect other medicines.

• Do not take Finasteride Tablets if you are already taking finasteride or dustasteride, used for a prostate problem called benign prostatic hyperplasia (BPH).
• No information is available about the use of Finasteride Tablets with minoxidil, another type of medicine for male pattern hair loss which is applied to the head.

Finasteride Tablets are for the treatment of male pattern hair loss in men only. For effects on fertility see section 2.

• Finasteride Tablets should not be taken by women.
• Do not touch crushed or broken Finasteride Tablets if you are a woman who is pregnant or planning to become pregnant (whole tablets are coated to stop contact with the medicine during normal use). This is because this medicine may affect the baby’s sex organs.
• If a woman who is pregnant comes into contact with crushed or broken Finasteride Tablets, speak to your doctor.

Finasteride Tablets are 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’.

If you take too many tablets by mistake, contact your doctor immediately. Finasteride Tablets will not work faster or better if you take it more than once a day.

• Do not take a double dose to make up for a forgotten dose.

It may take 3 to 6 months for the full effect to develop. It is important to keep taking Finasteride Tablets for as long as your doctor tells you. If you stop taking Finasteride Tablets, you are likely to lose the hair you have gained within 9 to 12 months.

• Symptoms of an allergic reaction: swelling of your lips, face, tongue and throat; difficulty swallowing; lumps under your skin (hives) and breathing difficulties. Stop taking Finasteride Tablets and talk to your doctor immediately.
• Depression (feeling of severe sadness and unworthiness).
• Suicidal thoughts

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

• you may be unable to have an erection (impotence)
• you may have less desire to have sex
• you may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function

Frequency not known:

• breast swelling or tenderness
• palpitations (feeling your heartbeat)
• changes in the way your liver is working, which can be shown by a blood test
• pain in the testicles
• blood in semen
• persistent difficulty having an erection after discontinuation of treatment
• persistent decrease in sex drive after discontinuation of treatment
• persistent problems with ejaculation after discontinuation of treatment
• male infertility and/or poor quality of semen
• anxiety
• Suicidal thoughts

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.

Finasteride Tablets do 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 Finasteride Tablets) for 7 years showed:

• the number of men who developed prostate cancer was lower in men taking finasteride compared with those taking nothing
• the number of men who had a high score in a tumour grading system was higher in some of those taking finasteride compared to those taking nothing
• the effect of long-term use of finasteride on tumours of this kind is unknown.

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.

• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, sodium starch glycollate(type A), lauroyl macrogoglycerides, magnesium stearate, purified water.
• Coating: hypromellose (E464), titanium dioxide (E171), polyethylene glycol/macrogol, yellow iron oxide (E172), red iron oxide (E172).

• Finasteride film-coated tablets are available as reddish brown, round biconvex, film-coated tablets, marked with a ‘F1’ on one side and plain on the other side.
• Finasteride film-coated tablets are supplied in blister packs of 12’s, 28’s, 30’s and 56’s tablets.