Finasteride 1mg tablets

• 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 is and what it is used for
2. What you need to know before you take Finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
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 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.

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

Do not take Finasteride 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 if:

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

Mood alterations and depression

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride. If you experience any of these symptoms stop taking Finasteride and contact your doctor for further medical advice as soon as possible.

Effects on fertility

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 effect of finasteride on fertility in men have not been conducted.

Breast cancer

See section 4.

Finasteride 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. Finasteride does not usually affect other medicines.

• Do not take Finasteride 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 with minoxidil, another type of medicine for male pattern hair loss which is applied to the head.

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

• Finasteride should not be taken by women.
• Do not touch crushed or broken tablets of Finasteride 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 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’.

If you take too many tablets by mistake,contact your doctor immediately. Finasteride 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 the forgotten tablet.

It may take 3 to 6 months for the full effect to develop. It is important to keep taking Finasteride as long as your doctor tells you. If you stop taking Finasteride, 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 and talk to your doctor immediately.
• Depression (feeling of severe sadness and unworthiness).

You should promptly report to your doctor any changes in the 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
• difficulty having an erection
• you may have problems with ejaculation for example decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function

Not known: frequency

• breast swelling or tenderness
• pain in the testicles
• blood in semen
• palpitations (feeling your heartbeat)
• 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
• changes in the way your liver is working, which can be shown by a blood test
• 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 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 finasteride) 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 finasteride.
• The other ingredients are:
  Tablet core: Lactose monohydrate, cellulose, microcrystalline, sodium starch glycolate, starch pregelatined [maize starch], docusate sodium, magnesium stearate
  Tablet coat: Hypromellose, hydroxy propyl cellulose, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).

Film-coated tablet

Brown coloured, octagonal, biconvex, film-coated tablets debossed with ‘J’ on one side and ‘81’ on the other side.

Finasteride film-coated tablets are available in white opaque PVC/PE/PVdC – Aluminium foil blister pack and HDPE bottle with polypropylene cap containing silica gel as desiccant.

Package size:

Blister pack: 28, 56, 84, & 98 film-coated tablets

HDPE bottle pack: 30 & 1000 film-coated tablets

Not all pack sizes may be marketed

or