FINASTERIDE 1 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Package leaflet: Information for the user Finasteride 1 mg film-coated tablets

This medicine is for use in men only.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

► Keep this leaflet. You may need 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.

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The name of your medicine is Finasteride 1 mg film-coated tablets but it will be referred to as ‘Finasteride’ throughout this leaflet.

What is in this leaflet:

• 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

1. what finasteride is and what it is used for

Finasteride belongs to a group of medicines called Type II ‚5-alpha reductase inhibitors‘. Finasteride is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). Finasteride 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 Finasteride.

How does the hair on your head grow?

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.

What is male pattern hair loss?

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.

MALE PATTERN HAIR LOSS

How does Finasteride work?

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.

2. what you need to know before you take finasteridedo not take finasteride► 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.

Warnings and precautions

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 Finasteride can affect the result of this test.

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

Breast Cancer

See section 4.

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.

Children and adolescents

Finasteride should not be used in children. There are no data demonstrating efficacy or safety of finasteride in children under the age of 18.

Other medicines and Finasteride

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.

Pregnancy, breast-feeding and fertility

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

► Finasteride 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.

Driving and using machines

Finasteride is not likely to affect you being able to drive, use tools or machines.

Finasteride 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.

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‚sodium-free‘.

3. how to take finasteride

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• ► The recommended dose is one tablet each day. The tablet can be taken with or without food.

If you take more Finasteride than you should

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.

If you forget to take Finasteride

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

If you stop taking Finasteride

It may take 3 to 6 months for the full effect to develop. It is important to keep taking Finasteride for 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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.

Stop taking Finasteride and talk to your doctor if you experience:

• ► 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 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 unknown:

► 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.

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.

Will the use of Finasteride affect the hair on other parts of your body?

Finasteride does not affect hair on other parts of the body.

What else should you know about Finasteride?

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) 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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at 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.

5. how to store finasteride

• ► 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 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.

• ► This medicinal product does not require any special temperature storage conditions.

• ► 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 protect the environment.

6. contents of the pack and other informationwhat finasteride containsthe active substance is finasteride. each tablet contains 1 mg finasteride.

The other ingredients are:

lactose monohydrate, maize starch pregelatinised, docusate sodium, iron oxide yellow (E172), sodium starch glycolate (type A), cellulose microcrystalline, silica colloidal anhydrous, magnesium stearate,

hydroxypropyl cellulose, hypromellose, talc, titanium dioxide (E171), iron oxide red (E172), and iron oxide yellow (E172).

What Finasteride looks like and contents of the pack

Finasteride tablets are red, round, biconvex film coated tablets.

Finasteride film-coated tablets are available in white PVC/PE/PVDC/A­luminium and/or Aluminium/Aluminium blisters. The blisters are packed in cardboard boxes containing 28, film-coated tablets.

Marketing Authorisation Holder

SyriMed

Unit 4, Bradfield Road,

Ruislip, Middlesex

HA4 0NU, UK

Manufacturer

Genepharm S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece.

This leaflet was last revised in 03/2021.

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