What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

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: PL08553/0261.


Finasteride 5mg Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Finasteride 5 mg 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.

In this leaflet:

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

1. What Finasteride 5 mg Tablets are and what they are used for

Finasteride 5 mg Tablets contain a medicine called finasteride. This belongs to a group of medicines called ‘5-alpha-reductase inhibitors’. Finasteride 5 mg Tablets shrink the prostate gland in men when it is swollen. The prostate gland is found underneath the bladder (but only in men). It produces the fluid found in semen. A swollen prostate gland can lead to a condition called ‘benign prostatic hyperplasia’ or BPH.

What is BPH?

If you have BPH it means that your prostate gland is swollen. It can press on the tube that urine passes through, on its way out of your body.

This can lead to problems such as:

  • feeling like you need to pass urine more often, especially at night
  • feeling that you must pass urine right away
  • finding it difficult to start passing urine
  • when you pass urine the flow of urine is weak
  • when you pass urine the flow stops and starts
  • feeling that you cannot empty your bladder completely.

In some men, BPH can lead to more serious problems, such as:

  • urinary tract infections
  • a sudden inability to pass urine
  • the need for surgery.

What else should you know about BPH?

  • BPH is not cancer and does not lead to cancer, but the two conditions can be present at the same time.
  • Before you start Finasteride 5 mg Tablets, your doctor will do some simple tests to check whether you have prostate cancer.

Talk to your doctor if you have any questions about this.

2. What you need to know before you take Finasteride 5 mg Tablets

Do not take Finasteride 5mg Tablets:

  • if you are a woman (because this medicine is for men)
  • if you are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in Section 6).

Do not take Finasteride 5 mg Tablets 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 5 mg Tablets if:

  • your partner is pregnant or planning to become pregnant. You should use a condom or other barrier method of contraception when taking Finasteride 5 mg Tablets. This is because your semen could contain a tiny amount of the drug and may affect the normal development of the baby’s sex organs
  • you are going to have a blood test called PSA. This is because Finasteride 5 mg Tablets can affect the results of this test.

If you are not sure, talk to your doctor or pharmacist before taking Finasteride 5 mg Tablets.

Mood alteration and depression

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride 5 mg Tablets. If you experience any of these symptoms contact your doctor for further medical advice as soon as possible.

Children

Finasteride 5 mg Tablets should not be used in children.

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Finasteride 5 mg Tablets do not usually affect other medicines.

Taking Finasteride 5 mg Tablets with food and drink

Finasteride 5 mg Tablets can be taken with or without food.

Pregnancy and breast feeding

  • 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 normal development of 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 5 mg Tablets are not likely to affect you being able to drive, use tools or machines.

Finasteride 5 mg Tablets contain

  • Lactose. This is a type of sugar. If you have ever been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor or pharmacist before taking this medicine.
    Those patients on a sodium controlled diet should be aware that each tablet contains 6.6mg of sodium.

3. How to take Finasteride 5 mg Tablets

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

Taking this medicine

  • The usual dose is one tablet each day.
  • Take this medicine by mouth.
  • Your doctor may prescribe Finasteride 5 mg Tablets along with another medicine (called doxazosin) to help control your BPH.

If you take more Finasteride 5 mg Tablets than you should

If you take too many tablets by mistake, contact your doctor immediately.

If you forget to take Finasteride 5 mg Tablets

  • If you forget to take a tablet, skip the missed dose.
  • Take the next dose as usual.
  • Do not take a double dose to make up for a forgotten dose.

If you stop taking Finasteride 5 mg Tablets

Your condition may show an early improvement after taking Finasteride 5 mg Tablets. However, it may take at least six months for the full effect to develop. It is important to keep taking Finasteride 5 mg Tablets for as long as your doctor tells you, even if you do not feel any benefit straight away.

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. The following side effects may happen with this medicine.

Allergic reactions:

Stop using Finasteride 5mg Tablets and immediately contact a doctor if you experience any of the following symptoms:

  • swelling of face, lips, tongue or throat, difficulty swallowing and breathing difficulties (angioedema)
  • skin rashes, itching, or lumps under your skin (hives).

Other side effects may include:

  • 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.

These side effects above may disappear after a while if you continue taking Finasteride 5 mg Tablets. If not, they usually resolve after stopping Finasteride 5 mg Tablets. Other side effects reported in some men are:

  • 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 your testicles
  • an inability to have an erection which may continue after stopping the medication
  • male infertility and/or poor quality of semen. Improvement in the quality of the semen has been reported after stopping medication
  • depression
  • anxiety
  • decrease in sex drive that may continue after stopping the medication
  • problems with ejaculation that may continue after stopping the medication.

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.

If any of the side effects get serious, or if you notice any side effects not listed in 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.

What else should you know about Finasteride 5 mg Tablets?

Finasteride 5 mg Tablets are not licensed to treat prostate cancer. Information collected for a clinical trial in men taking 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 not known.

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 the Yellow Card Scheme website: 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.

5. How to store Finasteride 5 mg Tablets

Keep this medicine out of the sight and reach of children.

Do not store your tablets above 30°C. Keep them in the original package.

Do not use Finasteride 5 mg Tablets 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 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.

6. Contents of the pack and other information

What Finasteride 5 mg Tablets contain

  • The active substance in your medicine is finasteride. Each tablet contains 5 mg finasteride.
  • The other ingredients are: lactose monohydrate, cellulose microcrystalline (E460), starch pregelatinised, sodium starch glycolate (Type A), magnesium stearate (E470b), docusate sodium. The coating of these tablets contains hypromellose (E464), titanium dioxide (E171), macrogol and indigo carmine (E132). The sodium content of each tablet is 6.6 mg.

What Finasteride 5 mg Tablets look like and the content of the pack

Finasteride 5 mg Tablets are blue, oval, film-coated tablets with the following markings: ‘FIN’ on one side and ‘5’ on the other side. The tablets are presented in blister strips containing 28, 30, 50 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd
6 Riverview Road
Beverley
HU17 0LD
UK

This medicine is authorised in Member States of the EEA under the following names:

UK: Finasteride 5 mg Tablets (PL 08553/0261)

This leaflet was last revised in 08/2018

This leaflet gives you some important patient information about Finasteride 5 mg Tablets. If you have questions after you read it ask your doctor or pharmacist, who will give you further information.