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: PL 00025/0279.
Proscar 5mg film-coated Tablets
PROSCAR® 5 mg film-coated tablets
This medicine is for use in men only
1. What Proscar is and what it is used for
2. What you need to know before you take Proscar
3. How to take Proscar
4. Possible side effects
5. How to store Proscar
6. Contents of the pack and other information
Proscar contains a medicine called finasteride. This belongs to a group of medicines called ‘5-alpha reductase inhibitors’.
Proscar shrinks 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.
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:
In some men, BPH can lead to more serious problems, such as:
Talk to your doctor if you have any questions about this.
Do not take Proscar 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 Proscar if:
If you are not sure, talk to your doctor or pharmacist before taking Proscar.
Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Proscar. If you experience any of these symptoms contact your doctor for further medical advice as soon as possible.
Proscar should not be used in children.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Proscar does not usually affect other medicines.
Proscar can be taken with or without food.
Proscar is not likely to affect you being able to drive, use tools or machines.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
If you take too many tablets by mistake, contact your doctor immediately.
Your condition may show an early improvement after taking Proscar. However, it may take at least six months for the full effect to develop. It is important to keep taking Proscar 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Stop using Proscar and immediately contact a doctor if you experience any of the following symptoms:
These side effects above may disappear after a while if you continue taking Proscar. If not, they usually resolve after stopping Proscar. Other side effects reported in some men are:
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.
Proscar (finasteride) is not licensed to treat prostate cancer. Information collected for a clinical trial in men taking finasteride for 7 years showed:
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, 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 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.
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.
If you have been given a calendar pack, do not remove the tablets from the blister until you are ready to take the medicine.
Do not use Proscar 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.
Proscar is available as blue, apple-shaped tablets. Proscar Tablets are supplied in blister packs of 28 tablets or 30 tablets.
Not all pack sizes may be marketed.
The Marketing Authorisation Holder
This leaflet was last revised in February 2021
This leaflet gives you some important patient information about Proscar. If you have questions after you read it ask your doctor or pharmacist, who will give you further information.
© Organon Pharma (UK) Limited 2021 All rights reserved.