Active ingredient
- finasteride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
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: PL 00025/0279.
Proscar 5mg film-coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROSCAR® 5 mg film-coated tablets
(finasteride)
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.
In this leaflet:
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
1. What Proscar is and what it is used for
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.
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:
In some men, BPH can lead to more serious problems, such as:
What else should you know about BPH?
Talk to your doctor if you have any questions about this.
2. What you need to know before you take Proscar
Do not take Proscar
Do not take Proscar 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 Proscar if:
If you are not sure, talk to your doctor or pharmacist before taking Proscar.
Mood alterations and depression
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.
Children
Proscar 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. Proscar does not usually affect other medicines.
Taking Proscar with food and drink
Proscar can be taken with or without food.
Pregnancy and breast feeding
Driving and using machines
Proscar is not likely to affect you being able to drive, use tools or machines.
Proscar contains
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.
Proscar contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
3. How to take Proscar
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
If you take more Proscar than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Proscar
If you stop taking Proscar
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.
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 Proscar and immediately contact a doctor if you experience any of the following symptoms:
Other side effects may include:
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.
What else should you know about Proscar?
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.
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 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.
5. How to store Proscar
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.
6. Contents of the pack and other information
What Proscar contains
What Proscar looks like and the content of the pack
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.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation Holder
Manufacturer
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.
PIL.PSC.20.UK.7544.IA-ORG.NoRCN
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