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FINASTERIDE 5 MG FILM-COATED TABLETS
Active substance(s): FINASTERIDE
This medicine is for use in men only
PATIENT INFORMATION LEAFLET
Your medicine is available in above name but will be referred to as Proscar
throughout the leaflet.
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
- 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 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
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 Proscar, 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 PROSCAR
Do not take Proscar:
- 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 Proscar if any of the above apply to you. If you are not sure, talk
to your doctor or pharmacist.
Taking Proscar with food and drink
Proscar can be taken with or without food.
Pregnancy and breast feeding
- Proscar should not be taken by women.
- Do not touch crushed or broken Proscar 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
Proscar tablets, speak to your doctor.
Driving and using machines
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
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
- The usual dose is one tablet each day.
- Take this medicine by mouth.
- Your doctor may prescribe Proscar along with another medicine (called
doxazosin) to help control your BPH.
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 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 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
Stop using Proscar and immediately contact a doctor if you experience any
of the following symptoms:
- Swelling of face, lips, tongue or throat, difficulty swallowing and breathing
- 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.
Proscar should not be used in children.
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:
- Breast swelling or tenderness
- Palpitations (feeling your heartbeat)
- Changes in the way your liver is working, which can be shown by a blood
- Pain in your testicles
- An inability to have an erection which may continue after stopping the
- Male infertility and/or poor quality of semen. Improvement in the quality of
the semen has been reported after stopping medication
- Decrease in sex drive that may continue after stopping the medication
- Problems with ejaculation that may continue after stopping the medication
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.
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Proscar if:
- your partner is pregnant or planning to become pregnant. You should use
a condom or other barrier method of contraception when taking Proscar.
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 Proscar
can affect the results of this test.
If you are not sure, talk to your doctor or pharmacist before taking Proscar.
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
- 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
- The effect of long-term use of finasteride on tumours of this kind is not
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 (see details below). By reporting side effects you
can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme Website:
5. HOW TO STORE PROSCAR
Keep this medicine out of the sight and reach of children.
Do not store above 30oC.
Store in the original package. Protect from light.
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 and
blister labels. The expiry date refers to the last day of that month.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Proscar contains
- The active substance is finasteride.
Each film-coated tablet contains 5 mg finasteride.
- The other ingredients are:
- Core: docusate sodium, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, pregelatinised starch, carboxymethyl starch
sodium and iron oxide E172.
- Coating: hydroxypropyl cellulose, hypromellose, talc, titanium dioxide
E171 and indigotine E132.
What Proscar looks like and contents of the pack
Proscar is available as blue-coloured, apple-shaped, film-coated tablets
marked ‘PROSCAR’ on one side and ‘MSD 72’ on the other.
Proscar Tablets are supplied in a calendar blister pack of 28 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER:
Manufactured by Merck Sharp & Dohme BV, 2031 BN, Haarlem, The
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
Leaflet revision and issue date (Ref) 28.10.15
Proscar is a trademark of Merck Sharp & Dohme Corp.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.