Finasteride 5mg Tablets
121 LEAFLET Proscar 20150917
PACKAGE LEAFLET: INFORMATION FOR THE USER
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROSCAR
PROSCAR® 5mg TABLETS
(finasteride)
Your medicine is known by above names but will be referred to as Proscar throughout the following leaflet.
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 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:
• 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.
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.
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.
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
• 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.
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.
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.
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 at: www.mhra.gov.uk/yellowcard
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:
• 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 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 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
• 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 Proscar?
Proscar (finasteride) is 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.
5. HOW TO STORE PROSCAR
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C. Store in the original package. Keep container tightly closed to protect from light and moisture.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• Do not use after the expiry date printed on the carton label or blister strip.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your 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
• Each film-coated tablet contains 5mg of the active ingredient, finasteride.
• Proscar Tablets also contain the following: talc, microcrystalline cellulose, docusate sodium, lactose, magnesium stearate, pregelatinised maize starch, sodium starch glycollate, yellow iron oxide (E172), hydroxypropylcellulose, indigocarmine aluminium lake (E132), hypromellose, and titanium dioxide (E171).
What Proscar looks like and contents of the pack
• Proscar tablets are blue, apple-shaped tablets marked ‘MSD 72' on one side and 'Proscar' on the other.
• Proscar Tablets are available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, hA0 1DX.
Manufacturer
This product is manufactured by Merck Sharp and Dohme Ltd, Cramlington, Northumberland Ne23 3JU, England.
| POM | PL 08747/0121
Leaflet revision date: 17 September 2015 Proscar is a registered trade mark of Merck & Co Inc, USA.
121 LEAFLET Proscar20150917
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE TABLET
FINASTERIDE 5mg TABLETS
Your medicine is known by above names but will be referred to as Finasteride Tablet throughout the following leaflet.
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 Tablet is and what it is used for
2. What you need to know before you take Finasteride Tablet
3. How to take Finasteride Tablet
4. Possible side effects
5. How to store Finasteride Tablet
6. Contents of the pack and other information
1. WHAT FINASTERIDE TABLET IS AND WHAT IT IS USED FOR
Finasteride Tablet contains a medicine called finasteride. This belongs to a group of medicines called ‘5-alpha reductase inhibitors'.
Finasteride Tablet 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:
• 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 Tablet, 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.
Do not take Finasteride Tablet:
• 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 Tablet 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 Tablet if:
• your partner is pregnant or planning to become pregnant. You should use a condom or other barrier method of contraception when taking Finasteride Tablet. 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 Tablet can affect the results of this test.
If you are not sure, talk to your doctor or pharmacist before taking Finasteride Tablet.
Children
Finasteride Tablet 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 Tablet does not usually affect other medicines.
Taking Finasteride Tablet with food and drink
Finasteride Tablet can be taken with or without food.
Pregnancy and breast feeding
• Finasteride Tablet should not be taken by women.
• Do not touch crushed or broken Finasteride Tablet 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 Tablet is not likely to affect you being able to drive, use tools or machines.
Finasteride Tablet 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.
3. HOW TO TAKE FINASTERIDE TABLET
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 Tablet along with another medicine (called doxazosin) to help control your BPH.
If you take more Finasteride Tablet than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Finasteride Tablet
• 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 Tablet
Your condition may show an early improvement after taking Finasteride Tablet. However, it may take at least six months for the full effect to develop. It is important to keep taking Finasteride Tablet 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.
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 at: www.mhra.gov.uk/yellowcard
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE FINASTERIDE TABLET
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 Tablet 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 Tablet. If not, they usually resolve after stopping Finasteride Tablet. 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
• 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 Tablet?
Finasteride Tablet (finasteride) is 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.
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C. Store in the original package. Keep container tightly closed to protect from light and moisture.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• Do not use after the expiry date printed on the carton label or blister strip.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your 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 Finasteride Tablet contains
• Each film-coated tablet contains 5mg of the active ingredient, finasteride.
• Finasteride Tablets also contain the following: talc, microcrystalline cellulose, docusate sodium, lactose, magnesium stearate, pregelatinised maize starch, sodium starch glycollate, yellow iron oxide (E172), hydroxypropylcellulose, indigocarmine aluminium lake (E132), hypromellose, and titanium dioxide (E171).
What Finasteride Tablet looks like and contents of the pack
• Finasteride tablets are blue, apple-shaped tablets marked ‘MSD 72' on one side and 'Finasteride Tablet' on the other.
• Finasteride Tablets are available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Parallel Import Product Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex, hA0 1DX.
Manufacturer
This product is manufactured by Merck Sharp and Dohme Ltd, Cramlington, Northumberland Ne23 3JU, England.
POM PL 08747/0121
Leaflet revision date: 17 September 2015
121 LEAFLET Finasteride 20150917
If you would like further information about the tumour grading
system or this trial, please talk to your doctor.