FINASTERIDE 5MG TABLETS
Active substance: FINASTERIDE
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D a u g h t e r L e a f l e t
PACKAGE LEAFLET: INFORMATION FOR THE USER PROSCAR TABLETS / FINASTERIDE 5mg TABLETS (finasteride) This medicine is available as one of the above names but will be referred to as Proscar throughout this leaflet. This medicine is for use in men only Read all of this leaflet carefully before you start to take this medicine. Keep this leaflet. You may want to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1. What Proscar is and what it is used for 2. Before you take Proscar 3. How to take Proscar 4. Possible side effects 5. How to store Proscar 6. Further 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 5alpha 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. 2. BEFORE YOU TAKE PROSCAR Do not take Proscar if: you are a woman (because this medicine is for men) you are allergic (hypersensitive) to finasteride or any of the other ingredients (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. Proscar should not be used in children. Take special care with Proscar Check with your doctor or pharmacist before taking your medicine 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 normal development of the babys 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. Taking other medicines Proscar does not usually affect other medicines. Always tell your doctor about all medicines you are taking or planning to take, including any obtained without a prescription. 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 babys 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. Important information about some of the ingredients of Proscar Proscar contains lactose which 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 before taking this medicine. 3. HOW TO TAKE PROSCAR You should take your tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The translation of the days of the week on the blister strip is as follows: MON TUES WED THURS FRI SAT Lunes Martes Miercoles Jueves Viernes Sabado
SUN Domingo
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, Proscar can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Allergic reactions If you have an allergic reaction, stop taking it and see your doctor straight away. The signs may include: Skin rashes, itching, or lumps under your skin (hives) Swelling of your lips and face. 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
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement of the breast tissue 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. If you would like further information about the tumour grading system or this trial, please talk to your doctor. 5. HOW TO STORE PROSCAR Keep out of the sight and reach of children. Proscar should be stored in a dry place, protected from light. Keep in the original container. Do not remove the tablets from the blister strip until you are ready to take your medicine. Crushed or broken Proscar should not be handled by women who are or may become pregnant. Do not use after the expiry date printed on the carton or blister label. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show 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. FURTHER INFORMATION Each tablet contains 5mg of the active ingredient finasteride in a blue apple-shaped film coated tablet coded 'MSD 72' on one side and 'PROSCAR' on the reverse. Proscar also contain the following: docusate sodium, hydroxypropylcellulose, hypromellose, indigo carmine aluminium lake (E132), lactose, magnesium stearate, microcrystalline cellulose, pregelatinised maize starch, sodium starch glycollate, talc, titanium dioxide (E171) and yellow iron oxide (E172). Proscar is available in a calendar blister pack of 28 tablets. 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. PL No: 15814/0248 Proscar Tablets / Finasteride 5mg Tablets POM
This product is manufactured by Merck Sharp & Dohme Ltd, Shotton Lane, Cramlington, Northumberland, England and is procured from within the EU by the Product Licence holder: OPD Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD2 4PR. Leaflet revision date (ref) 07/01/2013
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
PACKAGE LEAFLET: INFORMATION FOR THE USER PROSCAR TABLETS / FINASTERIDE 5mg TABLETS (finasteride) This medicine is available as one of the above names but will be referred to as Proscar throughout this leaflet. This medicine is for use in men only Read all of this leaflet carefully before you start to take this medicine. Keep this leaflet. You may want to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. 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. In this leaflet: 1. What Proscar is and what it is used for 2. Before you take Proscar 3. How to take Proscar 4. Possible side effects 5. How to store Proscar 6. Further 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 5alpha 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. 2. BEFORE YOU TAKE PROSCAR Do not take Proscar if: you are a woman (because this medicine is for men) you are allergic (hypersensitive) to finasteride or any of the other ingredients (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. Proscar should not be used in children. Take special care with Proscar Check with your doctor or pharmacist before taking your medicine 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 normal development of the babys 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. Taking other medicines Proscar does not usually affect other medicines. Always tell your doctor about all medicines you are taking or planning to take, including any obtained without a prescription. 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 babys 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. Important information about some of the ingredients of Proscar Proscar contains lactose which 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 before taking this medicine. 3. HOW TO TAKE PROSCAR You should take your tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The translation of the days of the week on the blister strip is as follows: MON TUES WED THURS FRI SAT Lunes Martes Miercoles Jueves Viernes Sabado
SUN Domingo
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, Proscar can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Allergic reactions If you have an allergic reaction, stop taking it and see your doctor straight away. The signs may include: Skin rashes, itching, or lumps under your skin (hives) Swelling of your lips and face. 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
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement of the breast tissue 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. If you would like further information about the tumour grading system or this trial, please talk to your doctor. 5. HOW TO STORE PROSCAR Keep out of the sight and reach of children. Proscar should be stored in a dry place, protected from light. Keep in the original container. Do not remove the tablets from the blister strip until you are ready to take your medicine. Crushed or broken Proscar should not be handled by women who are or may become pregnant. Do not use after the expiry date printed on the carton or blister label. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show 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. FURTHER INFORMATION Each tablet contains 5mg of the active ingredient finasteride in a blue apple-shaped film coated tablet coded 'MSD 72' on one side and 'PROSCAR' on the reverse. Proscar also contain the following: docusate sodium, hydroxypropylcellulose, hypromellose, indigo carmine aluminium lake (E132), lactose, magnesium stearate, microcrystalline cellulose, pregelatinised maize starch, sodium starch glycollate, talc, titanium dioxide (E171) and yellow iron oxide (E172). Proscar is available in a calendar blister pack of 28 tablets. 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. PL No: 15814/0248 Proscar Tablets / Finasteride 5mg Tablets POM
This product is manufactured by Merck Sharp & Dohme Ltd, Shotton Lane, Cramlington, Northumberland, England and is procured from within the EU by the Product Licence holder: OPD Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD2 4PR. Leaflet revision date (ref) 07/01/2013
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
