Finasteride 5 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Finasteride 5mg Film-coated Tablets
This medicine is for use in men only Read all this leaflet carefully before you start taking this medicine:
- 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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What are Finasteride Tablets and what are they used for
2. Before you take Finasteride Tablets
3. How to take Finasteride Tablets
4. Possible side effects
5. How to store Finasteride Tablets
6. Further information
1. WHAT ARE FINASTERIDE TABLETS AND WHAT THEY ARE USED FOR
Finasteride 5mg Film-Coated Tablets (also called Finasteride Tablets in this leaflet) contain a medicine called finasteride. This belongs to a group of medicines called '5-alpha reductase inhibitors'.
Finasteride Tablets shrink 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 Tablets, 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 FINASTERIDE TABLETS
Do not take Finasteride Tablets 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 Finasteride Tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Finasteride Tablets should not be used in children.
Take special care with Finasteride Tablets
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 Finasteride Tablets. 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 Tablets can affect the results of this test.
If you are not sure, talk to your doctor or pharmacist before taking Finasteride Tablets.
Taking other medicines
Finasteride Tablets do 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 Finasteride Tablets with food and drink
Finasteride Tablets can be taken with or without food.
Pregnancy and breast feeding
• Finasteride Tablets should not be taken by women.
• Do not touch crushed or broken Finasteride 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 Finasteride Tablets, speak to your doctor.
Driving and using machines
Finasteride Tablets is not likely to affect you being able to drive, use tools or machines.
Important information about some of the ingredients of Finasteride Tablets
Finasteride Tablets contain 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 FINASTERIDE TABLETS
You should take your tablets exactly as your doctor 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 Tablets along with another medicine (called doxazosin) to help control your BPH.
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If you take more Finasteride Tablets than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Finasteride Tablets
• 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 Tablets
Your condition may show an early improvement after taking Finasteride Tablets. However, it may take at least six months for the full effect to develop. It is important to keep taking Finasteride Tablets 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, Finasteride Tablets 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.
The side effects above may disappear after a while if you continue taking Finasteride Tablets. If not, they usually resolve after stopping Finasteride Tablets.
Other side effects reported in some men are:
• Breast swelling or tenderness
• Skin rashes
• 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.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
What else should you know about Finasteride Tablets?
Finasteride Tablets are 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 YOUR FINASTERIDE TABLETS
Keep your Finasteride Tablets in a safe place out of the reach and sight of children. There are no special precautions for storage. Do not take this medicine after the expiry date, which is stated on the blister and carton.
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
What Finasteride Tablets contain
The active substance in your medicine is finasteride. Your medicine also contains lactose monohydrate, microcrystalline cellulose, pregelatinised maize starch, sodium starch glycolate, sodium lauril sulphate, magnesium stearate, hypromellose, macrogol stearate.
What Finasteride Tablets looks like and contents of the pack
Finasteride 5mg Film-coated Tablets are white, round, biconvex, film-coated tablets with the following markings: ‘F' and ‘5' on one side. The tablets are presented in blister strips containing 20, 28, 30, 50 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only) Please be ready to give the following information:
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Product name |
Reference number |
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Finasteride 5mg Film-coated Tablets |
29831/0449 |
This is a service provided by the Royal National Institute of Blind People. The leaflet was last approved in: 07/2013.
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