Finasteride 5mg Film-Coated Tablets
Finasteride 5 mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
■ Keep this leaflet. You may need to read it again.
■ If you have 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 Finasteride Tablets are and what they are 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.
The name of your medicine is Finasteride 5 mg Film-coated Tablets (we call them Finasteride Tablets throughout this leaflet).
1. What Finasteride Tablets are and what they are used for
Finasteride belongs to a group of medicines called “5-alpha reductase inhibitors”.
It can be used to treat men with benign prostatic hyperplasia (BPH). In this condition, your prostate is enlarged and this can make it difficult to pass urine. Your prostate is a gland near the bladder. It produces a fluid which carries sperm.
Finasteride works by shrinking the prostate gland. This allows urine to pass more easily. It also helps lower the risk of you suddenly being unable to pass urine. This is called “acute urinary retention” and may need surgery.
Although BPH is not cancer and does not cause cancer, the two conditions can be present at the same time. Only a doctor can assess the symptoms and their possible causes.
2. Before you take Finasteride Tablets
Do not take Finasteride Tablets:
• Are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• Are a woman who is pregnant, or may potentially be pregnant Finasteride is only for men.
• It is not recommended for use in women or children.
Warnings and Precautions:
Talk to your doctor or pharmacist before taking finasteride if you:
• Have a large amount of residual urine in your bladder after urinating and/or severely reduced urinary flow. If this is the case, you should closely be monitored for narrowing of the urinary tract.Need a blood test for something called “PSA” which stands for ‘prostate-specific antigen’(test used to detect prostate cancer). This is because Finasteride can lower PSA levels and affect the results of this test. PSA is released into a man's blood by his prostate gland. The amount of PSA in the blood normally increases as a man's prostate enlarges.
• If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen which could contain tiny amount of the drug (see ‘Pregnancy and Breastfeeding’ section below).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.
Taking other medicines
Finasteride does not usually interfere with other medicines. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Finasteride Tablets with food and drink
Finasteride Tablets can be taken with or without food.
Pregnancy and breastfeeding
Finasteride must not be given to women, including pregnant women. It can affect the normal development of a male baby’s sex organs.
• Crushed or broken tablets should not be handled by a pregnant woman because of the risk of Finasteride being absorbed through the skin.
• If your sexual partner is pregnant, you must use a condom. This is because Finasteride has been found in the semen of men taking Finasteride.
If you have any questions, ask your doctor.
Driving and using machines
Finasteride Tablets should not affect your ability to drive or use machines.
Finasteride Tablets contains lactose monohydrate.
Finasteride Tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take Finasteride Tablets
Always take Finasteride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults (including the elderly):
• Swallow one tablet each day. You can take it with or without food.
• In some cases, your doctor may also give you other medicine to take (such as Doxazosin).
Finasteride works best when it is taken long-term. It may take at least six months before some patients notice an improvement.
Children: Finasteride must not be given to children
If you forget to take Finasteride, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you take more Finasteride than you should, tell your doctor immediately or go to your nearest casualty department.
4. Possible side effects
Like all medicines, Finasteride can cause side effects, although not everybody gets them.
Stop taking Finasteride and immediately contact a doctor if you experience any of the following symptoms:
• Angiooedema: swelling of face, tongue or throat; difficulty swallowing; hives and breathing difficulties
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.
Other side
Common (may affect up to 1 in 10 people):
• impotence or less desire to have sex
• ejaculation problems and less fluid produced than normal (this does not appear to affect normal sexual function)
Uncommon (may affect up to 1 in 100 people):
• rash
• sore or enlarged breasts
Not known (frequency cannot be estimated from the available data):
• depression
• less desire to have sex that continued after discontinuation of treatment
• fast or irregular heartbeats, also called palpitation
• increase of the liver enzymes
• itchy skin, hives
• pain in the testicles.
• erectile dysfunction: problems getting or keeping an erection, that continued after discontinuation of treatment
• male infertility and/or poor seminal quality.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your pharmacist or doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store this medicine
• Keep out of the reach and sight of children
• This medicinal product does not require any special storage conditions.
• Do not take this medicine after the expiry date which is shown on the pack.
6. Further information
What Finasteride Tablets contain:
Each tablet contains 5 mg of the active ingredient Finasteride. It also contains docusate sodium, magnesium stearate, microcrystalline cellulose, lactose monohydrate, pregelatinised maize starch, sodium starch glycolate and povidone. The tablet coating contains indigo carmine (E132), titanium dioxide (E171), hypromellose, hydroxypropylcellulose and purified talc.
What Finasteride Tablets look like and contents of the pack:
Your medicine comes as a ‘film-coated’ tablet The tablets are light blue.
Finasteride Tablets are available in blister packs of 28 tablets.
Marketing Authorisation Holder and manufacturer: Generics [UK] Limited, Station Close, Potters Bar, Herts. EN6 1TL.
Date leaflet prepared: September 2015