Finasteride 5 Mg Film-Coated Tablets
PIL Size 170 x 270 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
Finasteride 5 mg Film-coated tablets (Finasteride)
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. What is in this leaflet
1. What Finasteride is and what it is used for
2. What you need to know before you take Finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Contents of the pack and other information
1. What Finasteride is and what it is used for
The name of your medicine is Finasteride 5 mg Film-coated Tablets. Finasteride tablets are film-coated tablets and contain the active ingredient finasteride. This belongs to a group of medicines called ‘testosterone-5-alpha reductase inhibitors'.
Finasteride 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.
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.
• 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, 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 Finasteride
Do not take Finasteride
if you are a woman (because this medicine is for men) if you are allergic (hypersensitive) to finasteride or any of the other ingredients Do not take finasteride if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist.
Finasteride should not be used in children.
Warnings and precautions
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. 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 can affect the results of this test.
If you are not sure, talk to your doctor or pharmacist before taking finasteride.
Other medicines and Finasteride
Finasteride does not usually affect other medicines. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Finasteride with food and drink Finasteride can be taken with or without food.
Pregnancy and breast-feeding
finasteride 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.
In addition, these women should not be exposed to the drug through sexual contact with a man taking finasteride. Therefore, if your sexual partner is or may potentially be pregnant, you must avoid exposing her to your semen which could contain a tiny amount of the drug - for example, by using a condom during sexual activity.
if a woman who is pregnant comes into contact with crushed or broken finasteride tablets, speak to your doctor.
Driving and using machines
Finasteride is not likely to affect you being able to drive, use tools or machines.
Finasteride tablet contains lactose
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.
Always take your tablets exactly as your doctor has told you. You should 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 along with another medicine (called doxazosin) to help control your BPH.
If you take more Finasteride than you should
If you take too many tablets by mistake, contact your doctor immediately.
If you forget to take Finasteride
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
Your condition may show an early improvement after taking finasteride. However, it may take at least six months for the full effect to develop. It is important to keep taking finasteride 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 can cause side effects, although not everybody gets them.
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 lips and face.
The following side effects may happen with this medicine:
Common (affects 1 to 10 users in 100):
changes with ejaculation (such as a decrease in the amount of semen released during sex which does not appear to interfere with normal sexual function.), impotence (an inability to have an erection), less desire to have sex
Uncommon (affects 1 to 10 users in 1,000):
problems with ejaculation, breast swelling and/or tenderness, rash
Not known (cannot be estimated from the available data):
depression, testicular pain, impotency that continued after stopping the treatment, male infertility and/or poor semen quality (semen quality refers to both sperm quality and quantity), feeling your heartbeat, increased liver enzymes.
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain or nipple discharge as these may be signs of a serious condition, such as breast cancer.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet
5. How to store Finasteride
Keep out of the sight and reach of children.
Store in original package.
Do not use Finasteride after the expiry date which is stated on the carton after “Exp”. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Finasteride contains
The active substance is finasteride. Each tablet contains 5 mg finasteride.
The other ingredients are: Lactose monohydrate, sodium starch glycolate Type A, maize starch, colloidal anhydrous silica, docusate sodium, sodium benzoate E211, magnesium stearate, hypromellose 2910, titanium dioxide E171, macrogol/PEG 6000, indigo carmine lake E132.
What Finasteride looks like and contents of the pack
Finasteride 5 mg Film-coated tablets are light blue, circular, biconvex, film-coated tablets, debossed with FIN on one side and plain on the other side. Finasteride 5 mg Film-coated tablets are supplied in blister packs of 28 tablets.
Marketing Authorisation Holder
Aptil Pharma Limited,
9th Floor, C.P. House, 97 -107 Uxbridge Road, Ealing, London, W5 5TL.
Manufacturer
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th Floor, C.P. House, 97 -107 Uxbridge Road, Ealing, London, W5 5TL.
This leafletwas last revised in 10/2012.
