Finasteride 5 Mg Tablets
Package leaflet: Information for the patient FINASTERIDE 5 mg FILM-COATED TABLETS
(finasteride)
The name of this medicine is Finasteride 5 mg Film-coated Tablets, which will be referred to as Finasteride Tablets throughout this leaflet.
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.
What is in this leaflet:
1. What Finasteride Tablets are and what they are used for
2. What you need to know before you take Finasteride Tablets
3. How to take Finasteride Tablets
4. Possible side effects
5. How to store Finasteride Tablets
6. Contents of the pack and other information
1. WHAT FINASTERIDE TABLETS ARE AND WHAT THEY ARE USED FOR
Finasteride Tablets are used for the treatment of a condition called benign prostatic hyperplasia (BPH) which is common in older men. BPH is caused by the prostate gland growing too big and obstructing the flow of urine from the bladder. This leads to some unpleasant symptoms such as weak or interrupted urine flow, a need to pass water more frequently and / or a sudden need to pass water.
Finasteride Tablets belong to a group of medicines called 5-alpha reductase inhibitors. Finasteride Tablets work by helping to shrink the enlarged prostate and relieve your symptoms. It will help reduce the risk of you developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE TABLETS
Do not take Finasteride Tablets if you:
• are allergic (hypersensitive) to finasteride, any other 5-alpha reductase inhibitor or any of the other ingredients in the tablets (these are listed in section 6, Contents of the pack and other information)
• are female - Finasteride Tablets are for use by men only
• are a male under 18 years of age
• are or may potentially be pregnant
If any of the above apply to you, talk to your doctor who will decide what to do.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride Tablets.
Pregnant and breast-feeding women
Women who are pregnant, likely to become pregnant or are breast-feeding must not be exposed to finasteride. They must not take Finasteride Tablets or handle broken or crushed tablets. Also, if your sexual partner may potentially be pregnant, you must avoid exposing her to your semen which could contain a small amount of finasteride which could affect the normal development of a male baby. This can be done by using a condom during sexual activity. Talk to your doctor who will help decide what you should do.
If a pregnant woman comes into contact with the active ingredient in Finasteride Tablets (for example by handling broken tablets or by unprotected sex), please consult a doctor.
PSA blood test
Finasteride Tablets can affect the result of a blood test called PSA (prostate-specific antigen). If you have a PSA test done, tell the doctor or medical staff that you are taking Finasteride Tablets.
Decreased liver function
Caution is advised in patients with decreased liver function.
Children
Finasteride should not be used in children.
Other medicines and Finasteride Tablets
Finasteride Tablets do not usually interfere with other medicines. However, you should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Driving and using machines
Finasteride Tablets should not impair your ability to drive or operate tools or machinery.
Finasteride Tablets contain lactose.
These tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE FINASTERIDE TABLETS
Dosage
Always take Finasteride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how many tablets to take and when.
The recommended dose for Finasteride Tablets is as follows:
Adult and older men: the dose is one tablet once a day with or without food.
In order to treat your symptoms and control your BPH effectively, it is important that you continue to take Finasteride Tablets for as long as your doctor prescribes, even if you do not feel an immediate benefit. Some patients show early improvement in symptoms, but you may need to take Finasteride Tablets for at least six months to see if it improves your symptoms. Finasteride Tablets works best when taken long term.
Your doctor may prescribe Finasteride Tablets along with another medicine called doxazosin to help you control your BPH.
Finasteride Tablets are not suitable for use by females.
Method of Administration
Each tablet should be swallowed whole with plenty of water with or without food. Take your tablet at the same time each day.
If you take more Finasteride Tablets than you should
If you have accidentally taken more than your prescribed dose, contact your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.
If you forget to take Finasteride Tablets
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not take a double dose or make up for a forgotten dose.
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. Allergic Reactions:
All medicines can cause allergic reactions although serious reactions are rare. If you get any of the following symptoms after taking these tablets, you should stop taking these tablets and contact your doctor immediately:
• Any sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips, tongue or throat
• Peeling and blistering of the skin, mouth, eyes and genitals
• Rash affecting your whole body.
The following side effects have also been reported:
Common side effects (may affect up to 1 in 10 people)
• impotence (not able to achieve or maintain an erection), that may continue after stopping the medication
• decreased libido (less desire to have sex)
• changes or problems with ejaculation such as a decrease in the amount of semen released during sex
Uncommon side effects (may affect up to 1 in 100 people)
• breast enlargement and tenderness
• skin rash
• ejaculation disorder
Unknown (frequency cannot be estimated from the available data)
• itch (pruritus), hives (urticaria)
• palpitations (feeling your heartbeat)
• hypersensitivity reactions (such as swelling of the lips or face)
• changes in the way your liver is working, which can be shown by a blood test
• decreased libido (less desire to have sex), that may continue after stopping the medication
• depression
• male infertility and/or poor quality of semen. Improvement in the quality of the semen has been reported after stopping medication
• Testicular pain and erectile dysfunction, which may continue after discontinuation of treatment
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible 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 FINASTERIDE TABLETS
Keep Finasteride Tablets out of the sight and reach of children.
This medicinal product does not require any special storage conditions. Do not use Finasteride Tablets 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 use this medicine if you notice any signs of discolouration or visible signs of deterioration.
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 Tablets contain:
The active substance is finasteride. Each tablet contains 5 mg of finasteride.
The other ingredients are: lactose monohydrate, sodium starch glycolate, maize starch, colloidal anhydrous silica, docusate sodium, sodium benzoate, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol and indigo carmine (E132).
What Finasteride Tablets look like and the contents of the pack:
Finasteride Tablets are light blue, round film-coated tablets, marked with ‘FNS 5’ on one side and plain on the other.
Your medicine is available in blisters containing 28 tablets.
Marketing Authorisation Holder:
Cadila Pharmaceuticals (Europe) Limited, The Pavilion, 56 Rosslyn Crescent, Harrow, Middlesex HA1 2SZ, UK
Manufacturer responsible for batch release: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.
This leaflet was last approved in March 2015