Patient leaflet - Finasteride 5 mg tablets
1. What Finasteride 5 mg Tablets are and what they are used for
Finasteride belongs to the group of medicines called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men. Finasteride 5 mg Tablets act by shrinking the enlarged prostate gland in men. Your doctor has prescribed the medicine for you to treat a condition known as benign prostatic hyperplasia or BPH. The prostate gland which is near the bladder has become enlarged and is making it more difficult to pass urine. Finasteride 5 mg Tablets will help to relieve these symptoms and will help reduce the risk of you developing a sudden inability to pass urine (known as acute urinary retention) and the need for surgery.
What is the prostate gland?
The prostate is a walnut-sized gland found only in men. It is located below the bladder and it surrounds the urethra, a tube that carries urine from the bladder out through the tip of the penis. The prostate gland's main function is to produce fluid for semen, the fluid that carries sperm.
What is Benign Prostatic Hyperplasia (BPH)?
BPH is a benign enlargement of the prostate gland which is common in men over 50 years old. Because the prostate gland is close to the bladder and surrounds part of the urethra, its enlargement may affect your ability to urinate. You may experience symptoms such as a need to urinate often, especially at night, a feeling that you must urinate right away, difficulty in starting to urinate, a weak or interrupted urinary stream, or a feeling that you cannot empty your bladder completely.
In some men, BPH can lead to serious problems, including urinary tract infections, and a sudden inability to pass urine at all as well as the need for surgery. For this reason, a man with symptoms of BPH should see his doctor.
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 5 mg Tablets,
your doctor will do some simple tests to check whether you have prostate gland cancer.
Talk to your doctor if you have any questions about this.
2. What you need to know before you take Finasteride 5 mg Tablets
Do not take Finasteride 5 mg Tablets if:
You are allergic (hypersensitive) to
finasteride or any of the other ingredients of this medicine (listed in section 6)
You are a woman (because this medicine is
for men).
Do not take Finasteride 5 mg Tablets if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride 5 mg Tablets if:
Your partner is pregnant or planning to
become pregnant. You should use a condom or other barrier method of contraception when taking this medicine. 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 5 mg Tablets can affect the results of the test.
Mood alterations and depression
Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Finasteride 5 mg Tablets. If you experience any of these symptoms contact your doctor for further medical advice as soon as possible.
If you are not sure, talk to your doctor or pharmacist before taking Finasteride 5 mg Tablets.
Children
Finasteride 5 mg Tablets should not be used in children.
Other medicines and Finasteride 5 mg Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Taking Finasteride 5 mg Tablets with food and drink
Finasteride 5 mg Tablets can be taken with or without food.
Pregnancy and breast-feeding
Finasteride 5 mg Tablets SHOULD NOT
be taken by women.
Do not touch crushed or broken Finasteride
5 mg 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 tablets, speak to your doctor.
Driving and using machines
Finasteride 5 mg Tablets are not likely to affect your ability to drive, use tools or machines.
Finasteride 5 mg Tablets contain Lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicinal product.
Information on sodium content
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
3. How to take Finasteride 5 mg Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose is one tablet containing 5 mg finasteride to be taken by mouth once a day with or without food.
Your doctor may prescribe Finasteride 5 mg Tablets along with another medicine called doxazosin to help you control your BPH.
If you take more Finasteride 5 mg Tablets than you should
If you have taken too many tablets by mistake, contact your doctor immediately.
If you forget to take Finasteride 5 mg Tablets
If you miss a dose, just carry on with the next one as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Finasteride 5 mg Tablets Your condition may show an early improvement after taking Finasteride 5 mg Tablets. However, it may take at least six months for the full effect to develop. It is important to keep taking Finasteride 5 mg 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, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine 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, tongue, throat and
face difficulty swallowing and breathing difficulties (angioedema).
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 this medicine. If not, they usually resolve after stopping taking this medicine.
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
- Blood in semen
- 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
- Anxiety
- Suicidal ideation
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
What else do you need to know about Finasteride 5 mg Tablets?
Finasteride 5 mg Tablets are not licensed to treat prostate gland cancer. Information collected for a clinical trial in men taking finasteride for 7 years showed:
The number of men who developed
prostate gland 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 Finasteride 5 mg Tablets
Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.
- This medicine does not require any special storage conditions.
- 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 5 mg Tablets contain
The active substance is finasteride. One film- coated tablet contains 5 mg of finasteride.
The other ingredients are:
Tablet core - Lactose monohydrate, cellulose microcrystalline, pregelatinised starch, sodium starch glycolate (Type-A), lauroyl macrogolglycerides and magnesium stearate.
Film coating - Hypromellose, titanium dioxide (E171), indigocarmine-lake (E132) and macrogol 6000.
They are supplied in blister packs of 12, 28, 30 and 56 tablets and bottles of 50, 75 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.
Product Licence Number: PL 20395/0067
This leaflet was last revised in March 2024. FINASTERIDE 5 MG TABLETS
POM
PRODUCT NAME
PRODUCT LICENCE NO.
STRENGTH
PACK SIZE
FONT & SIZE
REMARKS
REASON FOR CHANGE
COUNTRY
MANUFACTURER
SOFTWARE
ARTIST
Finasteride 5 mg Tablets
20395-0067
Pil
148 x 370 mm
5 mg
-
Humanst521 BT (Min 9pt)
NA
Comments received from Shrinidhi on 07.03.2024
UK (English)
Bafna
Adobe illustrator CC Bhuddish
NO. OF COLORS 01
██ Black
██ Dieline
2.2
VERSION XXXXXX DATE 07.03.2024