Finasteride 5mg Film-Coated Tablets
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
Finasteride is for use by men to treat and control:
• benign prostate enlargement, which is a non-aggressive prostate growth.
Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors. It reduces the size of the prostate gland, improving urinary flow and other symptoms of prostate enlargement. Finasteride decreases the risk of suddenly being unable to pass urine and needing surgery.
Do not take Finasteride if you are
• allergic to:
- finasteride
- or any of the other ingredients of this medicine (listed in section 6).
• female.
• an adolescent or a child under 18 years.
Warnings and precautions
Talk to your doctor before taking Finasteride.
Inform your doctor if any of the following apply to you:
• difficulty emptying your bladder completely or a greatly reduced flow of urine.
Your doctor will examine you before beginning Finasteride treatment to eliminate the possibility of other urinary tract obstructions.
• need a blood test for “PSA”, a protein produced in the prostate gland.
Tell your doctor or nurse that you take Finasteride as it may alter the test results.
• Reduced liver function.
Other medicines and Finasteride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Finasteride is not known to influence or be influenced by other medicine.
Pregnancy and breast-feeding Finasteride must not be used by women.
• If your sexual partner is or may be pregnant:
Semen can contain traces of finasteride. Therefore avoid allowing your semen to come into contact with your partner, for example by using a condom.
• Women who are pregnant or may become pregnant should not touch broken or crushed Finasteride film-coated tablets.
If finasteride is absorbed by pregnant women, the male foetus may be born with deformed genital organs. Tablets are therefore film-coated to prevent contact with finasteride.
Driving and using machines
There are no data to suggest that Finasteride affects the ability to drive or use machines.
Important information about some of the ingredients of Finasteride
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
• 1 tablet once daily.
Women who are or may potentially be pregnant must not come into contact with finasteride (for example via semen or broken or crushed tablets - please see section "Pregnancy and breast-feeding”).
Administration
Swallow the film-coated tablet whole with one glass of water. It may be taken with or without food, however always at the same time.
Duration of use
To be decided by your attending doctor.
Although an improvement is often noticed after a short time, it is necessary to continue the treatment for at least 6 months.
If you take more Finasteride than you should
Contact your doctor or pharmacist immediately.
If you forget to take Finasteride
Do not take a double dose to compensate the forgotten dose. Just take the next dose when it is due.
5 How to store Finasteride
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 carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25 °C.
If you stop taking Finasteride
Do not alter or stop treatment without your doctors’ permission, as this can seriously harm you and reduce the therapy effect.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most frequent side effects are inability to obtain an erection and reduced sex drive. These side effects occur early in the course of therapy and resolve with continued treatment in the majority of patients.
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.
Side effects can occur with the following frequencies: Common, may affect up to 1 in 10 people:
• inability to obtain an erection
• reduced sex drive
• reduced volume of ejected semen.
Uncommon, may affect up to 1 in 100 people:
• skin rash
• tenderness and/or enlargement of the breasts
• difficulty discharging semen
• depression.
Very rare, may affect up to 1 in 10,000 people:
• fluid discharge from the breasts
• breast nodules, which in some cases are surgically removed.
Unknown, frequency can not be estimated from the available data:
• skin reactions with itching and/or hives
• allergic reactions such as swelling of the face and lips
• palpitations
• increased liver enzymes
• testicle pain
• inability to obtain an erection that continued after discontinuation of treatment
• male infertility and/or poor quality of semen. Normalization or improvement of semen quality has been reported after discontinuation of treatment.
What Finasteride contains
• The active substance is finasteride.
One film-coated tablet contains 5 mg of finasteride.
• The other ingredients are:
- docusate sodium
- hypromellose
- indigo carmine
- lactose monohydrate
- magnesium stearate
- microcrystalline cellulose
- povidone K30
- propylene glycol
- sodium starch glycolate (type A)
- talc
- titanium dioxide.
What Finasteride looks like and contents of the pack
Finasteride film-coated tablets are round, blue, biconvex and approximately 8 mm in diameter.
The film-coated tablets are supplied in the following package sizes:
10, 15, 30, 50, 60,, 120 100 tablets in standard blister.
14, 28 and 56 tablets in weekly blister.
50 tablets (50 x 1) in single dose blister.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
This leaflet was last revised in 03/2013.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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