Finasteride 5mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Finasteride 5 mg film-coated tablets
Finasteride
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 onto 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 5 mg film-coated tablet (hereinafter: 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
Your doctor has prescribed Finasteride because you have a condition known as benign prostatic hyperplasia or BPH.
Your prostate, a gland located near your urinary bladder that produces a fluid in which the spermatozoids are transported, has become bigger and is making it more difficult for you to pass urine.
Finasteride reduces the size of the enlarged prostate and relieves urinary symptoms, such as the need to urinate frequently especially at night, painful urination, weak urine stream, sensation that the urinary bladder is not completely empty. Finasteride reduces the need for surgery.
2. what you need to know before you take
FINASTERIDE Do not take Finasteride
• If you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• Women and children should not take Finasteride. The condition for which Finasteride is prescribed occurs only in men.
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride.
• Tell your doctor about any medical problems you have or have had, and about any allergies.
• Finasteride is for use in men only in the treatment of BPH. Women who are or may potentially be pregnant must not use Finasteride, nor should they handle crushed or broken tablets of Finasteride. If the active ingredient in Finasteride is absorbed after oral use or through the skin by a woman who is pregnant with a male fetus, then it is not known whether the development of the external male organs in the fetus may be adversely affected. If your sexual partner is or may be pregnant then avoid exposing her to your semen which could contain a small amount of finasteride -e.g. by using a condom during sexual activity. If a woman who is pregnant comes into contact with the active ingredient in the tablet, a doctor should be consulted. Finasteride tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed. If you have any doubts, ask your doctor.
• BPH develops over a long period of time. Sometimes symptoms improve promptly, but you may need to take Finasteride for at least six months to see if it improves your symptoms. Whether or not you notice any improvement or change in symptoms, therapy with Finasteride may reduce the risk of inability to pass urine and, therefore, the need for surgery. You must visit your doctor regularly for periodic checkups and an evaluation of your progress. While BPH is not cancer and does not lead to cancer, the two conditions can exist at the same time.
Only a doctor can evaluate your symptoms and their possible causes.
• Finasteride can reduce the prostate-specific antigen levels (PSA, a body substance which increases when the prostate grows and can cause obstruction). If you have a PSA test done, tell your doctor that you are taking Finasteride.
• Promptly report any changes in your breast tissue such as lumps, pain, enlargement of your breast or nipple discharge.
children
Finasteride is contraindicated in children.
other medicines and Finasteride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Finasteride with food and drink
Finasteride tablet can be taken with or without food.
Pregnancy and breast-feeding
Finasteride is for use in men only. If a woman who is pregnant comes into contact with the active ingredient in the tablet, a doctor should be consulted. Finasteride may harm the male fetus! Pregnant women should not handle crushed or broken tablets of Finasteride.
If your sexual partner is or may be pregnant you should minimise exposing her to your semen (e.g. by using a condom during sexual activity) which could contain a small amount of finasteride.
Driving and using machines
Finasteride should not affect your ability to drive or operate machinery.
Finasteride contains lactose (milk sugar)
It should be taken into account that Finasteride contains 102.63 mg lactose. If your attention was drawn to intolerance of certain kinds of sugar by your doctor, you should see your doctor before you take this medicine.
3. how to take finasteride
Atake this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Do not change the doses or stop taking it without consulting your doctor before.
Take one tablet of Finasteride every day, with or without food. Follow these instructions unless your doctor gave you different advice, otherwise Finasteride may not produce the desired effect. Remember to take your medicine.
Although early improvement in symptoms may be seen, sometimes you may need to take Finasteride for at least six months to achieve a beneficial response.
Use in elderly patients and in patients with renal impairment
No dosage adjustment is required in the elderly or in patients with varying degrees of renal insufficiency.
Use in patients with liver impairment
There are no data available in patients with liver insufficiency.
If you take more Finasteride than you should
In case of overdose, contact your doctor immediately.
If you forget to take Finasteride
Do not take a double dose to make up for a forgotten dose. Just take the next tablet as usual.
If you stop taking finasteride
You should not stop taking it without consulting your doctor before.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Finasteride can cause the following side effects:
common (may affect up to 1 in 10 people):
• inability to have an erection (impotence),
• decreased sex drive,
• decreased amount of semen released during sex (this does not appear to interfere with normal sexual function).
uncommon (may affect up to 1 in 100 people):
• ejaculation disorder,
• breast enlargement or tenderness,
• skin rash.
other side effects with frequency not known:
• increased level of hepatic enzymes,
• palpitation,
• pain in testicles,
• decreased sex drive that may continue after discontinuation of therapy, depression,
• ejaculation disorder or inability to have an erection which may continue after discontinuation of treatment,
• male infertility and/or poor seminal quality,
• allergic reactions such as itching, urticaria (hives), swelling of lips, tongue, throat and face.
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.
In some cases, these side effects disappear while the patient continues to take Finasteride. If symptoms persist, they usually resolve on discontinuing Finasteride treatment.
If any of the following happen, stop taking Finasteride and tell your doctor immediately or go to the casualty department at your nearest hospital:
• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing,
• urticaria (hives),
• fainting.
If you have any of these side effects, you may be having an allergic reaction to finasteride. You should see a doctor immediately, so the doctor can assess how serious these side effects are.
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 Yellow Card Scheme, Website: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
Store in the original package in order to protect from light.
Keep out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton and blisters after mm.yyyy (abbreviation used for expiry date). The expiry date refers to the last day of that month.
Leave your tablets in the foil. Only remove them when it is time to take your medicine.
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: 5 mg of finasteride in each tablet.
• The other ingredients are:
Tablet core: magnesium stearate, talc, sodium starch glycolate (type A), pregelatinised starch, microcrystalline cellulose, lactose monohydrate.
Tablet coating: titanium dioxide (C.I.77891, E171), lactose monohydrate, macrogol 6000, hyprolose, hypromellose.
What Finasteride looks like and contents of the pack
White or almost white, rounded triangle shaped, slightly biconvex film-coated tablets, with an imprinted mark “RG” on one side.
Blister packs of hard aluminium foil and white, hard PVC foil containing 7x, 10x, 14x, 15x, 28x, 30x, 50x, 56x, 90x, 98x,
100x, 105x, 120x tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicinal product, please contact the Marketing Authorisation Holder.
Marketing Authorisation Holder:
Gedeon Richter Plc., 1103 Budapest Gyomroi ut 19-21., Hungary
Manufacturer:
Gedeon Richter Plc., 1103 Budapest Gyomroi ut 19-21., Hungary
Distributor:
Consilient Health (UK) Limited. No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE
This leaflet was last revised in 02/2016
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