Finasteride 5mg Film Coated Tablets
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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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Finasteride is and what it is used for
2. Before you take Finasteride
3. How to take Finasteride
4. Possible side effects
5. How to store Finasteride
6. Further 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. BEFORE YOU TAKE FINASTERIDE Do not take Finasteride
• If you are allergic (hypersensitive) to finasteride or any of the other ingredients.
• Women and children should not take Finasteride. The condition for which Finasteride is prescribed occurs only in men.
Take special care with 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 foetus, then it is not known whether the development of the external male organs in the foetus may be adversely affected. If your sexual partner is or may be pregnant then avoid exposing her to your semen (during and for two months after treatment ends) 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Taking Finasteride with food and drink
Take one tablet of Finasteride every day, with or without food.
Pregnancy, breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Finasteride is for use in men only.
Finasteride is not indicated for use in women or children.
Driving and using machines
Finasteride should not affect your ability to drive or operate machinery.
Important information about some of the ingredients of Finasteride
In patients with lactose intolerance it should be taken into account that Finasteride contains 102.63 mg lactose as well. 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
Always take Finasteride exactly as your doctor has told you. You should 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. Finasteride is administered orally.
Follow these instructions unless your doctor gave you different advice, otherwise Finasteride may not produce the desired effect. Remember to take your medicine.
The improvement of the symptoms might be visible at once, though sometimes you may need to take Finasteride for at least six months to see improvement.
If you TAKE MORE Finasteride than you should
In case of overdose or accidental ingestion, advise your doctor immediately.
If you FORGET TO TAKE Finasteride
If you miss a dose, do not take an extra one. Just take the next tablet as usual.
Do not take a double dose to make up for a forgotten dose.
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, Finasteride can cause side effects, although not everybody gets them.
Finasteride can cause the following side effects:
Common (affecting at least 1 in 100 and less than 1 in 10 patients treated):
• 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 (affecting at least 1 in 1000 and less than 1 in 100 patients treated):
• ejaculation disorder,
• breast enlargement or tenderness,
• skin rash
Other side effects with unknown frequency:
• increased hepatic enzymes,
• palpitation,
• pain in testicles,
• allergic reactions such as itching, urticaria, swelling of lips 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 disappeared while the patient continued to take Finasteride.
If symptoms persisted, they usually resolved 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FINASTERIDE
Store in the original package in order to protect from light.
Keep out of the reach and sight of children.
Do not take Finasteride 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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER 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) Ltd., 500 Chiswick High Road London W4 5RG UK
This leaflet was last revised in June 2010
P0084