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.
- 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. Do not pass it on to 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 film-coated tablets
6. Further information
1. What finasteride is and what it is used for
Finasteride belongs to a group of medicines called 5-alpha reductase
inhibitors. Finasteride reduces an enlarged prostate gland in men.
Finasteride is used for:
- the treatment and control of benign enlargement of the prostate (benign prostatic hyperplasia, BPH)
- It causes regression of the enlarged prostate, improves urinary flow and symptoms caused by BPH and reduces the risk of sudden acute urinary retention and the need for surgery.
2. Before you take finasteride
You may well see a specialist doctor known as an Urologist before
starting treatment with finasteride.
Do not take finasteride
• if you are allergic (hypersensitive) to finasteride or any of the other ingredients of Finasteride film-coated tablets.
• your doctor or Urologist have confirmed that obstruction is caused
by a condition known as 'trilobular growth pattern'
• if you are a woman (see also "Pregnancy and breastfeeding")
• if you are a child.
Take special care with finasteride
• If you have a large amount of residual urine and/or severely reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract and you may need to undergo surgery.
• if you have impaired liver function. The level of finasteride in your blood may increase.
• if you have a PSA test (test used to detect prostate cancer). Tell your doctor that you are taking finasteride. Finasteride can affect the blood levels of the substance being tested, PSA.
• If your sexual partner is or may potentially be pregnant, you should avoid exposing her to your semen which could contain a tiny amount of the drug.
Consult your doctor if any of the above warnings is applicable to you or has been applicable to you in the past.
Taking other medicines
No significant drug interactions have been identified.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This also applies to medicines obtained without a prescription.
Taking finasteride with food and drink
Finasteride can be taken with or without food.
Pregnancy
Finasteride is intended only for men.
Women who are pregnant or may become pregnant should not handle broken or crushed finasteride tablets. If finasteride is absorbed through the skin or taken by mouth by a woman Pregnant with a male foetus, the child may be born with malformed genital organs.
The tablets are film-coated, which prevents contact with finasteride provided the tablets are not broken or crushed.
If the patient's sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by using a condom) or discontinue treatment with finasteride.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
As far as is known, finasteride has no influence on the ability to drive or use machines.
Important information about some of the ingredients of Finasteride film-coated tablets
Finasteride film-coated tablets contain lactose monohydrate. If your doctor has told you that you cannot tolerate some sugars, contact your doctor before taking this medicinal product.
3. How to take finasteride
Always take finasteride exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adults
The usual dose is one 5 mg tablet daily (equivalent to 5mg Finasteride). The Film-coated tablets can either be taken on an empty stomach or with a meal. The film-coated tablets should be swallowed whole and should not be divided or crushed
Although early improvement may be seen, treatment for at least six months may be necessary to assess whether a beneficial response has been achieved.
Your doctor will tell you how long you should continue to take finasteride 5mg. Do not interrupt treatment early or the symptoms may come back.
Patients with impaired liver function
There is no experience of the use of finasteride in patients with restricted liver function (see also "Take special care with Finasteride 5mg)
Patients with Impaired Kidney Function
No Dosage adjustment is required (see "Adults"). The use of
Finasteride 5mg in patients who have to undergo haemodialysis has not been investigated to date.
Elderly Patients
No dosage adjustment is required (See "Adults")
Please speak to your doctor or pharmacist if you feel that the effect of Finasteride 5mg is too strong or too weak.
If you take more finasteride than you should or if children have been taking medicine by accident please notify your doctor or pharmacaist immediately.
If you forget to take finasteride
If you forget tot take a dose of Finasteride 5mg you can take it as soon as you remember unless it is almost time for the next dose, in which case you should continue with your medication as prescribed.
Do not take a double dose to make up for a forgotten dose.
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.
Allergic reactions
If you have an allergic reaction, stop taking finasteride and see your doctor straight away. The signs may include:
• Skin rashes, itching, or lumps under your skin (hives)
• Swelling of your lips, face and/or tongue
• Difficulty in swallowing
• Difficulty in breathing.
You should promptly report to your doctor any changes in your breast tissue such as breast swelling and/or tenderness, lumps, pain or nipple discharge as these may be signs of serious condition, such as breast cancer.
Very common: may affect more than 1 in 10 people
impotence (an inability to have an erection)
Common: may affect up to 1 in 10 people
problems with ejaculation, changes with ejaculation (such as a decrease in the amount of semen released during sex which does not appear to interfere with normal sexual function, less desire to have sex, rash
Uncommon: may affect up to 1 in 100 people
testicular pain
Rare: may affect up to 1 in 1,000 people
itching, hives (urticaria)
Not known: frequency cannot be estimated from the available data Sleepiness/drowsiness, depression, impotency that continued after stopping the treatment, male infertility and/or poor semen quality which often improves after finishing treatment (semen quality refers to both sperm quality and quantity), feeling your heartbeat, increased liver enzymes, less desire to have sex that continued after stopping the treatment.
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: http://www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.
5. How to store Finasteride film-coated tablets
Keep out of sight and reach of children.
Do not use Finasteride film-coated tablets after the expiry date which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not use Finasteride film-coated tablets if you notice visible signs of deterioration.
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 film-coated tablets contains
The active substance is finasteride.
Each film-coated tablet contains 5mg of finasteride.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (E460), sodium starch glycolate, pregelatinized starch, docusate sodium, magnesium stearate (E470b), hydroxypropyl cellulose (E463), hypromellose 6Cp (E464), titanium dioxide (E171), talc, indigo carmine aluminium lake (E132), yellow iron oxide (E172)
What Finasteride film-coated tablets looks like and contents of the pack
Finasteride 5 mg film-coated tablets are blue, circular, biconvex film-coated tablets with a bevelled edge, engraved with an 'E' on one side and '61' on the other side.
Finasteride 5 mg film-coated tablets are supplied in PVC/PE/PVdC-aluminium foil blister packs containing 10, 14, 15, 20, 28, 30, 45, 50, 60, 90, 98, 100 or 120 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK E-mail : info@medreich.co.uk Finasteride 5 mg - PL 21880/0052 POM
Revised: August 2013
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