Finasteride 1 Mg Film-Coated Tablets
TEVA UK Ref: 231-30-53003-D LEA FINASTERIDE 1mg FC TAB TUK Version: 3 08 July 2015
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Pharma code 371
First bar is 105mm from the top edge of the leaflet.
Top of page cut-off to middle of registration mark: 44 mm.
PACKAGE LEAFLET INFORMATION FOR THE USER
Read all of this leaflet carefully before you start using 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 of 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 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
OWhat Finasteride is and what it is used for
• Finasteride contain a medicine called finasteride
• Finasteride is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). If after reading this leaflet, you have any questions about male pattern hair loss, ask your doctor • male pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT). DHT contributes to shortening of the growth phase of the hair and to thinning of the hair
• in the scalp, finasteride specifically lowers the levels of DHT by blocking an enzyme (type 2 5-alpha reductase) that converts testosterone to DHT. Only men with mild to moderate, but not complete hair loss can expect to benefit from the use of Finasteride. In most of the men treated with finasteride for 5 years, the progression of hair loss was slowed, and at least half of these men also had some kind of improved hair growth.
What you need to know before you take Finasteride
Do not take Finasteride
• if you are a woman (because this medicine is for men, see Pregnancy). It has been shown in clinical trials that finasteride does not work in women with hair loss • if you are allergic (hypersensitive) to finasteride or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Finasteride
• Finasteride should not be taken by children and teenagers under the age of 18 years
• if you are to have a blood test called prostate-specific antigen (PSA) tell your doctor or pharmacist that you are taking Finasteride as it may affect the results
• tell your doctor or pharmacist about any medical problems you have or have had, and about any allergies.
Other medicines and Finasteride
Finasteride can usually be taken with other medicines. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Finasteride with food and drink
Finasteride can be taken with or without food.
Pregnancy and breast-feeding
• Finasteride is for the treatment of male pattern hair loss in men only
• women must not use Finasteride due to the risk of pregnancy
• do not touch crushed or broken tablets of Finasteride if you are a woman who is pregnant or may potentially be pregnant
• if the active ingredient of Finasteride is absorbed after oral use or through the skin by a woman who is pregnant with a male baby, this may cause the male baby to be born with abnormalities of the sex organs
•if a woman who is pregnant comes into contact with the active ingredient of Finasteride, a doctor should be consulted
• Finasteride tablets are coated and will prevent contact with the active ingredient during normal use.
If your sexual partner is or may be pregnant, you must avoid exposing her to your semen (e.g. by using a condom).
If you have questions, ask your doctor.
Driving and using machines Finasteride is not expected to or known to affect your ability to drive or operate machinery.
Finasteride contains lactose
Patients who are intolerant to lactose should note that Finasteride tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How to take Finasteride
Always take Finasteride exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
The recommended dose is one tablet each day.
The tablets can be taken with or without food. Finasteride will not work faster or better if you take it more than once a day.
PAGE 2: REAR FACE (OUTSIDE OF REEL)
Your doctor will help you to determine if Finasteride is working for you. It is important to take Finasteride for as long as your doctor prescribes it. Finasteride can only work over the long term if you continue taking it.
Use in children and adolescents
Finasteride should not be used in children. There are no data demonstrating efficacy or safety of finasteride in children under the age of 18.
If you take more Finasteride than you should
If you take too many tablets by mistake, talk to your doctor promptly.
If you forget to take Finasteride
If you forget to take a tablet, skip the missed dose. Take the next one as usual. Do not take a double dose to make up for the forgotten dose.
If you stop taking Finasteride
It may take 3 to 6 months for the full effect to develop. It is important to keep taking Finasteride as long as your doctor tells you. If you stop taking Finasteride, you are likely to lose the hair you have gained within 9 to 12 months.
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.
Stop taking Finasteride and immediately contact a doctor if you experience any of the following symptoms (angioedema):
• swelling of face, tongue or throat
• difficulty swallowing
• hives
• breathing difficulties.
The side effects have usually been temporary with continued treatment or disappeared when treatment is stopped:
Uncommon: may affect up to 1 in 100 people
• less desire to have sex
• difficulty having an erection
• problems with ejaculation such as a decrease in the amount of semen released
• depressed mood.
Not known: frequency cannot be estimated from the available data
• allergic reactions such as rash, itching, lumps under your skin (hives) and swelling of your lips and face
• breast swelling or tenderness
• pain in the testicles
• faster heartbeat
• persistent difficulty having an erection after discontinuation of treatment
• infertility has been reported in men who took finasteride for a long time and had other risk factors that may affect fertility. Normalisation or improvement of seminal quality has been reported after discontinuation of finasteride. Long-term clinical studies about the effect of finasteride on fertility in men have not been conducted
• elevated liver enzymes.
You should promptly report to your doctor any changes in the 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.
Reporting of side effects
If you get any side effects talk to your doctor or pharmacists. This includes any possible side effects not listed in this leaflet.
You can also report any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Finasteride
Keep this medicine out of the sight and reach of children.
Do not use Finasteride after the expiry date that is stated on the blister and carton.
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 waste water or household waste. Ask your pharmacist how to throw away medicines you no longer required. These measures will help protect the environment.
©Contents of the pack and other information
What Finasteride contains
• The active ingredient is finasteride.
• The other ingredients are lactose monohydrate, pregelatinised maize starch, sodium laurilsulfate, sodium starch glycolate (type A), povidone, microcrystalline cellulose, magnesium stearate, hypromellose 6 cP (E464), titanium dioxide (E171), macrogol 6000, macrogol 400, iron oxide red (E172) and iron oxide yellow (E172).
What Finasteride looks like and the contents of the pack
• Finasteride 1 mg Film-coated Tablets are brown and round in shape. The tablets are marked with "FNT1" on one side and plain on the other.
• The product is available in blister packs of 7, 28, 30, 50 (hospital packs), 84, 98 and 100 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Eastbourne, BN22 9AG, UK.
This leaflet was last revised in 06/2015
PL 00289/0826
ET7W71
53003-D 160x323
TEVA UK LIMITED