Finasteride 1 Mg Film-Coated Tablets
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Finasteride 1 mg film-coated tablets
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
6. Further information
1. WHAT FINASTERIDE IS AND WHAT IT IS USED FOR
This medicine is for use in men only and should not be taken by women or children.
This medicine contains the active ingredient finasteride. This medicine is used for the treatment of early stages of male pattern hair loss (also known as androgenetic alopecia) in men 18-41 years of age. 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 II 5-alpha reductase) that converts testosterone to DHT Only men with mild to moderate, but not complete hair loss or bitemporal recession can expect to benefit from the use of this medicine. In most of the men treated with this medicine 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.
2. BEFORE YOU TAKE FINASTERIDE
Do not take this medicine:
• if you are hypersensitive (allergic) to finasteride or any of the other ingredients of these tablets.
• If you are a child or adolescent (< 18 years)
• if you are a woman (see also under 'Pregnancy and breast feeding').This medicine has been found to be ineffective in the treatment of hair loss (androgenetic alopecia) in women in clinical studies.
This medicine should not be taken by men who are taking other medicinal product containing finasteride, or any other 5a-reductase inhibitor for benign prostatic hyperplasia or any other condition.
Take special care with this medicine:
Pregnant women or women able to conceive must not touch broken or divided Finasteride tablets. There is a possibility that finasteride might be absorbed by the skin, which may interfere with the development of external genitals in the male embryo. If pregnant women should come into contact with finasteride (the active substance), they must report to their doctor.
Finasteride tablets can affect a blood test called PSA. If you have blood tests to check your prostate gland you must tell your doctor you are taking Finasteride.
Determination of prostate-specific-antigen (PSA) in serum should be carried out prior to initiating therapy with finasteride and during treatment.
This medicine may affect male fertility. Patients who are planning to father a child should consider stopping treatment.
Taking other medicines
This medicine does not usually interfere with other medicines.
However, you should always tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
No data is available on the use of Finasteride 1 mg Tablets together with topical (applied to the skin) minoxidil in male pattern hair loss.
Taking this medicine with food and drink
This medicine can be taken with or without food.
Pregnancy and breast-feeding
This medicine must not be taken by women. Women who are or may potentially be pregnant must not handle Finasteride 1 mg Tablets especially if broken or crushed. If finasteride is absorbed through the skin or taken by mouth by women pregnant with a male foetus, the child may be born with malformed genital organs. The tablets are film-coated, which helps to prevent contact with finasteride provided the tablets are not broken or crushed.
When the patient's sexual partner is or may become pregnant, the patient should either avoid exposure of his partner to semen (e.g. by use of a condom) or discontinue treatment with finasteride.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no data to suggest that this medicine affects the ability to drive and use machines.
Important information about some of the ingredients of this medicine
This medicinal product contains 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.
3. HOW TO TAKE FINASTERIDE
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking the tablets: The tablets should be swallowed whole with some water. They must not be crushed or divided. You can take the tablets with a meal or on an empty stomach.
Unless otherwise prescribed by the doctor, the usual dose for all patients is one tablet per day.
Follow the instructions of your doctor. Do not change the dosage or stop taking this medicine without asking your doctor first.
This medicine does not work any quicker or better, if you take it more than once a day.To achieve increased hair thickness or decreased hair loss, you need to take this medicine every day for 3 to 6 months or more.
This medicinal product is authorised in the Member States of the EEA under the following names:
Germany
Austria
Belgium
Spain
France
Luxemburg
Netherlands
Poland
Portugal
Sweden
United Kingdom
You and your doctor can then assess whether the treatment with this medicine has benefited you. No change in normal hair care routine is needed during treatment with this medicine.
If you have the impression that the effect of this medicine is too weak or too strong, please talk to your doctor or pharmacist.
If you take more Finasteride than you should
If you have accidentally taken too many tablets, please contact your doctor or hospital for advice.
If you forget to take your medicine
Do not take a double dose to make up for a forgotten dose. Continue the treatment at the usual dose at the next scheduled time.
If you stop taking your medicine
In order to maintain the benefit of treatment, continuous use of this medicine is recommended. If you stop treatment with this Finasteride, any increased hair thickness gained during treatment will probably be lost 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.
Potential side effects of Finasteride are generally mild and temporary in nature.
Stop taking this medicine and talk to your doctor immediately if you have any of the following symptoms:
• swelling of your face, tongue or throat
• difficulty swallowing
• lumps under your skin (hives)
• breathing difficulties
The side effects have usually been temporary with continued treatment or disappeared when treatment is stopped.
Uncommon (occur in less than 1 in 100 users):
• less desire to have sex
• difficulty having an erection
• problems with ejaculation such as a decrease in the amount of semen released
Frequency unknown:
• 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
• fast heart beat
• persistent difficulty having an erection after discontinuation of treatment
• infertility has been reported in men who took finasteride for long periods of 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.
• increased liver enzymes
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
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the outer carton after 'EXP'. The expiry date refers to the last day of that month.
HDPE container and LDPE screw cap:
Use within 4 months after first opening of the plastic container.
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 this medicine contains
The active substance is: finasteride.
One tablet contains 1 mg of finasteride.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, pregelatinised starch, lauroyl macrogol glyceride, sodium starch glycolate (type A) and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), red and yellow iron oxide (E172) and macrogol 6000.
What this medicine looks like and contents of the pack
Finasteride 1 mg tablets are reddish-brown, round, biconvex film-coated tablets, stamped "F1" on one side.
Finasteride 1 mg film-coated tablets are available in packs of
Blister (Aluminium/PVC; Aluminium/Aluminium): Pack sizes:
7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 180 tablets.
Unit dose blister:
Pack sizes:
28x1,30x1,50x1,98x1, 100x1 tablets.
HDPE container and LDPE screw cap:
Pack sizes:
100, 250, 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: ratiopharm GmbH, Graf-Arco-Str.3, 89079 Ulm, Germany.
Manufacturer: Merckle GmbH, Ludwig-Merckle-Str.3, 89143 Blaubeuren, Germany.
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For a large print, audio, Braille or CD-rom version of this patient information leaflet, phone 02392 313592.
This leaflet was last revised in:
July 2010.