Finasteride 1 Mg Film-Coated Tablets
12mm
11 mm
7 mm
E
E
CO
Package leaflet: Information for the patient
cellulose, talc, titanium dioxide (E171), iron oxide red and yellow (E172))
What this medicine looks like and contents of the pack
• These tablets are red, round, biconvex film coated tablets, with a 6.5 mm nominal diameter and embossed with ‘BL1’ on one side .
• This medicine is available in packs of 7, 28, 30, 84 or 98 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Bristol Laboratories Ltd.,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
This medicinal product is authorised in the Member States of the EEA under the following names:
DE- Finasterid axcount 1 mg Filmtabletten ES- Finasterida Brill Pharma 1 mg comprimidos recubiertos con pelicula EFG
Finasteride 1 mg film-coated tablets; PL 17907/0497
This leaflet was last revised in July 2016
To request a copy of this leaflet in Braille, large font or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V8 18-07-16 DO
296 mm
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 on to 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 this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
Finasteride contains a medicine called finasteride. This belongs to a group of medicines called Type II ‘5-alpha reductase inhibitors’.
Your doctor has prescribed Finasteride because you have male pattern hair loss (also known as androgenetic alopecia). Men with mild to moderate, but not complete hair loss, can benefit from using Finasteride.
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 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.
2. What you need to know before you take this medicine
Do not take this medicine if:
• you are allergic (hypersensitive) to finasteride or any of the other ingredients (listed in Section 6)
• you are a woman (because this medicine is for men). It has been shown in clinical trials that this medicine does not work in women with hair loss
• you are a child or adolescent.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist.
210 mm
SAME SIZE ARTWORK Front
6 mm
6 mm
E
E
CO
Warnings and precautions
Talk to your doctor or pharmacist before taking your medicine:
• if you are going to have a blood test for prostate cancer caked PSA (prostate-specific antigen). This is because finasteride can affect the result of this test.
Other medicines and Finasteride
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
This medicine does not usually affect other medicines. Do not take this medicine if you are already taking finasteride or dustasteride, used for a prostate problem called benign prostatic hyperplasia (BPH).
Taking this medicine with food and drink
This medicine can be taken with or without food.
Pregnancy and breast-feeding
• This medicine should not be taken by women.
• Do not touch crushed or broken tablets if you are a woman who is pregnant or planning to become pregnant (whole tablets are coated to stop contact with the medicine during normal use). This is because this medicine may affect the baby’s sex organs.
• If a woman who is pregnant comes into contact with crushed or broken tablets, speak to your doctor.
• If your sexual partner is or could be pregnant, you must avoid exposing her to your semen, which could contain a small amount of finasteride — for example by using a condom during sexual activity.
Driving and using machines
Driving and using machinery is not known to be affected by this medicine.
This medicine contains lactose
If you have been told by your doctor that you
E
E
CO
SAME SIZE ARTWORK Back
have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take this medicine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults: The recommended dose is one tablet each day with or without food.
The tablets should be swallowed whole and must not be crushed or divided.
• Finasteride 1 mg Tablets will not work faster or better if you take them more than once a day.
• Male pattern hair loss is a condition that develops over a long period of time. In general, daily use for three to six months may be necessary before you notice any increase in the hair density or reduction in hair loss.
• Your doctor will help you to assess if Finasteride 1 mg Tablets are working. It is important to continue taking Finasteride 1 mg Tablets for as long as your doctor prescribes them.
Patients with renal or hepatic impairment:
Usually no dose adjustment is needed and the same dose as for other adults should be used.
If you take more of this medicine than you should
If you take more of this medicine than you should, talk to a doctor straight away.
If you forget to take this medicine
If you forget to take a dose, just take your next dose as normal. Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
It may take 3 to 6 months for the full effect to develop. It is important to keep taking this medicine for as long as your doctor tells you. If you stop taking this medicine, 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 medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should promptly report to your doctor any changes in your breast tissue such as lumps, pain, enlargement or nipple discharge as these may be signs of a serious condition, such as breast cancer. Stop taking this medicine, and see your doctor straightaway, if you notice any signs of allergic reaction which may include:
• Skin rashes, itching, or lumps under your skin (hives)
• Swelling of lips, face, tongue or throat
• difficulty swallowing
• 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
Frequency unknown (cannot be estimated from the available data)
• hypersensitivity reactions, including swelling of the lips, tongue, throat and face
• breast swelling or tenderness
• pain in the testicles
• fast heart beat
• persistent difficulty having an erection after discontinuation of treatment
• persistent decrease in sex drive after discontinuation of treatment.
• persistent problems with ejaculation after discontinuation of treatment.
• infertility has been reported in men who took finasteride for 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 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 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.
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special temperature storage conditions
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• 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.
210mm
What this medicine contains
• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are lactose monohydrate, maize starch pregelatinised, docusate sodium, iron oxide yellow (E172), sodium starch glycollate, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, opadry pink (consists of hypromellose, hydroxypropyl