Finasteride 1 Mg Film-Coated Tablets
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Package leaflet: Information for the user
Finasteride 1 mg film-coated tablets
Finasteride
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.
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
1. What Finasteride is and what it is used for
- Finasteride 1 mg film-coated tablets 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 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 Finasteride
Do not take Finasteride
- if you are allergic to finasteride or the other ingredients of this medicine (listed in section 6).
- 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
- you are already taking finasteride or dutasteride used for a prostate problem called benign prostatic hyperplasia (BPH).
Warnings and precautions
Talk to your doctor or pharmacist before taking Finasteride.
- Finasteride should not be taken by children and teenagers under the age of 18 years.
- Check with your doctor or pharmacist before taking your medicine if you are going to have a blood test for prostate cancer called PSA (prostate-specific antigen). This is because Finasteride can affect the result of this test.
- Finasteride may affect male fertility. Patients who are planning to father a child should consider stopping treatment.
- 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.
- 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. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Finasteride if you are already taking finasteride or dustasteride, used for a prostate problem called benign prostatic hyperplasia (BPH).
Finasteride with food and drink and alcohol
Finasteride can be taken with or without food.
Pregnancy, breast-feeding and fertility
- Women must not use Finasteride due to the risk in 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 in 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 in 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 are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 should note that Finasteride film-coated tablets contains lactose. If you have ever been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Using other medicine for male pattern hair loss with Finasteride
No information is available about the use of finasteride with minoxidil, another type of medicine for male pattern hair loss which is applied to the head.
3. How to take Finasteride
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- The usual 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.
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.
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
Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next tablet as directed.
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.
Black
P150
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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
- depressed mood 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
- 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
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.
Stop taking Finasteride 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
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Malta
ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-13 68 Gzira Website:
www.medicinesauthority.gov.mt e-mail:
postlicensing.medicinesauthority@gov.mt
5. How to store Finasteride
Keep this medicine out of the sight and reach 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 label, carton, bottle 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.
6. Contents of the pack and other information
What Finasteride contains
- The active substance is finasteride. Each film-coated tablet contains 1 mg finasteride.
- The other ingredients are:
Tablet core: Lactose monohydrate, cellulose, microcrystalline, sodium starch glycolate, starch pregelatined [maize starch], docusate sodium, magnesium stearate Tablet coat: Hypromellose, hydroxy propyl cellulose, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172).
What Finasteride looks like and contents of the pack
Film-coated tablet
Brown coloured, octagonal, biconvex, film-coated tablets debossed with 'J' on one side and '81' on the other side.
Finasteride film-coated tablets are available in white opaque PVC/PE/PVdC -Aluminium foil blister pack and HDPE bottle with polypropylene cap containing silica gel as desiccant.
Package size:
Blister pack: 28, 56, 84, & 98 film-coated tablets HDPE bottle pack: 30 & 1000 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorization Holder
UK - Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
MT -Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront Floriana FRN 1913 Malta
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
France: FINASTERIDE ARROW LAB 1 mg, comprime pellicule
Germany: Finasterid Aurobindo 1 mg Filmtabletten
Italy: Finasteride Aurobindo Pharma Italia 1 mg compresse
rivestite con film
Malta: Finasteride 1 mg film-coated tablets
Portugal: Finasterida Aurobindo
Spain: FINASTERIDA AUROBINDO 1 mg comprimidos recubiertos
con pelfcula EFG
United Kingdom: Finasteride 1 mg film-coated tablets This leaflet was last revised in 04/2015.
