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FINASTERIDE 1MG TABLETS

Active substance(s): FINASTERIDE

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210 mm

210 mm

!
If a woman who is pregnant comes into contact with crushed or
If any of these side effects gets serious, or if you notice any side
broken Finasteride tablets, speak to your doctor.

Finasteride 1mg film-coated tablets

Driving and using machines
Finasteride is not likely to affect you being able to drive, use tools
or machines.

Finasteride

Will the use of Finasteride affect the hair on other parts of
your body?
Finasteride does not affect hair on other parts of the body.

Finasteride contains Lactose
If you have been told by your doctor that you have an intolerance
How does Finasteride work?
Read all of this leaflet carefully before you start taking this
to some sugars, contact your doctor before taking this medicinal
What else should you know about Finasteride?
Finasteride lowers the levels of DHT in the scalp. This helps to
medicine because it contains important information for you.
product.
Finasteride can also be used for a type of prostate problem called
reverse the balding process, leading to an increased hair growth
!
Keep this leaflet. You may want to read it again.
'benign prostatic hyperplasia' or BPH. Information collected from a
and prevention of further hair loss.
!
If you have any further questions, ask your doctor or
3.
How
to
take
Finasteride
clinical trial in men taking finasteride 5 mg (a dose 5 times higher
pharmacist.
than Finasteride) for 7 years showed:
2. What you need to know before you take Finasteride
!
This medicine has been prescribed for you only. Do not pass it
Always
take
this
medicine
exactly
as
your
doctor
or
pharmacist
!
The number of men who developed prostate cancer was lower
on to others. It may harm them, even if their signs of illness are
has told you. Check with your doctor or pharmacist if you are not
in men taking finasteride compared with those taking nothing.
Do not take Finasteride:
the same as yours.
sure.
!
The number of men who had a high score in a tumour grading
!
If you are a woman (because this medicine is for men). It has
!
If you get any side effects, talk to your doctor or pharmacist.
system was higher in some of those taking finasteride
been shown in clinical trials that Finasteride does not work in
This includes any possible side effects not listed in this leaflet.
!
The recommended dose is one tablet each day. The tablet can
compared to those taking nothing
women with hair loss.
See section 4.
be taken with or without food.
!
The effect of long-term use of finasteride on tumours of this
!
If you are allergic (hypersensitive) to finasteride or any of the
kind is unknown.
other ingredients of this medicine (listed in Section 6).
What is in this leaflet:
If you take more Finasteride than you should
!
If you would like further information about the tumour grading
!
If you are already taking finasteride or dutasteride used for a
1. What Finasteride is and what it is used for
If
you
take
too
many
tablets
by
mistake,
contact
your
doctor
system or this trial, please talk to your doctor.
prostate problem called benign prostatic hyperplasia (BPH).
2. What you need to know before you take Finasteride
immediately. Finasteride will not work faster or better if you take it
Do not take Finasteride if any of the above apply to you. If you are
3. How to take Finasteride
more than once a day.
Reporting of side effects
not sure, talk to your doctor or pharmacist.
4. Possible side effects
If you get any side effects, talk to your doctor or pharmacist. This
5. How to store Finasteride
If you forget to take Finasteride
includes any possible side effects not listed in this leaflet. You can
Warnings and Precautions
6. Contents of the pack and other information
!
Do not take a double dose to make up for a forgotten dose.
also report side effects directly (see details below). By reporting
Talk to your doctor or pharmacist before taking Finasteride if:
side effects you can help provide more information on the safety of
!
You are going to have a blood test for prostate cancer called
1. What Finasteride is and what it is used for
If you stop taking Finasteride
this medicine.
PSA (prostate-specific antigen). This is because Finasteride
It may take 3 to 6 months for the full effect to develop. It is
United Kingdom: Yellow Card Scheme at
can affect the result of this test.
Finasteride contains a medicine called finasteride. This belongs to
important to keep taking Finasteride for as long as your doctor tells
www.yellowcard.mhra.gov.uk
!
Mood alterations and depression: Mood alterations such as
a group of medicines called Type II '5-alpha reductase inhibitors'.
you. If you stop taking Finasteride, you are likely to lose the hair
depressed mood, depression and, less frequently, suicidal
you have gained within 9 to 12 months.
5. How to store Finasteride
thoughts have been reported in patients treated with
Finasteride is used for the treatment of male pattern hair loss (also
Finasteride. If you experience any of these symptoms stop
known as androgenetic alopecia). Finasteride increases hair
If you have any further questions on the use of this medicine, ask
Keep this medicine out of the sight and reach of children.
growth on the scalp and prevents further hair loss in men. Men
taking Finasteride and contact your doctor for further medical
your doctor or pharmacist.
Do not use Finasteride Tablets after the expiry date which is stated
with mild to moderate, but not complete hair loss, can benefit from
advice as soon as possible.
on the blister, carton or bottle after 'Expiry date:' The expiry date
using Finasteride.
4. Possible side effects
refers to the last day of that month. This medicinal product does
Effects on fertility
not require any special storage conditions.
How does the hair on your head grow?
Infertility has been reported in men who took finasteride for long
Like all medicines, this medicine can cause side effects, although
On average your hair grows about 1 centimetre (half an inch) each
time and had other risk factors that may affect fertility.
not everybody gets them. Some of the side effects are temporary
Medicines should not be disposed of via wastewater or household
month. Hair grows from hair follicles, which are located under your
Normalisation or improvement of seminal quality has been
with continued treatment or disappear when treatment is stopped.
waste. Ask your pharmacist how to dispose of medicines no longer
skin.
reported after discontinuation of finasteride. Long-term clinical
required. These measures will help to protect the environment.
A single scalp hair grows continuously for 2-4 years (growth
studies about the effects of finasteride on fertility in men have not
Stop taking Finasteride and talk to your doctor immediately if you
phase) and then stops growing for 2-4 months (rest phase). After
been conducted.
have any of the following symptoms of an allergic reaction:
6. Contents of the pack and other information
this the hair falls out. In its place a new healthy hair begins to grow,
swelling of your lips, face, tongue and throat; difficulty swallowing;
and the cycle is repeated. The hairs on your scalp are always in
Breast Cancer
lumps under your skin (hives) and breathing difficulties.
What Finasteride tablets contain the active substance is finasteride
different stages of this cycle so it is normal to lose scalp hair every
See section 4
!
Depression (feelings of severe sadness and unworthiness).
1 mg the other ingredients are lactose monohydrate,
day.
microcrystalline cellulose, pregelatinised starch, lauroyl
Children and adolescents
You should promptly report to your doctor any changes in your
macrogolglycerides, sodium starch glycollate Type A, magnesium
What is male pattern hair loss?
Finasteride should not be used in children. There are no data
breast
tissue
such
as
lumps,
pain,
enlargement
or
nipple
discharge
stearate, hypromellose, titanium dioxide (E171), yellow and red
Male pattern hair loss is a common condition in which men
demonstrating efficacy or safety of finasteride in children under the
as these may be signs of a serious condition, such as breast
iron oxide (E172), and macrogol 6000.
experience thinning of the hair on the scalp, often resulting in a
age of 18.
cancer.
receding hairline and/or balding on the top of the head. This
What Finasteride tablets look like and contents of the pack:
condition is thought to be caused by a combination of genetic
Other medicines and Finasteride
Uncommon:
may
affect
up
to
1
in
100
people
Finasteride 1mg film-coated tablets are round, biconvex reddishfactors and a particular hormone, DHT (dihydrotestosterone).
Tell your doctor or pharmacist if you are taking, have recently
!
You may be unable to have an erection (impotence)
brown tablets, with the markings 'F1'
taken or might take any other medicines. Finasteride does not
!
You
may
have
less
desire
to
have
sex
DHT causes a decrease in the growth phase and thinning of the
usually affect other medicines.
!
You may have problems with ejaculation, for example a
They are supplied in:
hair (see picture). This leads to male pattern hair loss. These
!
Do not take Finasteride if you are already taking finasteride or
decrease in the amount of semen released during sex. This
Blister packs containing 28 tablets
changes can start to occur in some men in their 20s and become
dustasteride, used for a prostate problem called benign
decrease in the amount of semen does not appear to affect
Plastic bottles containing 28 tablets
more common with age. Once hair loss has occurred over a long
prostatic hyperplasia (BPH).
normal sexual function.
period of time, the hair may be permanently lost.
!
No information is available about the use of Finasteride with
!
Depression
Marketing Authorisation Holder
minoxidil, another type of medicine for male pattern hair loss
Relonchem Limited, Cheshire House, Gorsey lane, Widnes, WA8
which is applied to the head.
Frequency unknown:
0RP, UK.
!
breast swelling or tenderness
Pregnancy, breast feeding and fertility
!
palpitations (feeling your heartbeat)
Manufacturer
Finasteride is for the treatment of male pattern hair loss in men
!
changes in the way your liver is working, which can be shown
Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland.
only. For effects on fertility see section 2.
by a blood test
!
pain in the testicles
MA Number: PL 20395/0068
!
Finasteride should not be taken by women.
!
persistent difficulty having an erection after discontinuation of
!
Do not touch crushed or broken Finasteride tablets if you are a
treatment
Revision date: September 2017
woman who is pregnant or planning to become pregnant
!
persistent
decrease
in
sex
drive
after
discontinuation
of
(whole tablets are coated to stop contact with the medicine
treatment
during normal use). This is because this medicine may affect
!
persistent problems with ejaculation after discontinuation of
the baby's sex organs.
treatment
!
male infertility and/or poor quality of semen

296 mm

296 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

effects not listed on this leaflet please tell your doctor or
pharmacist. It will help if you make a note of what happened, when
it started and how long it lasted.

PHARMACODE

PHARMACODE

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