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AINDEEM 1MG FILM-COATED TABLETS

Active substance(s): FINASTERIDE

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Package leaflet: Information for the patient

Aindeem 1mg Film-coated Tablets
Finasteride
Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
•K
 eep 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 Aindeem is and what it is used for
2 What you need to know before you
take Aindeem
3 How to take Aindeem
4 Possible side effects
5 How to store Aindeem
6 Contents of the pack and other
information
1 What Aindeem is and what it is used

for

Aindeem contains the active substance finasteride
which belongs to a group of medicines called Type
II ‘5-alpha reductase inhibitors’.
Aindeem is used to treat early forms of male
pattern hair loss (also called androgenetic
alopecia).

2 What you need to know before you

take Aindeem

Do not take Aindeem if you
• are allergic to finasteride or any of the other

ingredients of this medicine (listed in section 6).
• are a woman (because this medicine is for men).
• 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
Aindeem if you
• notice 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. You
should promptly report to your doctor if you
notice any of these changes.
• need to have a blood test called “PSA” (prostatespecific antigen). Make sure you tell your doctor
or pharmacist first since finasteride may alter the
results of the test.

Children

Aindeem should not be used in children.

Other medicines and Aindeem

Aindeem can normally 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 Aindeem if you are already taking
finasteride or dustasteride, used for a prostate
problem called benign prostatic hyperplasia (BPH).

Aindeem with food

Aindeem can be taken with or without food.

Pregnancy and breastfeeding

• Aindeem should not be taken by women.
•W
 omen who are pregnant or may become
pregnant should not handle broken or crushed
Aindeem tablets. If finasteride is absorbed
through the skin or taken by mouth by a woman
pregnant with a male foetus, the child may be
born with malformed genital organs. The tablets
are film-coated, which prevents contact with
finasteride provided the tablets are not broken or
crushed.
If your sexual partner is or may possibly be
pregnant, you must avoid exposing her to your
semen, which could contain a small amount of the
drug, by using a condom.
If you think a pregnant woman has come into
contact with finasteride, you should consult a
doctor.

Driving and using machines

There is no evidence to suggest that Aindeem
affects the ability to drive or use machines.

Aindeem contains lactose monohydrate

Aindeem contains lactose monohydrate. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine

Using other medicine for male pattern hair
loss with Aindeem
No information is available about the use of
Aindeem with minoxidil, another type of medicine
for male pattern hair loss which is applied to the
head.

3 How to take Aindeem
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 recommended dose is one tablet (1mg
finasteride) daily.
• The tablet should be swallowed whole and
should not be broken or crushed.
• Aindeem may be taken with or without food.
• Aindeem will not work faster or better if you take
it more than once a day.
Continued over page

Continued top of next column
AAAH9698

Finasteride 1mg tablets PIL UK

colours/plates:
1. Black

item no: AAAH9698

dimensions: 160 x 270

print proof no: 02

pharmacode:

origination date: 27-05-2015

min pt size: 9pt

3.
4.
5.
6.

originated by: MH
approved for print/date

2.

revision date: 08-06-2015

Technical Approval

revised by: MH

date sent: 27-05-2015

supplier: IL/Intas Pharmaceuticals, Ltd

technically app. date: 28-05-2015

Non Printing Colours
1. Profile
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

If you stop taking Aindeem

It may take 3 to 6 months for the full effect to
develop. It is important to keep taking Aindeem
for as long as your doctor tells you. If you stop
taking Aindeem, you are likely to lose the hair you
have gained within 9-12 months.

If you take more Aindeem than you should
If you (or someone else) swallow a lot of the
tablets at the same time, or you think a child has
swallowed any of the tablets, contact your nearest
hospital casualty department or your doctor
immediately.

If you forget to take Aindeem

Do not take a double dose to make up for a
forgotten tablet. Just take the next one when it is
due.
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.
Stop taking Aindeem and immediately contact
a doctor if you experience any of the following
symptoms of an allergic reaction:
• Skin rashes, itching, or lumps under your skin
(hives)
• (angioedema) swelling of lips, face, tongue or
throat
• Difficulty swallowing
• Breathing difficulties
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.
Other possible side effects
Uncommon (affects 1 to 10 users in 1,000):
• inability to develop or maintain an erection
(impotence)
• problems with ejaculation (such as reduced
amount of ejaculatory fluid)
• less desire to have sex
• depressed mood.
Not known (frequency cannot be estimated from
the available data):
• awareness of your heart beating (palpitation)
• increase of liver enzymes (as seen in blood tests)
• testicular pain
• infertility
• persistent difficulty having an erection after
discontinuation of treatment
• persistent decrease in sex drive that may continue
after discontinuation of treatment
• persistant problems with ejaculation after
discontinuation of treatment, for example a
decrease in the amount of semen released during
sex.

5 How to store Aindeem
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date which is stated on the blister, carton
or bottle after ‘EXP’. The expiry date refers
to the last day of that month.
This medicinal product does not require
any special storage conditions. 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 Aindeem contains

• The active substance is finasteride. Each filmcoated tablet contains 1mg finasteride.
• The other ingredients are lactose monohydrate,
microcrystalline cellulose, pregelatinised
starch, lauroyl macrogolglycerides, sodium
starch glycollate – Type A, magnesium stearate,
hypromellose, titanium dioxide (E171), yellow and
red iron oxide (E172), and macrogol 6000.

What Aindeem looks like and contents of
the pack

Aindeem 1mg film-coated tablets are round,
biconvex reddish-brown tablets, with the markings
‘F1’
They are supplied in: Blister packs containing 28
and 84 tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis hf
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland
or
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland
This leaflet was last revised in May 2015

If you would like a
leaflet with larger
text, please contact
01271 385257.

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
Website: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more
information on the safety of this medicine.

Continued top of next column
AAAH9698

Actavis, Barnstaple, EX32 8NS, UK

Finasteride 1mg tablets PIL UK

colours/plates:
1. Black

item no: AAAH9698

dimensions: 160 x 270

print proof no: 02

pharmacode:

origination date: 27-05-2015

min pt size: 9pt

3.
4.
5.
6.

originated by: MH
approved for print/date

2.

revision date: 08-06-2015

Technical Approval

revised by: MH

date sent: 27-05-2015

supplier: IL/Intas Pharmaceuticals, Ltd

technically app. date: 28-05-2015

Non Printing Colours
1. Profile
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

Package leaflet: Information for the patient

Aindeem 1mg 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 Aindeem is and what it is used for
2.
What you need to know before you take Aindeem
3.
How to take Aindeem
4.
Possible side effects
5.
How to store Aindeem
6.
Contents of the pack and other information

1.

What Aindeem is and what it is used for

Aindeem contains the active substance finasteride which belongs to a group of medicines called Type II ‘5alpha reductase inhibitors’.

Aindeem is used to treat early forms of male pattern hair loss (also called androgenetic alopecia).
2.
What you need to know before you take Aindeem
Do not take Aindeem if you are
allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
a woman (because this medicine is for men).
already taking finasteride or dutasteride, used for prostate problem called benign prostatic hyperplasia
(BPH).
Warnings and precautions
Talk to your doctor or pharmacist before taking Aindeem if you
notice 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. You should promptly
report to your doctor if you notice any of these changes.
need to have a blood test called “PSA” (prostate-specific antigen). Make sure you tell your doctor or
pharmacist first since finasteride may alter the results of the test.

Children
Aindeem should not be used in children.
Other medicines and Aindeem
Aindeem can normally be taken with other medicines. Tell your doctor or pharmacist if you are taking,
have recently taken, or might takeany other medicines.
Do not take Aindeem if you are already taking finasteride or dustasteride, used for a prostate problem called
benign prostatic hyperplasia (BPH).
1

Aindeem with food
Aindeem can be taken with or without food.
Pregnancy and breastfeeding
Aindeem should not be taken by women.
Women who are pregnant or may become pregnant should not handle broken or crushed
Aindeem tablets.
If finasteride is absorbed through the skin or taken by mouth by a woman pregnant with a male foetus,
the child may be born with malformed genital organs.
The tablets are film-coated, which prevents contact with finasteride provided the tablets are not
broken or crushed.
If your sexual partner is or may possibly be pregnant, you must avoid exposing her to your semen, which
could contain a small amount of the drug by using a condom.
If you think a pregnant woman has come into contact with finasteride, you should consult a doctor.
Driving and using machines
There is no evidence to suggest that Aindeem affects the ability to drive or use machines.

Aindeem contains lactose monohydrate
Aindeem contains lactose monohydrate. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine

Using other medicine for male pattern hair loss with Aindeem
No information is available about the use of Aindeem with minoxidil, another type of medicine for
male pattern hair loss which is applied to the head.
3.

How to take Aindeem

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 recommended dose is one tablet (1mg finasteride) daily.
The tablet should be swallowed whole and should not be broken or crushed.
Aindeem may be taken with or without food.
Aindeem will not work faster or better if you take it more than once a day.

If you stop taking Aindeem

It may take 3 to 6 months for the full effect to develop. It is important to keep taking Aindeem for as
long as your doctor tells you. If you stop taking Aindeem, you are likely to lose the hair you have
gained within 9-12 months.
If you take more Aindeem than you should
If you (or someone else) swallow a lot of the tablets at the same time, or you think a child has swallowed
any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
If you forget to take Aindeem
Do not take a double dose to make up for a forgotten tablet. Just take the next one when it is due.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects
2

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Aindeem and immediately contact a doctor if you experience any of the following symptoms of
an allergic reaction:
Skin rashes, itching, or lumps under your skin (hives)
(angioedema) swelling of lips, face, tongue or throat
Difficulty swallowing
Breathing difficulties
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.

Other possible side effects
Uncommon (affects 1 to 10 users in 1,000):
inability to develop or maintain an erection (impotence)
problems with ejaculation (such as reduced amount of ejaculatory fluid)
less desire to have sex
depressed mood.
Not known (frequency cannot be estimated from the available data):
awareness of your heart beating (palpitation)
increase of liver enzymes (as seen in blood tests)
testicular pain
infertility
persistent difficulty having an erection after discontinuation of treatment
persistent decrease in sex drive that may continue after discontinuation of treatment.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
5.

How to store Aindeem

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, carton or bottle after ‘EXP’.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.

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 Aindeem contains
The active substance is finasteride. Each film-coated tablet contains 1mg finasteride.
The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch,
lauroyl macrogolglycerides, sodium starch glycollate – Type A, magnesium stearate, hypromellose,
titanium dioxide (E171), yellow and red iron oxide (E172), and macrogol 6000.
What Aindeem looks like and contents of the pack
Aindeem 1mg Film-coated Tablets are round, biconvex reddish-brown tablets, with the markings ‘F1’
3

They are supplied in:
Blister packs containing 28 tablets
Blister packs containing 84 tablets
Plastic bottles containing 28 tablets
Marketing Authorisation Holder

Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturers
Actavis hf
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland.
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland
This leaflet was last revised in May 2015

4

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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