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AVODART 0.5 MG SOFT CAPSULES

Active substance: DUTASTERIDE

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Package Leaflet: Information for the User

Avodart

®

0.5 mg soft capsules
dutasteride
Read all of this leaflet carefully before you
start using 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:
What Avodart is and what it’s used for
Before you take Avodart
How to take Avodart
Possible side effects
How to store Avodart
Further information

What Avodart is and what it’s
used for

Avodart is used to treat men with an enlarged
prostate (benign prostatic hyperplasia) - a
non-cancerous growth of the prostate gland,
caused by producing too much of a hormone
called dihydrotestosterone.
The active ingredient is dutasteride. It belongs
to a group of medicines called 5-alpha reductase
inhibitors.
As the prostate grows, it can lead to urinary
problems, such as difficulty in passing urine and
a need to go to the toilet frequently. It can also
cause the flow of the urine to be slower and
less forceful. If left untreated, there is a risk
that your urine flow will be completely blocked
(acute urinary retention). This requires
immediate medical treatment. In some
situations surgery is necessary to remove or
reduce the size of the prostate gland. Avodart
lowers the production of dihydrotestosterone,
which helps to shrink the prostate and relieve
the symptoms. This will reduce the risk of acute
urinary retention and the need for surgery.
Avodart may also be used with another
medicine called tamsulosin (used to treat the
symptoms of an enlarged prostate).

0.5 mg soft capsules
dutasteride

Avodart

®

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Replacement No.:

115927

Point of sale code No.:

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Do not take Avodart

• Avodart affects a blood test for PSA
(prostate-specific antigen), which is
sometimes used to detect prostate cancer.
Your doctor should be aware of this effect
and can still use the test to detect prostate
cancer. If you are having a blood test for
PSA, tell your doctor that you are taking
Avodart. Men taking Avodart should have
their PSA tested regularly.
• In a clinical study of men at increased risk of
prostate cancer, men taking Avodart had a
serious form of prostate cancer more often
than men who did not take Avodart. The
effect of Avodart on this serious form of
prostate cancer is not clear.
• Avodart may cause breast enlargement and
tenderness. If this becomes troublesome, or
if you notice breast lumps or nipple
discharge you should talk to your doctor
about these changes as these may be signs of
a serious condition, such as breast cancer.
➔ Contact your doctor or pharmacist if you
have any questions about taking Avodart.

• if you’re allergic (hypersensitive) to
dutasteride, other 5-alpha reductase
inhibitors, soya, peanut or to any of the
other ingredients of Avodart
• if you have a severe liver disease.
➔ Tell your doctor if you think any of these
apply to you.
This medicine is for men only. It must not be
taken by women, children or adolescents.

Take special care with Avodart
• In some clinical studies, more patients taking
dustasteride and another medicine called an
alpha-blocker, like tamsulosin experienced
heart failure than patients taking only
dustasteride or only an alpha-blocker. Heart
failure means your heart does not pump
blood as well as it should.
• Make sure your doctor knows about liver
problems. If you have had any illness affecting
your liver, you may need some additional
check-ups while you are taking Avodart.
• Women, children and adolescents must not
handle leaking Avodart capsules, because
the active ingredient can be absorbed
through the skin. Wash the affected area
immediately with soap and water if there is
any contact with the skin.
• Use a condom during sexual intercourse.
Dutasteride has been found in the semen of
men taking Avodart. If your partner is or
may be pregnant, you must avoid exposing
her to your semen as dutasteride may affect
the normal development of a male baby.
Dutasteride has been shown to decrease
sperm count, semen volume and sperm
motility. This could reduce your fertility.

Taking other medicines
Tell your doctor if you’re taking, or have
recently taken, any other medicines. This
includes any medicines you’ve bought without
a prescription.
Some medicines can react with Avodart and
may make it more likely that you’ll have
side effects. These medicines include:
• verapamil or diltiazem (for high blood
pressure)
• ritonavir or indinavir (for HIV)
• itraconazole or ketaconazole (for fungal
infections)
• nefazodone (an antidepressant)

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Pregnancy and breast-feeding
Women who are pregnant (or may be) must not
handle leaking capsules. Dutasteride is absorbed
through the skin and can affect the normal
development of a male baby. This is a particular
risk in the first 16 weeks of pregnancy.
Use a condom during sexual intercourse.
Dutasteride has been found in the semen of
men taking Avodart. If your partner is or may
be pregnant, you must avoid exposing her to
your semen.
Avodart has been shown to reduce sperm
count, semen volume and sperm movement.
Therefore male fertility may be reduced.
➔ Contact your doctor for advice if a
pregnant woman has come into contact
with dutasteride.

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GSK-POL-Poznan-PLPZN
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Food and drink with Avodart
Avodart can be taken with or without food.

Avodart is unlikely to affect your ability to drive
or operate machinery.
Important information about some of the
ingredients of Avodart
This medicine contains lecithin from soya,
which may contain soya oil. If you
are allergic to peanut or soya, do
not use this medicinal product.
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• alpha-blockers (for enlarged prostate or high
blood pressure).
➔ Tell your doctor if you are taking any of
these medicines. Your dose of Avodart may
need to be reduced.

Driving and using machines

Avodart

148 x 345 mm

Carton dimensions

Before you take Avodart

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How to take Avodart

Always take Avodart exactly as your doctor
has told you to. If you do not take it
regularly the monitoring of your PSA levels
may be affected. Check with your doctor or
pharmacist if you are not sure.

How much to take
The usual dose is one capsule (0.5 mg)
taken once a day. Swallow the capsules
whole with water. Do not chew or break
open the capsule. Contact with the contents
of the capsules may make your mouth or
throat sore.
Avodart is a long term treatment. Some men
notice an early improvement in their
symptoms. However, others may need to
take Avodart for 6 months or more before it
begins to have an effect. Keep taking
Avodart for as long as your doctor tells you.

If you take too much Avodart
Contact your doctor or pharmacist for advice
if you take too many Avodart capsules.

If you forget to take Avodart
Don’t take extra capsules to make up for a
missed dose. Just take your next dose at the
usual time.

Don’t stop Avodart without advice
Don’t stop taking Avodart without talking to
your doctor first. It may take up to 6 months
or more for you to notice an effect.
➔ If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

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Possible side effects

Like all medicines, Avodart can cause side
effects, although not everybody gets them.

Allergic reaction
The signs of allergic reactions can include:
• skin rash (which can be itchy)
• hives (like a nettle rash)
• swelling of the eyelids, face, lips, arms or
legs.
➔ Contact your doctor immediately if you
get any of these symptoms, and stop
using Avodart.

Not known side effects
The frequency cannot be estimated from the
available data:
• depressed mood
• pain and swelling in your testicles
➔ 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.

Common side effects

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How to store Avodart

Keep out of the sight and reach of children.
Don’t store Avodart above 30°C.
Don’t use Avodart after the expiry date
which is stated on the carton or the foil
blister strip. The expiry date refers to the last
day of that month.
If you have any unwanted Avodart capsules,
don’t dispose of them in waste water or
household rubbish. Take them back to your
pharmacist, who will dispose of them in a
way that won’t harm the environment.

These may affect up to 1 in 10 men taking
Avodart:
• not able to achieve or maintain an
erection (impotence), this may continue
after you stop taking Avodart
• decreased sex drive (libido), this may
continue after you stop taking Avodart
• difficulty with ejaculation, this may
continue after you stop taking Avodart
• breast enlargement or tenderness
(gynecomastia)
• dizziness when taken with tamsulosin.

Further information

What Avodart contains

Other formats:

The active substance is dutasteride. Each
soft capsule contains 0.5 mg dutasteride.
The other ingredients are:
• inside the capsule: mono and diglycerides
of caprylic/capric acid and butylated
hydroxytoluene (E321).
• capsule shell: gelatin, glycerol, titanium
dioxide (E171), iron oxide yellow (E172),
triglycerides (medium chain), lecithin (may
contain soya oil).

To listen to or request a copy of this leaflet
in Braille, large print or audio please call,
free of charge:

What Avodart looks like and contents of
the pack
Avodart soft capsules are oblong opaque,
yellow, soft gelatin capsules marked with
GX CE2. They are available in packs of
30 capsules.

0800 198 5000 (UK Only)

Please be ready to give the following
information:
Product name
Avodart
Reference number
19494/0006
This is a service provided by the Royal
National Institute of Blind People.
Leaflet date: March 2013
Avodart is a registered trademark of the
GlaxoSmithKline group of companies
© 2013 GlaxoSmithKline group of
companies. All rights reserved

Marketing authorisation holder:
GlaxoSmithKline UK Limited
Stockley Park West
Uxbridge
Middlesex UB11 1BT

Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka 189
60-322 Poznań
Poland

Uncommon side effects
These may affect up to 1 in 100 men taking
Avodart:
• heart failure (heart becomes less efficient
at pumping blood around the body. You
may have symptoms such as shortness of
breath, extreme tiredness and swelling in
your ankles and legs).
• hair loss (usually from the body) or hair
growth

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BACK PAGE
Page 2 of 2
Poznan – Additional Artwork Information Panel
Leaflet / dimensions after folding

N/A

Foil / Laminates width

N/A

Label dimensions

N/A

Tube dimensions

N/A

Replacement No.:

115927

Point of sale code No.:

N/A

K

117803
GSK-POL-Poznan-PLPZN

148 x 345 mm

Carton dimensions

Avodart

United Kingdom-GBR

DRW_L_016_01_FD

3

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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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