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AVODART 0.5 MG SOFT CAPSULES

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Package Leaflet: Information for the patient

Avodart

0.5 mg soft capsules
dutasteride
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.

What is in this leaflet:
1 What Avodart is and what it is used for
2 What you need to know before you take
Avodart
3 How to take Avodart
4 Possible side effects
5 How to store Avodart
6 Contents of the pack and other information

W
1  hat Avodart is and what it is
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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Do not take Avodart
• if you’re allergic to dutasteride, other
5-alpha reductase inhibitors, soya, peanut or
to any of the other ingredients of this
medicine (listed in section 6)
• if you have a severe liver disease.
➔ If you think any of these apply to you, don’t
take this medicine until you have checked
with your doctor.
This medicine is for men only. It must not be
taken by women, children or adolescents.

Warnings and Precautions

Talk to your doctor before taking 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.
• 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.

Other medicines and Avodart
Tell your doctor if you are taking, have recently
taken, or might take any other medicines.
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)

• 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.

Avodart with food and drink
Avodart can be taken with or without food.

Pregnancy, breast-feeding and fertility
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.

Driving and using machines
Avodart is unlikely to affect your ability to drive
or operate machinery.
Avodart contains lecithin from soya
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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2 What you need to know before you take Avodart

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3 How to take Avodart

4 Possible side effects

Always take Avodart exactly as your doctor
or pharmacist 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 recommended 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 more Avodart than you should
Contact your doctor or pharmacist for advice
if you take too many Avodart capsules.

If you forget to take Avodart
Do not take a double dose to make up for a
forgotten 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.

5 How to store Avodart

Like all medicines, this medicine 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.

Common side effects
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.

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.

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 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.

6 Contents of the pack and other information

Keep this medicine out of the sight and
reach of children.
Don’t store Avodart above 30°C.
Do not use this medicine 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.
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.

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.

Marketing Authorisation Holder:

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.
This leaflet was last revised in September
2014
Avodart is a registered trade mark of the
GSK group of companies
© 2014 GSK group of companies. All rights
reserved

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

120418

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GSK-POL-Poznan-PLPZN

United Kingdom-GBR

Avodart

N/A

DRW_L_016_01_FD

N/A

N/A

Poznan – Additional Artwork Information Panel
Leaflet / dimensions after folding
Carton dimensions

1

N/A

Replacement No.:
N/A

N/A

Tube dimensions

N/A

N/A

Label dimensions

1

N/A

Foil / Laminates width

K

148x345 mm

117803

Point of sale code No.:

N/A

8.0pt

8.5pt
8.0pt

85%
N

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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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