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DUTASTERIDE 0.5 MG SOFT CAPSULES

Active substance(s): DUTASTERIDE / DUTASTERIDE / DUTASTERIDE

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T06031

AVODART® 0.5 mg Soft capsules /
DUTASTERIDE 0.5 mg Soft capsules
(dutasteride)

Patient Information Leaflet
This product is available by either of the above
product names but will be referred to as Avodart
throughout the patient information leaflet.
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

1. What 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).

2. What you need to know before you take
Avodart
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.

3. How to take Avodart
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 recommanded 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.

BACK PAGE
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.

4. Possible side effects
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.

6. Contents of
information

the

pack

and

other

What Avodart contains
The active substance is dutasteride. Each soft
capsule contains 0.5 mg dutasteride.
There are some inactive ingredients in your
medicine.
Capsule contents:
• mono and diglycerides of caprylic/capric
acid and butylhydroxytoluene (E321).
The capsule shell contents:
• gelatin, glycerol, titanium dioxide (E171), iron
oxide yellow (E172), triglycerides (medium
chain) and lecithin (may contain soya oil).
What Avodart looks like and contents of the
pack
Avodart soft capsules are oblong, opaque,
yellow, soft gelatin capsules marked 'GX CE2'
in grey. They are available in packs of 30
capsules.
Manufacturer and Product Licence Holder
This
product
is
manufactured
by
GlaxoSmithKline Pharmaceuticals S.A., UI.
Grunwaldzka 189, 60-322 Poznan, Poland.
It is procured from within the EU by the Product
Licence Holder: Swinghope Ltd, Brandon
House, Marlowe Way, Croydon CR0 4XS and
repackaged by Interport Ltd, Brandon House,
Marlowe Way, Croydon CR0 4XS.
POM
PL No: 10380/1218
Leaflet revision date: 12/10/2015
Avodart® is registered trademark of
GlaxoSmithKline group of companies.

the

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
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.

5. How to store Avodart
• As with all medicines, it is important to keep
Avodart out of the sight and reach of children.
• Do not store Avodart above 30°C.
• Do not use Avodart after the expiry date
printed on the carton or the foil blister strip.
• If your capsules become discoloured or have
deteriorated, take them back to your
pharmacist.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

T06031

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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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