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DUTASTERIDE 0.5MG SOFT CAPSULES

Active substance(s): DUTASTERIDE / DUTASTERIDE / DUTASTERIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

Avodart® 0.5mg Soft Capsules /
Dutasteride 0.5mg Soft Capsules
(dutasteride)

Your medicine is available using the names Avodart 0.5mg
Soft Capsules / Dutasteride 0.5mg Soft Capsules, but will be
referred to as Avodart throughout the 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.
2.
3.
4.
5.
6.

What Avodart is and what it is used for
What you need to know before you take Avodart
How to take Avodart
Possible side effects
How to store Avodart
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).

Contact your doctor or pharmacist if you have any
questions about taking Avodart.

2. What you need to know before you take
Avodart



Do not take Avodart

Other medicines and 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
dutasteride and another medicine called an alphablocker, like tamsulosin experienced heart failure than
patients taking only dutasteride or only an alphablocker. 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 (prostatespecific 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.
Page 1 of 2

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 ketoconazole (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 recommended dose is one capsule (0.5mg) 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.

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.

Not known side effects

The frequency cannot be estimated from the available data:

depressed mood

pain and swelling in your testicles


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






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.

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.

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.



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store Avodart above 30°C. Store the capsules in
the original pack.
Do not 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 Avodart left after completing your
course of treatment, please return them to your
pharmacist who will get rid of them safely.
If your doctor decides to stop treatment, return any
leftover Avodart to the pharmacist. Only keep them if
your doctor tells you to.
If your Avodart appear discoloured, or show any other
sign of deterioration, please return to your pharmacist
who will advise you.
If you have any unwanted Avodart, 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.

6. Contents of the pack and other
information
What Avodart contains

Each capsule contains: 0.5mg dutasteride.
There are also some inactive ingredients in your medicine.
The solution inside the capsule shell contains mono and
diglycerides of caprylic/capric acid,
and butylhydroxytoluene (E321).
The capsule shell contains gelatin, glycerol,
titanium dioxide (E171), yellow iron oxide (E172),
medium chain triglycerides, lecithin (which may contain soya
oil) and may contain red printing ink containing red iron oxide
(E172) as the colourant, polyvinyl acetate phthalate,
propylene glycol and macrogol 400.

Page 2 of 2

What Avodart looks like and contents of the pack

Avodart are pale yellow, oblong soft gelatin capsules, printed
with GX CE2 in red or grey and are available in packs of 30
capsules.

Manufacturer

Manufactured by: CARDINAL HEALTH FRANCE 404,
74 Route Principale, 67 930 Beinheim, France.
Or
GlaxoSmithKline Pharmaceuticals S.A., Ul. Grunwaldzka 189,
60-322 Poznan, Poland.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall Industrial
Estate, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder:
BR Lewis Pharmaceuticals Ltd., Kirk Sandall Industrial Estate,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0176

POM

Other formats:

To listen to or request a copy of this leaflet in Braille, large
print or audio please call: 01302 365000
Please be ready to give the following information:
Product name:
Avodart 0.5mg Soft Capsules /
Dutasteride 0.5mg Soft Capsules
Reference number:
08929/0176
Leaflet revision and issue date (Ref): 15.07.16
Avodart® is a registered trademark of the GlaxoSmithKline
group of companies.

Expand Transcript

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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