AVODART 0.5MG CAPSULES

Active substance: DUTASTERIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AVODART® 0.5MG Soft Capsules /
DUTASTERIDE 0.5MG Soft Capsules
(dutasteride)
This product is available as either of the above names but
will be referred to as Avodart throughout this leaflet.
Please read this information leaflet carefully before you
start taking your 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:
1. What Avodart is and what it’s used for
2. Before you take Avodart
3. How to take Avodart
4. Possible side effects
5. How to store Avodart
6. Further information
1.

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).
2.

Before you take 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 can affect 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.
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)
 alpha-blockers (for enlarged prostate or high blood
pressure).
 your doctor if you are taking any of these medicines.
Tell
Your dose of Avodart may need to be reduced.
Food and drink with Avodart
Avodart can be taken with or without food.
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.

Do not take Avodart
 if you’re allergic (hypersensitive) to dutasteride, other 5alpha 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.

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.

This medicine is for men only. It must not be taken by women,
children or adolescents.

Avodart has been shown to reduce sperm count, semen volume
and sperm movement. Therefore male fertility may be reduced.

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.


Contact your doctor for advice if a pregnant woman has
come into contact with dutasteride.

3.

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.
 you have any further questions on the use of this product,
If
ask your doctor or pharmacist.

Further information

What Avodart contains
The active substance is dutasteride. Each soft 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 butylated hydroxytoluene
(E321).
The capsule shell contains gelatin, glycerol, titanium dioxide
(E171), yellow iron oxide (E172), triglycerides, lecithin and red
printing ink containing iron oxide (E172) as the colourant,
polyvinyl acetate phthalate, propylene glycol and polyethylene
glycol (macrogol).
What Avodart looks like and contents of the pack
Avodart 0.5mg Soft Capsules are oblong opaque, yellow soft
gelatin capsules printed ‘GX CE2’ on one side in red printing ink.
They are available in packs containing 30 capsules.
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka 189
60-322 Pozań
Poland.

Possible side effects

Like all medicines, Avodart can cause side effects, although
not everybody gets them.
Very rare 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:
 impotence (not able to achieve or maintain an erection)
 decreased sex drive (libido)
 difficulty with ejaculation
 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
 any of the side effects gets serious, or if you notice any
If
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Keep out of the sight and reach of children.
Don’t store Avodart above 30°C.

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.

6.

or
4.

5. How to store Avodart
Driving and using machines
Avodart is unlikely to affect your ability to drive or operate
machinery.

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.

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.

Catalent France Beinheim S.A.
74 Route Principale,
67930 Beinheim,
France.
or
Cardinal Health France 404.
74 Route Principale,
67930 Beinheim,
France.

POM

Product Licence holder: G Pharma Ltd, Salford M50 2PU.
PL No: 16369/1167

Avodart 0.5mg Soft Capsules
19th December 2012

‘Avodart’ is a registered trademark of the GlaxoSmithKline
Group of Companies.

PACKAGE LEAFLET: INFORMATION FOR THE USER
AVODART® 0.5MG Soft Capsules /
DUTASTERIDE 0.5MG Soft Capsules
(dutasteride)
This product is available as either of the above names but
will be referred to as Avodart throughout this leaflet.
Please read this information leaflet carefully before you
start taking your 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:
1. What Avodart is and what it’s used for
2. Before you take Avodart
3. How to take Avodart
4. Possible side effects
5. How to store Avodart
6. Further information
1.

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).
2.

Before you take 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 can affect 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.
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)
 alpha-blockers (for enlarged prostate or high blood
pressure).
 your doctor if you are taking any of these medicines.
Tell
Your dose of Avodart may need to be reduced.
Food and drink with Avodart
Avodart can be taken with or without food.
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.

Do not take Avodart
 if you’re allergic (hypersensitive) to dutasteride, other 5alpha 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.

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.

This medicine is for men only. It must not be taken by women,
children or adolescents.

Avodart has been shown to reduce sperm count, semen volume
and sperm movement. Therefore male fertility may be reduced.

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.


Contact your doctor for advice if a pregnant woman has
come into contact with dutasteride.

3.

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.
 you have any further questions on the use of this product,
If
ask your doctor or pharmacist.

Further information

What Avodart contains
The active substance is dutasteride. Each soft 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 butylated hydroxytoluene
(E321).
The capsule shell contains gelatin, glycerol, titanium dioxide
(E171), yellow iron oxide (E172), triglycerides, lecithin and red
printing ink containing iron oxide (E172) as the colourant,
polyvinyl acetate phthalate, propylene glycol and polyethylene
glycol (macrogol).
What Avodart looks like and contents of the pack
Avodart 0.5mg Soft Capsules are oblong opaque, yellow soft
gelatin capsules printed ‘GX CE2’ on one side in red printing ink.
They are available in packs containing 30 capsules.
Manufacturer:
GlaxoSmithKline Pharmaceuticals S.A.
Ul. Grunwaldzka 189
60-322 Pozań
Poland.

Possible side effects

Like all medicines, Avodart can cause side effects, although
not everybody gets them.
Very rare 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:
 impotence (not able to achieve or maintain an erection)
 decreased sex drive (libido)
 difficulty with ejaculation
 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
 any of the side effects gets serious, or if you notice any
If
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Keep out of the sight and reach of children.
Don’t store Avodart above 30°C.

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.

6.

or
4.

5. How to store Avodart
Driving and using machines
Avodart is unlikely to affect your ability to drive or operate
machinery.

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.

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.

Catalent France Beinheim S.A.
74 Route Principale,
67930 Beinheim,
France.
or
Cardinal Health France 404.
74 Route Principale,
67930 Beinheim,
France.

POM

Product Licence holder: G Pharma Ltd, Salford M50 2PU.
PL No: 16369/1167

Avodart 0.5mg Soft Capsules
19th December 2012

‘Avodart’ is a registered trademark of the GlaxoSmithKline
Group of Companies.

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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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