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AVIDART 0.5MG SOFT CAPSULES

Active substance(s): DUTASTERIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AVIDART® 0.5MG SOFT CAPSULES
(dutasteride)



This product is available as the above name but will be
referred to as Avidart throughout this 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 Avidart is and what it is used for
2 What you need to know before you take Avidart
3 How to take Avidart
4 Possible side effects
5 How to store Avidart
6 Contents of the pack and other information
1.

What Avidart is and what it is used for

Avidart 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. Avidart 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.
Avidart 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 Avidart

Do not take Avidart
• 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.
Warnings and Precautions
Talk to your doctor before taking Avidart.
• 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 Avidart.
• Women, children and adolescents must not handle leaking
Avidart 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 Avidart. 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.
Avidart 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 Avidart. Men taking Avidart should have
their PSA tested regularly.
In a clinical study of men at increased risk of prostate cancer,
men taking Avidart had a serious form of prostate cancer
more often than men who did not take Avidart. The effect of
Avidart on this serious form of prostate cancer is not clear.
Avidart 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 Avidart.
Other medicines and Avidart
Tell your doctor if you are taking, have recently taken, or might
take any other medicines.
Some medicines can react with Avidart 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 Avidart may need to be reduced.
Avidart with food and drink
Avidart can be taken with or without food.

3.

How to take Avidart

Always take Avidart 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.

Use a condom during sexual intercourse. Dutasteride has
been found in the semen of men taking Avidart. If your partner is
or may be pregnant, you must avoid exposing her to
your semen. Avidart 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
Avidart is unlikely to affect your ability to drive or operate
machinery.
Avidart 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.

5. How to store Avidart
Keep out of the sight and reach of children.
Don’t store Avidart above 30°C.

Avidart is a long term treatment. Some men notice an early
improvement in their symptoms. However, others may need to
take Avidart for 6 months or more before it begins to have an
effect. Keep taking Avidart for as long as your doctor tells you.
If you take more Avidart than you should
Contact your doctor or pharmacist for advice if you take too
many Avidart capsules.
If you forget to take Avidart
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 Avidart without advice
Don’t stop taking Avidart 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 Avidart.

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.

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.

Don’t use Avidart 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 Avidart 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.
6.

Contents of the pack and other information

What Avidart contains
The active ingredient is: Dutasteride. Each soft capsule
contains 0.5mg of the active ingredient dutasteride.
The other ingredients are: Each capsule also includes mono and
diglycerides of caprylic/capric acid and butylated hydroxytoluene
(E321) in the solution inside the capsule shell. The capsule shell
contains gelatin, glycerol, titanium dioxide (E171), iron oxide
yellow (E172), medium chain triglycerides and lecithin.
What Avidart looks like and contents of the pack
Oblong opaque yellow, gelatin capsules marked with ’GX CE2’ in
grey and are available in packs of 30 capsules.
Manufacturer
GlaxoSmithKline Pharmaceuticals S.A. Ul. Grunwaldzka 189
60-322 Poznan, Poland.
Product Licence holder: G Pharma Ltd, Salford M50 2PU.
POM

PL No: 16369/0040
Common side effects
These may affect up to 1 in 10 men taking Avidart:
• not able to achieve or maintain an erection (impotence), this
may continue after you stop taking Avidart
• decreased sex drive (libido), this may continue after you stop
taking Avidart
• difficulty with ejaculation, this may continue after you stop
taking Avidart
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.
Uncommon side effects
These may affect up to 1 in 100 men taking Avidart:
• 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.

Avidart 0.5mg Soft Capsules

11/08/2015

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
AVIDART® 0.5MG SOFT CAPSULES
(dutasteride)



This product is available as the above name but will be
referred to as Avidart throughout this 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 Avidart is and what it is used for
2 What you need to know before you take Avidart
3 How to take Avidart
4 Possible side effects
5 How to store Avidart
6 Contents of the pack and other information
1.

What Avidart is and what it is used for

Avidart 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. Avidart 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.
Avidart 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 Avidart

Do not take Avidart
• 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.
Warnings and Precautions
Talk to your doctor before taking Avidart.
• 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 Avidart.
• Women, children and adolescents must not handle leaking
Avidart 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 Avidart. 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.
Avidart 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 Avidart. Men taking Avidart should have
their PSA tested regularly.
In a clinical study of men at increased risk of prostate cancer,
men taking Avidart had a serious form of prostate cancer
more often than men who did not take Avidart. The effect of
Avidart on this serious form of prostate cancer is not clear.
Avidart 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 Avidart.
Other medicines and Avidart
Tell your doctor if you are taking, have recently taken, or might
take any other medicines.
Some medicines can react with Avidart 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 Avidart may need to be reduced.
Avidart with food and drink
Avidart can be taken with or without food.

3.

How to take Avidart

Always take Avidart 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.

Use a condom during sexual intercourse. Dutasteride has
been found in the semen of men taking Avidart. If your partner is
or may be pregnant, you must avoid exposing her to
your semen. Avidart 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
Avidart is unlikely to affect your ability to drive or operate
machinery.
Avidart 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.

5. How to store Avidart
Keep out of the sight and reach of children.
Don’t store Avidart above 30°C.

Avidart is a long term treatment. Some men notice an early
improvement in their symptoms. However, others may need to
take Avidart for 6 months or more before it begins to have an
effect. Keep taking Avidart for as long as your doctor tells you.
If you take more Avidart than you should
Contact your doctor or pharmacist for advice if you take too
many Avidart capsules.
If you forget to take Avidart
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 Avidart without advice
Don’t stop taking Avidart 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 Avidart.

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.

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.

Don’t use Avidart 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 Avidart 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.
6.

Contents of the pack and other information

What Avidart contains
The active ingredient is: Dutasteride. Each soft capsule
contains 0.5mg of the active ingredient dutasteride.
The other ingredients are: Each capsule also includes mono and
diglycerides of caprylic/capric acid and butylated hydroxytoluene
(E321) in the solution inside the capsule shell. The capsule shell
contains gelatin, glycerol, titanium dioxide (E171), iron oxide
yellow (E172), medium chain triglycerides and lecithin.
What Avidart looks like and contents of the pack
Oblong opaque yellow, gelatin capsules marked with ’GX CE2’ in
grey and are available in packs of 30 capsules.
Manufacturer
GlaxoSmithKline Pharmaceuticals S.A. Ul. Grunwaldzka 189
60-322 Poznan, Poland.
Product Licence holder: G Pharma Ltd, Salford M50 2PU.
POM

PL No: 16369/0040
Common side effects
These may affect up to 1 in 10 men taking Avidart:
• not able to achieve or maintain an erection (impotence), this
may continue after you stop taking Avidart
• decreased sex drive (libido), this may continue after you stop
taking Avidart
• difficulty with ejaculation, this may continue after you stop
taking Avidart
• breast enlargement or tenderness (gynecomastia)
• dizziness when taken with tamsulosin.
Uncommon side effects
These may affect up to 1 in 100 men taking Avidart:
• 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.

Avidart 0.5mg Soft Capsules

11/08/2015

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

Expand view ⇕

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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